(11 days)
Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.
The all-titanium prosthesis consists of a clip with seven (7) resilient prongs, a shaft, and a head plate.
This appears to be a 510(k) premarket notification document for a medical device, specifically an ossicular prosthesis. The document states that the device is a "Clip Partial Prosthesis - Titanium "Dresden"" and it is a modification of a previously cleared device made of gold.
Based on the provided text, a conventional study demonstrating clinical acceptance criteria with statistical endpoints like sensitivity, specificity, or AUC for a diagnostic AI device is not applicable or present. This document describes a medical device (an implant) and its physical characteristics, rather than an AI/ML-based diagnostic or prognostic tool.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or MRMC comparative effectiveness studies as these concepts are primarily relevant to AI/ML device evaluations, which this document does not describe.
The document focuses on demonstrating substantial equivalence to an predicate device, primarily through changes in material and design. The "acceptance criteria" here would be demonstrating that the new device is as safe and effective as the predicate device, despite the modifications.
Here's a breakdown of what can be extracted and why other parts cannot:
1. A table of acceptance criteria and the reported device performance:
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Cannot provide this for AI/ML performance metrics.
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However, the document does compare the new device to the predicate device in terms of physical characteristics and safety/effectiveness justifications. This isn't a table of "acceptance criteria" in the AI sense, but rather a comparison for regulatory equivalence.
Characteristic Clip Partial Prosthesis "Dresden" (New Device) Dresden Bell Prosthesis (Predicate Device - Gold) Device Clip Partial Prosthesis "Dresden" Dresden Bell Prosthesis Catalog # 1002 250 - 257 1001 023 - 030 Intended Use Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes Identical # of Sizes 8 Identical Length 1.75 - 3.5 mm (0.25 mm intervals) Identical Head Plate Ø 2.6 mm N/A (Not explicitly specified for gold bell) Shaft Ø 0.2 mm N/A (Not explicitly specified for gold bell) Material ASTM F67 Titanium Pure Gold Weight 4-5 mg 10-12 mg Single Use Yes Identical Sterile Yes Identical Design Comparison Clip with seven (7) resilient prongs securely clips around stapes head and upper part of stapes. No manipulation and/or adjustment in situ. The four (4) gold strips of Bell prosthesis are gently pushed against stapes with wire crimper to achieve mechanically close fit. Custom Accessories KURZ Sizer Cat.# 8000 121, KURZ Precise Cat # 8000 101 Identical Safety & Effectiveness of Material and Design Changes Titanium is a clinically well-established implant material with excellent biocompatibility. Much lighter weight appears better suited. Clinical evidence suggests excellent sound conduction properties resulting in improved hearing gain. Tensile clip mechanism significantly reduces dislocation risk and improves long-term hearing gains. N/A (Baseline for comparison)
2. Sample sized used for the test set and the data provenance:
- Cannot provide. This is not an AI/ML device tested on a "test set" of data. The device itself is the physical product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot provide. Not applicable to a physical medical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot provide. Not applicable.
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:
- Cannot provide. This study pertains to human reader performance with AI, which is not relevant to this physical implant device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot provide. Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot provide. Not applicable. The "ground truth" for a physical implant like this would be its physical properties, biocompatibility, mechanical stability, and clinical performance (which is alluded to as "clinical evidence" but not detailed as a formal study in this document). The document mentions "Testing in a 0.5 Tesla nuclear magnetic resonance (NMR) tomograph has revealed no implant movement and no adverse tissue effects attributable to MRI-generated heating." which is a form of performance testing.
8. The sample size for the training set:
- Cannot provide. Not applicable to a physical medical implant.
9. How the ground truth for the training set was established:
- Cannot provide. Not applicable.
In summary, this document is a regulatory submission (510(k)) for a conventional medical device (an implant) and not an AI/ML-driven diagnostic or treatment device. Therefore, most of the requested information, which is specific to AI/ML device evaluations, is not present or applicable.
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.