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510(k) Data Aggregation
(57 days)
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25 may be used in either arthroscopic or open surgical procedures are anchored to the bone, both may be used to reattach soft tissue, such as ligant capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.
OTS 25 is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill bit; and drill guide are made of stainless steel; and drill guide obturator is made of polypropylene.The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use.
The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is an FDA 510(k) clearance letter for a medical device called "OTS 25," which is a non-absorbable suture anchor used to reattach soft tissue to bone. It focuses on demonstrating substantial equivalence to predicate devices, not on the performance of an AI system.
Therefore, I cannot provide the requested information from the given input.
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(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.
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(85 days)
The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation. Specific indications for the TenoTac® device include:
Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux malleus repair and reconstruction, metatarsal ligament/tendon repair and reconstruction including plantar plate attenuation and tear, and the correction of hammer toe, claw toe, mallet toe, crossover toe, floating toe, and any other lesser toe deformities, correction of metatarsophalangeal joint instability due to shortening from interphalangeal fusion, correction of metatarsophalangeal joint instability due to shortening from Weil osteotomy, Achilles tendon repair.
Hand & Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, tendon transfers in phalanx, Volar plate reconstruction.
The TenoTac® Soft Tissue Fixation System is manufactured from titanium alloy (Ti-6Al4V ELI per ASTM F136) and is comprised of specialized threaded tacks/male implants and associated threaded sleeves/female implants for attaching soft tissue to bone. The tacks and sleeves are available in various sizes and lengths to accommodate different bone sizes.
The provided document is a 510(k) premarket notification from the FDA for a medical device called the "TenoTac® Soft Tissue Fixation System." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical or non-clinical studies.
Therefore, the document explicitly states:
- "Neither clinical or non-clinical testing were necessary to support substantial equivalence of the subject device."
This means that the document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria in the way you've outlined for performance evaluation of a novel or significantly modified device, especially one involving AI or diagnostic performance.
The 510(k) process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, and that any differences do not raise new questions of safety or effectiveness. For the TenoTac® Soft Tissue Fixation System, the substantial equivalence was based on:
- Same intended use: Soft tissue to bone fixation.
- Same technological characteristics: It is a two-piece titanium tack and sleeve construct inserted on two ends of a bone canal, similar to the predicate TenoTac device. Differences in material and shape compared to a reference device (JuggerKnot) were considered not to raise new questions of safety or effectiveness.
In summary, because this is a 510(k) submission based on substantial equivalence, there is no performance study described that would meet your detailed requirements for acceptance criteria, sample sizes, expert evaluations, or ground truth establishment.
Therefore, I cannot populate the table or answer the specific questions you've asked based on the provided text.
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(70 days)
The Arthrex Knotless FiberTak Suture Anchor is intended for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
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
Hip: Acetabular Labral repair
The Arthrex Knotless FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. It is constructed from a hollow braid of polyester. An UHMWPE suture construct is assembled through the hollow braid coupled with a nitinol passing wire. The device comes preloaded on a disposable inserter.
Here's an analysis of the provided text regarding the Arthrex Knotless FiberTak Suture Anchor, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: Arthrex Knotless FiberTak Suture Anchor
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary indicates that the primary acceptance criterion is substantial equivalence to predicate devices. This means the new device must perform comparably to existing, legally marketed devices for its intended use.
Specifically, the document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Basic Design Features are the same as predicate devices. | "The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same." |
| Intended Uses are the same as predicate devices. | "The Arthrex Knotless FiberTak Suture Anchor is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same." (Specific intended uses for various anatomical locations are listed in detail for the device itself, implying they align with the uses of the predicate devices). |
| Material Composition is substantially equivalent to predicate devices. | "The proposed devices are comprised of polyester and UHMWPE. These materials are substantially equivalent to the materials found in the predicate devices." |
| Tensile Strength (pull-out) is substantially equivalent to predicate devices for the desired indications. | "The submitted mechanical testing data demonstrates that the tensile strength (pull-out) of the proposed devices are substantially equivalent to the predicates for the desired indications." |
| Safety and Effectiveness are not compromised by any minor differences. | "Any differences between the Arthrex Knotless FiberTak and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This is a general statement that encompasses the overall assessment of the device's performance relative to the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions "mechanical testing data" to demonstrate tensile strength (pull-out). However, it does not specify the sample size used for this mechanical testing.
The data provenance is implied to be from laboratory-based mechanical testing, likely conducted by Arthrex, Inc. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of mechanical testing for a medical device, it would inherently be prospective in its execution (i.e., tests were performed specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" established by experts, as typically applied in AI/ML studies, is not applicable here. This document describes the premarket notification for a physical medical device (suture anchor), not a diagnostic algorithm or AI system. The "truth" or performance is established through direct mechanical testing, not through expert interpretation of data.
4. Adjudication Method for the Test Set
Since ground truth as per AI/ML context is not applicable, an adjudication method in that sense is not relevant for this mechanical device submission. The results of the mechanical tests themselves would be the "data" that are then compared against the predicate device's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI systems, particularly how human readers perform with or without AI assistance. This submission is for a physical surgical anchor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML device. The "standalone performance" here would be the tensile strength and other mechanical properties of the device itself, which were indeed tested.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on objective mechanical testing data, specifically "tensile strength (pull-out)." This is a direct physical measurement, not expert consensus, pathology, or outcomes data. The comparison is made against documented performance characteristics of legally marketed predicate devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This is not an AI/ML device that requires a training set for model development. The device itself is being tested, not an algorithm.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML model, this question is not applicable.
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