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OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

The provided text is an FDA 510(k) Pre-Market Notification for a medical device called OPTIME® R, which is an absorbable surgical suture. The document primarily focuses on establishing substantial equivalence to a predicate device (Safil Quick Aesculap, K031286) based on technological characteristics and performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document states that the OPTIME® R suture was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. The following tests and their corresponding USP standards are mentioned:

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ADVANTIME® synthetic absorbable surgical sutures are intended for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery, and neurological tissue.

ADVANTIME® sutures are intended to be used in suturing and/or tissue ligation in open or laparoscopic surgery. These sutures are available with a disposable needle attachment.

ADVANTIME® is a single use, sterile, single-stranded (monofilament), synthetic bioabsorbable thread made of a poliglecaprone (a copolymer of glycolide and E- caprolactone of low tissue reactivity). Sutures are commonly used in digestive, urological, aesthetic, gynecological and intradermal surgery. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. The same applies to double-armed needles. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

The provided document is a 510(k) summary for a surgical suture device (ADVANTIME Absorbable Suture) and does not describe an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, and performance measures (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) related to AI/ML devices are not applicable.

The document discusses the substantial equivalence of the ADVANTIME Absorbable Suture to a predicate device based on physical and biological performance testing for a medical device that is not an AI/ML device.

Here's the information that is relevant from the provided text regarding this medical device:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

The device was subjected to the requirements of the United States Pharmacopeia (U.S.P.) monograph for Synthetic Absorbable Sutures.

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device study. Performance was evaluated based on physical and biological tests according to USP standards and ISO 10993-1.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device. Ground truth for physical properties is defined by USP standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device. Performance is objectively measured against USP 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 as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the physical characteristics, the ground truth is defined by the United States Pharmacopeia (USP) standards and test methodologies. For biological evaluation, the ground truth is established by standardized testing protocols detailed in ISO 10993-1.

8. The sample size for the training set: Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

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1. PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

2. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The provided text describes the acceptance criteria and the studies performed for two medical devices: PINION™ PDO Knotless Suture and PINION™ PGA-PCL Knotless Suture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria are based on comparison to predicate devices and adherence to USP (United States Pharmacopoeia) and ISO standards. The "Reported Device Performance" column reflects whether the subject device meets these criteria. Since the document states "No change," "Identical," or indicates the subject device provides "more safety" than the predicate device, it implies successful meeting of the criteria.

PINION™ PDO Knotless Suture

PINION™ PGA-PCL Knotless Suture

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

The document details performance testing for both sutures, including:

• Diameter USP
• Tensile strength USP
• Needle attachment USP
• Suture Length
• Number of barbs per linear length of suture
• Barb size (length)
• Barb size Direction
• Barb Angle
• Barb holding strength
• Sterility USP
• Biocompatibility as per ISO 10993-1

However, the specific sample sizes used for each of these performance tests are not explicitly stated in the provided document.

The document mentions "implantation studies in animals" for the predicate devices to establish in-vivo tensile strength retention and absorption profiles. For the subject devices, it explicitly mentions "The results of in vitro study using PINION™ PDO Knotless Suture" and "PINION™ PGA-PCL Knotless Suture retains approximately 62 % of its original strength 7 days post implantation," implying similar in-vitro or animal studies were conducted for the subject devices to demonstrate equivalent performance.

The data provenance is related to the manufacturing country, which is India (M/s. Meril Endo Surgery Private Limited, Gujarat, India). The studies would therefore likely align with standard regulatory practices and be conducted to meet FDA requirements for prospective testing to demonstrate device performance and safety. The document does not specify if any retrospective data was used for direct performance comparison of the subject device, beyond referencing predicate device characteristics.

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 this type of medical device submission. The devices are surgical sutures, and their performance is evaluated through measurable physical and biological properties against established standards (USP, ISO) and comparison to predicate devices, not through expert-reviewed interpretations of images or clinical outcomes that require "ground truth" established by human experts in the same way an AI diagnostic device 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 readers and AI for diagnostic or screening tasks to establish a consensus "ground truth." For surgical sutures, the assessments are based on objective physical measurements and biological tests, not subjective interpretations requiring 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. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance for human readers. These sutures are physical medical devices, not diagnostic software.

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

This section is not applicable. This question pertains to AI/software device performance, which is not relevant to surgical sutures.

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

For these surgical sutures, the "ground truth" or reference standards are:

• United States Pharmacopoeia (USP) standards for properties like diameter, tensile strength, and needle attachment.
• ISO 10993-1 standards for biocompatibility.
• Established performance profiles of the legally marketed predicate devices (e.g., STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device) for characteristics like tensile strength retention and absorption rates.

These are objective, quantitative and scientifically established benchmarks or comparisons.

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. Surgical sutures are physical devices, not AI/ML systems, and therefore do not have training sets.

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

This section is not applicable for the same reason as above.

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StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.

The provided text describes a 510(k) premarket notification for a medical device called StitchKit®. This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a minor modification related to the device's insertion and removal method (allowing use through an 8mm trocar incision in addition to a 12mm trocar).

Crucially, this document does NOT describe the acceptance criteria or a study proving the device meets performance criteria for a complex AI/ML medical device. The device in question is a suture delivery canister, a physical surgical tool, not an AI or imaging device. Therefore, many of the requested points related to AI/ML device validation (like expert adjudication, MRMC studies, ground truth for training/test sets, effect size of human reader improvement with AI assistance, and standalone AI performance) are not applicable to this submission.

The "clinical data" mentioned (retrospective case review n=422) is cited in the context of supporting the modification to the instructions for use, not for establishing the core performance of an AI algorithm. The performance data section refers to "functional performance test consisting of simulated surgical testing in an animal model" to demonstrate compatibility with the new insertion/removal technique, which is a physical device test, not an AI/ML study.

Therefore, I cannot fulfill most of your request for an AI/ML device, as the provided document pertains to a physical surgical device and its minor instruction for use modification.

However, I can extract the safety and efficacy information relevant to this device (the StitchKit® suture delivery canister) as presented in the document, acknowledging that it doesn't align with the detailed AI/ML validation questions.

Based on the provided document for the StitchKit® Suture Delivery Canister (a non-AI device):

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

The document does not specify formal, quantitative acceptance criteria for device performance in the typical sense of accuracy, sensitivity, or specificity, as it's a physical tool. Instead, the "performance" demonstrated relates to its functional compatibility with a new surgical technique.

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

• Test Set (for the modification validity):
  • Sample Size: n=422 (Cited as a "retrospective case review clinical study").
  • Data Provenance: Conducted by "an academic medical center." The country of origin is not specified but is implicitly in the US due to FDA submission. The study was retrospective.
• Functional Performance Test: Conducted in an "animal model." Sample size for this specific test is not 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 a physical device, not an AI/ML diagnostic or image analysis device where "ground truth" would be established by experts interpreting medical data. The "ground truth" for the retrospective case review would likely be the surgical outcomes or successful use reported in the patient records.

4. Adjudication method for the test set

• Not Applicable. As above, no expert adjudication process is described or relevant for this type of device and study.

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. No MRMC study was done, as this is not an AI-assisted diagnostic device.

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

• Not Applicable. No standalone algorithm performance was evaluated, as this is not an algorithm-based device.

7. The type of ground truth used

• For the retrospective case review (n=422), the "ground truth" would be derived from clinical records and surgical outcomes related to the use of the device in actual patient cases, rather than expert interpretation of images or pathology. The document doesn't explicitly state how "success" or "performance" was quantified from these cases, but it supports the safety/effectiveness of the device, particularly with the proposed instruction modification.
• For the animal model functional test, the "ground truth" was direct observation of the device's physical handling and compatibility with the 8mm trocar site.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an machine learning model.

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

• Not Applicable. No training set was used.

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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

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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MONOFIX PGCL, knotless wound closure device is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. MONOFIX PGCL, knotless wound closure device should not be used to approximate tissue under tension and the use of barbed suture has not been shown to be safe in the closure of hernias, laparotomy incisions, bowel anastomosis or suture lines, vascular suture lines, and vaginal cuff closure in controlled clinical or preclinical studies for minimally invasive or open surgery.

MONOFIX PGCL, knotless wound closure device, comprised of Poly(glycolide-co-carprolactone)(PGA-PCL) is a synthetic absorbable monofilament undyed-suture. It is available sterile, developed by Samyang Holdings Corp., Ltd. The MONOFIX PGCL, knotless wound closure device consists of a Barb-type suture and a surgical needle, with a suture at one end and a stopper shaped end for tissue anchoring at the stopper is attached to the end of the suture and has a triangular shape with one side length of 1.8 to 3.3 mm and a thickness of 0.7 to 1.0 mm. The device is designed with small uni-directional barbs in size 0.18-0.55 mm along the length and stopper that eliminate the need to tie knots during approximation. The device is available in lengths of 15 to 60cm and diameter sizes 1 through 3-0 with needles in 1/2 circle, 5/8 circle, 1/2 curved and straight shapes attached to each end.

This appears to be an FDA 510(k) clearance letter and a summary of the predicate device comparison for a surgical suture, not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert consensus, MRMC studies, standalone performance), and ground truth establishment, which are typical for AI/ML device submissions, are not applicable in this context.

The document describes the non-clinical tests performed to demonstrate the device's compliance with established standards for surgical sutures. These include:

• Bench tests: To verify design specifications, focusing on:
  • USP Suture Diameter
  • USP Suture-Needle attachment
  • USP Tensile Strength Surgical Suture
  • USP Monographs: Absorbable Surgical Suture
  • EP Monographs: Sutures, Sterile Synthetic Absorbable Monofilament
• Sterilization validation: ISO 11135:2014, ISO 10993-7
• Sterile barrier system testing: ASTM F 88
• Accelerated aging stability testing: ASTM F 1980
• Biocompatibility testing: A comprehensive suite of ISO 10993 standards (e.g., ISO 10993-5, -10, -11, -4, -12, -3, -6) and ASTM F756-17.
• In vivo tensile strength: Performed to evaluate tensile strength retention rate.

The "Acceptance Criteria" in this document would refer to the specific thresholds and performance requirements defined by these standards (e.g., minimum tensile strength, maximum/minimum diameter, acceptable levels of residuals, successful sterilization). The "Reported Device Performance" would be the results from the tests confirming the device met these criteria.

Therefore, it is impossible to provide the table and study details as requested because this document does not pertain to an AI/ML device. The study outlined is a non-clinical, benchtop and biocompatibility assessment, not a clinical performance study with human readers or AI algorithms.

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StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile. Each StitchKit® contains strands of existing legally-marketed Suturing Materials, cleared for use within the device.

The provided document is a 510(k) summary for the StitchKit® Suture Delivery Canister, which is a Class II medical device. This document details the device's indications for use, technological characteristics, and substantiates its substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria in the typical sense of a human-in-the-loop AI effectiveness study.

The device itself is a delivery system for existing sutures and not an AI-powered diagnostic or assistive device. Therefore, many of the requested criteria related to AI performance, AI effect size on human readers, expert ground truth, and training data are not applicable to this submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the StitchKit® are based on demonstrating substantial equivalence to legally marketed predicate devices. The performance data provided focuses on the physical and chemical properties of the device and its included sutures.

• Sutures are legally marketed and have not been modified, only trimmed to length and packaged within the StitchKit® canister. | - Canister is confirmed to be legally marketed and unchanged.
• Sutures are confirmed to be legally marketed, not modified other than trimming and packaging for the StitchKit®. |
  | Performance Testing | - Comparative Physico-Chemical analysis
• LAL Pyrogen testing
• Material Mediated Pyrogen testing
• Stability Evaluations (including USP suture tensile strength, diameter, and needle attachment testing)
• Comparative in-vitro simulated biodegradation testing for absorbable sutures | - Testing performed to verify substantial equivalence to predicate devices.
• Specific results or thresholds are not provided in this summary, but the conclusion states that the device "has been shown to be substantially equivalent to its predicate devices" based on this data. |
  | Indications for Use | - Facilitates minimally invasive robotic surgery by transporting suture and removing used needles.
• Suture intended for soft tissue approximation where use of specific absorbable/non-absorbable sutures is appropriate. | - The device's design directly supports these indications. No performance metrics are given here for success rate of needle removal or ease of transport, rather it's implicit in its design that it fulfills these functions. |

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

The document does not specify a "test set" in the context of an AI study. Instead, it refers to various forms of performance testing on the device and its components. The document doesn't provide specific sample sizes for these tests (e.g., number of sutures tested for tensile strength or number of canisters tested for pyrogenicity). The provenance of the data (e.g., country of origin, retrospective/prospective) is also not specified, as this type of information is typically not included in a 510(k) summary for a physical device.

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

Not applicable. As this is not an AI or diagnostic device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The performance criteria are based on objective physical/chemical tests.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As there are no expert interpretations or subjective assessments requiring adjudication, no such method was used.

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. The StitchKit® is a physical surgical delivery device and does not involve AI or human readers for diagnostic assistance. Therefore, an MRMC study and AI effect size are irrelevant.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance validation is based on established engineering and material science standards (e.g., USP standards for suture properties, LAL pyrogen testing standards, physicochemical analysis). It's not clinical "ground truth" derived from patient outcomes or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

Not applicable. There is no AI component requiring a training set.

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

Not applicable. There is no AI component requiring a training set and associated ground truth.

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StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the StitchKit® device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

StitchKit® COMBO is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch. Each StitchKit® version contains strands of existing legallymarketed Suturing Materials, cleared for use within the StitchKit®.

This looks like a 510(k) summary for a medical device called "StitchKit® COMBO Suture Delivery Canister". Based on the provided text, the device is explicitly a suture delivery system and not an AI or imaging device, so the requested information about AI performance, ground truth, expert adjudication, etc., is not applicable.

Here's a breakdown of why the requested information cannot be provided given this document:

• No AI component: The document describes a "suture delivery canister which facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing." There is no mention of artificial intelligence, machine learning, image analysis, or any diagnostic capabilities.
• Physical device, not a diagnostic algorithm: The device handles physical sutures and needles. The performance data listed (knot-pull tensile testing, diameter, needle attachment, biodegradation testing, pyrogen testing, physico-chemical analysis, stability evaluations) are all related to the physical properties and safety of the surgical sutures and the delivery system itself, not to the performance of a software algorithm.

Therefore, since the device is not an AI/ML medical device, the following points from your request are not applicable and cannot be found in the provided text:

1. A table of acceptance criteria and the reported device performance (The "performance data" mentioned refers to physical product testing, not AI performance metrics)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, this document describes a traditional medical device (suture delivery system) and does not provide any information relevant to the performance or validation of an AI/ML component.

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MONOCRYL™ Plus Antibacterial Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL™ Plus Antibacterial Suture is a sterile, monofilament, synthetic, absorbable surgical suture composed of a copolymer of glycolide and (epsilon) s-caprolactone. The empirical formula of the polymer is (C2H2O2)m (C6H102)n.

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

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

This document is a 510(k) premarket notification for a medical device called MONOCRYL™ Plus Antibacterial Suture. It seeks to demonstrate substantial equivalence to a previously cleared device. Therefore, the information provided focuses on the equivalence of the modified device to its predicate, rather than detailing a de novo study to establish acceptance criteria and prove performance against them as would be typical for a novel device or AI/software.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific 510(k) submission:

Understanding the Context:

This submission (K201996) is for a modified device (MONOCRYL™ Plus Antibacterial Suture) that is largely identical to a predicate device (MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 with 510(k) number K050845). The only reported changes are to the labeling, specifically updating in vitro effectiveness against an additional microorganism and including new descriptors/icons.

For a 510(k) involving minor changes, the "acceptance criteria" revolve around demonstrating that the modified device remains as safe and effective as the predicate, or that the changes do not raise new questions of safety or effectiveness. The "study" in this context refers to the data presented to support this claim, rather than a clinical trial for a new product.

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

Since this is a submission for a modified device essentially claiming no change in technological characteristics, the "acceptance criteria" are implicitly that the modified device retains the performance attributes of the predicate. The "reported device performance" is essentially a reaffirmation of the predicate's performance, along with specific in vitro data for the antibacterial claims.

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

The document mentions "in vitro efficacy studies" for the antibacterial claims. Details on the specific sample sizes (e.g., number of suture samples, number of bacterial cultures) are not provided in this summary. The data provenance is described as "in vitro," implying laboratory studies, rather than patient data. No information on country of origin or retrospective/prospective nature is given, as it's not a clinical study.

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

This type of information is generally relevant for AI/radiology devices where expert consensus is used to label images. For a physical medical device like a suture, "ground truth" for material properties and antibacterial efficacy is established through standardized laboratory testing and validated analytical methods (e.g., chemical analysis, microbiology assays). The document does not specify the number or qualifications of experts involved in running these in vitro tests, as this is typically handled by qualified laboratory personnel following established protocols.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for imaging interpretation, to resolve discrepancies between readers. This document describes laboratory in vitro studies for which such an adjudication method is not relevant.

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 surgical suture, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are not relevant.

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

Not applicable. This document is about a physical medical device, not an algorithm or AI.

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

For the antibacterial claims, the "ground truth" would be established by the results of the microbiological in vitro assays which directly measure the inhibition of bacterial colonization on the suture material. For the material properties, the "ground truth" is established by chemical and physical testing against established standards (e.g., USP monographs). This is empirical data from laboratory studies, not consensus of human experts on subjective interpretations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires training data.

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

Not applicable, as explained in point 8.

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MINT™ is indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.

The MINT™ device is a sterile synthetic absorbable surgical suture comprised of polydioxanone, (GHoOJ)n. Polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment of the violet dye is D&C Violet No.2 (21CFR §74.3602). MINT™ is available in a range of gauge sizes and lengths. Each suture has bi-directional barbs along the long axis of the suture monofilament. The MINT™ Synthetic Absorbable PDO suture approximates tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues. Barbed suture lifting is a minimally invasive surgical technique for facial rejuvenation. The MINT™ Product Family includes models which are supplied with needles. For those models supplied with a needle, designated as "Lifting Thread Combined with needle" in the MINT™ Product Family instructions for use, the needle is used to make the insertion point and for threading of the suture in the patient's dermis.

Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the supporting study:

Device: MINT™ Product Family (Absorbable Polydioxanone Surgical Suture) for mid-face suspension surgery.
Indication: Temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with quantifiable targets for the clinical study. However, the primary effectiveness endpoint and several secondary effectiveness evaluations serve as the de-facto acceptance criteria for clinical efficacy. The reported performance for these criteria is extracted below.

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Clinical Study): 62 male and female subjects (referred to as "FA set" in results, with 61 subjects for some analyses).
• Data Provenance: Prospective clinical study. The country of origin of the data is not explicitly stated, but the sponsor, Hans Biomed Corporation, is located in the Republic of Korea, suggesting the study may have been conducted there.

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

• Number of Experts: Unspecified, but referred to as "independent, blinded assessors" and "blinded evaluators." Also, "testers" (who may or may not be the same as independent evaluators) were involved.
• Qualifications of Experts: Not specified. They are generally referred to as "evaluators" or "assessors."

4. Adjudication Method for the Test Set

The document mentions "Independent, blinded assessors" and that the analysis was based on "blinded evaluator Global Aesthetic Improvement Scale (GAIS) ratings" and "comparing the photos... by blinded evaluators." It also refers to "evaluation of independent evaluators" and "evaluation of testers."

However, no specific adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements between multiple evaluators is described. It implies individual independent ratings were collected and analyzed (e.g., averaging or using individual scores).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a MRMC comparative effectiveness study was not done in the sense of comparing human readers' performance with and without AI assistance, as this is a medical device (suture) and not an AI/CADe system for image analysis.
• The clinical study evaluates the device's effectiveness through expert assessment of clinical outcomes (WSRS, GAIS) performed directly on subjects or their photos, not through a reader-AI interaction for diagnosis or interpretation.

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

• Yes, a standalone performance was done for the device in the context of its mechanical and biological properties.
• The "non-clinical performance data" (USP compliance, barb holding strength) and "animal performance data" (absorption, mechanical strength in vivo) represent standalone performance assessments of the physical characteristics of the suture itself, without human intervention in the device's inherent function.
• The clinical study then assessed its performance in vivo in human subjects, which is the ultimate "standalone" performance for a medical implant like a suture.

7. The Type of Ground Truth Used (Clinical Study)

• Expert Consensus and Subjective Scales: The primary ground truth for the clinical study was established using validated subjective rating scales like the 5-grade Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). These were applied by:
  • Independent, blinded assessors/evaluators.
  • Testers (likely clinicians involved in the study).
  • The subjects themselves (for GAIS).
• This represents a form of expert assessment/consensus based on observable clinical outcomes, rather than objective pathology or hard outcomes data like mortality.

8. The Sample Size for the Training Set

• Not Applicable. This document describes a medical device (surgical suture), not an AI/Machine Learning model. Therefore, there is no "training set" in the context of machine learning. The clinical study served as the primary evidence for the expanded indication.

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

• Not Applicable, as there is no training set for an AI/ML model.

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