(130 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated by Compliance to Standards) | Reported Device Performance (as stated in the submission) |
|---|---|---|
| Risk Management | Compliance with ISO 14971 (Application of risk management to medical devices) | "The changes have been appropriately validated and raise no new questions of safety and effectiveness." |
| Sterilization Efficacy | - Sterility Assurance Level (SAL) of 10^-6 for Ethylene Oxide (EO) sterilization (DIN EN ISO 11135-1) |
- 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.
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.