(92 days)
The Extremity All Suture System is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
The Extremity All Suture System (EASS) includes the Griplasty™ System – Base of Thumb and Griplasty™ System – Micro, Mini and Small Suture Anchor. The system incorporates soft tissue fixation devices; 'all suture' anchors with an expandable push-in design, provided preloaded in an inserter handle with associated single-use instruments, and supplied sterile (ethylene oxide) for single use. The EASS anchors are constructed from a hollow braid with a suture component assembled through the hollow braid.
All sutures, inclusive of suture line and anchor, are made with non-absorbable Ultra High Polyethylene (UHMWPE) per ASTM F2848. All needles are made with Stainless Steel per ASTM F899. The instrumentation is made stainless steel and medical grade Acrylonitrile Butadiene Styrene (ABS). The anchor and impacted into a pilot hole. The sutures are manually tensioned to set the anchor by bunching the suture sleeve.
Griplasty" System – Base of Thumb: Comprises a suture anchor implant (with or without needles) and associated instrumentation for use in carpometacarpal (CMC) joint arthroplasty.
Griplasty" System – Micro, Mini and Suture Anchor: Comprises a range of all suture anchor implants (with or without needles) and associated instrumentation for use in securing soft tissue to bone.
The provided text describes the "Extremity All Suture System" (EASS) and its mechanical testing for FDA 510(k) clearance. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on worst-case anchors) | Reported Device Performance (Worst-case anchors) |
|---|---|
| Pulled-out load non-inferior to predicate devices of similar size. | Demonstrated non-inferior (i.e. similar / 'substantially equivalent') pull-out load and performance compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of anchors tested, but it mentions testing the "worst-case size anchors."
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It is implied to be a prospective, lab-based mechanical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a mechanical testing study, not a study requiring expert clinical judgment for ground truth. The "ground truth" was established by engineering analysis and direct measurement of pull-out force.
4. Adjudication Method for the Test Set
Not applicable. This was a mechanical testing study, not a study requiring adjudication of expert opinions.
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 device is a surgical fixation system, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical fixation system, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for the mechanical testing was the measured pull-out load of the anchors, determined through standardized mechanical tests (as per FDA Guidance Document for Suture Anchors, ASTM F543-17, and ASTM F1839-08). The acceptance criteria for this ground truth were based on direct comparison to the performance of "similar sized predicate suture anchor devices."
8. The Sample Size for the Training Set
Not applicable. This device is a medical implant, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned for this device.
Study Details from the provided text:
- Study Type: Non-clinical mechanical testing.
- Objective: To demonstrate that the Extremity All Suture System (EASS) has a non-inferior pull-out load compared to predicate devices.
- Methodology:
- Mechanical testing was performed on "worst-case size anchors" of the EASS.
- Tests were conducted following the FDA Guidance Document for Suture Anchors, ASTM F543-17, and ASTM F1839-08.
- Engineering analysis identified the smallest anchor as the ""worst-case" (least resistance to pull-out force).
- Statistical analysis and comparison of subject and predicate device pull-out loads were performed.
- Results: The study "showed the subject device to have non-inferior (i.e. similar / 'substantially equivalent') pull-out load and performance as the predicate devices."
§ 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.