FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless BR Anchor is manufactured from "biocryl rapide" material.

AI/ML Overview

The provided document does not describe the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML device.

Instead, this document is a 510(k) summary for a medical device called the "HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm)". It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the performance of an AI/ML algorithm against predefined acceptance criteria.

The device in question is a physical bone anchor for soft tissue reattachment, not an AI/ML diagnostic or treatment planning system. Therefore, most of the requested information (like sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of medical device submission.

Here's the relevant information that can be extracted, framed within the context of a traditional medical device submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are tied to demonstrating that the new device (6.5mm anchor) performs similarly from a safety and effectiveness perspective to the predicate devices (4.75mm and 5.5mm anchors). The "reported device performance" are the results of non-clinical bench testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Device performance is comparable to predicate devices in terms of mechanical properties	Product Design Verification and Design Validation activities, such as:

Insertion Torque tests
Torque to Failure tests
Anchor Pullout tests
Results demonstrated that the proposed device is substantially equivalent to the predicate devices regarding performance and safety. (Specific numerical values or thresholds are not provided in this summary but would be in the full submission). |
| No new technological characteristics are introduced that would raise new safety/effectiveness concerns. | The proposed 6.5mm anchor has the same design principles and is manufactured from the same "biocryl rapide" material as the predicate 4.75mm and 5.5mm anchors. The only change is size. |

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as this is non-clinical bench testing. The "test set" would refer to the number of anchors or test specimens used for the mechanical tests (Insertion Torque, Torque to Failure, Anchor Pullout).
Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" comes from laboratory bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth in this context is determined by validated engineering test methods and measurements, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human readers.

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 device is not an AI/ML system.

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

Not applicable. This device is not an AI/ML system.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by validated engineering standards and measurement equipment for mechanical properties (e.g., torque, force).

8. The sample size for the training set

Not applicable. This device is not an AI/ML system.

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

Not applicable. This device is not an AI/ML system.

Summary

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.