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The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

The subject device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polvethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (2-)] copper

This document is a 510(k) premarket notification for the "ExpressBraid Graft Manipulation" device. It is a re-submission due to the addition of a new contraindication, not a new device or significant modification. As such, it relies heavily on the data and conclusions from the previously cleared K152868 submission. Therefore, detailed acceptance criteria and a new study proving performance are not present in this document because it references prior clearance.

However, based on the provided text, we can infer some information about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this 510(k) is not for a new device but for an update to its Indications for Use (specifically, adding a contraindication), explicit acceptance criteria and new performance data are not provided. The document states:

• "The performance of ExpressBraid Graft Manipulation device has not changed since its last clearance in K152868 as there are no changes to design, material, or intended use. The performance data submitted in K152868 is still valid and therefore no additional testing was performed."

Therefore, the acceptance criteria and performance would be consistent with what was submitted and accepted for the K152868 clearance. This current document simply reaffirms that the device still meets those (unspecified in this document) criteria because its fundamental design and function have not changed.

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

• Since no new testing was performed for this specific 510(k), no new sample size or data provenance details are provided. This information would be found in the K152868 submission.

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

• Not applicable for this 510(k) as no new testing was conducted, and it's not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set:

• Not applicable, as no new clinical or non-clinical tests requiring adjudication were performed for this submission.

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 device is a surgical suture for soft tissue approximation/ligation, 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 device is a physical surgical suture, not an algorithm.

7. The type of ground truth used:

• Not applicable as it is a physical medical device, not a diagnostic or AI-based product requiring ground truth for validation. The "ground truth" for a surgical suture would typically involve mechanical testing (e.g., tensile strength, knot security) and biocompatibility, which were presumably assessed in K152868.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable for the same reason as above.

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The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

The ExpressBraid Graft Manipulation device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The suture may be all white or blue/white MaxBraid suture. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polyethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (-2)] cooper

This document describes the ExpressBraid Graft Manipulation device, a non-absorbable surgical suture. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in a clinical context with AI.

However, based on the provided text, we can extract details related to the performance testing conducted to support substantial equivalence. It's important to note that this is not a study assessing AI performance or human reader improvement.

Here's an analysis of the provided text in relation to your request, with the understanding that the "device" in this context is the ExpressBraid Graft Manipulation suture:

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

The document doesn't explicitly present a table of acceptance criteria with corresponding performance data in the typical sense for an AI device. Instead, it states that the device was tested against USP (United States Pharmacopeia) standards for non-absorbable surgical sutures and also compared to a predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for the performance testing (tensile strength, diameter, needle attachment, or comparative testing).
The data provenance is from laboratory testing performed by the manufacturer, Biomet Manufacturing Corp., as part of their 510(k) submission. No information on country of origin of the data or whether it's retrospective or prospective is given, as it's mechanical and biocompatibility testing, not clinical data.

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

This question is not applicable to the type of device and testing described. The "ground truth" for mechanical and biocompatibility testing is established by adherence to recognized standards (USP, ISO 10993-1) and direct measurement, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or image interpretations, not for direct mechanical or chemical property testing.

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, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant to AI-assisted diagnostic tools, not to a surgical suture. The document describes comparative performance between two sutures (the subject device and a predicate) in terms of mechanical properties.

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

This question is not applicable. This device is a physical surgical suture, not a software algorithm.

7. The type of ground truth used

The "ground truth" used for this device's performance assessment relies on:

• Established standards: United States Pharmacopeia (USP) requirements for surgical sutures and ISO 10993-1 for biocompatibility.
• Direct measurement and comparison: Mechanical and chemical properties were measured and compared to the predicate device.

8. The sample size for the training set

This question is 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

This question is not applicable. As there is no training set for an AI model, there is no ground truth established for one.

In summary: The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a surgical suture based on its mechanical properties and biocompatibility as compared to predicate devices and recognized standards. It does not contain information related to AI performance, clinical trials with human readers, or expert-based ground truth establishment as would be relevant for an AI/ML medical device.

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