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STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable single-use surgical suture device composed of a copolymer of glycolide and (epsilon) s-caprolactone. The device contains IRGACARE®: MP (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m. The colorant employed is D&C Violet No.2, in <0.050% w/w concentration. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. The subject device is intended for professional use only.

Same as the currently marketed undyed version, the subject device consists of a unidirectional barbed suture material, armed with a surgical needle on one end and an anchoring fixation loop at the opposite end. The barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the subject STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Unidirectional Device can be compared to USP knot strength of non-barbed sutures. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm.

The subject device is sterilized by Ethylene Oxide, and is available in lengths of 6, 9, and 12 inches, with a USP diameter size 2-0 and 3-0 (metric sizes 3.0 and 2.0), and single armed with various needle sizes.

This document describes a 510(k) premarket notification for a medical device, specifically a surgical suture. It does not contain information about an AI/ML medical device, which would typically include acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert qualifications, etc.), or details of human reader studies (MRMC).

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as the provided text pertains to a traditional medical device (surgical suture) and not an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than the detailed clinical validation studies common for AI/ML products.

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PDS™ Plus Suture is indicated for use in general soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur. PDS™ Plus Suture is not indicated in adult cardiovascular and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDS™ Plus Antibacterial Suture is a sterile synthetic absorbable monofilament suture made from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)n.

PDS™ Plus Antibacterial Suture is available undyed and dyed with D&C Violet No. 2

PDS™ Plus Antibacterial Suture contains Irgacare®† MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 ug/m.

This document is a 510(k) premarket notification for a medical device called PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture. The document focuses on establishing substantial equivalence to a predicate device (K061037) rather than presenting a performance study with detailed acceptance criteria for a new AI/CAD device.

Therefore, the requested information regarding acceptance criteria, study details, and AI/CAD specific metrics cannot be found or inferred from the provided text.

The document states: "The subject device is identical to the predicate device in terms of material, construction, specification, manufacturing, and sterilization process." and "There are no physical or technological characteristic changes to the currently marketed predicate device." The primary change described is a revision to the Indications for Use, removing ophthalmic surgery and adding in-vitro effectiveness against Enterobacter cloacae.

To address the prompt, I can only provide the information that is present in the document.

Based on the provided text, the following information is not available:

• A table of acceptance criteria and reported device performance (as would be typical for a new performance claim or an AI/CAD device).
• Sample size used for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth for a test set.
• Qualifications of experts.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI vs. without AI assistance.
• Standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
• Sample size for a training set.
• How ground truth for a training set was established.

However, the document does mention an in-vitro study related to antibacterial efficacy. Here's what can be extracted about that:

1. Acceptance Criteria and Reported Device Performance (Related to antibacterial efficacy for the new claim):

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

• The document refers to "in-vitro studies" but does not specify sample sizes for these studies or data provenance beyond being "in-vitro."

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/Not mentioned. The efficacy claim is for an antibacterial agent, likely assessed through microbiological methods, not human expert interpretation of images or other clinical data.

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

• Not applicable/Not mentioned.

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 not an AI/CAD or diagnostic imaging device.

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

• Not applicable. This is not an AI/CAD or diagnostic imaging device.

7. The type of ground truth used:

• For the antibacterial claim, the ground truth is established through quantitative in-vitro attachment assays measuring bacterial colonization. This is primarily a laboratory measurement rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable/Not mentioned. This is not a machine learning or AI device that would typically have a "training set."

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

• Not applicable/Not mentioned.

In summary, the provided document is a 510(k) for a surgical suture and does not contain the detailed performance study information typically requested for an AI/CAD device. The "study" mentioned is an in-vitro assay for antibacterial efficacy, and even for that, specific sample sizes and detailed methodology are not provided in this regulatory summary.

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DERMABOND™ PRINEO™ System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND™ PRINEO™ System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

This is a 510(k) premarket notification for a medical device (DERMABOND™ PRINEO™ Skin Closure System) applying for clearance from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a de novo study with detailed acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device cannot be fully extracted from this document in the manner typically expected for a new device submission.

Here's a breakdown of why and what can be extracted:

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

• Not Applicable in the traditional sense. This document explicitly states: "This section is not applicable, as both nonclinical testing are not necessary to support substantial equivalence since there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device."
• Since there were no new non-clinical or clinical studies conducted to demonstrate performance against new acceptance criteria, such a table cannot be created from this document. The submission is based on the premise that the modified device (reduced adhesive volume) performs equivalently to the predicate, which has already met its acceptance criteria.

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

• Not Applicable. No new test set data is presented for performance evaluation because no new studies were deemed necessary. The assessment hinges on the predicate device's existing data and the argument that a reduced adhesive volume does not alter the fundamental safety or effectiveness.

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. No new test set requiring expert ground truth establishment was conducted.

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

• Not Applicable. No new test set requiring adjudication was conducted.

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 physical medical device (skin closure system), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human "readers" or AI assistance are irrelevant to this submission.

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

• Not Applicable. As above, this is not an algorithm-based device.

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

• Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established performance and safety of the predicate device.

8. The sample size for the training set

• Not Applicable. This document does not pertain to the development of a predictive model or AI, so there is no "training set."

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

• Not Applicable. As above, there is no training set.

Summary based on the provided document:

The core of this 510(k) submission is to demonstrate substantial equivalence of the modified DERMABOND™ PRINEO™ Skin Closure System (with reduced adhesive volume) to its predicate device (K133864).

The document explicitly states that non-clinical and clinical testing were not necessary to support substantial equivalence because "there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device."

Therefore, the "proof" that the device meets acceptance criteria implicitly relies on:

• The predicate device (K133864) having already met its acceptance criteria through its original clearance.
• The argument that a reduction in adhesive volume does not compromise the fundamental safety and effectiveness of the device, given that all other technological characteristics, materials, design, intended use, and manufacturing processes remain identical to the cleared predicate.

In a situation like this, the "acceptance criteria" are effectively met by demonstrating that the changes are minor and do not affect the established performance characteristics of the predicate device. No new study data is presented to prove independent performance against new acceptance criteria.

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The absorbable VICRYL™ Mesh may be used wherever temporary wound support is required. VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.

Two weave configurations are available, knitted and woven. VICRYL™ Knitted Mesh is more porous than VICRYL™ Woven Mesh and may be used in instances in which compliant and stretchable support material is desired.

This document, an FDA 510(k) Premarket Notification for VICRYL™ Mesh (K201143), does not describe a study involving an AI/image analysis device. It is a submission for a surgical mesh, and the basis for its clearance is substantial equivalence to a previously cleared device (K191373), with the only change being a revision to the Instructions for Use labeling.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this specific FDA submission.

However, I can extract the general acceptance criteria and "performance" of this device within the context of a 510(k) clearance, which is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence for a Medical Device)

Since this document is a 510(k) clearance for a surgical mesh and not an AI/image analysis device, the concept of "acceptance criteria" and "device performance" is framed in terms of demonstrating substantial equivalence to a legally marketed predicate device. The primary "acceptance criteria" for a 510(k) submission like this is that the new device is as safe and effective as a predicate device and does not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This 510(k) submission did not involve a "test set" in the sense of a dataset for evaluating an AI algorithm's performance. The clearance was based on substantial equivalence, meaning the device itself (VICRYL™ Mesh) was deemed equivalent to a previously cleared version.
• Data Provenance: Not applicable as no new clinical or non-clinical testing data were generated or relied upon for this specific submission, other than the updated labeling. The core "data" supporting this clearance is the demonstration of sameness to the predicate device and the predicate's existing clearance history.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. No ground truth establishment by experts was required for this 510(k) given that no new performance data was submitted or required. The review process is primarily regulatory and technical comparison to a predicate, not clinical validation of performance with a study.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set requiring adjudication was used.

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

• Not Applicable. This is not an AI/image analysis device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

• Not Applicable. This is not an AI/image analysis device. Therefore, no standalone algorithm performance was assessed.

7. Type of Ground Truth Used:

• Not Applicable. No clinical "ground truth" (e.g., pathology, outcomes data) was used or generated for this submission as it was based on substantial equivalence and a labeling change for an existing device. The "ground truth" in a regulatory sense here is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

• Not Applicable. As this is not an AI/image analysis device, there was no "training set."

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

• Not Applicable. As there was no "training set," there was no ground truth to establish for it.

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STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

The STRATAFIX™ Spiral PDS™ Plus Bidirectional Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HzO3)y. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The STRATAFIX™ Spiral PDSTM Plus Device barbs allow for tissue approximation without the surgical knots.

Acceptance Criteria and Device Performance for STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device

This document outlines the acceptance criteria and the study that demonstrates the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device meets these criteria. The information is extracted from the provided FDA 510(k) summary (K192144).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device are based on the USP Monograph for absorbable surgical sutures, specifically focusing on tensile strength. The claimed performance relates to meeting the knot tensile strength of equivalent non-barbed USP and EU Pharmacopoeia polydioxanone devices.

Note: The device's straight tensile strength is compared to the knot tensile strength of conventional non-barbed sutures, as the barbs reduce the overall tensile strength of the barbed suture itself.

2. Sample Size and Data Provenance

The document states that "Non-clinical laboratory performance testings were performed" and "Bench and Animal testings show that the device performed as intended and as claimed." However, specific sample sizes for these tests are not provided in the given text.

• Sample Size for Test Set: Not specified.
• Data Provenance: The tests are described as "Non-clinical laboratory performance testings" and "Bench and Animal testings." This suggests the data is likely generated in a controlled laboratory environment. The country of origin of the data is not explicitly mentioned, but given the submitter (Ethicon, Inc., New Jersey, USA) and the FDA submission, it is likely that parts of these studies were conducted in the USA or by facilities adhering to US regulatory standards. The tests are prospective in nature, as they are conducted to demonstrate compliance with standards for device clearance.

3. Number and Qualifications of Experts for Ground Truth

This information is not applicable and not provided in the given text. The evaluation of this device relies on objective physical property measurements (tensile strength, diameter, etc.) and animal studies. It does not involve human expert interpretation for establishing a "ground truth" in the way an AI diagnostic device would.

4. Adjudication Method

This information is not applicable and not provided in the given text, as the "ground truth" for this device is established through objective physical measurements and animal model observations, not through human expert consensus requiring adjudication.

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

An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance, to assess the AI's impact on human performance. The STRATAFIX™ device is a surgical suture, and its performance is evaluated through physical and biological testing, not through human interpretation of cases.

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

This information is not applicable and not provided in the given text. The STRATAFIX™ device is a physical surgical suture, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. Type of Ground Truth Used

The ground truth for evaluating the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device is based on:

• Objective Physical Measurements: Adherence to the USP Monograph for absorbable surgical sutures for properties such as tensile strength (specifically, meeting the knot tensile strength of equivalent non-barbed sutures) and general characteristics (except for diameter, which has minor variations acceptable by the manufacturer).
• Animal Testing: Demonstration that the "device performed as intended and as claimed" in animal models.

8. Sample Size for the Training Set

This information is not applicable and not provided in the given text. As a physical medical device (suture) rather than a machine learning algorithm, there is no "training set" in the context of data-driven model development. The development process would involve materials science and engineering principles, with testing conducted to optimize design and verify performance.

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

This information is not applicable and not provided in the given text. As there is no "training set" for this physical device, there is no ground truth established in that context. Device development and testing rely on established engineering standards and biological effects, not on a machine learning training paradigm.

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STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The device is available in a dyed and undyed version. The pigment for the dyed version is D&C Violet No. 2. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Bidirectional Device Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitation of the device use. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs allow for tissue approximation without the need to tie surgical knots.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document provides specific acceptance criteria for "Tensile Strength." For other characteristics, it broadly states conformance to the USP Monograph for absorbable surgical sutures, with an exception for diameter, and mentions other tests performed.

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

The document does not specify the sample sizes used for the test sets (e.g., number of sutures, number of measurements for each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission for a medical device and the tests are non-clinical laboratory performance tests, the data would typically be generated in a controlled laboratory environment, likely within the manufacturer's R&D facilities or contracted labs, rather than from human patients.

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 section is not applicable to the provided document. The "ground truth" for this type of device (surgical suture) is established through objective, quantifiable physical and chemical properties and performance characteristics, as defined by standard monographs (like USP and EU Pharmacopoeia) and engineering test methods. It does not rely on expert interpretation or consensus in the way, for example, an image analysis AI would.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human evaluators and subjective assessments, particularly when establishing ground truth for AI algorithms or clinical endpoints. The studies described here are bench and ex vivo performance tests.

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. The device described is a physical surgical suture, not an AI software or a device that assists human readers in diagnostic tasks. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

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

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

The "ground truth" for the device's performance is based on established industry standards and objective physical measurements. Specifically:

• USP Monograph for absorbable surgical sutures: This serves as the primary standard for characteristics like suture diameter (with an noted exception), needle attachment strength, in vitro breaking strength, and ex vivo wound closure strength.
• EU Pharmacopoeia: Also referenced for device size and tensile strength.
• Defined Tensile Strength values: Specific numeric criteria for minimum knot tensile strength are provided in Table 2, which are objective quantitative targets.

8. The sample size for the training set

This section is not applicable. The device is a physical product (surgical suture) and not an AI algorithm that requires a training set.

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

This section is not applicable, as there is no AI algorithm training set involved. The "ground truth" for the performance of the suture itself is established by the methods described in point 7.

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VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.

VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.

The provided document is a 510(k) Premarket Notification for the VICRYL™ Mesh device. It asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested categories regarding acceptance criteria, study design, ground truth, and statistical analysis are not applicable (N/A) because this type of submission focuses on demonstrating equivalence to existing devices, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.

Here's a breakdown based on the information available:

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

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

• N/A. This 510(k) submission does not describe a test set or data provenance for a performance study. It's a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use, not clinical performance data.

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)

• N/A. As no test set performance study is described, there's no mention of experts establishing ground truth.

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

• N/A. No test set performance study is described, therefore no adjudication method.

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

• N/A. This is a medical device (surgical mesh), not an AI-based diagnostic tool. No MRMC study was conducted or described.

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

• N/A. This is a physical medical device (surgical mesh), not an algorithm.

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

• N/A. No new performance study requiring ground truth is described. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their known safety and effectiveness serve as the "ground truth" for the category.

8. The sample size for the training set

• N/A. This 510(k) submission pertains to a physical medical device (surgical mesh) and does not involve an algorithm or an AI model with a training set.

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

• N/A. As there is no training set for an algorithm, there's no ground truth establishment for it.

Summary of the 510(k) Submission:

The submission for VICRYL™ Mesh (K191373) focuses on demonstrating substantial equivalence to two predicate devices: VICRYL™ (Polyglactin 910) Mesh (K810428) and VICRYL™ Mesh Bag (K051701).

The core argument for equivalence is:

• Technological Characteristics: Both the subject and predicate devices are synthetic absorbable sterile copolymers made from glycolide and L-lactide.
• Intended Use: All devices are designed for temporary wound or organ support (kidney, liver, spleen) and can be cut to size.
• Manufacturing and Sterilization: The subject mesh is manufactured within existing processes for the predicate device, with no changes to manufacturing, packaging, sterilization, or shelf life.
• Differences: The only notable difference for the subject device is a revision to the Instructions for Use (IFU) to clarify indications and align with evolving regulatory expectations.

Therefore, Ethicon, Inc. did not conduct a performance study with acceptance criteria and a test set to "prove the device meets the acceptance criteria" in the manner typically expected for a novel device or AI algorithm. Instead, they demonstrated that their device is fundamentally the same as already cleared devices, making it "as safe and effective as the predicates."

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VICRYL™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

PDSTM II Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS™ II Suture is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

PDSTM Plus Suture is indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS™ Plus is not indicated in adult cardiovascular tissue and neurological tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to 6 weeks) is desirable.

VICRYL™ (Polyglactin 910) Suture is a sterile, synthetic, absorbable, surgical suture composed of a copolymer made of 90% glycolide and 10% L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. VICRYL™ Suture is available as a coated or an uncoated suture.

VICRYL™ Suture is coated with a mixture composed of equal parts of copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and Polyglactin 370 with calcium stearate have been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

VICRYL™ Suture is available undyed and dyed with D&C Violet #2 (Color Index 60725) to enhance visibility in the surgical field.

VICRYL™ Suture is available in a range of gauge sizes and lengths, types and sizes, and in presentations non-needled or attached to needles of various types and sizes.

PDSTM II (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HoO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.

PDS™ II Suture is available undyed and dyed with D&C Violet Number 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ II Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of various types and sizes.

PDSTM Plus Antibacterial (Polydioxanone) Suture is a sterile, synthetic, absorbable, surgical monofilament suture made from the polyester poly(p-dioxanone). The empirical molecular formula of the polymer is (C4HaO3)n. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic, and elicits only a slight tissue reaction during absorption.

PDS™ Plus Suture is available undyed and dyed with D&C Violet No. 2 (Color Index 60725) to enhance visibility in the surgical field.

PDS™ Plus Suture contains Irgacare® : MP (triclosan), a broad-spectrum antibacterial agent at no more than 2360 µg/m.

PDSTM Plus Suture is available in a range of gauge sizes and lengths, non-needled or attached to needles of varying types and sizes.

Here's an analysis of the provided text regarding acceptance criteria and study information:

This document describes a 510(k) premarket notification for surgical sutures (VICRYL™, PDS™ II, and PDS™ Plus). It does NOT involve a device that utilizes AI or requires complex performance studies with acceptance criteria in the typical sense of a diagnostic or therapeutic AI medical device.

The document explicitly states: "The technological characteristics of the subject devices are identical to the predicate devices and performance data are not necessary to establish substantial equivalence."

Therefore, a detailed breakdown of acceptance criteria and a study proving a device meets them (as would be expected for an AI/ML device) is not applicable here. The nature of this submission is to demonstrate substantial equivalence to previously cleared sutures, primarily based on identical functionality, technological characteristics, and intended use. The only change mentioned is to the labeling (Instructions for Use) for clarification, standardization, and harmonization.

However, if we try to interpret the "acceptance criteria" in the context of this specific 510(k) submission, it refers to the conditions that allow the FDA to determine the device is "substantially equivalent" to predicate devices. The "study" (or rather, the justification) for meeting these criteria is the comparison to the existing predicate devices.

Here's how we might frame the information based on the provided text, while acknowledging the limitations:

Acceptance Criteria and Justification of Substantial Equivalence for VICRYL™, PDS™ II, and PDS™ Plus Sutures

Given that this 510(k) submission is for surgical sutures and not an AI/ML diagnostic or therapeutic device, the concept of "acceptance criteria" and a "study proving the device meets the acceptance criteria" differs significantly from what your detailed request implies. The core "acceptance criterion" for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" isn't a complex clinical trial with performance metrics but rather a comparison of technological characteristics, intended use, and materials.

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

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

Not applicable. This submission does not involve a "test set" in the context of evaluating performance data from a patient population or algorithmic output. The demonstration of substantial equivalence is based on the inherent design, composition, and manufacturing of the sutures, and a comparison of these attributes to predicate devices. No specific "sample size" of patients or data is mentioned for performance evaluation.

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. There is no "ground truth" establishment in the context of diagnostic accuracy for this type of medical device submission. The determination of substantial equivalence is made by the FDA's regulatory experts based on the manufacturer's submission and comparison to predicate devices, drawing upon established scientific and engineering principles for surgical sutures.

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

Not applicable. There is no "test set" or adjudication process of interpretations as would be found in a clinical study for a diagnostic device.

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 not an AI-assisted diagnostic or therapeutic tool.

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 (expert consensus, pathology, outcomes data, etc)

Not applicable. As described, there is no "ground truth" in the diagnostic sense. The "truth" here is the established safety and effectiveness of the predicate devices, to which these new sutures are being compared for substantial equivalence in their fundamental characteristics.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML model.

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

Not applicable.

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STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.

STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (pdioxanone). The empirical molecular formula of the polymer is (C+HgO3). The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2.

STRATIX™ Symmetric PDS™ Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral PDS™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDSTM Plus Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.

STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE® MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360ug/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.

STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament. synthetic absorbable device prepared from a copolymer of glycolide and e-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral MONOCRYL™ Device is designed to anchor with a closed loop at one end and unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces tensile strength relative to non-barbed suture material of the same size, tving of knots in non-barbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.

The provided document is a 510(k) Summary for several STRATAFIX™ Knotless Tissue Control Devices. It primarily discusses substantial equivalence to predicate devices based on technological characteristics and proposed labeling changes.

Crucially, this document states: "Summary of Technological Characteristics: The technological characteristics of the subject devices are identical to their predicate devices, therefore performance data are not necessary to establish substantial equivalence."

This means that the FDA determined that the applicant did not need to conduct new studies to prove the device met acceptance criteria because the device's technical characteristics, materials, and performance were considered identical to previously cleared predicate devices. The submission focuses on explaining the equivalence and justifying minor labeling changes.

Therefore, for the information requested in your prompt, the answer is largely that no new studies or performance data were deemed necessary or provided in this 510(k) submission to establish acceptance criteria for the device itself. The acceptance criteria are implicitly met by the substantial equivalence to the predicate devices, which would have undergone their own testing.

Here's a breakdown of the requested information based on the provided document:

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

   • Acceptance Criteria: Not explicitly stated as new, independent criteria for this submission. The device is considered to meet the acceptance criteria of its predicate devices due to substantial equivalence. The document highlights that the subject devices are "identical to their respective predicate devices with respect to functionality, technological characteristics, intended uses, and indications." Performance specifications are also stated as unchanged.
   • Reported Device Performance: No new performance data is reported as no new studies were deemed necessary. The performance is presumed to be equivalent to the predicate devices. The document explicitly states: "performance data are not necessary to establish substantial equivalence."

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. No new test set data was generated or submitted for this 510(k) as the devices were found to be substantially equivalent to predicates without new performance studies.

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. No new test set requiring expert ground truth was generated or submitted.

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

   • Not applicable. No new test set requiring adjudication was generated or submitted.

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 device is a surgical suture, not an algorithm.

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

   • Not applicable. No new ground truth was established for this submission. The ground truth for the predicate devices would have been established through their original clearance processes, likely involving physical and mechanical testing, biocompatibility, and potentially animal or clinical studies to support their indicated uses.

8. The sample size for the training set

   • Not applicable. This device is a surgical suture, not a machine learning model requiring a training set.

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

   • Not applicable. This device is a surgical suture, not a machine learning model.

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Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues.

Coated VicryI™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is a sterile, synthetic absorbable surgical suture (dyed and undyed) and is composed of a copolymer made from 90% glycolide and 10% L-lactide. Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate. The suture contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 472 µg/m. The copolymers in the product have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. The suture is available undyed(natural) or dyed (D&C Violet No. 2).

This document describes the FDA's decision regarding the substantial equivalence of a medical device, specifically Coated Vicryl™ Plus Antibacterial (Polyglactin 910) Absorbable Suture, to a predicate device.

It is crucial to understand that this document is a 510(k) summary, which is a premarket notification for demonstrating substantial equivalence. It is NOT a study report for an AI/ML medical device that would involve performance metrics like sensitivity, specificity, or AUC.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML performance, are not applicable to this document. This submission relies on the device being identical to its predicate.

Here's the breakdown based on the provided document:

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

• Acceptance Criteria: Based on this 510(k) submission, the primary acceptance criterion for this device to achieve substantial equivalence is that its technological characteristics, intended use, and performance are identical to the legally marketed predicate device (K132580).
• Reported Device Performance:

  Criterion	Reported Performance
  Functionality	Identical to the predicate device.
  Technological Characteristics	Identical to the predicate device.
  Intended Use	Identical to the predicate device.
  Material	No material changes from the currently marketed devices.
  Device Construction	No device construction changes from the currently marketed devices.
  Performance Specification	No performance specification changes from the currently marketed devices.
  Packaging	No packaging changes from the currently marketed devices.
  Sterilization	No sterilization changes from the currently marketed devices.
  Manufacturing Process	No manufacturing process changes from the currently marketed devices.
  Safety and Effectiveness	The proposed device does not raise new questions of safety or effectiveness compared to the predicate device.

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

• Not Applicable. This document does not describe a performance study with a test set in the context of AI/ML validation involving patient data. The basis of equivalence is the device's technical and material identity to an already cleared predicate.

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

• Not Applicable. Ground truth establishment by experts is not described as part of this 510(k) submission, as it's not an AI/ML device requiring such performance validation.

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

• Not Applicable. No test set or adjudication method is described.

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 not an AI/ML device, and no MRMC study was conducted or is relevant to this type of device submission.

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

• Not Applicable. This is not an AI/ML algorithm.

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

• Not Applicable. The concept of "ground truth" as applied to AI/ML performance validation is not relevant here. The "truth" of equivalence is based on industrial and chemical specifications and previous FDA clearances.

8. The sample size for the training set:

• Not Applicable. No training set is involved as this is not an AI/ML device.

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

• Not Applicable. No training set ground truth was established.

In summary, this document is a regulatory submission demonstrating the substantial equivalence of a surgical suture based on its identical nature to a previously cleared predicate device. It does not contain information related to the performance testing typically associated with AI/ML medical devices.

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