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Smith & Nephew ULTRATAPE is indicated for use in approximation and/or ligation of soft tissues, including allograft tissue for orthopedic surgeries.

Smith & Nephew ULTRATAPE is a non-absorbable, sterile, synthetic surgical suture composed of UHMW (Ultra High Molecular Weight) polyethylene, offered braided, in both blue and a co-braid of blue/ white. ULTRATAPE is flat in shape, and has a width of 2mm, meeting USP tensile strength requirement for size #2 surgical suture. ULTRATAPE does not comply with USP size classifications. When used with various anchoring implants in orthopedic procedures, it secures and holds the reattached tendon to bone.

Here's a summary of the acceptance criteria and study information for the Smith & Nephew ULTRATAPE surgical suture, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the numerical sample size for the mechanical testing. However, it indicates that the testing was conducted "in accordance with USP requirements," which would imply a scientifically sound and sufficient sample for demonstrating compliance.

• Sample size for test set: Not explicitly stated (implied by "in accordance with USP requirements").
• Data provenance: Not explicitly stated (likely laboratory testing conducted by the manufacturer as part of the 510(k) submission process).

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

This information is not applicable to the type of device and study presented. The study involves mechanical testing against a recognized standard (USP), not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. This was a mechanical test against a technical standard, not a study requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. This device is a surgical suture, and its performance is evaluated through mechanical testing, not by human readers interpreting images or data.

6. If a Standalone (algorithm only without human-in-the-loop) performance study was done:

Not applicable. This device is a physical medical device (suture), not an algorithm or AI system. Its performance is inherent to its physical properties, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this study was the USP standard for Knot Tensile Strength for non-absorbable, #2 size surgical suture. The device's performance was compared directly against this established technical specification.

8. The Sample Size for the Training Set:

Not applicable. There is no AI or machine learning component to this device, so there is no concept of 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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The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 meniscal repair systems are intended for use as suture retention devices to facilitate percutaneous or endoscopic soft tissue procedures. The ULTRA FAST-FIX, ULTRA FAST-FIX AB, AND FAST FIX 360 are indicated for use in meniscal repairs and allograft transplant procedures. The ULTRA FAST-FIX, ULTRA FAST-FIX AB AND FAST-FIX 360 devices are intended to be used for anchoring the . allograft to the meniscal rim during allograft transplant procedures.

The Smith & Nephew ULTRA FAST-FIX, ULTRA FAST-FIX AB, and FAST-FIX 360 Meniscal Repair Systems are all-inside meniscal repair device includes two polymer implants, pretied with non-absorbable suture pre-loaded into a stainless steel needle delivery system with an adjustable length depth penetration limiter. Product variants are offered with either a straight, curved or reverse curved delivery needle, and are provided sterile for single use only.

Here's a breakdown of the acceptance criteria and study information for the ULTRA FAST-FIX Meniscal Repair System, ULTRA FAST-FIX AB Meniscal Repair System, and FAST-FIX 360 Meniscal Repair System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not specify numerical sample sizes for the performance testing (cyclic load and ultimate tensile strength). It only refers to "performance testing."
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

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

This information is not applicable to this submission. The device is a physical medical device (suture retention system), and the performance evaluation is based on mechanical testing (cyclic load, ultimate tensile strength), not on expert assessment of images or clinical data for diagnostic purposes.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study was not done and is not applicable. This device is not an AI/imaging device requiring human reader analysis. The study focused on the physical performance of the device.

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

A standalone performance evaluation was done, in the context of mechanical testing. The device's fixation properties were tested independently to demonstrate equivalence to predicate devices, without human intervention in the device's operational performance during testing.

7. The Type of Ground Truth Used

The ground truth used was the mechanical performance characteristics (cyclic load and ultimate tensile strength) of legally marketed predicate devices. The new devices were compared against these established benchmarks.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device and study. This is a medical device submission based on showing substantial equivalence through mechanical performance, not an AI/machine learning model that requires a training set.

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

This information is not applicable for the same reasons as point 8.

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