(445 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
Fixone All suture anchor consists of one "fix Suture" and two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE and PET fibers. Fixone All suture anchor is implanted using its self-punching option. They are pre-loaded on a handled insertion device is provided sterile, for single use only. This device is medical device. Prescription use only. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 4 models. It provide non-sterile (user must sterilization before use).
The provided text describes a 510(k) premarket notification for a medical device called "Fixone All Suture Anchor." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria for AI/ML performance.
The document details bench testing for the physical device, including mechanical properties and biocompatibility, but does not describe an AI/ML-based device or a study involving AI/ML performance. Therefore, most of the requested information regarding AI/ML acceptance criteria, test sets, expert ground truth, MRMC studies, or AI algorithm-only performance cannot be extracted from this text.
The "Performance data" section (Section 6) refers to laboratory bench tests for the physical product, not a study evaluating an AI/ML component.
Therefore, I cannot provide the requested information regarding AI/ML validation studies from the given input.
The document states:
- Device: Fixone All Suture Anchor
- Purpose: Reattach soft tissue to bone in orthopedic surgical procedures.
- Nature of evidence provided for FDA clearance: Bench testing (mechanical and biocompatibility) comparing it to a predicate device (K133224, ConMed Corporation / Y-Knot RC All-Suture Anchor w/Two and Three #2).
If this question was mistakenly associated with an AI/ML device, and the intent was to ask about the acceptance criteria and studies for this physical medical device, here's what can be inferred:
Acceptance Criteria and Study for Fixone All Suture Anchor (Physical Medical Device)
Based on the provided FDA 510(k) summary, the device is a physical suture anchor, not an AI/ML diagnostic or therapeutic device. The "acceptance criteria" here refer to demonstrating substantial equivalence through various bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Requirements (Acceptance Criteria) | Results (Reported Performance) |
|---|---|---|
| Physical/Mechanical Tests | ||
| Surface | When examined by normal vision, the surface shall be free from defects. | Pass |
| Nominal size (Exclude suture) | When tested by Vernier calipers, micrometer or tapeline, the measurement should be in accordance with standard. | MD201 |
| 8-00210 (Implies it met the standard) | ||
| Insertion test (Comparison with predicate) | Must perform in a substantially equivalent manner to the predicate device in 10pcf/40pfc Polyurethane block, self-punching, @ 90° implantation angle. | Results provided (AJU_M, implying successful comparison with predicate "Yknot") |
| Pull-out test (Comparison with predicate) | Must perform in a substantially equivalent manner to the predicate device in 10pcf/40pfc Polyurethane block, self-punching, @ 90° pull-out angle with MTS Bionix servohydraulic tester. | Results provided (D20201 |
| 006_PT( | ||
| Js, Yknot), implying successful comparison with predicate "Yknot") | ||
| Fatigue test (Comparison with predicate) | Must perform in a substantially equivalent manner to the predicate device in 10pcf/40pfc Polyurethane block, self-punching, with same cycle loading and rate. | Results provided (Js, Yknot), implying successful comparison with predicate "Yknot") |
| Biocompatibility Tests | ||
| Cytotoxicity | ISO 10993-5 (Tests for in vitro cytotoxicity) | Pass |
| Systemic toxicity test | ISO 10993-11 (Tests for systemic toxicity) | Pass |
| Pyrogen Test | ISO 10993-11 (Pyrogen test) | Pass |
| Intracutaneous reactivity test | ISO 10993-10 (Tests for irritation and skin sensitization) | Pass |
| Maximization sensitization | ISO 10993-10 (Maximization test for delayed hypersensitivity) | Pass |
| Genotoxicity test | ISO 10993-3, OECD 471 (Bacterial reverse mutation test) | Pass |
| Implantation test | ISO 10993-6 (Tests for local effects after implantation, Annex D test for implantation in bone) | Pass |
| Hemolysis test | ISO 10993-4 (Selection of tests for interactions with blood) | Pass |
| Subchronic toxicity | ISO 10993-11 (Tests for systemic toxicity) | Pass |
| Sterilization & Packaging | ||
| Sterilization | ISO 11135:2014 (Ethylene oxide sterilization requirements) | ME-SVP-1802 (Implies meeting the standard) |
| Shelf Life and Packaging | ISO11607-2 / EN 868-5 / ASTM F1980-16 / ASTM F88-15 / ASTM F1929:1998 | AJ-SL1702 (Implies meeting the standard) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the mechanical tests (Insertion, Pull-out, Fatigue), the text explicitly states "10pcf/40pfc Polyurethane block." This refers to specific foam densities used for testing bone-like properties. While it mentions "10pcf/40pfc," it doesn't specify the number of samples (individual devices) tested for each condition. For biocompatibility tests, typically multiple replicates are used, but specific numbers are not provided.
- Data Provenance: The tests were "Bench tests," meaning laboratory-based experimental data. No information about country of origin for the "data" itself, as it's not patient-derived data. The manufacturer is AJU Pharm Co., Ltd. from Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is for a physical device and involves objective measurements in a lab setting (e.g., force, dimensions, biological reactions based on ISO standards), not expert interpretation of complex data (like medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Ground truth is established through standardized laboratory testing parameters and measurements, not subjective expert opinion requiring adjudication.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- "Ground truth" for this device is based on objective physical and chemical measurement standards and comparison to the established performance of a legally marketed predicate device. For instance, the ISO 10993 series for biocompatibility provides the "ground truth" criteria.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.