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510(k) Data Aggregation
(30 days)
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
The Responsive Arthroscopy Mustang Knotless Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Report, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicylitis Repair
The Mustang and Mustang Knotless Suture Anchors are modified versions of the RA Large Screw-in Suture Anchors and the Large Push-In Suture Anchors, respectively, that were previously cleared under K180951. The Mustang and Mustang Knotless Suture Anchors are families of suture anchors intended for the fixation of soft tissue to bone. Both Mustang systems include two diameter sizes of suture anchors made of polyether ether ketone (PEEK) per ASTM F2026 along with repair suture tape, inserters, awls, and taps.
Both the Mustang and Mustang Knotless device families include several configurations that differ in anchor diameter and suture offerings to accommodate various procedures and patient anatomies.
The Mustang Suture Anchors will be offered in two diameter sizes (4.5 and 5.5mm) and are provided with either two #2 sutures or one 1.5 mm suture tape (4.5mm anchor); or three #2 sutures or two 1.5mm suture tapes (5.5mm anchor).
The Mustang Knotless Suture Anchors will be offered in two diameter sizes (4.75 and 5.5mm) and are designed to accept up to six #2 suture tails or two 1.5mm suture tape tails (4.75mm anchor); or up to eight #2 suture tails or four 1.5mm suture tape tails (5.5mm anchor). The Mustang Knotless Suture Anchors also feature a suture pull tab and an auxiliary #0 suture that holds the anchor in place until use.
The Mustang and Mustang Knotless Suture Anchors are pre-loaded on disposable inserters and provided sterile via ethylene oxide (EO).
The only differences between the subject devices and the predicate devices are considered minor and include modified anchor body geometry, modified anchor body dimensions, increase in the number of sutures or suture tapes compatible with the implants, modified internal locking screw geometry and dimensions, and the addition of vent holes to the anchor bodies. In addition, the subject Mustang Knotless Suture Anchor inserter has been modified slightly to correspond with the anchor changes. No other changes are being made to the inserters or other instrumentation that may be used during a procedure.
Here's a breakdown of the acceptance criteria and study information for the Responsive Arthroscopy Mustang Knotless Suture Anchors, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document unfortunately does not list specific numerical acceptance criteria or detailed numerical results for each test. Instead, it makes a general statement that "All testing met acceptance criteria and demonstrated that the devices met design specifications and performed as intended."
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Insertion Force Testing | Not explicitly stated (likely internal design specifications for ease of insertion and prevention of damage) | Met acceptance criteria, performed as intended |
| Insertion Torque Testing | Not explicitly stated (likely internal design specifications for secure placement and prevention of damage) | Met acceptance criteria, performed as intended |
| Cyclic Pullout Force Testing | Not explicitly stated (likely internal design specifications for mechanical durability and fixation strength over repeated loading) | Met acceptance criteria, performed as intended |
| Suture Locking Force Testing | Not explicitly stated (likely internal design specifications for secure suture retention under tension) | Met acceptance criteria, performed as intended |
2. Sample Sized Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions that "bench testing was performed on the subject devices" without detailing the number of units tested.
- Data Provenance: The studies were retrospective in the sense that they were conducted on the developed device. The data is internal to the manufacturer (Responsive Arthroscopy LLC) and generated through controlled bench testing rather than patient data. Country of origin for the data is implicitly the United States, given the company's location and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable as the studies conducted were bench testing (mechanical performance tests) on inert medical devices, not clinical studies involving patient data that would require interpretation by medical experts to establish a "ground truth." The ground truth for these tests is the physical measurement of force or torque.
4. Adjudication Method for the Test Set
This section is not applicable for the same reason as point 3. Bench testing results are objective measurements and do not typically involve adjudication by experts.
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
This section is not applicable. The device is a physical medical implant (suture anchors), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of improving human reader performance with AI are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a physical medical implant and does not involve any algorithms or AI for its function.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing mentioned in the document is the physical measurement of the mechanical properties of the suture anchors. This includes:
- Measurement of forces required for insertion.
- Measurement of torque generated during insertion.
- Measurement of resistance to cyclic pullout force.
- Measurement of force required for suture locking.
These are direct physical quantities measured using laboratory equipment, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical implant, not a machine learning model. Therefore, there is no concept of a "training set." The design and materials are based on established engineering principles and prior predicate devices.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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