(129 days)
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:
Shoulder:
- Bankart lesion repairs
- SLAP lesion repairs
- Acromioclavicular separation repairs
- Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions
- Biceps tenodesis
- Deltoid repairs
Foot and Ankle:
- Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
- Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions
- Lateral epicondylitis repair
- Biceps tendon reattachment
Knee:
- Extra-capsular repairs;
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament - Iliotibial band tenodesis
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit composed of machined cortical bone. The anchor is of a threaded design with two (2) evelets, to which braided #2 USP suture is attached (one per eyelet). The proximal end of the anchor accepts a disposable driver, which is used as the insertion device. The anchor requires a tapping procedure prior to implantation. Following the implantation of the anchor, the free ends of the suture are used to reattach soft tissue to bone.
The provided text is a 510(k) summary for the Smith & Nephew Phoenix 5.0 Allograft Anchor Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or performance testing that generated quantitative performance metrics against pre-defined thresholds.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided document.
The document states: "Performance testing has been performed to support substantial equivalence." However, it does not detail these performance tests, their acceptance criteria, or the specific results. It primarily compares the new device to predicate devices based on design, function, intended use, and materials.
Based on the provided text, the following aspects cannot be answered:
- 1. A table of acceptance criteria and the reported device performance: No specific quantitative acceptance criteria or performance metrics are reported.
- 2. Sample sized used for the test set and the data provenance: No information on a test set sample size or data provenance is provided. The performance testing mentioned is likely mechanical/bench testing to support equivalence rather than a clinical study with a "test set" in the context of AI/diagnostic devices.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert ground truth for performance evaluation in the provided text.
- 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: Not applicable. This type of study is for diagnostic or AI-assisted devices, not for a surgical anchor.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of what can be inferred from the document regarding "proof of meeting acceptance criteria":
The "proof" in this 510(k) is the demonstration of substantial equivalence to existing legally marketed predicate devices, not the meeting of quantitative performance acceptance criteria in a clinical study.
- Predicate Devices: Smith & Nephew Preloaded PRC5 5.0 mm Polyacetal Suture Anchor (K982963) and Multitak SS Bone Anchor (K993115).
- Basis for Equivalence: "The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is substantially equivalent in design, function and intended use to the Smith & Nephew PRC5 Polyacetal Anchor. Performance testing has been performed to support substantial equivalance. It is substantially equivalent in its materials and use to the Mutlitak SS Bone Anchor."
- "Study" (Implied): Performance testing (likely mechanical/bench testing) was conducted to demonstrate that the new allograft anchor performs comparably to the predicate polyacetal anchor in terms of design, function, and intended use characteristics. The specific methodology or results of this testing are not detailed in this summary. The material equivalence is drawn from comparison to the Multitak SS Bone Anchor.
§ 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.