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Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

The provided text describes a 510(k) premarket notification for a medical device called "Fix2Lock (PEEK Self Punching)". This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not pertain to an AI/ML device or its performance criteria, as indicated by the nature of the acceptance criteria and the listed tests. The device is a physical orthopedic implant. Therefore, I cannot extract information related to AI/ML specific criteria such as sensitivity/specificity, AUC, reader studies, ground truth establishment for AI, or training/test set sample sizes for an AI model.

The "acceptance criteria" discussed in the document are primarily related to physical and material properties, sterilization, packaging, and shelf life of the bone fixation fastener. The "study" proving these criteria refers to bench tests conducted to verify the device meets all design specifications and is substantially equivalent to the predicate device.

Here's a summary of the information that can be extracted based on the provided text, using the closest applicable interpretations:

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

Since this is not an AI/ML device, the "acceptance criteria" are compliance with relevant standards for medical devices and meeting design specifications. The "reported device performance" is a statement of compliance with these standards and equivalency to the predicate.

• ASTM F2848: 2021 (Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants) | The subject device utilizes PEEK material, and bench tests demonstrated compliance with these standards. |
  | Mechanical Performance | - ASTM F543: 2017 (Metallic medical bone screws) | Bench tests demonstrated compliance with this standard. |
  | Sterilization | - ISO 11135:2014 (Ethylene oxide sterilization methods)
• ISO 11138-1:2017, ISO 11138-2:2017 (Biological indicators for sterilization)
• ISO 11140-1:2014 (Chemical indicators) | Bench tests demonstrated compliance with these standards, ensuring the device is sterile via EtO sterilization. |
  | Microbiological | - ISO 11737-1:2018 [AMD1:2021] (Determination of microorganism population)
• ISO 11737-2:2019 (Tests of sterility) | Bench tests demonstrated compliance with these standards. |
  | Packaging & Shelf Life | - ISO 11607-1:2019, ISO 11607-2:2019 (Packaging for terminally sterilized medical devices)
• ASTM F1980:2016 (Accelerated Aging of Sterile Barrier Systems)
• ASTM F88/F88M-21 (Seal strength)
• ASTM F1929:2015 (Detecting Seal Leaks) | Bench tests demonstrated compliance with these standards, confirming packaging integrity and a 3-year shelf life. |
  | Bacterial Endotoxin | - USP (Bacterial Endotoxin Test)
• USP (Medical Devices-Bacterial Endotoxin and Pyrogen Tests)
• ISO 11737-3:2023 (Bacterial endotoxin testing) | Bench tests demonstrated compliance with these standards. |
  | Substantial Equivalence | Device must be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness. | The subject device (Fix2Lock PEEK Self Punching) is determined to be Substantially Equivalent (SE) to the predicate device (K231322) in respect of safety and effectiveness. |

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 mentions "bench tests" were conducted. It does not specify sample sizes for these tests, nor does it provide details on data provenance beyond the product's manufacturer (Osteonic Co., Ltd., South Korea) and the standards used. These are typical engineering tests, not clinical studies.

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 is not an AI/ML device involving expert "ground truth" for diagnostic or analytical tasks. The "ground truth" here is compliance with engineering and material standards, typically verified by laboratory testing and technical experts/engineers according to standard protocols.

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

Not applicable. This concept applies to expert review processes, typically in clinical studies or AI ground truth establishment. The "adjudication" for this device would be the interpretation of bench test results against established standard specifications.

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 device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device is established by compliance with internationally recognized engineering and medical device standards (e.g., ISO, ASTM, USP) for materials, mechanical performance, sterilization, packaging, and biological safety.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

The provided text is a 510(k) premarket notification for a medical device called "Fix2Lock (PEEK Self Punching)". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the detailed acceptance criteria and study results for a new, AI-powered device's performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and training set specifics cannot be extracted from this document. This type of information is typically found in study reports or technical documentation submitted for devices that involve AI/ML components requiring performance validation against defined metrics.

The document primarily discusses:

• Device Identification: Fix2Lock (PEEK Self Punching), a Class II device for orthopedic surgery.
• Intended Use: Fixation of soft tissue to bone using suture (shoulders, knees, foot/ankle, hand/wrist, elbow).
• Substantial Equivalence (SE) Claim: The subject device (K231322) is substantially equivalent to a predicate device (K202763), and a reference device (K081511).
• Non-Clinical Tests: Bench tests were conducted to verify design specifications and SE to the predicate device, citing compliance with various ASTM and ISO standards for material, mechanical performance, sterilization, shelf life, packaging, and bacterial endotoxin (e.g., ASTM F2026, F543, ISO 11135, 11607, USP ).
• Comparison Table: Details similarities and differences in product code, regulatory class, intended use, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf life between the subject, predicate, and reference devices.

In essence, this document is a regulatory submission for a traditional medical device demonstrating equivalence, not a performance study for an AI/ML diagnostic or assistive device that would have the requested acceptance criteria and study design details.

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Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders and knees.

This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

The provided document is a 510(k) summary for the medical device Fix2Lock (PEEK Self Punching). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. It primarily details a non-clinical bench study to verify design specifications and compliance with material and mechanical performance standards.

Therefore, many of the requested sections regarding clinical study design, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance are not applicable or not available in this type of submission.

Here's the information that can be extracted or inferred from the provided text:

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: Not specified. The study described is a bench test, and the number of units tested to demonstrate compliance with the listed standards is not provided.
• Data Provenance: Not applicable, as this is a bench test for materials, mechanical properties, and sterilization, not a clinical study with patient data.

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

• Not applicable. Ground truth as typically understood in clinical studies (e.g., disease presence/absence determined by experts) is not relevant for this type of bench testing. Compliance with engineering standards and material specifications would be assessed by engineers and quality control personnel.

4. Adjudication method for the test set

• Not applicable. There is no mention of adjudication for the bench tests. Compliance is determined against established engineering and material standards.

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-assisted diagnostic 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

• For the bench tests, the "ground truth" is defined by the specifications and requirements stipulated in the referenced international and national standards (e.g., ASTM F2026 for PEEK, ISO 11135 for sterilization). The device's performance is compared against these quantitative and qualitative standard requirements.
• For the overall submission, the "ground truth" for demonstrating marketability is the substantial equivalence to the predicate device, Arthrex Corkscrew and SwiveLock Suture Anchors (K143745).

8. The sample size for the training set

• Not applicable. This is a physical medical device and not an AI/machine learning model 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 device.

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