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HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.

HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).

Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the HyperSuture All Blue Extension Line. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to a predicate device. It does not contain information related to software performance, clinical studies, or AI algorithm validation. The device in question is a surgical suture, not a software or AI-powered diagnostic tool.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because these are concepts applicable to software or AI device validation, which is not what this document addresses.

The document focuses on establishing substantial equivalence to a predicate device based on material, manufacturing, and physical performance characteristics, primarily adhering to USP (United States Pharmacopeia) standards for surgical sutures.

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HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture Extension Line". This process is for claiming substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study of its performance in a clinical setting (such as for an AI/ML device where performance metrics like sensitivity/specificity are evaluated).

The documentation does cover acceptance criteria for physical and material characteristics of the suture, and outlines how the device meets these in comparison to a predicate device. So, while it doesn't involve an AI/ML style study, I can extract information related to acceptance criteria for the suture itself and the testing performed.

Here's a breakdown of the requested information based on the provided text, focusing on the available information regarding the device's characteristics and acceptance, rather than an AI/ML performance study:

Acceptance Criteria and Study for the HyperSuture Extension Line (K234079)

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove clinical efficacy through a multi-reader, multi-case study, or standalone algorithm performance. The "acceptance criteria" here refer to the physical and material performance specifications of the suture itself, as well as biocompatibility, to ensure it is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each physical test (e.g., how many sutures were measured for diameter or tensile strength). However, it states that "The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength." This implies adherence to the sample size and testing methodology defined by the USP standards for those specific tests.

• Data Provenance: The document does not explicitly state the country of origin of the data. The testing appears to be non-clinical (mechanical and biocompatibility testing) and not based on prospective or retrospective patient data.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies validating AI/ML algorithms, especially in diagnostic imaging, where human expert consensus is used to establish "true" disease presence. For this device, the "ground truth" for the physical characteristics and biocompatibility is established by adherence to recognized international and national standards (USP, ISO, ASTM).

The biocompatibility evaluation of the blue dye was conducted "by trained, board certified veterinary pathologists." The number of such pathologists is not specified.

4. Adjudication Method for the Test Set

Not applicable in the context of physical property testing or substantial equivalence claims for a medical device like a suture. Adjudication methods (e.g., 2+1, 3+1) are primarily used in clinical studies where human readers provide interpretations (e.g., radiology reads) and their disagreements need to be resolved to establish ground truth.

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

No. An MRMC study is relevant for evaluating the performance of AI-assisted systems in diagnostic scenarios (e.g., whether AI improves a radiologist's accuracy). This submission is for a surgical suture, which is a physical medical device, not an AI/ML algorithm.

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

No. This concept is applicable to AI/ML algorithms. The HyperSuture Extension Line is a physical surgical suture. The "performance" assessment refers to its physical and material properties, not an algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for the device's characteristics (diameter, tensile strength, biocompatibility, etc.) is established by:

• Established Standards: Compliance with United States Pharmacopeia (USP) standards (USP 43 <861> for Diameter, <881> for Tensile Strength, <871> for Needle Attachment).
• International Standards: Compliance with ISO 10993-1:2009 for Biological Evaluation of Medical Devices.
• Material Specifications: Adherence to material specifications (e.g., AISI 302 Medical Grade Stainless Steel per ASTM F899 for needles).
• Expert Evaluation: Biocompatibility evaluation of the blue dye was assessed by trained, board-certified veterinary pathologists.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this type of medical device submission.

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HyperSutures (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation. including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture cables are available in USP 2-0, USP 2, and USP 5 and meet all surqical suture requirements established by the USP for class II non- absorbable surgical sutures.

HyperSuture tapes are non-absorbable, sterile, braid for surgery composed of multiple multifilament strands of ultra-high molecular weight polvethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in Threadstone tape size 0.5 (USP 2-0 equivalent), tape 1.5 (USP 2 equivalent), and tape 2.5 (USP 5 equivalent).

Both HyperSuture cables and tapes are available in white/black, 40 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the device "HyperSuture." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria for performance, nor does it detail a study that explicitly "proves the device meets the acceptance criteria" in terms of statistical comparisons or clinical outcomes for an AI/software device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, manufacturing, and general performance requirements for surgical sutures.

Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it is for a physical medical device (surgical sutures), not a diagnostic AI/software device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document states "HyperSuture cables... meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures." and "HyperSuture tapes... meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures." The specific numerical or qualitative targets for these USP requirements are not detailed in this summary document, but the device states it meets them.)

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

• Not Applicable. This document is for a physical medical device (suture) and the "test set" would refer to physical or mechanical bench testing, not a data-driven clinical study. The performance data section refers to "HyperSuture cables are tested per USP performance requirements..." but does not specify sample sizes or data provenance in the context of an AI/software device.

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. Ground truth in the context of expert consensus is not relevant for the performance testing of a surgical suture.

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

• Not Applicable. This pertains to expert review of data, not physical device 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

• Not Applicable. This device is a surgical suture, 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 not an algorithm or AI device.

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

• Standards-based performance: The ground "truth" or reference standard for this device's performance is established by the United States Pharmacopeia (USP) requirements for surgical sutures, as well as Threadstone's internal specifications for tape width. Biological evaluations followed ISO 10993-1:2018 and endotoxin assessments followed FDA guidance for "Pyrogens and Endotoxins Testing."

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

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