(89 days)
The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the 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
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicylitis repair
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
Foot and Ankle
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is nonabsorbable 2.3 mm suture anchor manufactured from PEEK and comes preloaded with non-absorbable ultra high molecular weight braided polyethylene #2 suture preassembled to a flexible stainless steel inserter.
The provided text describes the 510(k) summary for the BIORAPTOR Curved 2.3 PK Suture Anchor. It details the device's intended use and a comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, which are common for AI/ML devices.
This document pertains to a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence to a predicate device through functional testing (insertion, pull out, suture slide properties). The questions posed are more relevant to the evaluation of AI/ML-based medical devices.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative targets. | "The performance testing demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any performance testing.
- Data Provenance: Not specified. This typically refers to the source of patient data for AI/ML models, which is not applicable here as it's a physical device.
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)
- Number of Experts & Qualifications: Not applicable. Ground truth for physical device performance (like pull-out strength) is typically established through direct measurement and engineering standards, not expert consensus as would be the case for image interpretation or diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in expert opinions, which is not described for this physical device 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
- MRMC Study: No. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a suture anchor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This refers to the performance of an AI algorithm on its own, without human interaction. This is not applicable to a physical suture anchor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For physical device testing, "ground truth" would be established through direct physical measurements of properties such as insertion force, pull-out strength, and suture slide characteristics using standardized testing methods. The document states "performance testing demonstrates that the insertion, pull out and suture slide properties... are substantially equivalent."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. There is no AI/ML algorithm being "trained" for this physical device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. (See answer to #8).
Summary of the Study:
The provided document describes a non-clinical performance study to demonstrate substantial equivalence of the BIORAPTOR Curved 2.3 PK Suture Anchor to its predicate device, the BIORAPTOR 2.3 PK Suture Anchor (K071586).
- Acceptance Criteria (Implicit): The implicit acceptance criterion is that the new device's "insertion, pull out and suture slide properties" are "substantially equivalent" to those of the predicate device. This typically means the measured values for these properties fall within acceptable ranges or demonstrate similar statistical distributions compared to the predicate.
- Study Design: Performance testing was conducted.
- Reported Performance: The testing "demonstrates that the insertion, pull out and suture slide properties of the BIORAPTOR Curved 2.3 PK anchors are substantially equivalent to the Smith & Nephew BIORAPTOR 2.3 PK anchors."
- Key takeaway: This is a submission for a physical medical device, not an AI/ML device, hence the lack of information pertaining to AI/ML specific evaluation criteria.
§ 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.