(67 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 comes preconfigured with MagnumWire® sutures for traditional knot tying and is 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 describes a 510(k) submission for the ArthroCare Spartan PEEK Suture Implant System, which is a medical device for fixing soft tissue to bone. However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations.
The "study" mentioned in the document is a "bench performance testing" to demonstrate substantial equivalence to predicate devices, and it involves "ultimate strength and cyclic loading tests" in a simulated human bone substrate. This is a biomechanical engineering test, not a clinical study or an AI/ML performance evaluation.
Therefore, for aspects related to AI/ML device performance (like specific metrics, test sets, expert adjudication, MRMC studies, and training data information), the provided document does not contain the requested details.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for intended use, device design, technology, and components. | Demonstrated through bench performance testing. |
| Performance testing in accordance with FDA Guidance Document Testing for Bone Anchors. | Performed "ultimate strength and cyclic loading tests." |
| Safe and effective for its intended use. | Performance testing and device comparison demonstrate substantial equivalence, and thus, implicitly, safe and effective for 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 for Test Set: Not specified. The study involved "insertion of the anchors in a simulated human bone substrate," implying a number of implanted anchors and test cycles, but a specific count is not given.
- Data Provenance: Not applicable in the human data sense. The tests were performed in a "simulated human bone substrate," which suggests a lab-based, synthetic or cadaveric bone analog environment, not human patient data. This is a form of prospective bench testing.
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. Ground truth for a biomechanical bench test is typically established by the results of the physical tests (e.g., force at failure, cycles to failure) as measured by calibrated equipment, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for clinical studies or image interpretation, not for biomechanical bench testing.
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 is not an AI/ML device, and no MRMC study was performed.
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. The "standalone" performance here refers to the physical device's mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this type of device (bone anchor) would be directly measured mechanical properties:
- Ultimate Strength: The maximum force the anchor can withstand before failure or pullout.
- Cyclic Loading Performance: The number of cycles the anchor can endure under specified loads without significant displacement or failure, simulating repetitive physiological stresses.
- These are directly measured physical parameters, not derived from expert opinion or clinical outcomes in the traditional sense.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the AI/ML sense. "Training" for such a device would involve its design, manufacturing processes, and materials science.
9. How the ground truth for the training set was established
- Not applicable for AI/ML training data. For the device itself, "ground truth" (i.e., meeting design specifications and material properties) would be established through material testing, engineering calculations, and quality control during manufacturing.
§ 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.