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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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