(28 days)
An 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. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include:
(a) Chronic middle ear disease,
(b) Otosclerosis,
(c) Congenital fixation of the stapes,
(d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and
(e) Surgically correctible injury to the middle ear from trauma.
The family of Grace Medical Nitinol Partial Ossicular Replacement Prostheses consists of: Nitinol Locking Incudo-Stapedial Joint Nitinol Locking Angular Piston Nitinol Locking Piston Nitinol Locking Malleus Piston Nitinol Locking PORP Footplate Shoe. The prostheses are manufactured from Nitinol (ASTM F2063-05), Unalloyed titanium (ASTM F67), Titanium alloy (ASTM F136), Hydroxylapatite (ASTM F1185), Fluoroplastic (USP Class VI for plastics, ASTM D1710 and ASTM F754), and Medical grade silicone.
The provided text is a 510(k) summary for the Grace Medical Partial Ossicular Replacement Prostheses. This type of document is a premarket notification to the FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device.
Crucially, a 510(k) does not typically involve the kind of rigorous clinical studies, acceptance criteria, and performance metrics (like sensitivity, specificity, F1 score) that would be present for a novel device or an AI/software as a medical device (SaMD). The "study" here is primarily a comparison to predicate devices, focusing on materials, intended use, and design features to establish substantial equivalence, not a direct performance study against defined acceptance criteria in terms of clinical outcomes or diagnostic accuracy.
Therefore, many of the requested fields cannot be directly answered as they are not applicable to the nature of a medical device 510(k) for a physical implant like an ossicular replacement prosthesis.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the traditional sense for a SaMD or novel device. For a 510(k) of a physical implant like this, "acceptance criteria" are generally met by demonstrating substantial equivalence to predicate devices in:
- Intended Use: Must be the same.
- Technological Characteristics: Must be the same or, if different, any differences must not raise new questions of safety or effectiveness.
- Materials: Must be biocompatible and safe.
- Performance: Implied to be similar to predicate devices based on design and materials.
The document implicitly "accepts" the device by demonstrating these similarities. There are no quantitative performance metrics (e.g., sensitivity, accuracy, etc.) reported for "device performance" in the way one would for a diagnostic algorithm.
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Intended Use | Same as predicate devices: functional reconstruction of ossicular chain, sound wave conduction from tympanic membrane to inner ear, restoration of ossicular chain in conductive hearing loss. | Met: Explicitly stated as having "the same primary intended use as the predicate devices" and confirmed in comparison charts. |
| Material(s) | Biocompatible and safe; comparable to predicate devices. | Met: Materials (Nitinol, Titanium, Hydroxylapatite, Fluoroplastic, Silicone) are listed and stated as "the same materials as the predicate devices" or "Substantially Equivalent" in comparison charts. |
| Method of Attachment | Safe and effective; comparable to predicate devices. | Met: "Manual or Heat Crimp-Assist" described as "Same as SMart ISJ and SMart Piston. Different than but SE to Kurz Angular Prosthesis." for the Nitinol Locking Incudo-Stapedial Joint. |
| Lengths/Dimensions | Appropriate for intended anatomical use; comparable range to predicate devices. | Met: Listed ranges (e.g., 3.0mm to 9.0mm for Pistons, 0.5mm to 9.0mm for PORPs) are compared to predicate devices and deemed "Substantially Equivalent." |
| How Supplied (Sterility) | Sterile, comparable to predicate devices. | Met: "Sterile" for all device types, "Same" as predicate devices confirmed in comparison charts. |
| Safety and Effectiveness | No new questions of safety or effectiveness raised by differences from predicate devices. | Met (by FDA determination): Stated, "Differences between the Grace Medical Modified Partial Ossicular Replacement Prostheses and the predicate devices should not affect the safety or effectiveness." and confirmed by FDA clearance. |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This submission is not based on a "test set" of patient data or clinical images in the way an AI/SaMD would be evaluated. Performance is established through comparison to legally marketed predicate devices, along with materials testing and design specifications, not through a prospective or retrospective study on a clinical dataset for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" establishment in the context of clinical expert review for this type of device submission. The FDA reviewers (Division of Ophthalmic and Ear, Nose and Throat Devices) evaluate the submission based on regulatory guidelines and comparison to established predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No test set or expert adjudication process described or performed for this 510(k) submission.
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
Not applicable. This is a physical implant device, not an AI or software assistant for human "readers." Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. The "truth" for this 510(k) is whether the device is substantially equivalent to known safe and effective predicate devices, based on materials, design, and intended use as assessed by the FDA. There is no "ground truth" derived from patient-specific data or pathology results mentioned as a basis for device performance evaluation in this document.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an algorithm described.
§ 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.