(88 days)
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle:
Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist:
Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair
Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair
The Smith & Nephew PEEK Interference Screws, consisting of non-absorbable PEEK material, are interference screws for use in fixation of ligament, tendon or soft tissue grafts to bone in shoulder, elbow, knee, foot/ankle and hand/wrist procedures. The screws are cannulated.
The provided text describes a 510(k) summary for the Smith & Nephew PEEK Interference Screws. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving performance against them in the way modern AI/ML device submissions do.
Here's a breakdown of why many of your requested points cannot be answered from this extract, and what information can be extracted:
- This is not an AI/ML device. The device described is a physical medical implant (interference screws made of PEEK material). Therefore, concepts like "test set," "training set," "ground truth experts," "MRMC studies," and "standalone algorithm performance" are not applicable in the context of this submission.
- Performance is generally shown through comparison to predicate devices. For traditional medical devices like this, the "acceptance criteria" are often implicitly met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "study" is a comparison study, not a performance study against predefined metrics.
Despite these limitations, I will extract what is relevant and indicate where information is not present or applicable.
Acceptance Criteria and Device Performance for Smith & Nephew PEEK Interference Screws
As this submission is for a physical medical device (interference screws) and not an AI/ML-based device, the concept of "acceptance criteria" in the AI/ML context (e.g., sensitivity, specificity, AUC) and associated studies (e.g., MRMC, standalone algorithm performance) are not applicable. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness through performance testing.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary Performance Data) |
|---|---|
| Intended Use: Device performs the same function as predicates. | The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone, matching the intended use of predicate devices. |
| Technological Characteristics: Similar materials, design, and function as predicates. | Composed of non-absorbable PEEK material; cannulated screws for fixation of ligament/tendon/soft tissue grafts to bone in various joints. Similar to predicate devices. |
| Safety & Effectiveness: Device is as safe and effective as predicates. | Performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew PEEK Interference Screws are substantially equivalent to the Smith & Nephew Bioraptor 2.3PK and the Arthrex Interference Screw. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not specified for "test set" in an AI/ML sense. The document refers to "performance testing" but does not detail the sample sizes for these tests (e.g., number of screws tested, type of mechanical tests conducted).
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective for this type of performance testing. Such details are typically found in more comprehensive test reports, not the 510(k) summary itself.
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" in the AI/ML sense (e.g., expert consensus on image interpretation) is not relevant for a physical medical device. Performance testing for this device would involve engineering and mechanical tests (e.g., pull-out strength, insertion torque), not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are specific to interpretative tasks, typically in AI/ML or clinical trial settings where agreement among experts is crucial for establishing ground truth or evaluating outcomes. This device's testing would not involve such a process.
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. MRMC studies are exclusively for evaluating diagnostic or screening systems where human readers interpret medical cases, often with and without AI assistance. This device is a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This question pertains to the performance of an AI algorithm operating independently of human input. The Smith & Nephew PEEK Interference Screws are a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. For this device, "ground truth" would be established by validated engineering standards, biomechanical testing protocols, and mechanical measurements (e.g., force, torque, displacement) to assess properties like insertion force, pull-out strength, and resistance to fracture or bending. These are objective measurements, not expert consensus on an interpretation.
8. The sample size for the training set:
- Not applicable. There is no "training set" for a physical device like this. Training sets are used in machine learning to teach an algorithm.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.