(246 days)
The Smith & Nephew Osteoraptor OS Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy), Hip (Hip capsule repair, Acetabular labrum reattachment), Knee (Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs: Vastus medialis obliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization: Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis).
The Smith & Nephew OSTEORAPTOR OS Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone until healing occurs. The device consists of a resorbable composite suture anchor with attached non-absorbable suture(s) preloaded onto an insertion device. A 24 month ovine bone implantation study demonstrated that 9x10 mm implants typically resorb in approximately two years and are replaced by bone. This device is provided sterile, for single use only.
The provided text describes a 510(k) premarket notification for a medical device called the OSTEORAPTOR OS Suture Anchor. This is a submission to demonstrate substantial equivalence to previously marketed devices, not a study setting specific acceptance criteria and proving performance against them in the way clinical trials for new medical technologies typically do.
Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or not detailed in this type of regulatory document, which focuses on demonstrating equivalence rather than establishing novel performance metrics.
However, I can extract the information that is present and indicate where the requested information is not available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (OSTEORAPTOR Suture Anchors (K082215) and DePuy Mitek LUPINE BR Anchor (K070925)) in intended use, operating principle, and design features. | The OSTEORAPTOR OS Suture Anchor is considered substantially equivalent to the predicate devices. The only noted difference is the anchor material. |
| Biocompatibility | Biocompatibility studies demonstrated equivalence. |
| Resorption properties and replacement by bone | A 24-month ovine bone implantation study showed 9x10 mm implants typically resorb in approximately two years and are replaced by bone. |
| In vitro testing performance | In vitro testing demonstrated equivalence. |
| Safety and efficacy are not negatively impacted by material change. | The proposed modification to the anchor material does not raise new questions of safety and efficacy. |
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 the test set: Not explicitly stated as a "test set" in the context of algorithm performance. The ovine implantation study involved an unspecified number of 9x10 mm implants.
- Data Provenance:
- Ovine bone implantation study: Performed in animals (ovine). Country of origin not specified. This would be considered a prospective animal study.
- Biocompatibility and in vitro testing: Details on data provenance are not provided.
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 document is not describing a study that establishes ground truth based on expert review for a test set in the way an AI/algorithm validation would. The ground truth for the animal study would be based on histological and imaging analysis conducted by veterinary pathologists/researchers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe a study involving human adjudication of a test set in relation to an algorithm's output.
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 comparative effectiveness study, nor does it involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical suture anchor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the ovine implantation study, the "ground truth" for resorption and bone replacement would be established through pathological examination (histology) and potentially imaging studies of the bone/implant site over time.
- For biocompatibility, the ground truth is established through standard biocompatibility testing methods (e.g., cytotoxicity, irritation, sensitization based on ISO 10993 standards).
- For in vitro testing, the ground truth is established through mechanical testing specifications and results.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm study that uses a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.