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510(k) Data Aggregation
(87 days)
SMART COUPLER, MODEL M015401
The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.
The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Here's an analysis of the provided 510(k) summary for the "Smart Coupler" device, focusing on acceptance criteria and the study to prove it, as requested.
It's important to note that the provided document is a 510(k) summary for a device accessory (an acoustic coupler), not a complex AI-powered diagnostic device. Therefore, many of the requested elements like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts," and detailed "training set" information are not applicable or described in the context of this type of submission. The focus for this device is on safety, biocompatibility, and functional equivalence to a predicate device, rather than diagnostic accuracy.
Acceptance Criteria and Device Performance for Smart Coupler (K073384)
The "Smart Coupler" is a passive device accessory. The "acceptance criteria" for a device like this primarily revolve around demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. This is achieved by showing similar performance characteristics and demonstrating that any new features (like an additional model or specific materials) do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from Submission) | Reported Device Performance (Smart Coupler) |
|---|---|---|
| Biocompatibility | Meet ISO 10993 standards for short-term skin contact (cytotoxicity, skin irritation, skin sensitization). | All materials in contact with the patient successfully passed biocompatibility testing criteria specified in ISO 10993 for short-term skin contact. |
| Functional Equivalence | Provide a coupling interface for auditory stimulators for audiometric testing (same intended use as predicate). | Supports auditory evaluation studies (audiometers, auditory evoked potential, otoacoustic emissions devices). Same intended use as the predicate device. |
| Material Composition | Biocompatible, non-sterile, single-patient use, disposable. Materials similar to predicate (foam, flexible elastomeric material, adhesive). | Biocompatible, non-sterile, single-patient use, disposable. Similar materials (flexible elastomeric material, adhesive hydrogel) used, with the note "expect no foam" compared to predicate. |
| Safety (General) | No new issues of safety or effectiveness compared to predicate. | Device is passive, does not consume/produce energy, no chemicals involved, no mechanical parts, not electrical/thermal in nature. Results of performance testing were as expected, raising no new issues of safety or effectiveness. |
| Design | Provide coupling for circumaural or intra-aural application (at least, similar to predicate). | Available in circumaural, intra-aural, and supra-aural models. Offers an additional supra-aural model compared to the predicate's two models. |
| Human Factors | Simple, easy-to-follow instructions. | Same as predicate (implied to be simple, easy-to-follow instructions). |
2. Sample Size Used for the Test Set and Data Provenance
The submission primarily refers to "performance testing of prototype devices to specifications."
- Test Sample Size: Not explicitly stated as a number of devices or subjects. The context suggests that the testing was primarily focused on material properties (biocompatibility) and functional validation, not clinical trials with a defined "test set" sample size in the traditional sense for diagnostic accuracy.
- Data Provenance: Not specified regarding country of origin or retrospective/prospective. Given the nature of the device (acoustic coupler), it is highly likely that the biocompatibility testing was conducted in a laboratory setting. Functional testing would have involved prototypes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in the context of this device. The "Smart Coupler" is an accessory; its "ground truth" is its ability to meet material safety standards and functionally couple an auditory stimulator. This is assessed via technical standards (ISO 10993) and engineering verification, not by expert interpretation of output.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication" necessary for this type of device's performance assessment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size
- No. An MRMC study is relevant for AI-powered diagnostic tools where human readers are interpreting images or data. This device is a passive accessory and does not involve human interpretation of its output in a diagnostic capacity.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device does not contain an algorithm. It is a passive, mechanical accessory.
7. The Type of Ground Truth Used
The "ground truth" for this device relates to its fundamental safety and functional attributes:
- Biocompatibility: Established by adherence to ISO 10993 standards (e.g., cell viability assays for cytotoxicity, visual assessment for skin irritation/sensitization).
- Functional Performance: Established by engineering specifications and physical testing to confirm its ability to serve as a coupling interface for auditory stimulators, consistent with the intended use and predicate device. This would likely involve acoustic measurements and fit testing.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an algorithm or machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth establishment for one.
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