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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

Suture Performance (USP 0, UHMWPE)

Suture Performance (USP 2, UHMWPE)

Suture Performance (USP 0, USP 2, UHMWPE)

Biocompatibility (UHMWPE + PET)

Biocompatibility (Only UHMWPE)

(Same tests and results as UHMWPE + PET table, excluding PET interaction)

Sterilization/Endotoxin

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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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

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.

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