Search Results

The Javelot Ti and Javelot Ti-D Suture Anchor are intended for connection and fixation of soft tissue to bone in the knee, hip, shoulder, elbow, ankle, foot, wrist and hand for the following indications: Shoulder: - · Bankart lesion repair - · SLAP lesion repair - · Acromio-clavicular separation repair - · Rotator cuff tear repair - · Capsular shift or capsulolabral reconstruction - · Biceps tenodesis - · Deltoid repair Foot and Ankle: - Hallux valgus repair - · Medial or lateral instability repair/reconstruction - · Achilles tendon repair/reconstruction - · Midfoot reconstruction - · Metatarsal ligament/tendon repair/reconstruction Elbow, Wrist and Hand: - Ulnar or radial collateral ligament reconstruction - · Lateral epicondylitis repair - · Biceps tendon reattachment - · Scapholunate ligament reconstrontion (not for 4.5-6.5mm pro anchors) Knee: - · Extra-capsular repair - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - · Iliotibial band tenodesis - · Patellar realignment and tendon repair - Vastus medialis obliquus advancement Hip: (2.8-6.5mm anchors only) - · Capsular repair - · Acetabular labral repair

Javelot titanium anchors and sutures are preassembled onto an inserter, which enables insertion of the anchor into bone. After the anchor is fully seated, the inserter is removed from the implant site, leaving the anchor in the bone and the suture looped through the anchor. Javelot titanium suture anchors come in various configurations, including: with attached non-absorbable needle(s). In certain configurations, the Javelot titanium suture anchors are packaged with a drill, a drill guide and a drill guide handle. The anchors are offered in titanium material. The sutures are offered in non-absorbable USP braid Ultra High Molecular Weight Polyethylene (UHMWPE) material. The preassembled inserter consists of an insertion rod and an insertion handle, the insertion rods are offered in stainless steel material, the insertion handles are offered in polycarbonate (PC) material. The needles are offered in 302 stainless steel material, the drills are offered in 630 stainless steel material, the drill guides are offered in 304 stainless steel material, and the drill guide handles are offered in polyphenylsulfone (PPSU) material. Javelot titanium suture anchors are provided sterile, non-absorbable, for single use only.

The provided document is a 510(k) summary for a medical device (Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor), not a study report. Therefore, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study designed to meet those criteria for an AI/software device.

The requested information regarding acceptance criteria and a study proving the device meets them, particularly points 2-9 which are specific to the evaluation of AI/software performance, are not applicable to this submission. This document describes a physical medical device (suture anchors) and its performance is evaluated through bench testing (mechanical, biocompatibility, sterilization, shelf-life, and MRI safety), not through AI/software performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of what can be extracted from the provided text, recognizing that it doesn't align with the detailed AI/software performance study request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the standards and types of tests performed to demonstrate safety and effectiveness. The "reported device performance" refers to the successful completion of these tests in comparison to predicate devices, without specific numerical thresholds stated in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. These details would typically be found in the full test reports, which are not included here. The tests are bench tests, not clinical studies on patient data.

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 is a physical device, not an AI/software requiring expert adjudication for ground truth.

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

Not applicable, as this refers to expert review processes for AI/software data.

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 a physical device, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This does not involve an algorithm.

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

For mechanical tests, the "ground truth" would be the measured physical properties of the device under test conditions, evaluated against engineering specifications. For biocompatibility, it's compliance with established biological safety assessments. For sterilization, it's achieving a specified sterility assurance level. For MRI safety, it's adherence to defined safety limits for MR interaction. These are not types of ground truth relevant to AI performance.

8. The sample size for the training set

Not applicable. This is a physical device, no training data set is involved.

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

Not applicable. As there is no training set for a physical device.

In summary: The provided FDA 510(k) summary is for a physical medical device (suture anchors) and outlines the non-clinical bench testing conducted to demonstrate its substantial equivalence to predicate devices. The majority of the requested information pertains to the evaluation of AI/software performance, which is not relevant to this type of device submission.

Ask a specific question about this device