Search Results

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.

Ask a specific question about this device

The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) is intended for the following patients and indications for use:

• Patients aged 5 and older
• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the Baha 4 and Baha 5 sound processors, 55 db HL for use with the Baha 5 Power sound processors, and 65 db HL for use with the Baha 5 SuperPower Sound Processors.
• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is 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.

Specific models of the Cochlear Baha abutments can be used with either the Cochlear Baha Connect System or compatible sound processors from Oticon Medical AB. Refer to the Cochlear Baha abutment labeling for a list of compatible Oticon Medical sound processors.

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 BA310 abutments are modifications of the previously cleared BA300 abutments and provide additional sound processor compatibility than the previously cleared abutments. Compared to the currently cleared BA300 and BA400 Abutments, a small "flange" has been added to the upper part of the BA310 Abutment and the core diameter of the abutment has been reduced by 0.7mm. This design allows sound processors from Oticon Medical to snap on the outside of the abutment while maintaining the same snap in coupling design for connection to Baha sound processors.

This document describes the premarket notification for the Cochlear BA310 Abutment and BIA310 Implant/Abutment, a bone-conduction hearing implant system. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a design modification to the abutment.

Here's an analysis based on your request, highlighting what information is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance

Gaps in information: The document states that performance data "verifies the compatibility" and that "All design requirements were met," but it does not provide specific numerical acceptance criteria (e.g., a minimum rotation torque value) or the quantitative results from the tests. It broadly indicates that the relevant parameters were "tested and verified."

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

Sample Size for the test set: Not specified. The document mentions "non-clinical testing and analysis" but does not detail the number of units or conditions tested.
Data Provenance: Not specified. Given it's a non-clinical/bench testing study for a medical device modification, the data would typically originate from a laboratory setting. It is not a clinical study involving human patients.

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

This information is not applicable and not provided. The "ground truth" concept, in this context, would typically refer to clinical diagnosis or outcome verification against which an AI algorithm's performance is measured. This document describes bench testing of a physical device modification, not an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review processes, typically for establishing ground truth for diagnostic accuracy, which is not what this submission is about.

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

This information is not applicable and not provided. This submission concerns a physical medical device (a hearing implant abutment) and its bench testing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. This document does not describe an algorithm or AI device; it describes a mechanical component of a hearing aid system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable and not explicitly defined in the context of "ground truth" as typically used for AI/diagnostic studies. For this device modification, the "ground truth" would be the engineering specifications and functional requirements for the abutment's mechanical performance and compatibility. The document states that "All design requirements were met," implying these engineering specifications served as the "ground truth" for the non-clinical tests.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is not an AI/machine learning study, so there is no concept of a "training set."

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

This information is not applicable and not provided. As there is no training set, the establishment of its ground truth is irrelevant.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device

The Cochlear Baha® auditory osseointegrated implant system using model BA400 abutment is intended for the following patients and indications for use:

• Patients aged 5 and older
• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, 55 db HL for use with the BP110 Power sound processor, and 65 db HL for use with the Cordelle II Sound Processor.
• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 ав нг
• Baha for SSD is 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 Baha implant system functions by combining 3 parts: a titanium implant, a percutaneous abutment, and a sound processor. The system works by utilizing natural bone transmission as a pathway for sound to travel to the inner ear, bypassing the external auditory canal and middle ear. After surgical placement, the titanium implant naturally integrates with the skull bone over time through a process known as osseointegration. The external sound processor transmits sound vibrations through the percutaneous abutment to the titanium implant. The vibrating implant creates vibrations within the skull that stimulate the nerve fibers of the inner ear, allowing hearing. The minor changes to this device are only to the abutment, the piece that serves as the connection between the osseointegrated implant and the external sound processor. The changes include a modified design and the addition of a hydroxyapatite coating, neither of which modify the intended functionality or fundamental operating principles of the implant/abutment system.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for Cochlear™ Baha® Implant System (BA400 Abutment)

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing was conducted based on a comparison between proposed and predicate implant/abutment systems. The results were equal or better than established acceptance criteria, where predicate testing was used as a baseline."

However, the specific quantitative acceptance criteria (e.g., minimum tensile strength, corrosion resistance thresholds) and the exact reported performance values are not explicitly detailed in the provided text. The summary implies a successful comparison against the predicate device (Cochlear™ Baha® Implant System, K100360) for safety and effectiveness.

Based on the provided text, a detailed table with specific numerical acceptance criteria and reported device performance cannot be generated. The general statement is provided:

(Note: The actual numerical values for "Other Performance Tests" are not present in the provided document.)

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

The document states that "Performance testing was conducted based on a comparison between proposed and predicate implant/abutment systems." It does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in detailed study reports, which are not included in this 510(k) summary.

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

The document does not mention the use of experts to establish ground truth for any test set or their qualifications. The testing appears to be centered on direct performance comparison of the modified device against its predicate, rather than human interpretation tasks requiring expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method as typically used for human-reviewed test sets (e.g., 2+1, 3+1, none). This information is not relevant given the nature of the performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an implanted medical device (abutment for a hearing system), not a diagnostic imaging or interpretive aid that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physical component of a hearing system. Therefore, the concept of "standalone algorithm only" performance does not apply in this context. The performance testing would be mechanical, material, and potentially biocompatibility-related.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing appears to be the established performance characteristics and safety profile of the predicate device. The modified device (BA400 abutment) was shown to have "equal or better" performance compared to this baseline. This isn't "expert consensus" or "pathology" in the typical sense, but rather a direct comparison to an already-cleared, safe, and effective device.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is because the device is a hardware component; it doesn't involve machine learning or AI algorithms that would require a training set.

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

As there is no training set for this device, the question of how its ground truth was established is not applicable.

Ask a specific question about this device

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

The Ponto bone anchored hearing system (sound processors Ponto, Ponto Pro and Ponto Pro Power 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 and Ponto Pro sound processors, 55 dB HL for use with the Ponto Pro Power 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 the Ponto implant system (all models) or the Baha abutment snap coupling from Cochlear Bone Anchored Solutions (BAS) according to the below;

The Ponto implant system can be used for connection of the Ponto sound processors (all models) or the Baha sound processors with snap coupling from Cochlear BAS according to the below;

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.

Here's a breakdown of the acceptance criteria and study information for the Oticon Medical's Ponto Bone Anchored Hearing System, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific thresholds. Instead, it describes equivalency to predicate devices through design, functional testing, and intended use matching. The core "acceptance" is based on demonstrating that the Ponto system performs as intended and is as safe and effective as its predicate devices, especially regarding cross-compatibility.

Study Details

The provided document describes bench testing to demonstrate physical and functional compatibility, rather than a clinical study involving human subjects or a "test set" in the sense of patient data for an AI algorithm.

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

   • Sample Size: Not specified for the bench tests. The testing was done on "new couplings" and "after wear," implying multiple units were tested.
   • Data Provenance: Not explicitly stated as "country of origin." The testing was conducted by Oticon Medical AB (Sweden), implying the data originated from their internal testing. The nature of the data is retrospective in the sense that it describes tests performed on the physical devices.

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

   • Not applicable as this was bench testing of physical device performance, not an expert-driven assessment of ground truth on patient data. The "ground truth" was derived from predefined engineering specifications for force and vibration, and the expectation of "functioning as intended."

3. Adjudication method for the test set:

   • Not applicable. This was mechanical/vibrational testing, not a subjective assessment requiring adjudication.

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:

   • Not applicable. This device is a bone-anchored hearing system, not an AI-based diagnostic tool that assists human readers.

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

   • Not applicable. This is a physical hearing device, not an algorithm. The "standalone" performance here refers to the device's functional characteristics (force, vibration) independent of a human's subjective experience in the context of the testing performed.

6. The type of ground truth used:

   • The "ground truth" for the bench testing was based on engineering specifications and expected functional performance. This includes "maximum release force," "minimum retention force," and "vibration" measurements, compared against predefined acceptable ranges. The "intended function" also serves as a ground truth baseline.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and development of the device would have involved internal R&D, but not a formally characterized "training set" for an algorithm.

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

   • Not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device

The Ponto bone anchored hearing 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 and Ponto Pro sound processors, 55 dB HL for use with the Ponto Pro Power 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.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Oticon Medical AB Ponto Bone Anchored Hearing Implant System. The document confirms that the device is substantially equivalent to legally marketed predicate devices.

The document in the prompt does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study. It is a regulatory approval letter, not a study report. Therefore, I cannot provide the requested information based solely on the provided text.

The closest information available is the Indications for Use statement (Page 2), which outlines the patient criteria for which the device is intended. This specifies target hearing loss levels (e.g., "better than or equal to 45 dB HL" for certain processors) and conditions (conductive, mixed, or single-sided deafness). However, these are eligibility criteria for patients, not acceptance criteria for the device's performance measured in a study.

Ask a specific question about this device

The Baha Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant for the following patients and indications;

• . Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 65 dB HL.
• Bilateral fitting of the Cordelle II is intended for patients who meet the above e criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal # hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• . Baha for SSD is 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 Baha system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality.

The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.

The provided text describes the Baha® Cordelle II hearing aid, focusing on an expanded indication for use. Here's an analysis of the acceptance criteria and supporting studies based on the provided input:

Acceptance Criteria and Device Performance

The core of this submission is to expand the audiometric fitting range for the Baha Cordelle II. The original acceptance criterion for conductive and mixed hearing loss was a bone-conduction threshold of

Ask a specific question about this device