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

The Mitek Absorbable Toggle Anchor is cylindrical/conical in shape with an overall length of 0.44" x 0.11" in diameter. The Mitek Absorbable Toggle Anchor is molded from Poly-lactiac (PLA). Fixation of USP #2 suture below bone surface using unique design, insertion techniques, and materials.

AI/ML Overview

Here's an analysis of the provided text regarding the Mitek Absorbable Toggle Anchor, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary (K964013) for a medical device submitted in 1997. This type of submission generally relies on demonstrating substantial equivalence to a predicate device rather than extensive new clinical trials with detailed statistical designs and human reader performance assessments as you might find for novel or higher-risk devices today. Therefore, many of your requested criteria, particularly related to clinical performance, multi-reader studies, and detailed ground truth methodologies, are not explicitly, or at all, addressed in this specific document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence: The device should "hold" tissue with sutures locked into a predrilled bone hole for a period of rehabilitation, similar to predicate devices.	The document states the device is "similar to all other Mitek Anchors in use and function, i.e., to 'hold' tissue, with sutures that are locked into a predrilled bone hole, for a period of rehabilitation." This implies the functional requirement is met by similarity.
Mechanical Strength (Pull-Out Force): The anchor must withstand a certain load before failure when implanted in bone. (No specific threshold is stated as an "acceptance criterion" in this document, but a performance metric is provided.)	In pull tests from cadaver bone, the device achieved an "average failure load of 32 pounds."
Material Equivalence: The device should be made of a similar material to predicate devices, suitable for absorbable applications.	The device is molded from Poly-lactic acid (PLA), and the document states it is "similar to the Mitek Stealth and Wedge Anchor in materials."
Intended Use Equivalence: The device should be intended for similar orthopedic repair applications as predicate devices.	The intended uses (Rotator Cuff repair, Capsule shift/capsulo-labral reconstruction, various ligament repairs in the knee and ankle Achilles tendon repair/reconstruction) are listed, implying equivalence in scope to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for the "pull tests from cadaver bone." It refers to "cadaver bone" generally, not a specific number of anchors or cadavers.
Data Provenance: "Cadaver bone." Information on country of origin, retrospective or prospective nature is not provided. It's an in vitro (or ex vivo) test, not a clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This concept is not applicable to the type of testing described (mechanical pull tests). Ground truth for mechanical tests is typically based on objective physical measurements (e.g., force transducers) rather than expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. Mechanical pull tests do not involve human interpretation or adjudication in the way clinical studies or image-based diagnostic evaluations do.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No such study was done or reported. This document is for a 510(k) submission for a fixation device, not an imaging or diagnostic device that would typically involve MRMC studies. The device itself does not involve "human readers" in its intended use.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Not applicable. This is a physical orthopedic implant, not an algorithm or AI system.

7. Type of Ground Truth Used

Mechanical Measurement / Observed Failure Load: For the pull tests, the "ground truth" is the observed force at which mechanical failure (pull-out) occurred, measured by a testing apparatus.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set." The materials and design are based on established engineering principles and prior device history.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set for an AI/ML model. The design and material choices would have been informed by general engineering knowledge, biomechanical principles, and performance of predicate devices.

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.