Search Results

The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Hip

• Hip capsule repair
• Acetabular labrum reattachment

Shoulder

• Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral reconstructions
• Acromioclavicular separation repairs
• Deltoid repairs
• Rotator cuff tear repairs
• Biceps tenodesis

Foot and Ankle

• Hallux valgus repairs
• Medial or lateral instability repairs/reconstructions
• Achilles tendon repairs/reconstructions
• Midfoot reconstructions
• Metatarsal ligament/tendon repairs/reconstruction
• Bunionectomy

Elbow, Wrist and Hand

• Bicens tendon reattachment
• Ulnar or radial collateral ligament reconstructions
• Lateral epicondylitis repair
• Tennis elbow repair
• Scapholunate ligament reconstruction

Knee

• Extra-capsular repairs:
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
• Patellar realignment and tendon repairs Vastus medialis obliquous advancement
• Iliotibial band tenodesis

The Foundry NewcoXI Cincher-2.6 Suture Anchor is intended for single-use only.

The Cincher-2.6 Suture Anchor consists of a PEEK polymer suture anchor preloaded with a #2 polyethylene suture, loaded on an insertion tool. The Cincher-2.6 Suture Anchor is designed to facilitate fixation of soft tissue to bone. The design allows the surgeon to adjust the suture tension on the soft tissue after insertion of the anchor into bone. The device is provided sterile.

The provided text describes the Cincher-2.6 Suture Anchor, a medical device for soft tissue fixation to bone. The information primarily focuses on its substantial equivalence to predicate devices and results from non-clinical bench testing.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996) and focus on mechanical performance.

Study Proving Acceptance Criteria:

A series of non-clinical bench studies were conducted to evaluate the anchor performance. These studies demonstrated that the Cincher-2.6 Suture Anchor meets the design specifications for the listed performance criteria.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not specified in the provided document. The text only mentions "bench studies" without detailing the number of units tested.
• Data Provenance: The studies were non-clinical bench tests. The country of origin of the data is not explicitly stated, but the submission is to the US FDA by a company with a US address, suggesting the testing was likely conducted in the US or under US regulatory standards. The data is not applicable as retrospective or prospective since it refers to device testing, not patient data.

3. Number and Qualifications of Experts for Ground Truth

• This section is not applicable. The studies described are non-clinical bench tests evaluating the mechanical properties of a device, not studies involving interpretation of data by human experts for establishing ground truth as would be relevant for an AI/CAD device.

4. Adjudication Method

• This section is not applicable for the same reasons as point 3.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for AI/CAD devices assessing human performance with and without AI assistance, which is not the nature of this medical device.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone algorithm performance study was not conducted or described. This device is a physical medical implant, not an AI algorithm. The performance described is the standalone mechanical performance of the physical device itself.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical bench studies was based on engineering specifications and recognized test standards outlined in the FDA Guidance Document for Testing Bone Anchor Devices. This means the performance was measured against predefined acceptable ranges and thresholds for mechanical properties (e.g., minimum pull-out strength, maximum displacement).

8. Sample Size for the Training Set

• This section is not applicable. The device is a physical suture anchor, not an AI algorithm that requires a training set.

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

• This section is not applicable for the same reasons as point 8.

Ask a specific question about this device