(272 days)
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.
The provided document, K230891, describes the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and its substantial equivalence to a predicate device. However, the document does not contain acceptance criteria for the device's performance, nor does it detail a specific study proving the device meets said criteria with the requested level of detail for an AI/ML medical device.
The provided text focuses on the 510(k) submission for a physical medical implant (a suture and PEEK button for meniscus repair) and its comparison to a predicate device, rather than an AI/ML-driven device. As such, information regarding test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set (all typical for AI/ML device evaluations) are absent.
Here's an analysis based on the information that is available in the document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "pull-out strength must be X N"). Instead, it states the conclusion of the test:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs adequately regarding mechanical strength | SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant performs statistically equivalent to the predicate device. |
| Device meets pyrogen limit specifications | Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications. |
| Packaging maintains sterile barrier and product integrity | Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the pull-out strength, cyclical loading, bacterial endotoxin, or packaging tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are non-clinical, likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are non-clinical mechanical and biological compatibility tests, not evaluations that require expert interpretation of results to establish ground truth in the context of an AI/ML device.
4. Adjudication method for the test set
Not applicable. This concept is relevant for AI/ML performance ground truth establishment, not for the types of non-clinical tests described.
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 not an AI/ML device. The study described compares the subject device's mechanical performance to a predicate device, not human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
For the non-clinical tests described:
- Mechanical Performance (Pull-out strength, Cyclical loading): The "ground truth" is measured physical properties and comparison to a predicate device's measured physical properties.
- Biological Compatibility (Bacterial Endotoxin): The "ground truth" is adherence to established pyrogen limit specifications (USP ).
- Packaging: The "ground truth" is the confirmation of sterile barrier integrity and product protection during simulated conditions.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.