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REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Synthetic Absorbable PGA Suture With or Without Needle (REXSIN) are produced and provided by SM ENG Co., Ltd. REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. Suture of REXSIN is Trisorb manufactured by SAMY ANG Biopharmaceuticals Corporation. SM Eng is receiving bulk Trisorb from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXSIN suture. REXSIN is a sterilized medical device composed with absorbable, braided, coated suture with needle, stainless steel SUS 304. REXSIN Suture is a synthetic absorbable, braided, coated suture composed of a Polyglycolic acid (PGA). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately over 65% of tensile strength remain after 2week. Complete absorption in tissues takes around 90 days. REXSIN Sutures meets requirements established by the United States Pharmacopoeia (USP) for Absorbable Surgical Sutures. REXSIN Sutures is available in 8-0, 7-0, 6-0, 5-0, 2-0, 0, 1 and 2, which are the sizes identified in the currently recognized United States.

The provided text is related to a 510(k) Pre-market Notification for a medical device (surgical suture). It describes the device, its intended use, and non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria for an AI/ML powered device, a study proving device performance against such criteria, or details regarding ground truth, expert consensus, or specific effect sizes for human readers with AI assistance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document describes a traditional medical device (suture) and its non-clinical testing for substantial equivalence, not an AI/ML-powered diagnostic or decision-support system.

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REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.

REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1

The provided text is a 510(k) Premarket Notification from the FDA for a surgical suture device named REXLENE. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of AI or software performance metrics.

Instead, the document focuses on demonstrating that the REXLENE suture is "substantially equivalent" to already legally marketed predicate devices, primarily WG-Surgical Sutures with Needle (K080684) and PROLENE™ Polypropylene Nonabsorbable Suture (K133356). The "acceptance criteria" referred to in this document are compliance with established regulatory standards for surgical sutures.

Here's a breakdown of the information that is available, reframed to address your request as much as possible, and highlighting what is not present:

1. A table of acceptance criteria and the reported device performance:

The document outlines compliance with specific USP (United States Pharmacopoeia) and ISO standards for surgical sutures as the "acceptance criteria" for the REXLENE device, and states that the device meets these.

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

This information is not provided in the document. The document mentions "Non clinical tests were conducted," but does not detail the sample sizes for these tests, or the specific provenance of any data beyond the manufacturer being in Korea.

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)

This information is not applicable and not provided. The device is a surgical suture, not a diagnostic imaging device or AI-driven system that would require expert consensus for ground truth establishment. The "ground truth" here is compliance with scientific and regulatory standards as measured through laboratory testing.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, particularly for AI/CAD devices. This document deals with laboratory testing against physical and biological standards.

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 information is not applicable and not provided. REXLENE is a surgical suture, not an AI or CAD (Computer-Aided Detection) system. MRMC studies are used to evaluate the performance of diagnostic tools (often involving AI) with human readers.

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

This information is not applicable and not provided. REXLENE is a physical medical device (suture), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" is defined by the specifications and requirements set forth in the US Pharmacopoeia (USP) and ISO 10993 standards. For example, the device must meet specific diameter ranges as defined in USP .

8. The sample size for the training set

This information is not applicable and not provided. Training sets are relevant for AI/machine learning models, which this device is not.

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

This information is not applicable and not provided for the same reason as point 8.

In summary, the provided document is a regulatory submission for a surgical suture and outlines its compliance with established physical and biological standards. It does not describe an AI or software device and therefore lacks the information requested regarding AI acceptance criteria, study design, expert involvement, or data sets for AI development.

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REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

REXMONO: Synthetic Absorbable PGA-PCL Monofilament Suture With or Without Needle (REXMONO) are produced and provided by SM ENG Co., Ltd. REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. Suture of REXMONO manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOFAST. SM Eng is receiving bulk MONOFAST from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXMONO suture. REXMONO is a sterilized medical device composed with absorbable monofilament suture, poly (glycolide-co-caprolactone), with needle, stainless steel SUS 304. REXMONO Suture is a synthetic absorbable, monofilament, suture composed of poly (qlycolide-co-caprolactone). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 68~78% of tensile strength remain after 1 week. Complete absorption in tissues takes around 90 to 110 days.

PDREX: Synthetic Absorbable Monofilament Polydioxanone Suture With or Without Needle (PDREX) are produced and provided by SM ENG Co., Ltd. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue. Suture of PDREX manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOSORB. SM Eng is receiving bulk MONOSORB from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes PDREX suture. PDREX is a sterilized medical device composed with polydioxanone surgical suture, with needle, stainless steel SUS 304. PDREX Suture is a synthetic absorbable, monofilament, suture composed of a Poly (p-dioxanone). The suture is available dyed (D&C Violet No.2). Approximately 50~60% of tensile strength remain after 6 week. Complete absorption in tissues takes around 180 to 210 days.

This looks like a 510(k) premarket notification for surgical sutures (REXMONO and PDREX). The document indicates that the devices are substantially equivalent to predicate devices, and the "study" mostly consists of non-clinical bench tests and biocompatibility testing against established standards.

Here's an analysis of the acceptance criteria and the "study" information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal "acceptance criteria" table with specific quantitative thresholds for each parameter alongside the device's performance results in the way a clinical study report might. However, it states that the proposed devices comply with various USP and ISO standards.

Here's a table based on the implicit acceptance criteria (compliance with standards) and the reported performance (that the device met these standards):

It's important to note that the document generally states "complies" or "demonstrated in accordance with requirements" rather than providing specific numerical results for each test. The listed "MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P." for REXMONO and PDREX, and the remaining tensile strength percentages (68-78% for REXMONO after 1 week, 50-60% for PDREX after 6 weeks), are the most quantitative pieces of performance information provided for the sutures themselves.

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

• Sample Size: The document does not specify the sample sizes used for the non-clinical bench tests (e.g., how many sutures were tested for tensile strength or diameter). It refers to the tests performed to "verify that the proposed device...met all design specifications."
• Data Provenance: The tests are described as "Bench tests" conducted by the manufacturer/sponsor (SM ENG CO., LTD) or its design partner (Samyang Biopharmaceuticals Corporation). The origin (country) of the raw data for these tests is not explicitly stated beyond the companies being based in Korea. These are typically simulated or laboratory tests rather than trials with human subjects. The data is retrospective in the sense that the tests were completed before this submission.

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

This type of information is not applicable to this submission. The "ground truth" for surgical sutures in a 510(k) context is typically established by recognized standards (e.g., USP monographs, ISO standards) and regulatory guidance documents, not by expert consensus on individual cases. The FDA's review process itself involves subject matter experts (e.g., engineers, scientists) who evaluate the compliance of the submitted data with these standards.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" refers to physical product samples undergoing laboratory testing against predefined specifications, not clinical cases requiring expert adjudication.

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 section is not applicable. This submission is for surgical sutures, which are physical medical devices, not AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) software intended for interpretation by human readers. Therefore, no MRMC study looking at human reader performance with or without AI assistance would be relevant or performed.

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

This section is not applicable for the same reason as point 5. The device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating these sutures is primarily based on established industry standards and regulatory requirements:

• USP (United States Pharmacopeia) Monographs and Test Chapters: These define the physical and performance characteristics (e.g., diameter, tensile strength, needle attachment) accepted for surgical sutures.
• ISO (International Organization for Standardization) Standards: Specifically ISO 10993 for biocompatibility and ISO 11607 for packaging.
• ASTM (American Society for Testing and Materials) Standards: For seal strength and accelerated aging.
• FDA Class II Special Controls Guidance Document: Surgical Sutures: This document outlines specific performance testing requirements, including residual strength and absorption rate studies.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence. This concept is relevant to machine learning or AI models.

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

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

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REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

The provided text describes acceptance criteria and the results of a study to demonstrate substantial equivalence for two medical devices: REXLON (nonabsorbable polyamide surgical suture) and REXSIL (nonabsorbable silk surgical suture). Both devices are sutures and their acceptance criteria are based on established USP (United States Pharmacopoeia) and ISO (International Organization for Standardization) standards.

Here's a breakdown of the requested information, focusing on the REXLON and REXSIL devices as described:

REXLON (Nylon Monofilament Suture)

1. A table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes for each individual test conducted (e.g., how many sutures were measured for diameter or tensile strength). It only states that "REXLON were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing rather than human subject data. There is no information regarding country of origin for the data.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established standards.

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 is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXLON (and REXSIL) is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

REXSIL (Nonabsorbable Silk Suture)

1. A table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes for each individual test conducted. It only states that "REXSIL were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing. No information on country of origin for the data is provided.

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

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established standards.

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 is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXSIL is based on established industry standards and pharmacopoeia monographs, specifically:

• United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
• ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
• ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

Not applicable.

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

CRYLREX® is a sterilized medical device composed with multifilament absorbable, braided, coated suture, 90% glycolide and 10% L-lactide, with needle, stainless steel SUS 304. CRYLREX® Suture is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is available both dyed and undyed. CRYLREX® Suture is coated with poly(glycolideco-lactide)(30/70) and calcium stearate. The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70 days.

I apologize, but the provided text describes the 510(k) premarket notification for a surgical suture (CRYLREX®), not an AI-powered medical device or software.

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI device's performance
• Standalone (algorithm only) or human-in-the-loop performance studies
• Sample sizes for training or test sets for an AI algorithm
• Ground truth establishment by experts
• Multi-reader multi-case (MRMC) comparative effectiveness studies

The document focuses on demonstrating substantial equivalence to a predicate surgical suture through:

• Bench testing to verify meeting design specifications and various USP and ISO standards related to physical properties (diameter, tensile strength, needle attachment), sterility, biocompatibility, and shelf life.
• Comparison of physical and material properties of the proposed suture to a predicate device.

To answer your request, I would need a document describing the regulatory submission for an AI-powered medical device that involves performance studies and clinical evaluations.

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