(100 days)
The Arthrex SutureLoc™ Implant is intended to be used for suture (soft-tissue) fixation to bone in the knee for meniscal root repair.
The SutureLoc™ Implant is a suture construct comprised of a polyester sheath with multiple sutures assembled through the sheath.
This FDA 510(k) summary is for a medical device (SutureLoc™ Implant) and primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data. It does not describe a study involving an algorithm's performance, human readers, or expert adjudication as would be relevant for an AI/ML-based device.
Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies are not applicable or cannot be extracted from the provided text. The document describes performance testing for a physical implant, not a software algorithm.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions performance data, but does not provide specific quantitative acceptance criteria or detailed reported performance values for each criterion in a table format. It generally states that testing was done to "demonstrate that the differences do not negatively impact mechanical strength" and that the device "meets pyrogen limit specifications."
| Acceptance Criteria (Inferred from testing mentioned) | Reported Device Performance (General Statement) |
|---|---|
| Mechanical Strength (Ultimate load and cyclic displacement) | Demonstrated that differences (from predicate) do not negatively impact mechanical strength. |
| Pyrogen Limit Specifications (Bacterial endotoxin per USP ) | Meets pyrogen limit specifications. |
| Packaging Integrity (Shelf-life, sterile barrier, protection during shipping/handling) | Confirmed 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 (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample sizes used for the "ultimate load testing and cyclic displacement," "bacterial endotoxin," or "packaging testing." It does not mention data provenance (country of origin, retrospective/prospective).
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)
Not applicable. This is a physical medical implant, not an AI/ML-based device requiring expert ground truth establishment for software performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
Not applicable. This is a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be the measured physical properties and performance characteristics against established engineering standards or against the predicate device's performance. For biocompatibility/safety, it's compliance with compendial standards like USP . For packaging, it's meeting defined integrity and sterility standards.
8. The sample size for the training set
Not applicable. This is a physical medical implant, not an AI/ML-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.