SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT by ARTHROCARE CORPORATION

The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of suture to tissue.

The SpeedLock HIP consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The SpeedLock HIP Knotless Fixation System also includes associated instruments for implanting the anchor into bone.

The design modification that is the subject of this Premarket Notification relates to the internal detachment feature of the SpeedLock HIP anchor. The modification does not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the device's cleared indications for use.

AI/ML Overview

The provided document is a 510(k) summary for the ArthroCare® Corporation SpeedLock® HIP Knotless Fixation Implant. It describes a modification to an already cleared device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing. It does not involve studies to establish clinical acceptance criteria or assess AI/human reader performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, expert opinions, and AI studies is not applicable to this document. The document explicitly states: "No clinical or animal data are included in this submission."

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states that "Design Verification testing to demonstrate conformance with device specifications" was performed. This included:

Functional testing of all aspects of device performance.
Use of the device with ancillary devices.
Anchor deployment, bone lock, and suture lock in a foam bone model.
Insertion testing in a simulated hard bone substrate.
Side-by-side comparative testing of the modified and predicate devices, including static and cyclic suture and anchor pull testing, as well as elements of standard verification testing.

Acceptance Criteria and Reported Performance (Based on provided text)

Acceptance Criteria Domain	Reported Device Performance/Conclusion
Device Specifications	"conformance with device specifications"
Functional Performance	"functional testing of all aspects of device performance" (met)
Ancillary Device Compatibility	"use of the device with ancillary devices" (met)
Anchor Deployment	Demonstrated in foam bone model (met)
Bone Lock	Demonstrated in foam bone model (met)
Suture Lock	Demonstrated in foam bone model (met)
Insertion Performance	Successfully performed in simulated hard bone substrate (met)
Static Suture/Anchor Pull Test	"side-by-side comparative testing" demonstrated substantial equivalence to predicate
Cyclic Suture/Anchor Pull Test	"side-by-side comparative testing" demonstrated substantial equivalence to predicate
Design/Performance/Safety	"meets its design, performance, and safety specifications"
Substantial Equivalence	"performs substantially equivalently to the predicate SpeedLock HIP Knotless Fixation Implant."

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 for Test Set: Not specified. The document mentions "testing" (e.g., functional testing, insertion testing, side-by-side comparative testing) but does not provide specific sample sizes (e.g., number of anchors tested, number of cycles).
Data Provenance: The testing appears to be primarily laboratory-based mechanical and functional testing, not data from human or animal subjects. No country of origin is mentioned for the "data," but the submitter is based in Austin, TX, USA.
Retrospective or Prospective: Not applicable as it's non-clinical, mechanical 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. This submission focuses on engineering and mechanical testing, not clinical performance or diagnostic accuracy. Ground truth in the traditional sense for medical imaging or clinical diagnosis is not relevant here. The "truth" would be the measured mechanical properties and functional performance against predefined engineering specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation (e.g., by human readers). This document describes non-clinical, objective mechanical 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

Not applicable. No MRMC study was performed. The device is a surgical implant, not a diagnostic tool utilizing AI. The document explicitly states: "No clinical or animal data are included in this submission."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing, the "ground truth" would be defined by engineering specifications, material properties, and established test standards for mechanical performance (e.g., force required for pull-out, number of cycles before failure, successful deployment of anchor).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary

Regulation Number and Section

§ 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.