Search Results

CAPROLON® is Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures

CAPROLON® is a synthetic absorbable surgical suture. Primary material is Poly(L-lactide-co-ε-caprolactone), P(LA/CL) Material presentation is Monofilament Undyed and dyed (D&C violet No.2) variants Coated with a mixture of calcium stearate and the copolymer of L-lactide and ε-caprolactone Suture material is a sterile, flexible, thread offered in a variety of lengths (35cm to 90cm), reels, range of diameters (USP 7-0 to 2), with or without needles attached.

The provided text describes the 510(k) submission for CAPROLON®, an absorbable poly(glycolide/l-lactide) surgical suture. The review determined that the device is substantially equivalent to a legally marketed predicate device. The document does not describe a study involving an AI or an algorithm. Instead, it outlines the performance testing for a medical device (surgical suture) against established USP (United States Pharmacopeia) standards. Therefore, an answer to your request regarding AI/algorithm-specific acceptance criteria and studies cannot be fully provided from the given text.

However, I can extract information regarding the device's acceptance criteria and performance based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document. The text only mentions "the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph." Specific numbers of sutures tested for each characteristic (Diameter, Tensile strength, Needle attachment) are not provided.
• Data Provenance: The testing was conducted by Resorba Medical GmbH as part of their 510(k) submission. The document doesn't specify country of origin for the raw data, but the company is based in Germany. The testing appears to be conducted specifically for this submission, implying a prospective nature in the context of this regulatory filing.

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

• This is not applicable to the evaluation of a surgical suture against USP standards. "Ground truth" in this context refers to the defined parameters and methods set forth by the USP, which are established by expert consensus over time within the pharmaceutical and medical device industries. The testing itself is quantitative and objective, not reliant on expert interpretation for its results.

4. Adjudication method for the test set:

• Not applicable in the context of quantitative USP testing. Results are compared directly against predefined numerical and qualitative standards from the USP monograph.

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:

• This query is not applicable. The document is about a surgical suture, not an AI or algorithm-based diagnostic tool. No MRMC study was conducted or mentioned.

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

• This query is not applicable. The document is about a surgical suture, not an AI or algorithm.

7. The type of ground truth used:

• The "ground truth" used for this device's performance evaluation comprises the United States Pharmacopeia (USP) Monograph for Synthetic Absorbable Sutures and ISO 10993-1 for Biocompatibility. These are established, validated, and legally recognized standards that define acceptable performance characteristics for medical devices like surgical sutures.

8. The sample size for the training set:

• This query is not applicable. The document describes a physical medical device (suture) and its performance testing, not an AI algorithm requiring a training set.

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

• This query is not applicable as there is no AI algorithm or training set discussed.

Ask a specific question about this device

GLYCOLON® is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue.

PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.

The subject devices are synthetic absorbable surgical sutures.
PGA Resorba: Primary material Polyglycolic acid (PGA), Material presentation Multifilament, braided, Dyed or undyed Undyed and dyed D&C violet No.2, Coated or uncoated Coated Polycaprolactone + calcium stearate, Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.
PGA resoquick: Primary material Polyglycolic acid (PGA), Material presentation Multifilament, braided, Dyed or undyed Undyed, Coated or uncoated Coated Polycaprolactone + calcium stearate, Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.
Glycolon: Primary material Copolymer glycolide and E-caprolactone (PGA/CL), Material presentation Monofilament, Dyed or undyed Undyed and dyed D&C violet No.2, Coated or uncoated Uncoated, Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.

This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) related to an AI/ML study is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of three absorbable surgical sutures (PGA RESORBA, PGA RESOQUICK, GLYCOLON) to legally marketed predicate devices, focusing on their material, design, and performance characteristics in comparison to USP requirements.

Here's the relevant information that can be extracted, formatted as a table for "acceptance criteria" and "reported device performance," which in this context refers to meeting USP standards for surgical sutures.

1. Table of Acceptance Criteria and Reported Device Performance

The following information is not applicable as the document is a 510(k) submission for surgical sutures and does not describe an AI/ML device or its associated studies:

• Sample sizes used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

Ask a specific question about this device

Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

The subject devices are non-absorbable surgical sutures. They are available undyed and dyed. The sutures are supplied sterile, in monofilament, twisted and braided forms in sizes USP 11-0 to 7 (depending on suture type), with or without needles in a variety of cut lengths.

This document is a 510(k) premarket notification for surgical sutures, not an AI/ML device. Therefore, the requested information (acceptance criteria and study details for an AI-powered device) is not present in the provided text.

The document describes traditional medical devices (surgical sutures) and asserts their substantial equivalence to predicate devices based on:

• Intended use
• Material
• Design
• Performance (Diameter, Needle attachment, and Tensile strength)
• Sterilization method
• Biocompatibility evaluation

The performance testing summarized indicates that the sutures meet the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Non-absorbable Sutures. It also mentions biocompatibility evaluation, rabbit pyrogen and LAL testing, and compliance with ASTM F138-13 for steel sutures.

Ask a specific question about this device

Ask a specific question about this device