(44 days)
The Smith & Nephew Knotless Instability Anchor is intended for use in the attachment or reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum reattachment)
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
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs ( Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
The Smith & Nephew Knotless Instability Anchor is a tap in anchor that is manufactured from PEEK and comes pre-assembled on an inserter, sized appropriately to facilitate both hip and shoulder procedures. The device allows for knotless tissue attachment and reapproximation in surgical repairs of soft tissue to bone.
The provided document is a 510(k) Summary for the Smith & Nephew Knotless Instability Anchor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with detailed acceptance criteria and standalone performance studies typically seen with AI/ML medical devices.
Therefore, the information requested regarding acceptance criteria, study design for AI evaluation (sample size for test/training, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) is not applicable and not present in this document.
Instead, the document focuses on biomechanical equivalence to predicate devices. Here's what can be extracted:
Device Performance and Equivalence Study
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a physical medical device, not an AI/ML diagnostic, there are no specific "acceptance criteria" in the sense of accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" for this device are demonstrating substantial equivalence in biomechanical parameters to predicate devices.
| Performance Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Biomechanical | Substantially equivalent to the corresponding parameters of the predicate devices: Smith & Nephew BIORAPTOR 2.3PK, TwinFix FootPrint PK, and Mitek BioKnotless. | "The performance testing demonstrates that the biomechanical parameters of the Smith & Nephew Knotless Instability Anchor are substantially equivalent to the corresponding parameters of the Smith & Nephew BIORAPTOR 2.3PK(K071586), the Smith & Nephew TwinFix FootPrint PK(K073509), and the Mitek BioKnotless (K002639)." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided summary. Biomechanical testing typically involves a number of samples for each test (e.g., specific number of anchors for pull-out strength).
- Data provenance: Not specified. This would typically be laboratory-based biomechanical 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, in the context of AI/ML, refers to expert-validated labels. For a physical device's biomechanical testing, "ground truth" would be the measured physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are for resolving discrepancies in expert labeling or diagnoses, which is not relevant for biomechanical 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 relevant for a physical medical device. MRMC studies are for evaluating diagnostic performance, especially with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not relevant for a physical medical device as there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biomechanical testing, the "ground truth" is typically the objective measurement of physical properties (e.g., tensile strength, pull-out force, stiffness) under controlled laboratory conditions, using calibrated equipment and standardized testing protocols.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for a physical medical device; this concept is specific to machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is irrelevant.
§ 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.