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The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.

• Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Patients who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

· Prior to receiving the device, it is recommended that an individual has experience with appropriately fitted air conduction or bone conduction hearing aids.

· Patients 12 years of age or older.

The Sentio system is an osseointegrating, transcutaneous active bone conduction hearing system that uses the body's natural ability to transfer sound through bone conduction, thus offering improvement of hearing for patients with conductive or mixed hearing loss whether unilaterally or bilaterally fitted, or for those with single sided deafness. A bone conduction system transmits sound directly to the cochlea independently of the function of the ear canal and middle ear.

The Sentio system primarily consists of a sound processor (Sentio 1 Mini) and an implant (Sentio Ti Implant). The two components are kept in relation to each other by means of a magnetic retention system. The sound is picked up by the microphones in the external sound processor, processed and transmitted by a transmission coil using a radio frequency (RF) link through the intact skin to an implant placed in the temporal and mastoid bone area. The receiver coil of the implant receives the signal that is converted into mechanical energy (vibrations) by the transducer. The vibrations are conveyed from the bottom of the transducer to the skull and thereafter by means of bone conduction to the cochlea. In the cochlea the vibrations are converted to signals that are transmitted to the brain through the auditory nerve.

The Sentio system is intended for improvement of hearing for patients with conductive or mixed hearing losses up to 45 dB BC. The implant has been tested and verified to allow for larger mixed hearing losses, up to an anticipated 65 dB BC.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

The document describes the Sentio Active Implantable Bone Conduction Hearing System, including the Sentio Ti Implant Kit, Sentio 1 Mini, and Genie Medical BAHS. The primary study referenced for demonstrating safety and performance is Study BC101.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds for performance that the device must meet in a comparative format. Instead, it discusses performance results in context of showing meaningful improvement and equivalence to predicate devices. However, we can infer performance targets based on the documented results and comparisons to normal hearing/speech levels.

Note: PPS = Per Protocol Set, FAS = Full Analysis Set. The document clarifies that a calibration error impacted some early subjects, leading to the use of both sets for analysis.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Study BC101): 51 adult patients (18 years or older) were included in the Full Analysis Set (FAS).
• Data Provenance (Study BC101):
  • Country of Origin: Multi-center study, including six clinics in three countries (specific countries are not named in the provided text).
  • Retrospective or Prospective: Prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Clinical studies of this nature typically involve audiologists and ENT surgeons who administer tests and evaluate outcomes, but no explicit details are provided regarding their role in establishing a "ground truth" independent of the device's own performance measurements. The "normal hearing threshold for pure tones (20 dB HL)" and "normal speech level (65 dB SPL)" serve as general external benchmarks.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For an audiology study focused on objective measurements (e.g., dB HL, speech recognition percentages) and patient-reported outcomes, a formal adjudication process akin to image interpretation may not be necessary in the same way. The results are primarily based on quantifiable audiometric tests and standardized questionnaires.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted in the traditional sense involving multiple human readers interpreting cases with and without AI assistance. This device is a hearing aid system, not an imaging AI diagnostic tool. The "assistance" it provides is direct auditory amplification and sound processing for the patient, not a clinical interpretation aid for a human expert.

The study does compare aided performance (with the device) against unaided performance (without the device), demonstrating the effectiveness directly. For example:

• "Speech recognition in quiet is significantly improved with the Sentio system compared to unaided for patients with conductive and mixed hearing losses as well as patients with single sided deafness."
• "The study concludes that the primary end-points (improved hearing and improved speech recognition on the implanted ear) were statistically significant in favor of the Sentio when compared to reference values."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

The device's core function is as a "standalone" system in its operation for the patient. While it requires clinical fitting and programming (Genie Medical BAHS software, performed by a Hearing Care professional), the performance metrics presented (e.g., aided thresholds, speech recognition, functional gain) are reflective of the device's performance as used by the patient, meaning the algorithm's output directly impacts the patient's hearing perception. There's no separate human-in-the-loop task where the algorithm assists a human to perform a diagnostic task; rather, the device is the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is established through a combination of:

• Objective Audiometric Measurements: This includes bone conduction thresholds, air conduction thresholds, pure tone average (PTA), functional gain, and speech intelligibility percentages. These are standard, quantifiable audiological assessments.
• Patient-Reported Outcomes (PROs): Standardized questionnaires, specifically the Glasgow Benefit Inventory (GBI), were used to assess health-related quality of life and patient satisfaction.
• Safety Data: Adverse event reporting and MRI experience questionnaires.
• Comparison to Reference Values: Performance is compared to established "normal" hearing thresholds (20 dB HL) and speech levels (65 dB SPL), and also to unaided listening conditions.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the Sentio system in the context of an AI/machine learning model. The device is a medical device (active implantable bone conduction hearing system) with specific mechanical and electrical properties, and its "programming" or "fitting" (e.g., using Genie Medical BAHS software) is based on established audiological science and algorithms, not typically on a large-scale, iterative machine learning training process with a distinct training dataset.

The clinical studies (O1, C58, BC114, BC101) described are clinical trials to evaluate the device's safety and performance in humans, not "training sets" for an AI algorithm in the conventional sense. Previous design iterations or prototypes might have undergone internal development and testing, but the text doesn't detail this as a formal "training set."

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the typical AI/ML sense for this device based on the provided text. The device's design, functionality, and fitting parameters are developed and refined through engineering principles, audiological research, and validation against clinical needs and outcomes (as demonstrated in the clinical studies listed).

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Ponto 5 SuperPower sound processors are intended for the following patients and indications:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 65 dB HL for use with the Ponto 5 SuperPower sound processor.

· Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.

Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. . single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/ abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling.

The sound processors are individually adjusted to the patient audiogram and needs via the Genie Medical BAHS fitting software by the Hearing Care Professional (HCP). The HCP connects the sound processors to the computer running the Genie Medical BAHS fitting software through either a wireless connection or a cable.

Ponto 5 SuperPower sound processor is a further development of and substantially equivalent to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

As for both predicates, the Ponto 5 SuperPower sound processor is intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single-sided deafness.

Ponto 5 SuperPower sound processor is indicated for hearing losses up to and including 65 dB HL (BC), same as the primary predicate Ponto 3 SuperPower sound processor.

Ponto 5 SuperPower sound processor includes the same sound processing platform and wireless technology as the predicate Ponto 5 Mini sound processor, enabling the same sound processing features and compatibility options as Ponto 5 Mini.

A minor updated hardware design (electronic and mechanic) is implemented in Ponto 5 SuperPower sound processor as compared to Ponto 3 SuperPower (K161671), to allow for a side neutral design that carries the same design and look as Ponto 5 Mini (K211640).

The functionality and features of the firmware in Ponto 5 SuperPower are the same as for predicate device Ponto 5 Mini, however updated in a new revision. No functionality or features of the firmware are changed, added or removed by this update.

Other than the minor updates in hardware design and the very minor change to the firmware, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (as latest cleared in K161671 for Ponto 3 SuperPower and K211640 for Ponto 5 Mini).

Additional purposes of this 510(k) notice is to include a minor modification to the accessory Genie Medical BAHS fitting software and to include the addition of Softband 5 to the Ponto Bone Anchored Hearing System:

• The fitting software is, as part of this 510(k), updated to include compatibility with Ponto 5 SuperPower in addition to Ponto 5 Mini and Ponto 4. No feature or functionality is changed, added or deleted in Genie Medical BAHS 2022.1, when compared to the current version Genie Medical BAHS 2021.2 (cleared together with Ponto 5 Mini in K211640).
• -The Softband, previously cleared through K082108 and latest in K161671. consists of a band placed around the wearers head with a connector plate to which the sound processor is attached. The Softband can be used by patients in the pre-operative evaluation phase or as a long-term solution to benefit from the sound processor without having an implant (primarily children). The Softband can be used also bilaterally. The band and the connector plate have been modified for optimal comfort and use.

The provided text describes the regulatory clearance for the Ponto 5 SuperPower sound processor. It clarifies that this device is a modification of previously cleared sound processors, the Ponto 3 SuperPower (K161671) and Ponto 5 Mini (K211640), and asserts substantial equivalence to these predicates. The document focuses on demonstrating that the new device does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the primary "acceptance criterion" is proving substantial equivalence to predicate devices, particularly in terms of performance characteristics relevant to hearing aids. The key performance aspect explicitly mentioned and compared is "Maximum Force Output."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of human subjects or a defined dataset with a particular sample size for performance evaluation. Instead, it refers to "performance data" derived from standard engineering and regulatory tests. The provenance of this data (country of origin, retrospective/prospective) is not explicitly stated, but it is implied to be internal testing conducted by the manufacturer for regulatory compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable in the context of this document. The device is a medical device (hearing aid), not an AI/ML algorithm that requires expert consensus for ground truth on a test set. The performance evaluation relies on established engineering standards and comparative analysis with predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a hearing aid, not an AI diagnostic tool that assists human readers in interpreting medical images or data.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. The Ponto 5 SuperPower is a physical hearing aid device with embedded software and hardware for sound processing. Its performance is evaluated as a complete system, not as a standalone algorithm without human interaction.

7. Type of Ground Truth Used:

The "ground truth" here is based on established engineering standards and measurements for hearing aid performance (e.g., IEC 60118-9:2019 for Maximum Force Output) and the performance characteristics of the legally marketed predicate devices. The comparison relies on demonstrating that the new device meets or is comparable to these established standards and predicate performances.

8. Sample Size for the Training Set:

This information is not applicable. The Ponto 5 SuperPower is not an AI/ML device that requires a "training set" in the conventional sense for machine learning model development. Its development and verification involve engineering design, testing, and comparison to existing products and standards.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. See point 8.

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Ponto 5 Mini sound processors are intended for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 5 Mini sound processor.
• Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.
• Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
• Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
  The placement of a bone anchored implant is contraindicated for patient below the age of 5.
  The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the snap coupling.
Ponto 5 Mini is a further development of the Ponto 4, cleared in K190540.The main difference between Ponto 5 Mini and Ponto 4 is a modification to the firmware in the Ponto 5 sound processors to additionally include the sound processing feature OpenSound™ Optimizer and an added compatibility with Oticon RemoteCare App from SBO Hearing A/S. Other than the minor changes to the firmware and compatibility, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (most recently cleared in K190540).
Additionally, minor modifications to the accessory Genie Medical BAHS fitting software are made (e.g., added compatibility with Oticon RemoteCare App, addition of special purpose programs, and inclusion of DSL BC).

The provided text does NOT describe an AI/ML powered medical device, an acceptance criteria table, a study proving the device meets the acceptance criteria (except for performance data of an existing device), sample sizes for test/training sets, or details about establishing ground truth by experts. The document is an FDA 510(k) clearance letter for a hearing aid and focuses on substantial equivalence to a predicate device.

Therefore, I cannot answer the request with the information provided. The document outlines:

• Trade/Device Name: Ponto 5 Mini (a hearing aid)
• Predicate Device: Ponto 4
• Key Differences: Modification to firmware to include OpenSound™ Optimizer and compatibility with Oticon RemoteCare App.
• Performance Data: States "Electroacoustic verification includes Maximum output responses, Output for full-on gain at 50 dB SPL and 60 dB SPL, Equivalent input noise level, Total harmonic distortion, Frequency range, Battery voltage, Current Consumption, Battery lifetime, IRIL (input related interference level) and Processing delay. The results were according to requirements and equivalent to the performance of the predicate device, Ponto 4." It also mentions "same electrical and mechanical safety, electromagnetic compatibility (EMC), and radio properties and performance, that was established for the predicate, Ponto 4."

Since the request is about an AI/ML powered device and its validation study, this document does not contain the necessary information.

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The Ponto Bone Anchored Hearing System (Ponto sound processors and implant system) is intended for the following patients and indications:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 4 sound processors, 55 dB HL for use with the Ponto 3 Power sound processors and 65 dB HL for use with the Ponto 3 SuperPower sound processor.

· Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.

· Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/ abutment system (refer to the Ponto labeling for compatible BAHA sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling. The technological characteristics of the Ponto Bone Anchored Hearing System, Ponto Implant System, remain unchanged from the original design (most recently cleared in K152067).

The Ponto Bone Anchored Hearing System also include accessories and instruments for installation of the implantable components, and the Ponto Surgical Manual and Surgical Manual Addenda include step by step instructions for a number of safe alternative surgical approaches for implant installation.

The main purpose of this 510(k) notification is a modification to the drilling to prepare the osteotomy for installation of a Ponto bone anchored implant, from two-step drilling (MIPS previously cleared in K152067) to a single drill step (MONO). The MONO Surgery Kit is a further development of the MIPS Surgery Kit previously cleared in K152067.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Oticon Medical AB's Ponto Bone Anchored Hearing System, specifically the MONO Surgery Kit. This document focuses on demonstrating substantial equivalence to a predicate device (K152067), rather than providing detailed acceptance criteria and the comprehensive study results typical of a novel device or a device making significant new claims.

Therefore, many of the requested details about acceptance criteria, test set sizes, expert involvement, and ground truth establishment are not explicitly stated in this type of regulatory submission, as the primary goal is to show that the modified device (MONO Surgery Kit) is as safe and effective as the previously cleared predicate. The "study" here is a set of pre-clinical bench tests demonstrating equivalence rather than a clinical trial validating performance against specific acceptance criteria for diagnostic accuracy.

However, I can extract information related to the device modifications, the comparative testing performed, and the conclusions drawn for substantial equivalence.

Here's a breakdown of the available information:

Key Takeaway: This 510(k) submission is for a modification to an existing device (a new surgical drilling technique and associated kit - MONO Surgery Kit) and aims to prove substantial equivalence to a predicate device (K152067). It is not a submission for a novel device requiring extensive clinical validation against specific performance metrics for diagnostic accuracy. Therefore, information typically found in such studies (like MRMC, detailed ground truth establishment, or large-scale clinical trials) is largely absent or not relevant in this context.

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic AI device. Instead, it describes comparative bench testing against a predicate device to demonstrate equivalence.

The implicit acceptance criteria are that the new "MONO" drill performs comparably to the "MIPS" predicate drill across key metrics, confirming "equivalence" in safety and efficiency.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "Comparative testing to install 4 mm Ponto implant (Ø4.5 mm) in artificial bone." It does not specify the number of tests or samples conducted.
• Data Provenance: The tests were "Pre-clinical bench tests." The location of these tests or the origin of the "artificial bone" is not specified. It is a laboratory, not a clinical, test.
• Retrospective or Prospective: Not applicable as these are bench tests, not patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided in the document. The "ground truth" for these bench tests would be directly measured physical properties (heat, torque, etc.) in artificial bone, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable as the study involved bench testing of a physical device/technique, not human interpretation or adjudication of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is typically performed for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The device subject to this 510(k) is a surgical kit for a hearing system, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable to this device. The device is a surgical kit, not an algorithm. The "performance" evaluated was the physical interaction and outcomes of the drill in artificial bone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the pre-clinical bench tests was based on direct measurements of physical properties (heat generation, insertion torque, installation turns, seating, ISQ-value) in artificial bone. The performance was then compared against the established performance of the predicate device.

8. The sample size for the training set

• This document describes a 510(k) for a medical device (surgical kit), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• As there is no AI/Machine Learning algorithm or training set involved, this question is not applicable.

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Ponto 4 sound processors are intended for the following patients and indications:

· Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 4 sound processor.

· Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.

· Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto 4 sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto 4 labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements. The Ponto family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS).

Here's a breakdown of the acceptance criteria and study information for the Ponto 4 sound processor, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the Ponto 4 as a modification of a previously cleared device (Ponto 3) and relies on demonstrating similar safety and effectiveness. Therefore, the "acceptance criteria" presented are implicitly aligned with the performance and safety characteristics of the predicate device. The Ponto 4's reported performance is stated to be "as expected" and "as safe and effective" as the Ponto 3.

Table 1: Acceptance Criteria and Reported Device Performance

Study Information

The document describes the testing performed to demonstrate substantial equivalence, rather than a standalone clinical study to establish new performance metrics.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a "test set" in terms of patient data.
   • The testing described is primarily for device-centric performance verification (electroacoustic and EMC), not clinical data from patients.
   • Data provenance: Not applicable in the context of patient data for a test set, as the testing focuses on the device itself. The studies are described as internal verification tests by the manufacturer, Oticon Medical AB (Sweden).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as the testing is device-centric, not based on expert-adjudicated clinical data to establish a ground truth for a diagnostic or screening algorithm. The "truth" for electroacoustic measurements comes from established physical principles and measurement standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for the type of device-centric testing described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a hearing aid, not an AI-powered diagnostic or screening tool that would involve human "readers" or AI assistance in interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not an AI algorithm in the context of medical image analysis or diagnosis. The "standalone" performance refers to the device's inherent electroacoustic, EMC, and functional capabilities, which were indeed tested as described. The performance is assessed based on the device's output and specifications, without continuous human intervention during its operation.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the device's performance testing (electroacoustic, EMC), the "ground truth" is based on engineering specifications, physical laws, and established measurement standards. For example, a nominal frequency response or maximum output level would be the "ground truth" against which the device's measured performance is compared.
   • For biocompatibility, the ground truth refers to established standards for medical-grade materials and their safety.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm in the sense of requiring a training set from clinical data. The "training" for such devices involves product development, engineering design, and iterative testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set in the context of machine learning. The design and performance targets for the device are established through engineering design principles, previous device generations (Ponto 3), and relevant industry standards for hearing aids.

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Intended use:

The Ponto 3 sound processors are intended for improvements with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness.

Indications for use:

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower are intended for the following patients and indications:

· Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 3 sound processor, 55 dB HL for use with the Ponto 3 Power sound processor and 65 dB HL for use with the Ponto 3 SuperPower sound processor.

· Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.

· Indicated for patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto 3, Ponto 3 Power and Ponto 3 SuperPower sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto 3 labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto 3, Ponto 3 Power and Ponto 3 SuperPower are modifications of the previously cleared Ponto Plus and Ponto Plus Power (K132775) and represent three latest sound processor models in the Ponto bone anchored hearing system. (Hereinafter referred to as the Ponto 3 sound processors or as the Ponto 3 family when referring to all three models and Ponto 3, Ponto 3 Power and Ponto 3 SuperPower when referring to the 3 different models.) A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound. The sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements. The Ponto 3 family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS).

The Ponto 3 family incorporates Inium Sense platform that is also used in the predicate Oticon A/S air conduction hearing aids legally marketed as class II. 510(k)-exempt devices. With the Injum Sense platform the microphone directionality system is updated. Furthermore, for Ponto 3 wireless transmission is enabled allowing for binaural signal processing.

In addition to the regular and power version sound processors, the Ponto 3 family introduces a SuperPower version with UltraDrive, consisting of a redesigned amplifier and optimized transducer. Ponto 3 SuperPower provides equivalent maximum force output (MFO) as the Baha Cordelle II, previously cleared through K080363, and thus expanded indication up to and including 65 dB HL is proposed.

This submission also includes minor modifications to the previously cleared accessories Genie Medical fitting software, Soft band and Streamer.

This document is a 510(k) premarket notification for the Ponto 3, Ponto 3 Power, and Ponto 3 SuperPower hearing aid devices. It aims to demonstrate substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here relate to demonstrating substantial equivalence with predicate devices, rather than specific performance metrics against a fixed standard. The "acceptance criteria" are implied by the comparisons made to predicate devices and the absence of new safety/efficacy concerns.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes functional testing and firmware validation for the Ponto 3 sound processors.

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical trials. The testing seems to be primarily bench testing on the devices themselves.
• Data Provenance: Not applicable as it primarily describes bench testing, not patient data from a specific country or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this submission is based on engineering specifications and performance measurements against established standards for hearing aids and comparison to predicate devices, rather than expert interpretation of a clinical dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a human adjudication method, as the testing described is technical/bench-based.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a hearing aid, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself (hearing aid) without a human "in-the-loop" as a diagnostic interpreter. The "Performance data" section (Section 5) describes standalone performance testing:

• Ponto 3 SuperPower underwent EMC emissions, immunity, and ESD tests.
• Electroacoustical verification was conducted for Ponto 3 SuperPower (battery voltage, current consumption, frequency range, Peak OFLs, THD, EIN).
• Current consumption and battery voltage were verified for Ponto 3 and Ponto 3 Power.
• Bench tests were conducted to verify binaural coordination and updated microphone directionality system.
• Maximum output force measurements were done for Ponto 3 SuperPower.

These indicate standalone testing of the device's technical specifications and performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for demonstrating substantial equivalence is based on:

• Engineering Specifications and Performance Standards: The device's technical performance (e.g., EMC, electroacoustical output, MFO) against established industry standards for hearing aids.
• Predicate Device Performance: Comparison to the known and cleared performance characteristics of the Ponto Plus sound processors, Ponto Plus Power, Baha Cordelle II, and existing Class II 510(k)-exempt Oticon A/S air conduction hearing aids.
• Functional Equivalence: Demonstrating that new features (binaural signal processing, updated microphone directionality) are functionally equivalent to those in legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is a medical device (hearing aid), not an AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable, as no training set is used for this type of device.

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The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications:

• . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors.
• . Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 db on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 db at individual frequencies.
• Patients who have a profound sensorineural hearing loss in one ear and normal hearing . in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
• o Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patients below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user.

The technological characteristics of the Ponto bone anchored hearing system remain unchanged. The Abutment extension accessory added to the Ponto bone anchored hearing system is a noninvasive component to be mounted on the abutment as point of attachment for the Ponto sound processor. The Abutment extension can be used with Ponto abutments and selected abutments from Cochlear BAS. When attached to the abutment it allows for connection of Ponto sound processors.

The provided text describes a 510(k) premarket notification for the Oticon Medical AB's Ponto bone anchored hearing system, specifically for the addition of an abutment extension accessory. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML device's performance against specific acceptance criteria.

Therefore, many of the requested elements for an AI/ML device study are not directly applicable or available in this document.

However, I can extract the relevant information regarding performance testing that was conducted to support the substantial equivalence claim for the abutment extension.

Here's a breakdown of the available information structured to answer your request as closely as possible, with explicit notes about what is not applicable (N/A) or not provided in the document for an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format. Instead, it describes performance testing conducted to show the modified device is "as safe and effective as the previously cleared device." The performance data is summarized qualitatively.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the context of an AI/ML device. The performance data mentioned refers to engineering and functional testing of the device and its accessory.

• Sample Size: Not specified for any of the performance tests (coupling force, sound transmission, lever effect, MRI testing).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This would typically be laboratory or simulated testing rather than patient data.

3. Number of Experts and Qualifications for Ground Truth

• N/A: Ground truth based on human expert consensus is not applicable as this is not an AI/ML device for interpretation. The performance data is based on physical device measurements and engineering principles.

4. Adjudication Method for the Test Set

• N/A: Not applicable for device performance testing of this nature. Adjudication methods are typically relevant for human interpretation tasks or complex clinical endpoints.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This is not an AI/ML device, and no MRMC study is mentioned.

6. Standalone Performance Study

• Yes, in spirit (for device engineering): The performance data is for the "algorithm only" in the sense that it's for the device's physical performance, independent of human interaction for interpretation. The tests (coupling, sound transmission, lever effect, MRI) evaluate the physical characteristics of the device itself.
• The document states: "Performance data demonstrate that the modified device is as safe and effective as the previously cleared Ponto bone anchored hearing system and that the system will perform as intended during use." This implies standalone testing of the device's physical functions.

7. Type of Ground Truth Used

• Engineering/Physics-based Measurement: The "ground truth" for the performance data (coupling force, sound transmission, lever effect, MRI compatibility) would be established by established engineering standards, physical measurements, and comparison to the known performance of the predicate device. It's not clinical "ground truth" from pathology or outcomes data in the traditional sense for an AI/ML model.

8. Sample Size for the Training Set

• N/A: There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• N/A: Not applicable as there is no training set mentioned for an AI/ML algorithm.

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The Ponto bone anchored hearing system intended use is for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single-sided deafness.

The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications:

• . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors.
• . Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 db on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 db at individual frequencies.
• . Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
• . Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implant from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user.

The technological characteristics of the Ponto bone anchored hearing system remain substantially unchanged from the original design. A modification has been made to the 4.5 mm diameter implant, introducing Ponto BHX implants with a rougher surface topography on parts of the implant. The purpose of the modification is to enhance osseointegration properties of the implant.

In addition, minor modifications have been made to surgical instruments for a less invasive surgical approach, Minimally Invasive Ponto Surgery (MIPS), for installation of Ponto implants. Instead of a linear incision, a single circular incision is created by means of a biopsy punch equivalent in size to the implant/abutment, enabling access for placement of the implant in the bone.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Ponto Bone Anchored Hearing System (K152067).

Acceptance Criteria and Study Analysis for Ponto Bone Anchored Hearing System (K152067)

This document describes a 510(k) submission for a modification to an existing device, the Ponto Bone Anchored Hearing System. The modification involves a change in the implant's surface topography to enhance osseointegration and minor modifications to surgical instruments for a less invasive surgical approach. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Key takeaway for this section: The document does not provide specific quantitative acceptance criteria or numerical performance data. Instead, it relies on a qualitative statement of verification and enhancement for the modified components and an overall claim of substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any of the tests conducted (e.g., surface characterization, drill performance, cutting ability, bone anchorage). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). The Performance Data section only states that the modified device has been "tested in comparison to the previously cleared device."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the involvement of experts to establish a ground truth for any test set. The performance data appears to be derived from engineering and physical tests rather than clinical evaluation with human interpretation.

4. Adjudication Method for the Test Set

Since no human experts are mentioned in establishing ground truth for a test set, there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this document. The device is a hearing system, and the changes described are physical modifications (implant surface, surgical instruments) aimed at improving osseointegration and surgical technique, not at altering diagnostic accuracy requiring human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a medical implant and associated surgical tools, not an algorithm or AI system. The "performance data" refers to the physical and biological performance of the implant and instruments, which are inherently "standalone" in the sense of not involving a human-in-the-loop for their direct function (though a human surgeon installs them and a human user benefits from them).

7. Type of Ground Truth Used

The ground truth for the performance data appears to be based on:

• Engineering measurements and material science properties for surface characterization.
• Mechanical and operational testing for drill performance, cutting ability, and bone anchorage.
  The document implies that these tests are compared against established benchmarks or the performance of the predicate device, which serves as a de facto "ground truth" for substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is a physical device modification, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

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The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications:

• . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors.
• Bilateral fitting is applicable for most patients having a symmetrically conductive or ● mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 db on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 db at individual frequencies.
• Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
• Also indicated for any patient who is indicated for an air-conduction contralateral ● routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant is placed in or around the mastoid region of the skull on either one or both sides. The implant is then used as anchorage for the skin penetrating abutment that connects to the external sound processor. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor has a coupling so that it can easily be connected to and disconnected from the abutment by the user. This submission concerns the abutment component.

The provided text is a 510(k) summary for the Oticon Medical AB's Ponto Bone Anchored Hearing System. It describes a modification to an existing device rather than a new AI-powered device. Therefore, it does not contain the specific information requested about acceptance criteria, device performance, and study details typically associated with AI/ML medical devices.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through engineering and bench testing rather than clinical performance studies with human subjects that measure metrics like sensitivity, specificity, or reader improvement.

Here's why the requested information cannot be extracted from the document:

• AI/ML Device: The Ponto Bone Anchored Hearing System is a physical medical device (hearing aid/implant system), not an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" and "device performance" in your prompt (e.g., sensitivity, specificity, F1 score) do not apply in the same way.
• Study Type: The document states, "Performance data, including bench testing of mechanical forces, show that the modified device is as safe and effective as the previously cleared device." This refers to non-clinical (bench) testing, not clinical studies with human readers, ground truth establishment, or multi-reader multi-case studies.
• Ground Truth/Experts: Since it's a physical device and the "performance data" is bench testing, there's no mention of experts establishing ground truth for a test set, adjudication methods, or training sets as these are concepts relevant to diagnostic AI algorithms.

Based on the provided document, I can extract the following relevant information regarding the device and its testing:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:

• Sample size: Not specified. The performance data refers to "bench testing of mechanical forces," which typically involves testing a sample lot of manufactured devices rather than a patient test set.
• Data Provenance: Bench testing, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and qualifications:

• Not applicable/Not mentioned. Ground truth in the context of AI/ML diagnostic devices and expert review is not relevant for this physical device's bench testing.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Adjudication is relevant for expert review of clinical cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size:

• No, an MRMC comparative effectiveness study was not done, as this is a physical device regulatory submission, not an AI/ML diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable, as this is a physical device, not an algorithm.

7. The type of ground truth used:

• Not applicable/Not mentioned in the context of clinical ground truth. For bench testing, "ground truth" would be established engineering specifications and measurement standards.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (a new abutment size for a bone-anchored hearing system) and focuses on demonstrating substantial equivalence through bench testing. It does not provide the kind of information requested for AI/ML diagnostic devices, such as clinical performance metrics, expert review details, or training/test set characteristics.

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The Oticon Medical Sterilization Cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. It is intended to be sterilized and stored with non-disposable medical device instrumentation. The Sterilization Cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use.

The sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles:

The Oticon Medical Sterilization Cassette is a stainless steel cassette consisting of a base tray, a lid and an insert with instrument holders made of silicone. The lid is locked to the base tray by a locking tab. Once the lid is closed and locked, enclosed instruments are kept in place by the holders and a silicone rail in the lid.

The Sterilization Cassette is designed using materials that can be reused with steam sterilization methods. The base tray, lid and insert have evenly distributed perforations to allow for penetration of sterilant during steam sterilization. For the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap.

This document is a 510(k) summary for the Oticon Medical Sterilization Cassette, demonstrating its substantial equivalence to predicate devices. It focuses on the device's intended use and performance in cleaning and sterilization.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

• 132°C (270°F) for 4 minutes exposure, 20 minutes drying
• 134°C (273°F) for 3 minutes exposure, 16 minutes drying
• 135°C (275°F) for 3 minutes exposure, 16 minutes drying. | Showed that under the selected processing parameters, excellent steam penetration was achieved within the wrapped cassettes. Sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶ of the cassette and its contents when handled according to the recommended instructions. |
  | Wear Following Re-use and Processing | Testing for wear following re-use and repeated processing (no specific quantitative criteria mentioned, but implied satisfactory performance). | The Sterilization Cassette functioned as intended, and the performance observed was as expected. The document concludes that "further testing will not raise new issues of safety or efficacy," implying acceptable wear characteristics over repeated use. |
  | Material Compatibility | Material compatibility with sterilization process (based on comparison table). | "Yes" (stated in the comparison table, indicating compatibility). |
  | Microbial Barrier Properties | To be used in conjunction with a legally marketed sterilization wrap to maintain sterility (based on comparison table). | Confirmed that for the sterilization process, the cassette is to be used in conjunction with a legally marketed sterilization wrap. |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (e.g., number of cassettes, number of cleaning cycles, number of sterilization cycles) used for the performance testing. It generally refers to "Testing... includes" and "The testing demonstrated."

The data provenance is from Oticon Medical AB, Sweden, as indicated by the submitter's address and manufacturer information. The testing is prospective, conducted specifically for the purpose of demonstrating the device's performance for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The performance data section describes the outcomes of the tests (efficiency, steam penetration, SAL of 10⁻⁶), but does not detail the methodology for establishing ground truth or the involvement of experts in that process. For a sterilization cassette, the "ground truth" would typically be established by validated test methods (e.g., biological indicators for sterility assurance) rather than expert consensus on subjective observations.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or subjective assessments by multiple readers. For performance testing of a sterilization cassette, the results are derived from objective physical and microbiological measurements/assays, not from human interpretation that requires adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for a sterilization cassette. The document does not describe any AI component in this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently tied to its physical design and the validated processes it enables.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests would be based on objective scientific measurements and validated industry standards. For example:

• Cleaning and Disinfection: Ground truth would be the reduction of specific microbial loads or removal of simulated soil to predefined levels, typically measured quantitatively in a lab setting according to standards (e.g., ASTM, ISO).
• Sterilization Validation: Ground truth is achieved when test results (e.g., from biological indicators or physical monitoring) demonstrate a sterility assurance level (SAL) of 10⁻⁶, meaning a one-in-a-million chance of a non-sterile unit, as per relevant sterilization standards (e.g., ANSI/AAMI ST79).
• Wear Testing: Ground truth would be the maintenance of physical integrity and functionality after a specified number of reprocessing cycles, conforming to design specifications or acceptable wear limits.

The document states "sterilization testing further demonstrated a sterility assurance level (SAL) of 10⁻⁶," which is a key ground truth metric for sterilization.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As mentioned above, there is no AI/ML algorithm or training set for this device.

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