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The Sophono® Sound Processor is intended for use with the Sophono® Headband (no age limitations), or with the Sophono® Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

The Sophono® Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.
The Sophono® (S) configurations are held directly against the head using either a soft band or a headband with the Sophono™ Sound Processor. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below.
The Sophono® (M) configuration is magnetically attracted to the Sophono® Sound Processor through a Magnetic Implant, and a Magnetic Spacer. The Magnetic Implant attracts a Magnetic Spacer that is held against the head through magnetic attraction forces to the Magnetic Implant, with the Sound Processor also held magnetically against the Magnetic Spacer. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below to the inner ear.
The Sophono® Systems are designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Sophono® Systems for individual patient hearing loss.

The provided text describes the Sophono® Bone Conduction Systems (S and M Configurations) and their performance, primarily through bench testing to establish substantial equivalence to predicate devices. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or clinical outcomes for hearing improvement. Instead, the "Performance" section focuses on regulatory and engineering testing.

Therefore, I cannot populate sections regarding specific clinical performance metrics (e.g., sensitivity, specificity), sample sizes for clinical trials, expert ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided document.

Here's a summary of the information that can be extracted or inferred from the text, as well as where specific requested information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Sterilization testing in accordance with ISO 11138-1
• Sterilization testing in accordance with EN 1422 |
  | Biocompatibility | Implicit: Device materials must be biocompatible. | - Biocompatibility testing in accordance with ISO 10993-1, ISO 10993-7 |
  | Packaging Integrity | Implicit: Packaging must protect the device and maintain sterility. | - Packaging testing in accordance with ISO 11607-2
• ASTM F88/F88M-09. Standard Test Method for Seal Strength of Flexible Barrier Materials
• ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
  | Electrical Safety | Implicit: Device must meet electrical safety standards. | - Electrical testing in accordance with IEC 60601-1 |
  | Electromagnetic Compatibility (EMC) | Implicit: Device must operate without undue electromagnetic interference and be immune to it. | - Electromagnetic compatibility testing in accordance with IEC 60601-1-2 |
  | Transportation Durability | Implicit: Device must withstand transportation stresses. | - Transportation testing in accordance to ISTA 2A |
  | Software Verification & Validation | Implicit: Software must be safe and perform as intended. | - Software verification and validation in accordance with IEC 62304 |
  | MRI Compatibility | Implicit: Device must be safe for use in an MRI environment. | - ASTM F2503-08, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
• ASTM F2052-06e1, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2213-06, (Reapproved 2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2119-07, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
  | General Functional Performance | Implicit: Device must function as intended (e.g., sound transmission). | - Engineering and functional testing including system, mechanical, electrical and general functional testing |

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

• Sample size for test set: Not applicable and not mentioned. The document describes bench testing, not a clinical test set with patient data for assessing a device's diagnostic or therapeutic performance.
• Data provenance: Not applicable. The "Performance" section describes results from engineering and regulatory compliance testing, not clinical patient data.

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 testing described is engineering and regulatory, not clinical assessment requiring expert ground truth.

4. Adjudication method for the test set

• This information is not applicable and not provided.

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 comparative effectiveness study was not mentioned or performed, as this device is a hearing aid system, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is a bone conduction hearing system, not an algorithm, and its performance is assessed directly through physical and electrical testing.

7. The type of ground truth used

• The "ground truth" for the performance described relies on established engineering standards, accredited laboratory tests, and regulatory guidelines (e.g., ISO, ASTM, IEC standards). There isn't "expert consensus" or "pathology" in the traditional sense, but rather adherence to predefined technical specifications and safety parameters.

8. The sample size for the training set

• Not applicable and not mentioned. This device does not use an "AI algorithm" that requires a training set.

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

• Not applicable and not mentioned.

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The Otomag™ Alpha Scund Processor is intended for use with the Otomag™ Headband or Otomag™ Softband (no age limitations), or with the Otomag™ Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of . sound. The pure tose average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• 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 100B 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 bearing in the ● opposite ear, who for some reason will not or cannot use an AC CROS. The pure tome average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1. 2 and 3 kHz).

The subject of this Traditional 510(k) is to obtain clearance for a modification in the method of sterifization and packaging for the Alpha (M) Magnetic Implant, cleared under 510(k) K102199, and the Surgical and Implant Templates, via a Letter to File under 510(k) K102199, and to supply these components of the system as sterile. The predicate device components are provided nonsterile and must be sterifized prior to implantation by gravity steam (autoclaving). The proposed method of sterilization for these components is by Ethylene Oxide (EO).

The Otomag™ Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.

The Otomag™ System is configured in either of two configurations. The first configuration is the Alpha (S), where the Otomag™ Sound Processor is attached magnetically to a Headband or Softband. The second configuration is the Alpha (M), where the Otomag™ Sound Processor is attached magnetically to an implanted magnet. The Headband, Softband, or Magnetic Implant holds the sound processor against the head, and vibration is transduced through direct contact with the patient's skin and the bone below.

The Otomag™ System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing toss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments avoilable to the audiologist in the software allow for programming the Ottomage System for individual patient hearing loss.

The document provided describes a 510(k) submission for a modification to the Otomag Bone Conduction Hearing System, specifically regarding the method of sterilization and packaging for the Alpha (M) Magnetic Implant and associated surgical templates. This is a regulatory submission for a device change and does not include a study proving device performance against acceptance criteria in the typical sense of a clinical trial or comparative effectiveness study for a diagnostic or therapeutic output.

Instead, the submission focuses on validating the changes made to the manufacturing process (sterilization and packaging) to ensure the device remains safe and effective and substantially equivalent to the previously cleared predicate device (K102199). The "acceptance criteria" here relate to the successful completion of specific non-clinical tests demonstrating that the manufacturing changes do not compromise the device's safety or performance.

Therefore, many of the requested points regarding sample sizes, ground truth, expert adjudication, MRMC studies, and standalone performance for a diagnostic/therapeutic algorithm are not applicable to this type of submission.

Here's an analysis based on the provided document:

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

• Compliance with EN 556-1 (Requirements for medical devices to be designated "STERILE")
• Compliance with DIN EN ISO 11138-1 (Biological Indicators)
• Compliance with EN 1422 (Ethylene Oxide Sterilisers- Requirements and Test Procedures) | "Sterilization Validation: to assure a sterility assurance level (SAL) of 10^-6 using one half cycle" |
  | Sterilant Residuals | Compliance with ISO 10993-7 (Ethylene Oxide-Sterilization Residuals) | "Sterilant Residuals: to assure that the residuals that remain on the device are considered acceptable per ISO 10993-7:2009." |
  | Packaging Integrity | - Seal integrity (ASTM F1929-98, ASTM F88F88M-09)
• Requirements for materials, sterile barrier systems, and packaging systems (ISO 11607-1, ISO 11607-2, DIN EN 868-5)
• Resistance to environmental conditions (ISTA 2A) | "Packaging Process Validation: to assure that the sealing of the Tyvek® pouches maintains package integrity."
  "Packaging Validation: to assure seal integrity of the pouches that they would withstand the rigors of the intended sterilization and distribution environments." |
  | Biocompatibility | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) for patient contact materials. | "The materials that compose the Magnetic Implant Template and Surgical Template meet the requirements of ISO 10993-1 for biocompatibility." |
  | Shelf Life | Validation of product and packaging requirements after defined shelf life (ASTM F1980-07) | "Shelf Life Validation: to validate that product and packaging meet requirements after defined shelf life." |
  | Overall Safety & Effectiveness | Maintain substantial equivalence to predicate device (K102199) | "The testing information presented in this submission demonstrates the device is as safe and effective and substantially equivalent to the predicate device." |

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

This information is not provided in the document. The tests conducted (e.g., sterilization validation, packaging validation) typically involve a statistically relevant number of units for the specific test, but the exact sample sizes for each validation are not detailed in this summary. These are non-clinical engineering and manufacturing validation tests, not human subject trials, so "country of origin of the data" or "retrospective/prospective" does not apply in the usual sense. The data would originate from the testing laboratories.

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 is not applicable as the "ground truth" for these tests relates to validated manufacturing processes and material properties, not diagnostic or clinical outcomes requiring expert interpretation. The "experts" would be the engineers, scientists, and quality personnel conducting and reviewing the validation studies.

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

This is not applicable as there is no human interpretation or adjudication of outputs in these types of manufacturing process validation tests. The results are typically objective measurements against defined specifications.

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

An MRMC comparative effectiveness study was not done. This submission is for a modification to a medical device's manufacturing process (sterilization and packaging), not for a diagnostic or therapeutic algorithm where human reader performance would be a relevant metric.

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

A standalone performance evaluation of an "algorithm" was not done. This device is a hearing system, and the submission addresses changes to its sterilization and packaging, not the performance of an independent algorithm.

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

The "ground truth" for these validation studies is typically based on:

• Established scientific principles and engineering standards: For example, a sterility assurance level (SAL) of 10^-6 is a well-defined standard for sterile medical devices.
• Material specifications and biocompatibility standards: For the patient contact materials.
• Test methods from recognized standards organizations: Such as ISO, ASTM, DIN, AAMI for packaging, sterility, and residuals testing.
• Predicate device's established safety and effectiveness: The modifications are being compared to the existing cleared device to ensure substantial equivalence.

8. The sample size for the training set

This is not applicable. This submission is for a physical medical device and manufacturing process changes, not for an AI/ML algorithm that would involve training data.

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

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

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The Otomag™ Alpha Sound Processor is intended for use with the Otomag™ Headband or Otomag™ Softband (no age limitations), or with the Otomag™ Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• . Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• 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 10dB 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The Otomag™ Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations. The subject of this 510(k) is to obtain a labeling claim relative to the use of MRI with the Alpha (M) Magnetic Implant to specify the implant as Magnetic Resonance (MR) Conditional.

The Otomag™ System is configured in either of two configurations. The first configuration is the Alpha (S), where the Otomag™ Sound Processor is attached magnetically to a Headband or Softband. The second configuration is Alpha (M), where the Otomag™ Sound Processor is attached magnetically to an implanted magnet. The Headband, Softband, or Magnetic İmplant holds the sound processor against the head, and vibration is transduced through direct contact with the patient's skin and the bone below.

The Otomag™ System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Otomag™ System for individual patient hearing loss.

The system utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device, and represents that the magnetic implant can now undergo MRI scanning under certain conditions.

The provided text describes the safety and performance testing for the Otomag Bone Conduction Hearing System, specifically focusing on the Alpha (M) Magnetic Implant's MR Conditional status.

Here's an analysis based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

• Static magnetic field of 3 Tesla or less.
• Spatial gradient field of 720 Gauss/cm or less.
• Maximum whole-body averaged specific absorption rate (SAR) of 4 W/kg in First Level Controlled Mode.
• Maximum scan time of 15 minutes of continuous scanning. | The non-clinical testing demonstrated that the Alpha (M) Magnetic Implant is MR Conditional and can be scanned safely under these exact specified conditions. |
  | Translational Attraction | Magnetic force within the range of forces expected in normal daily usage (up to 2.5 N). | Maximum measured magnetic force was 2.29 Newtons (230 grams), which is within the range of forces expected in normal daily usage (up to 2.5 N). The implant is secured by 5 screws (holding force >150 N), mitigating hazard. |
  | Torque | No hazard to the patient. | Qualitatively measured torque was "+4 (very strong)," indicating rapid and forceful alignment. However, due to the implant's small mass (3.6 grams), relatively larger translational attraction (2.5 N), and securing by 5 screws (>150 N retention force), there are no concerns that torque will cause a hazard. |
  | MRI Related Heating | Maximum temperature rise less than specified thresholds during MR scanning. | Produced a maximum temperature rise less than 3.2°C during 15 minutes of continuous MR scanning (First Level Controlled Mode, 4 W/kg SAR).
  Computed implant temperature increase from worst-case gradient field is less than 2.6°C. |
  | Image Artifact | Characterization of artifact extent. | Image artifact extends approximately 5 cm from the device when scanned in non-clinical testing (T1-weighted, spin echo, and Gradient echo sequences in a 3 Tesla MR system). |
  | Implant Function After MR Scanning (Demagnetization) | Maintains sufficient magnetic strength (e.g., >95% of original magnetic strength) after exposure to MR environment. | Maintained over 95% of its original magnetic strength after 10 insertions into a static MRI field and over 10 minutes of pulse sequence in a 3 Tesla Siemens Tri Clinical MRI Scanner. |

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

• Sample Size: Not explicitly stated as a number of devices or implants tested. The text refers to "non-clinical testing" of "the Alpha (M) Magnetic Implant." For MRI compatibility testing, often a representative number of devices (e.g., 3-5) are used for each test (displacement, torque, heating, image artifact, function). It's typically not a clinical population sample size.
• Data Provenance: The studies are "non-clinical testing," meaning they were conducted in a laboratory setting. There is no mention of human or animal subjects for these specific tests.

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

Not applicable in this context. The "ground truth" here is established by standardized engineering tests and measurements against predefined physical criteria (magnetic force, temperature change, artifact size, magnetic strength retention), as outlined by ASTM standards. There is no expert consensus on clinical interpretation for these specific tests, as they are focused on device physics and safety.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of results requiring adjudication (e.g., medical image reading). The results are quantitative measurements from physical tests.

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

No. This submission is for establishing MR Conditional labeling, based on non-clinical engineering tests, not for evaluating human reader performance with or without the device in a clinical setting.

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

Yes, in a sense. The entire submission is based on the standalone performance and safety of the Alpha (M) Magnetic Implant itself, without human intervention or interpretation, in various magnetic resonance environments.

7. The Type of Ground Truth Used

The ground truth used for these tests is engineering measurement against industry standards. Specifically, the tests conform to the following ASTM standards:

• ASTM F2503-08: Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
• ASTM F2052-06e1: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
• ASTM F2213-06 (Reapproved 2011): Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
• ASTM F2182-11a: Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging.
• ASTM F2119-07: Evaluation of MR Image Artifacts from Passive Implants.

8. The Sample Size for the Training Set

Not applicable. These are non-clinical hardware tests, not machine learning model training.

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

Not applicable (as above).

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The Otomag Alpha I Sound Processor is intended for use with the Otomag Headband or Olomag Softband (no age limitations), or with the Otomag Osseointegrated Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• 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 10dB 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations. The Otomag System consists of two distinct configurations; Alpha 1 (S) and Alpha 1 (M). This 510(k) is being submitted to add the Alpha 1 (M) configuration to the existing product family.
In the Otomag Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below.
In the Otomag Alpha 1 (M), the Otomag Sound Processor is attached magnetically to an implanted magnet assembly. The magnetic field holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below. A variety of magnetic spacers, each with a different magnetic strength, are provided with the Alpha 1(M) configuration to allow adjustment of the magnetic field strength that holds the sound processor against the head.
The magnetic implant of the system is provided clean and non-pyrogenic, but is not sterile. The implant is intended to be sterilization at the healthcare facility immediately prior to implementation.
The Otomag System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Otomag System for individual patient hearing loss.

Here's an analysis of the acceptance criteria and study information for the Otomag Bone Conduction Hearing System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary for the Otomag Bone Conduction Hearing System (K102199) does not explicitly state pre-defined acceptance criteria for its clinical performance in terms of specific thresholds for "Unaided Speech Understanding," "Aided Speech Understanding," "Free Field Gain," or "Aided Free Field Thresholds."

Instead, it presents the results of clinical performance testing for the modified device (Alpha 1(M)) configuration and highlights that these results, along with non-clinical testing, support its substantial equivalence to predicate devices. The implicit acceptance criterion appears to be that the device demonstrates safe and effective performance that is comparable to or better than previously cleared predicate devices, as evidenced by the reported outcomes.

Here's a table summarizing the reported clinical performance measures:

The key non-clinical acceptance criteria were for:

• Device retention
• Vibration Transmission Comparison Alpha 1(M) vs. Alpha 1(S)
• Software Validation
• Sound Processor Performance: Frequency Response
• Immunity (IEC 60601-1-2)
• Implant Performance after 3x Sterilization
• Autoclave Cycle Performance (Sterilization)
• Accelerated Aging: Magnet Retention
• Dislodgement Force: Normal and Tangential
• Accelerated Aging: Screw Retention

The summary states that the testing demonstrated the device's performance is substantially equivalent to the predicate devices, indirectly indicating that the performance met the expected standards for these criteria.

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

• Sample Size (Clinical Test Set): 86 Alpha 1(M) devices implanted into 57 patients.
• Data Provenance: Not explicitly stated regarding the country of origin. The study was prospective in nature, as it describes a "trial" with "mean follow up time for the study was 1.6 years from the time of implant, with a range of 0.5 years." This indicates data collection after the implantation of the devices.

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

The summary does not mention the use of experts to establish ground truth in the context of the clinical performance data (e.g., for speech understanding or audiological thresholds). These measurements are typically obtained objectively through standardized audiological testing procedures.

4. Adjudication Method for the Test Set:

Not applicable. The clinical performance data presented appears to be direct measurements rather than subjective assessments requiring adjudication. The adverse events (e.g., redness, infections) were reported as part of the trial, but no specific adjudication method for these events is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done for this device. The study focused on assessing the performance of the new Alpha 1(M) configuration in patients and comparing it to the performance parameters of predicate devices (Otomag Bone Conduction Hearing System, Unmodified Version - K100193 and Xomed Audiant Bone Conductor - K855059 / K861971) based on the principles of substantial equivalence. There is no mention of human readers or AI assistance in the context of this hearing system.

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

Not applicable. This device is a medical device (a bone conduction hearing system) and not an AI or algorithm-based diagnostic tool. The "Software Validation" refers to the programming software for the hearing aid, not a standalone AI diagnostic algorithm. The performance metrics are direct outcomes from the device's function in patients.

7. The Type of Ground Truth Used:

The "ground truth" for the clinical performance testing was based on objective audiological measurements (e.g., pure tone average thresholds, speech understanding scores) collected from the participating patients, as well as clinical observations and patient reports for adverse events and dislodgement issues.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI model that requires a training set in the conventional sense. The "Alpha 1(M)" configuration is a modification of an existing product, and its design and performance build upon established principles of bone conduction hearing systems.

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

Not applicable, as there is no training set for an AI model. The device's design and engineering are based on established medical and acoustical principles, and its safety and effectiveness are supported by non-clinical and clinical validation studies against pre-defined performance standards and comparison to predicate devices, rather than a "training set" with ground truth in the AI context.

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The Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• 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 10dB 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, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
  The Otomag Alpha 1 (S) Sound Processor is intended to the Otomag Headband or Softband.

The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.
The Otomag System called the Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below.
The Otomag System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Otomag System for individual patient hearing loss.

The provided text describes the "Otomag Bone Conduction Hearing System" and its substantial equivalence determination, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with numerical results or statistical analysis.

Instead, the document focuses on:

• 510(k) Summary: A declaration that the device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway that primarily relies on demonstrating similarity to existing devices rather than new performance studies against predefined acceptance criteria.
• Indications for Use: Details when and for whom the device is intended.
• Contraindications: Situations where the device should not be used.
• Summary of Technical Characteristics: States that the device's technical specifications are "substantially equivalent" to predicate devices.
• Summary of Non-Clinical Testing: States that testing "demonstrates the Otomag System’s performance is substantially equivalent to the predicate devices."

Therefore, based only on the provided text, I cannot complete the requested tables/information. There is no mention of:

1. Acceptance criteria: Specific measurable thresholds the device needs to meet (e.g., a certain SNR, dB gain, or speech recognition score).
2. Reported device performance: Actual numerical results from a study showing how the Otomag performs against any criteria.
3. Sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, or ground truth establishment for training set. These are all details typically found in a performance study report, which is not present in this 510(k) summary.

Conclusion based on the provided text:

The document asserts "substantial equivalence" based on technical specifications and non-clinical testing to predicate devices (Oticon Medical Ponto Pro Bone Anchored Sound Processor K090996 and Cochlear BAS Baha BP100 Sound Processor K090720). However, it does not provide the specific performance data or the detailed study design elements requested in your prompt. The focus is on regulatory equivalence rather than a detailed performance study with explicit acceptance criteria.

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