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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 Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.

This document is a 510(k) summary for a medical device called "Force Fiber® Suture - Black." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study where specific performance criteria are measured against acceptance criteria. Therefore, much of the requested information regarding study design, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the general acceptance criteria and what is reported about the device's performance based on the provided text.

Acceptance Criteria and Reported Device Performance

• Suture diameter
• Tensile strength
• Needle attachment | "Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter."
  "Force Fiber Suture - Black is tested in accordance with USP - non-absorbable surgical sutures for suture diameter, tensile strength and needle attachment, and meet the requirements of the Class II Special Controls Guidance: Surgical Sutures; Guidance for Industry and FDA; June 3, 2003." |
  | Material Biocompatibility (ISO 10993-1:2018) | Evaluation through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. This implies meeting the safety requirements for medical devices in contact with the body. | "All materials used in the fabrication of the Force Fiber Suture - Black were evaluated through biological qualification safety tests as outlined in ISO 10993-1: 2018 --Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." |
  | MRI Safety | "MR Safe" designation, meaning it poses no known hazards in MR environments. | "Force Fiber Suture - Black is tested to demonstrate it is "MR Safe" and poses no known hazards in MR environments." |
  | Substantial Equivalence | No differences in technological characteristics and performance characteristics compared to predicate devices, and the difference (addition of black dye) does not raise new questions of safety or efficacy, making it as safe and effective as currently marketed predicate devices. This is the primary "acceptance criterion" for a 510(k) pathway. | "Force Fiber Suture – Black is substantially equivalent to its predicate Force Fiber Suture devices because there are no differences in technological characteristics and performance characteristics between the proposed and predicate devices. The proposed sutures have the same fundamental design and intended use as the predicate devices. The difference between Force Fiber Suture - Black and its predicate Force Fiber Suture devices is the addition of black dye... This difference does not raise new questions of safety or efficacy. Therefore, Force Fiber Suture - Black is as safe and effective as its currently marketed predicate devices." |

Information Not Available in the Document:

Because this document is a 510(k) summary demonstrating substantial equivalence for a surgical suture, not a clinical study report for an AI/imaging device, the following information is not provided:

2. Sample size used for the test set and the data provenance: Not applicable in this context. The testing mentioned refers to material properties and biocompatibility, not performance against a specific "test set" of 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 for AI algorithms (e.g., diagnostic accuracy) is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For material properties, the "ground truth" would be established by validated testing methods and specifications (e.g., USP standards), not expert consensus on medical images or outcomes.
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device (surgical suture) and demonstrates its compliance with established regulatory standards (USP, ISO) and substantial equivalence to existing predicate devices. It does not involve AI or imaging diagnostics, and therefore, many of the requested data points related to those types of studies are not relevant or present.

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

Force Fiber Fusion 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 Fusion Suture is braided to transition from round suture to tape suture and back to round suture within the same braid construction. The tape section(s) are flat in shape and differ from USP requirements. The round section(s) exceed USP for diameter. The suture meets USP tensile strength requirements and USP needle attachment requirements. Force Fiber Fusion suture is available in sizes 1 through 5 and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), UHMWPE/blue polyester co-braid, UHMWPE/black Nylon co-braid or UHMWPE/green Polyester co-braid.

This document is a 510(k) Summary of Safety and Effectiveness for the Teleflex Force Fiber Fusion™ Suture. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices. However, this submission does not describe a study involving an AI/ML device or its acceptance criteria. Therefore, I cannot provide the requested information.

The document discusses a surgical suture, which is a medical device, but it is not an AI/ML device. The submission is focused on demonstrating the substantial equivalence of a new suture design to existing, legally marketed predicate sutures through standard material and mechanical testing, not through performance metrics of an algorithm.

Thus, key sections of the requested output, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information, are not applicable to the content provided.

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