(96 days)
The GRAPPLER™ Suture Anchor System is intended for the fixation of soft tissue to bone including:
Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC
Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Chrisman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid Repair, Spring Ligament Reconstruction), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair
Hip: Capsular Repair, Acetabular Labral Repair
The GRAPPLER™ Suture Anchor System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in PEEK, titanium, and suture materials in multiple sizes and lengths. Each anchor is accompanied by round suture or suture tape composed of UHMWPE and PGLA.
This document is for a medical device called the "GRAPPLER™ Suture Anchor System," which is a physical device used to fix soft tissue to bone. It is not an AI/ML powered device, and therefore, does not have the types of acceptance criteria and study designs that would typically apply to such devices (e.g., diagnostic performance metrics like sensitivity, specificity, AUC, or MRMC studies for human-in-the-loop performance).
The document details the substantial equivalence determination for this device, comparing it to legally marketed predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and material testing to ensure the device performs as intended and is safe, rather than clinical performance studies measuring diagnostic accuracy or reader improvement.
Analysis of Acceptance Criteria and Device Performance (Based on Provided Text):
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not present the acceptance criteria in a formal table with specific numerical values or targets. Instead, it describes the types of tests performed and states that "All performance testing conducted for the GRAPPLER™ Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable."
Here's an interpretation based on the text:
| Acceptance Criteria Category | Description of Performance Test | Reported Outcome |
|---|---|---|
| Mechanical Performance | Torsional strength | Met predetermined acceptance criteria |
| Insertion/removal torque | Met predetermined acceptance criteria | |
| Pullout testing | Met predetermined acceptance criteria | |
| Tensile testing | Met predetermined acceptance criteria | |
| Shelf Life/Stability | Real-time aging events | Validated |
| Accelerated aging events | Validated | |
| Seal strength evaluation | Validated | |
| Visual inspection | Validated | |
| Dye penetration evaluation | Validated | |
| Pressurization evaluations | Validated | |
| Sterility & Biocompatibility | Bioburden testing | Validated |
| Bacterial endotoxin (LAL) testing | Verified (for pyrogenicity) |
Notes:
- The document states: "The device performance was characterized via torsional strength, insertion/removal torque, pullout testing and tensile testing."
- "Device shelf life was validated through real time and accelerate aging events assessed with seal strength, visual inspection, dye penetration, pressurization evaluations."
- "Device sterility was validated through bioburden testing. Pyrogenicity was verified through bacterial endotoxin (LAL) testing."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample sizes (e.g., number of anchors tested) for each of the performance tests (torsional strength, tensile, etc.). It only mentions that "All testing was performed on finished devices."
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The data provenance refers to the results of in-house or contracted laboratory mechanical and material testing. The country of origin of this testing data is not specified. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This is a physical device, and its acceptance criteria are based on engineering and material performance standards, not on expert consensus for clinical interpretations or diagnoses.
4. Adjudication Method for the Test Set:
- Not applicable. Ground truth for mechanical testing is established by direct measurement against engineering specifications, not through expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is typically performed for AI-powered diagnostic devices to assess how the AI assists human readers. This device is a physical surgical implant, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The "standalone performance" refers to the mechanical and material performance of the device itself (e.g., its tensile strength, resistance to torque), which was indeed assessed through the tests mentioned.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's acceptance is based on engineering specifications and established material and mechanical testing standards. For example, a suture anchor must withstand a certain pullout force, or its material must have a certain tensile strength. These are objective, measurable criteria, not subjective interpretations.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth establishment process.
Summary for this Specific Device:
The provided document is a 510(k) clearance letter for a physical medical device (suture anchor). The "acceptance criteria" and "study" described pertain to engineering and material performance testing, rather than clinical diagnostic performance or AI model validation. The FDA granted clearance based on the device demonstrating substantial equivalence to existing predicate devices, supported by data showing it meets relevant mechanical, material, sterility, and shelf-life requirements. The type of information requested in the prompt (e.g., MRMC studies, training/test sets for AI, expert adjudication) is typically relevant only for AI/ML-powered medical 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.