(72 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 fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.
The provided text describes a submission for a medical device (ArthroCare Spartan PEEK Suture Implant) seeking substantial equivalence to predicate devices, rather than a study proving performance against defined acceptance criteria (e.g., diagnostic accuracy metrics like sensitivity or specificity). Thus, many of the requested items (e.g., details on training/test sets, expert adjudication, MRMC studies) are not applicable to this type of submission.
However, the text does outline the type of assessment conducted and the criteria used to establish substantial equivalence.
Here's an attempt to answer the questions based on the provided document, noting where specific information is not present or applicable:
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence claim for a bone fixation fastener, the "acceptance criteria" are generally that the new device performs comparably to the predicate device in relevant mechanical tests, demonstrating similar safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in intended use, device design, technology, and components to predicate devices. | The ArthroCare Spartan PEEK Suture Implant was compared to predicate devices (ArthroCare Opus Magnum Speedscrew Knotless Fixation Device, Arthrocare Opus Speedscrew System, ArthroCare Titan Ti Suture Anchor, ArthroCare Titan Ti Suture Anchor System) and found to be substantially equivalent in these aspects. |
| Comparable mechanical performance to predicate devices according to FDA Guidance Document Testing for Bone Anchors. | Bench performance testing was completed. In vitro testing involved insertion of anchors in a simulated human bone substrate followed by both ultimate strength and cyclic loading tests. These tests demonstrated substantial equivalence to the predicate Speedscrew implant. |
| Safe and effective for its intended use. | The performance testing and device comparison demonstrate that the subject device is safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. The text mentions "bench performance testing" and "in vitro testing" involving "insertion of the anchors" in a "simulated human bone substrate," implying a laboratory-based study. The number of anchors tested, or repetitions performed, is not provided.
- Data Provenance: Not specified, but given it's "bench performance testing" and "in vitro testing," it's not applicable in terms of country of origin or retrospective/prospective human data. It is a laboratory study.
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 device is a bone fixation fastener. The "ground truth" here is established through objective mechanical testing, not expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical engineering bench test, not a diagnostic study requiring expert adjudication.
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 medical device (bone fixation fastener), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (bone fixation fastener), not an algorithm. The testing described is "standalone" in the sense that it's the device itself being tested mechanically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device is established by objective physical measurements from controlled mechanical testing (ultimate strength, cyclic loading performance) against established standards or predicate device performance.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a "training set." The product development likely involved iterative design and testing, but not in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI algorithm.
§ 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.