(224 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 one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only.
The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively.
The provided document is a 510(k) premarket notification for a medical device called "Fixone All Suture Anchor." This document primarily deals with the substantial equivalence of a new version of the suture anchor to previously cleared predicate devices. It focuses on engineering and biocompatibility testing rather than clinical study data involving AI or human readers evaluating image-based diagnostics.
Therefore, the information required to answer the prompt regarding acceptance criteria and study that proves the device meets the acceptance criteria, specifically related to AI in a clinical setting (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details), is not present in the provided text.
The document discusses acceptance criteria and proof of mechanical performance and biocompatibility for the suture anchor. Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical & Biocompatibility)
Please note that the acceptance criteria are generally implied by the "Requirements" column and "Pass" result, indicating the device met those requirements. Specific numerical requirements are given where applicable.
Anchor Performance
| Test Item | Requirements | Reported Device Performance |
|---|---|---|
| Insertion Strength | Insert each anchor with 5mm/min rate into 10pcf/40pcf combined urethane block. | Pass |
| Pull-out (FAS-1652802iw) | Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined urethane block. | Pass |
| Fatigue test (FAS-1652802iw) | Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 cycles from 10pcf/40pcf combined urethane block. | Pass |
| Pull-out (FAM-7615802fg) | Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined urethane block. | Pass |
| Fatigue test (FAM-7615802fg) | Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 cycles from 10pcf/40pcf combined urethane block. | Pass |
Suture Performance (USP 0, UHMWPE)
| Test Item | Requirements | Reported Device Performance |
|---|---|---|
| Appearance | The test article shall be no damage to the appearance in visual inspection. | Pass |
| Length | The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm. | Pass |
| Tensile Strength | For USP 0 size suture, tensile strength must be larger than 2.16 kgf. | Pass |
| Needle Attachment | For USP 0 size suture, needle attachment must be larger than 1.50 kgf. | Pass |
Suture Performance (USP 2, UHMWPE)
| Test Item | Requirements | Reported Device Performance |
|---|---|---|
| Length | The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm. | Pass |
| Tensile Strength | For USP 2 size suture, tensile strength must be larger than 3.52 kgf. | Pass |
Suture Performance (USP 0, USP 2, UHMWPE)
| Test Item | Requirements | Reported Device Performance |
|---|---|---|
| Appearance | The test article shall be no damage to the appearance in visual inspection. | Pass |
| Diameter | For USP 0 size suture, diameter must be within 0.35 | Pass |
| Tensile strength | With 25~35cm/min, record the load-displacement curves and maximum load. (N) | Pass |
Biocompatibility (UHMWPE + PET)
| Test Item | Test Method / Test Criteria | Reported Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Genotoxicity test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
| Subchronic toxicity | ISO 10993-11 Tests for systemic toxicity | Pass |
Biocompatibility (Only UHMWPE)
(Same tests and results as UHMWPE + PET table, excluding PET interaction)
| Test Item | Test Method / Test Criteria | Reported Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Genotoxicity test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
| Subchronic toxicity | ISO 10993-11 Tests for systemic toxicity | Pass |
Sterilization/Endotoxin
| Test Item | Test Method / Test Criteria | Reported Result |
|---|---|---|
| Endotoxin test | USP 43 , Bacterial endotoxin test (LAL) | Pass |
2. Sample size used for the test set and the data provenance:
This information is not provided in the context of an AI/image-based diagnostic test set. The document refers to "bench tests" performed on physical samples of the anchors and sutures. The number of samples for each mechanical test is not specified, only that "each anchor" or "the test article" was evaluated. The data provenance is implied to be from AJU Pharm Co., Ltd.'s internal testing, likely at their facility or a contracted lab. No country of origin for this specific testing data is given, but the company address is in South Korea (A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea). The data is retrospective of the device design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device (mechanical and biocompatibility testing). Ground truth is established by objective physical measurements and standardized biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical tests: Physical measurements against engineering specifications (e.g., tensile strength, length, diameter, pull-out force).
For biocompatibility tests: Standardized laboratory assays with pass/fail criteria based on ISO standards.
For sterilization/endotoxin: Standardized laboratory assays (e.g., LAL test) with pass/fail criteria.
8. The sample size for the training set:
Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.