(79 days)
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Hip: Hip capsule repair - Acetabular labrum reattachment/reconstruction Shoulder: Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff 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 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 Elbow, Wrist, and Hand: Lateral epicondylitis repair Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions
Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.
The provided document is a 510(k) summary for Smith & Nephew suture anchors, seeking to expand their indications for use. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a new study with performance metrics.
Therefore, many of the requested sections related to acceptance criteria, device performance from a test set, expert involvement, and ground truth are not explicitly available in the provided text. The submission relies on the prior clearances and the inherent characteristics of the device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that "Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence." This implies that the acceptance criteria for these mechanical properties were met in the original clearances of the predicate devices, and because there have been no changes to the design or materials, they are still considered met.
| Acceptance Criteria (Implied from Predicate Devices) | Reported Device Performance (Implied from Predicate Devices) |
|---|---|
| Sufficient insertion strength | Met (based on prior clearances of predicate devices) |
| Sufficient pull-out strength | Met (based on prior clearances of predicate devices) |
| Acceptable suture sliding characteristics | Met (based on prior clearances of predicate devices) |
| No significant changes in design or materials compared to predicate devices | Confirmed: "There have been no major changes in design or materials..." |
| No additional risk introduced by expanded indication (acetabular labrum reconstruction) | Confirmed: "...the expansion of indications for use to include labral reconstruction introduces no additional risk..." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission doesn't describe a new study with a "test set" for performance evaluation in the context of diagnostic accuracy or a similar measurable outcome. The "test set" implicitly refers to the mechanical testing performed for the original clearances of the predicate devices. The document does not provide details on the sample sizes or data provenance (country of origin, retrospective/prospective nature) of these original mechanical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. There is no mention of experts establishing a "ground truth" for a test set in this 510(k) submission. The evaluation is based on mechanical properties and substantial equivalence to previously cleared devices.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is described for a test set in this submission.
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. This is a medical device for surgical procedures (suture anchors), not an AI-assisted diagnostic tool. An MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device (suture anchors) is established through mechanical testing (e.g., measuring forces required for insertion, pull-out, and suture sliding) against engineering specifications and industry standards, and ultimately, through clinical outcomes data from the use of the device and its predicates. The submission references reliance on "mechanical testing" for the predicate devices and "published articles supporting the additional indication," suggesting that the clinical effectiveness and safety of such devices are established in the medical literature.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/machine learning device.
§ 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.