(19 days)
The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.
The provided text is a 510(k) summary for the ArthroCare Corporation Spartan™ PEEK Suture Implant System, outlining its substantial equivalence to a predicate device. It does not describe a study involving AI, human readers, or a test set with ground truth established by experts.
Therefore, many of the requested categories related to acceptance criteria, AI performance, expert adjudication, and ground truth establishment cannot be extracted from this document as they are not present.
However, I can provide the available information regarding the device's performance based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Performance Test) | Reported Device Performance |
|---|---|
| Ultimate strength testing | Testing completed to demonstrate substantial equivalence to predicate device. |
| Cyclic loading tests | Testing completed to demonstrate substantial equivalence to predicate device. |
Note: The document states "Bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant in accordance with FDA Guidance Document Testing for Bone Anchors." It does not provide specific numerical acceptance thresholds or detailed numerical results for the ultimate strength or cyclic loading tests beyond confirming they were performed and supported substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study described is a bench performance test for a medical device (suture implant), not a study involving a test set of data with human subjects or images.
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 was a physical bench performance test, not a study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a physical bench performance test.
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
No. This document does not mention any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not mention any algorithm or AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" equivalent for this device's performance evaluation was its mechanical behavior (ultimate strength and cyclic loading) in a simulated human bone substrate, compared against the predicate device. This is based on physical testing standards and comparisons.
8. The sample size for the training set
Not applicable. This was a physical bench performance test, not a machine learning study.
9. How the ground truth for the training set was established
Not applicable. This was a physical bench performance test, not a machine learning study.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was a series of bench performance tests. These tests involved:
- Insertion of anchors in a simulated human bone substrate.
- Ultimate strength testing.
- Cyclic loading tests.
The purpose of these tests was to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to its predicate device (Arthrocare 5.5mm Spartan PEEK Suture Implant System, K102262) in accordance with the "FDA Guidance Document Testing for Bone Anchors." The summary concludes that "The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use."
The document does not provide specific methodologies, number of samples tested, or detailed quantitative results for these bench tests, but states they were completed and supported the substantial equivalence claim.
§ 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.