(53 days)
The Smith & Nephew BIOSURE PK Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee (ACL Repairs, PCL Repairs, 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), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus (FLH), Tendon Transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Reconstruction)
Reattachment of ligament, tendon, soft tissue, or bone in, shoulder, foot/ankle, knee, elbow and hand/wrist.
The provided text describes a 510(k) premarket notification for a medical device called the "Smith & Nephew Biosure PK Interference Screw." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria and a detailed statistical analysis of device performance.
Therefore, the document does not report on acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically expected for a detailed clinical or diagnostic study.
Instead, the submission states:
- Acceptance Criteria & Reported Performance: The document doesn't explicitly list numerical acceptance criteria or detailed performance metrics. It rather asserts "The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew Biosure PK Interference Screw are substantially equivalent to the Smith & Nephew BIOSURE HA Screw, the Smith & Nephew BioRaptor 2.3PK and the Arthrex Interference Screw." This implies that the device's performance was measured against its predicate devices, and the results were deemed comparable.
Based on the provided text, the remaining information cannot be extracted:
- Sample size used for the test set and the data provenance: Not mentioned. The testing mentioned is "performance testing" which likely refers to mechanical or bench testing, not a clinical test set with patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set with ground truth is not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is an interference screw, not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the validated performance of the predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.