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The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.

The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter. The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage. The device is provided sterile for single use only.

This document describes the performance testing for the "Fixone Meniscal Repair" device. Primarily, it focuses on bench testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

Here's a breakdown based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests and their corresponding requirements. However, it does not provide specific numerical results or pass/fail outcomes for each criteria within the summary. It generally states that the tests "demonstrated that the device performs in a substantially equivalent manner to the prior related devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document describes bench testing, not clinical studies with human subjects or test sets in the context of diagnostic accuracy. Therefore, information about patient sample size, country of origin, or retrospective/prospective nature of data for a "test set" is not applicable. The samples used for mechanical and material testing would be device prototypes/production units.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable as the studies described are bench tests of mechanical and material properties, not studies requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies where expert consensus on interpretations is needed.

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 provided because an MRMC study is not mentioned. The device is a meniscal repair device, not an AI-powered diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device 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 the bench tests would be established through objective engineering and material science standards and measurements. For example, the "ground truth" for tensile strength is a numerical value measured by a testing machine according to a defined protocol. For biocompatibility, it's adherence to ISO 10993 standards and a lack of adverse biological reactions in defined tests.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of 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: Rotator Cuff Repair, Bankart Repair, SLAP Lesion 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 following indications are for the S and SL type anchors only:

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Hip: Capsular repair, Acetabular Labral repair

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

B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair.

Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type.

SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas.

S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist

The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone.

Devices are provided sterile. Single use only.

The provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) submission to the FDA. This submission aims to demonstrate substantial equivalence to previously cleared devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document discusses:

• Device Description: What the Fixone Biocomposite Anchor is, its components (PLGA copolymer and β-TCP anchor, UHMWPE suture), and how it's implanted.
• Intended Use: Fixation of suture (soft tissue) to bone in various anatomical locations (shoulder, foot/ankle, knee, elbow, hand/wrist, hip).
• Predicate Device Comparison: A detailed table comparing the subject device to several predicate devices (K171299, K192032, K192484, K213008) across various attributes like indications for use, materials, dimensions, fixation mechanism, suture characteristics, and sterilization.
• Performance Data: Mentions "Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues, shelf-life testing, pyrogenicity testing and endotoxin monitoring. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices."

Crucially, there is no mention of:

• AI/ML components: The device is a physical biocomposite anchor, not a software algorithm.
• Clinical study or diagnostic performance metrics: The performance data refers to bench testing for physical and material properties, not clinical outcomes, sensitivity, specificity, or AUC for a diagnostic tool.
• Ground truth, expert readers, sample sizes for AI models, or MRMC studies. These are concepts relevant to evaluating AI/ML diagnostic or predictive devices, which the Fixone Biocomposite Anchor is not.

Therefore, I cannot fulfill the request as the provided input does not contain the necessary information about acceptance criteria and a study proving an AI/ML device's performance. The device described is a traditional medical implant, and its evaluation focuses on physical and biological equivalence, not AI performance.

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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 Fixone Hybrid Knotless Anchor is 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 Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. 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 11 models. It provide non-sterile (user must sterilization before use).

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Fixone Hybrid Knotless Anchor.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document describes bench testing for mechanical and biocompatibility properties. It doesn't specify a "test set" in the context of patient data or clinical images. The tests were performed on the device components themselves.

• Sample Size: Not explicitly stated as a single number across all tests. Each test (e.g., tensile strength, insertion torque, various biocompatibility tests) would have its own sample size, which is not detailed but assumed to be sufficient for the relevant standards (e.g., ASTM, ISO, USP). For tensile strength, it mentions "measuring 10 suture threads."
• Data Provenance: The studies were bench tests conducted by the manufacturer, AJU Pharm Co., Ltd., which is located in Korea. The details provided do not indicate the use of retrospective or prospective patient data, as this is a physical device rather than a diagnostic or AI-driven system.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of medical device submission. The Fixone Hybrid Knotless Anchor is a physical surgical implant, not a device that generates or interprets diagnostic images or data requiring expert review for ground truth. The "ground truth" here is established through adherence to recognized international and national standards (e.g., ISO, ASTM, USP) for mechanical properties, material properties, and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the clinical imaging or diagnostic sense requiring expert adjudication. The performance is assessed against predefined quantitative and qualitative criteria in bench testing.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a surgical anchor, not an AI-assisted diagnostic tool or a system that involves human readers interpreting output. Therefore, there is no concept of improving human reader performance with or without AI assistance in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The Fixone Hybrid Knotless Anchor is a physical medical device, not a software algorithm or an AI system.

7. Type of Ground Truth Used

The "ground truth" in this submission is established through:

• International Standards: Adherence to widely recognized standards from organizations like ISO (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging), ASTM (e.g., ASTM F2502, F1839, F1980-02 for mechanical and aging tests), and USP (e.g., USP for material properties, USP39 for pyrogen, USP 43 for endotoxin).
• Predicate Device Comparison: The primary method for proving substantial equivalence is demonstrating that the test results of the Fixone Hybrid Knotless Anchor are comparable to a legally marketed predicate device (Fixone Biocomposite Anchor, K192484) and meet relevant performance benchmarks. The new device is substantially similar, with the only noted difference being the material of the tip (PEEK in the new device versus PLGA + β-TCP in the predicate).

8. Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or artificial intelligence device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons mentioned above.

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Fixone Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 6 models. It provide non-sterile (user must sterilization before use).

The provided text describes a medical device called "Fixone Biocomposite Interference Screw" and outlines its clearance process with the FDA. It includes a 510(k) summary focusing on bench testing and biocompatibility.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. A table of acceptance criteria and the reported device performance

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

The document primarily details bench testing for mechanical, physical, and biocompatibility properties. It does not mention a clinical test set or human subject data.

• Sample Size (for bench tests): The "Tensile strength" test mentions an "average strength of 10 stands," indicating a sample size of at least 10 for that specific test. Other tests, such as those related to "Extractable color" and "Residue after evaporation," refer to "a quantity of suture, equivalent to not less than 250mg" and standard protocols, but specific sample counts for each bench test are generally not provided.
• Data Provenance: The bench tests were conducted by AJU Pharm Co., Ltd. in Korea (per the applicant information). These are laboratory tests, not clinical data from patients. They are inherently retrospective in the sense that they are conducted on manufactured devices in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device approval is based on bench testing and biocompatibility assessments, not on studies requiring human experts to establish "ground truth" for diagnostic or clinical performance. The "ground truth" for the tests performed are the defined standards and specifications (e.g., ASTM, ISO standards, quantified limits for chemical properties).

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

Not applicable. As noted above, this is not a diagnostic or clinical performance study that would involve expert adjudication of results. The results are quantitative measurements against predefined criteria.

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 a medical device (an interference screw for ACL/PCL reconstruction) and not an AI-powered diagnostic or assistive tool.

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

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 the device's performance is established by:

• Industry Standards: ASTM F2502, ASTM F1839-08, various ISO 10993 series for biocompatibility.
• Pharmacopoeial Standards: USP (for external surface).
• Defined Quantitative Limits: Specific values for pH difference, potassium permanganate consumption, residue after evaporation, maximum absorbance, and tensile strength (e.g., "not less than 100N").
• Comparison to Predicate Device: The fixation strength (push-out test) directly compares the subject device to the predicate device under the same conditions. This implies the predicate device's established performance serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set.

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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: Rotator 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 β-ΤCP). 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 provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than presenting a study of AI/algorithm performance. Therefore, many of the requested criteria related to AI studies (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this document.

However, I can extract information related to the acceptance criteria and the studies performed for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards (ASTM, ISO, USP) and predefined limits for specific tests. The reported device performance for all listed tests is "Pass," indicating that the device met the established criteria.

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

The document does not specify exact sample sizes for each particular bench test. It indicates that "Bench test were performed" and "The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device." These tests are typically conducted in a laboratory setting.

• Sample Size: Not explicitly stated as a number of individual anchors or sutures. Each test would have involved a specific number of samples as per the relevant ASTM or ISO standard.
• Data Provenance: The document states "AJU Pharm Co.,Ltd. / Korea" as the manufacturer. The testing was likely conducted in a laboratory setting, presumably in Korea or by a certified testing facility contracted by the manufacturer. This is prospective data generation through controlled laboratory experiments.

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

Not applicable. This is not an AI/algorithm study involving expert review of medical images or patient data. The "ground truth" for this device's performance is established by adhering to widely accepted engineering, biocompatibility, and material testing standards (ASTM, ISO, USP).

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

Not applicable. This is not an AI/algorithm study involving expert adjudication. The "adjudication" is inherent in the pass/fail criteria defined by the standardized testing 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

Not applicable. This is a medical device for orthopedic fixation, not an AI diagnostic or assistance tool.

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

Not applicable. This is a medical device, not an AI algorithm.

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

The "ground truth" is defined by the technical specifications and performance requirements established by recognized standards organizations (ASTM, ISO, USP) for medical devices of this type. For example:

• Bench Tests: Mechanical properties (e.g., insertion torque, pull-out strength, fatigue) are measured against predefined engineering limits or compared directly to a predicate device's performance.
• Biocompatibility Tests: Biological response (e.g., cytotoxicity, systemic toxicity, irritation, implantation response) is assessed against criteria specified in ISO 10993 series for acceptable biological safety.
• Shelf-life Tests: Stability over time is assessed against physical, chemical, and functional criteria at accelerated and real-time aging conditions according to AAMI TIR17 and ASTM F 1980-02.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set as this is not an AI/machine learning device.

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The Fixone Biocomposite Small Anchor are intended to be used fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular repair, Acetabular Labral repair

The Fixone Biocomposite Small Anchor is intended for reattaching soft tissue to bone with sutures. It consists of Driver, Anchor, Non-absorbable suture and needle. A needle was attached to the end of the suture so that it could penetrate the damaged soft tissue to enable it to be used for OPEN surgery without arthroscopy. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A non absorbable suture manufactured from co-braided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.

The provided text is a 510(k) summary for the Fixone Biocomposite Small Anchor, a medical device intended for soft tissue to bone fixation. It details the device's characteristics, intended use, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Fixone Biocomposite Small Anchor are primarily based on demonstrating substantial equivalence to a predicate device (Arthrex SutureTak Suture Anchor) through a series of bench tests and biocompatibility evaluations. The "Requirements" column in the table implicitly defines the acceptance criteria, and the "Results" column indicates whether these criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The provided document describes a bench testing and biocompatibility testing study conducted to demonstrate the substantial equivalence of the Fixone Biocomposite Small Anchor to its predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance, where clinical trials are often not required if substantial equivalence can be demonstrated through non-clinical data.

2. Sample Size used for the test set and the data provenance:

   • Sample Size: The document does not explicitly state the specific number of units/samples used for each bench test (e.g., number of anchors for pull-out tests, number of extracts for chemical analysis). It simply states that "Bench test were performed." and "The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device." For biocompatibility, it states "Test result" for each test, implying a sufficient number of test articles were used as per the specified ISO/ASTM standards.
   • Data Provenance: The tests were performed by AJU Pharm Co.,Ltd. in Korea, which is the manufacturer. The data is retrospective, as it's presented after the tests were conducted.

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

   • Not Applicable. This type of study (bench testing and biocompatibility) does not involve human experts establishing "ground truth" for a test set in the way an AI diagnostic study would where radiologists label images. The "ground truth" here is established by adherence to recognized international standards (ISO, ASTM, USP, OECD) and their inherent testing methodologies, which are designed to be objective and reproducible.

4. Adjudication method for the test set:

   • Not Applicable. Adjudication methods (like 2+1 or 3+1 by experts) are pertinent to studies involving human interpretation or clinical outcomes, typically in AI/diagnostic device evaluations. For bench testing and biocompatibility, the results are typically quantitative or qualitative "pass/fail" outcomes based on pre-defined standard criteria.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the device to assist in interpretation. The Fixone Biocomposite Small Anchor is a physical implant, not a diagnostic tool.

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

   • Not Applicable. As a physical medical device (biocomposite anchor), the concept of "standalone algorithm only performance" does not apply. The device's performance is measured directly through physical and chemical properties and biological interactions, not through an algorithm.

7. The type of ground truth used:

   • The "ground truth" for this device is based on established industry standards and regulatory requirements for medical device safety and performance. This includes:
     • Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices (e.g., cytotoxicity, systemic toxicity, irritation, sensitization, genotoxicity, implantation).
     • Material and Mechanical Testing Standards: ASTM (e.g., F2502 for bioabsorbable devices, F1839 for foam testing) and USP (pharmacopeial standards).
     • Comparison to Predicate Device: The performance and safety profile of the predicate device (Arthrex SutureTak Suture Anchor) acts as a de facto "ground truth" for establishing substantial equivalence in terms of intended use, principle of operation, and general safety/performance characteristics.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of this device's evaluation. This is not an AI/machine learning device that requires training data. The device's design and manufacturing processes are established based on engineering principles and regulatory guidance, not learned from data.

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

   • Not Applicable. Since there is no training set, there is no ground truth established for one.

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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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