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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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The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.

This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).

The document provided describes the Fixone Biocomposite Anchor, a medical device intended for fixation of suture (soft tissue) to bone. The information primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a novel study evaluating the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.

The "acceptance criteria" in this context refer to the successful completion of a series of bench tests and biocompatibility tests to ensure the device meets established safety and performance standards for similar orthopedic implants, and demonstrates substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests performed and their results. The "Requirements" column implicitly serves as the acceptance criteria for each test, with the "Results" column indicating "Pass" for all listed tests.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of a series of bench tests and biocompatibility tests. The document states:
"Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device."

This means the device was subjected to physical, chemical, and biological evaluations according to recognized international and national standards (e.g., ASTM, USP, ISO). Each test had specific pass/fail criteria (as indicated in the "Requirements" or "Test method / Test criteria" columns of the tables), and the device successfully "passed" all of them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test set sample size: This information is not provided in the document. For bench and biocompatibility testing, sample sizes are typically determined by the specific test standards (e.g., number of test specimens for mechanical tests, number of animals for in vivo biocompatibility).
• Data provenance: The testing was conducted by AJU Pharm Co., Ltd. (company address in Korea) or subcontracted labs, according to international standards. The document does not specify the country of origin for each specific test report, but the manufacturer is based in Korea. These are prospective tests performed on the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable as the evaluation involved objective physical, chemical, and biological testing against established standards, not interpretation by human experts to establish a "ground truth" in the clinical AI sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable. As stated above, the evaluation was based on objective laboratory measurements and adherence to specified test methods.

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:

• This information is not applicable. This document describes the regulatory submission for a physical medical implant (biocomposite anchor), not an AI/diagnostic software device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this device's performance is established by objective measurements and results from standardized bench tests and biocompatibility assays against predefined limits and criteria specified in the relevant ASTM, USP, and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the context of clinical efficacy studies.

8. The sample size for the training set:

• This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

• This information is not applicable. This is a physical medical device, not an AI model that requires a training set with established ground truth.

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For introduction of instrumentation through a portal for surgical procedure.

This device is intended to puncture the tissue for making the path of surgical instrument in the orthopedic surgery. It is consisted with cannula and trocar. This device is single-use.This device has 3 types. (Threaded type, Smooth type, All smooth type)

The provided text is a 510(k) Pre-Market Notification for a medical device called the "JOINIX Cannular System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's clinical efficacy or diagnostic accuracy through extensive clinical trials.

As such, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning clinical performance (e.g., diagnostic accuracy, human reader improvement with AI assistance, MRMC studies, or detailed ground truth establishment for clinical data).

The "Performance data" section (Section 6) and "Predicate device comparison table" (Section 7) describe bench testing only, focusing on the device's physical properties, biocompatibility, and functional equivalence to a predicate device for its intended mechanical purpose (introduction of instrumentation through a portal for surgical procedure).

Here's why the requested information cannot be extracted from this document:

• No Clinical Study: The document explicitly states "Bench test were performed." and lists mechanical and biocompatibility tests. There is no mention of a clinical study involving human subjects or real-world data collection for performance evaluation in a diagnostic or clinical decision-making context.
• Device Type: The JOINIX Cannular System is an arthroscope, a surgical instrument used to create a portal. Its performance is assessed on its mechanical properties, material safety (biocompatibility), and functionality as a conduit, not on its ability to interpret medical images, make diagnoses, or assist human experts in complex tasks that would require accuracy metrics (like sensitivity, specificity, or AUC).
• 510(k) Scope: A 510(k) submission primarily aims to show that a new device is "substantially equivalent" to a legally marketed device (predicate device). This often relies on comparative performance against the predicate in bench tests or, if applicable, comparisons of design, materials, and intended use, rather than de novo clinical outcome studies demonstrating superiority or specific accuracy thresholds in a clinical setting.

Therefore, I cannot provide a table of acceptance criteria for clinical performance, details on test set sample sizes, expert qualifications for ground truth, MRMC studies, or training set details because this document pertains to a mechanical surgical instrument and its bench test performance for 510(k) clearance, not a diagnostic or AI-driven device requiring clinical performance validation.

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