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

The Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor, Knotless Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Apollo Suture Anchor System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human readers or AI.

Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and human-in-the-loop performance are not applicable to this type of regulatory submission and are not found in the provided text.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, AUC for AI, or improvement in human reader performance). Instead, it relies on demonstrating equivalence through various engineering and material tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility (ISO 10993-1)	"Biocompatibility was established according to ISO 10993-1."
Bacterial Endotoxins (for implantable components)	"Bacterial Endotoxin testing meets pyrogen limit specifications." (Determined using LAL testing).
Mechanical Performance (Axial Pull-Out)	"Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk." (The implicit acceptance criterion is that the performance is comparable to or better than the predicate, or at least not worse, suggesting the material additive does not negatively impact the established mechanical properties.) The document doesn't state specific numerical pull-out strength values, but implies acceptable performance.
Material Equivalence (Solvay Zeniva PEEK)	The materials (Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK) "share a MAF" (Master Access File, indicating they are known and acceptable materials). The additional configurations of Solvay Zeniva PEEK (ZA-600 and ZA-600 CF) are considered substantially equivalent to the predicate.
Suture Equivalence (UHMWPE)	An additional UHMWPE suture manufacturer is proposed, and its sutures "have been demonstrated to be substantially equivalent to those used in the predicate device."
Sterilization and Shelf-Life	"The subject and predicate devices are offered sterile (EtO), and have a shelf-life of 2 years." (Implicitly, the device successfully maintains sterility and functionality for this duration).
Intended Use & Indications for Use Equivalence	The device is intended for the "same indications" and "same fundamental technology" as the predicate. The Indications for Use are explicitly listed for various anatomical regions and repairs (Shoulder, Foot/Ankle, Knee, Elbow, Hip, Wrist/Hand). The acceptance is that the device can safely and effectively be used for these stated indications, similar to the predicate.
Overall Substantial Equivalence	"Based on the intended use, indications for use, technological characteristics, and comparison to the predicate device, the Subject device has been shown to be substantially equivalent to the legally marketed predicate device and is safe and effective for the intended use."

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

This document describes a 510(k) submission based on bench testing (e.g., mechanical, biocompatibility) and comparison to a predicate device, not a clinical test set with patient data for an AI/device performance study. Therefore, there's no "test set" in the context of a dataset of patient cases. The "samples" would refer to the physical devices or materials used for the specified laboratory tests. The provenance is internal testing by Valeris Medical.

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

Not applicable. As this is not an AI or diagnostic device that requires expert review of clinical images/data for ground truth.

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

Not applicable. No clinical case adjudication process described.

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 not an AI-assisted device.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this type of device lies in:

Material properties and standards: e.g., ASTM F2026 for PEEK, ISO 10993-1 for biocompatibility, ASTM F543-17 for mechanical testing.
Predicate device's established performance: The predicate's prior clearance serves as a benchmark for safety and effectiveness.
Laboratory test results: Measuring physical properties like pull-out strength and endotoxin levels against pre-defined specifications.

8. The sample size for the training set:

Not applicable. This is not an machine learning/AI device requiring a training set.

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

Not applicable.

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.