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Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.

Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in and neurological procedures.

Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.

Force Fiber Suture is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE). It is available as braided undyed (white), braided blue, co-braid of white UHMWPE and blue polypropylene (PP) monofilament strands, co-braid of white UHMWPE fibers and black Nylon monofilament strands, and co-braid of white UHMWPE fibers and green polyester (PET) fibers.

Force Fiber OthoTape Suture is an uncoated braid that is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid.

Bondek and Bondek Plus Suture is an absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The Bondek suture material is coated with polycaprolactone-glycerol monostearate solution, and is available in green and beige (undyed) USP sizes 8-0 through 2. The Bondek Plus suture material is coated with polycaprolactone-co-polygolycolic acid, and is available in violet, green or beige (undyed) USP sized 6-0 through2.

Monodek Absorbable Surgical Suture is a monofilament suture that meets all USP requirements except for oversize diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture may be supplied on ligating reels.

Polyglytone* 6211 suture, U.S.P size 2-0, is available, undyed (natural). The suture is monofilament, and may be provided with or without plegets.

The Teleflex surgical sutures are provided sterile (EO), for singe use only and may be provided in a variety of cut lengths with or without needles. A variety of attached needles are available from either 300 or 400 series stainless steel.

The provided text is a 510(k) Summary of Safety and Effectiveness for Teleflex Surgical Sutures. It details various types of sutures (Force Fiber, Bondek, Monodek, Polyglytone) and their characteristics, indications for use, and a comparison to predicate devices for substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of performance metrics for an AI/ML or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to previously cleared surgical sutures, primarily through similar technological characteristics and performance rather than a specific set of acceptance criteria and a study to meet them.

The only "testing" mentioned is non-clinical testing to demonstrate an "MR Safe" claim, which is a safety characteristic, not a performance metric in the traditional sense of AI/ML or diagnostic device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not present in the provided text. The document describes a traditional medical device (sutures) approval process, not an AI/ML or diagnostic device.

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Force Fiber® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.

Force Fiber OrthoTape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber OrthoTape suture is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid. Force Fiber OrthoTape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.

The provided document is a 510(k) premarket notification for the Teleflex Force Fiber® OrthoTape™ Suture. It establishes substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses an AI/ML-based device, human readers, or a ground truth involving pathology or outcomes data. Therefore, many of the requested sections about AI/ML device performance and clinical study details cannot be answered based on the provided text.

However, I can extract information related to the device's performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set (number of sutures or needles tested) for tensile strength and needle attachment. The testing was conducted in accordance with USP (United States Pharmacopeia) requirements, implying these are standard in vitro mechanical tests rather than clinical studies with patient data. Therefore, there is no country of origin for "data" in the context of patient data, nor is it retrospective or prospective.

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

Not applicable. The ground truth for tensile strength and needle attachment is based on objective, standardized physical measurements against USP specifications, not expert consensus or clinical interpretation.

4. Adjudication method for the test set

Not applicable. The "test set" refers to physical samples of the suture undergoing mechanical testing against defined specifications. There is no human adjudication involved in these objective measurements.

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/ML-based diagnostic or assistive device that would involve human readers or MRMC studies.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on objective physical and mechanical specifications outlined in the United States Pharmacopeia (USP) for non-absorbable surgical sutures, specifically for tensile strength and needle attachment. Additionally, biological qualification safety tests (AAMI ANSI ISO 10993-1: 2009/(R) 2013) were conducted on the materials.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment in that context.

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