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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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