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The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(O-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602). The Suture-TOOL System includes the following: • Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 1020S (Suture&Needle). • Suture-TOOL – 1018S (suture applicator). Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.

The provided FDA 510(k) clearance letter pertains to the Suture-TOOL System, which is a surgical suture device, not an AI or software-based medical device. Therefore, the information requested regarding acceptance criteria and study proving performance for an AI/software device (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) is largely not applicable to this submission.

However, I can extract the relevant acceptance criteria and performance study information for this physical medical device based on the provided text.

Acceptance Criteria and Study for Suture-TOOL System (Physical Device)

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

The acceptance criteria for the Suture-TOOL System are based on established USP (United States Pharmacopeia) standards for surgical sutures. The performance is reported as meeting or exceeding these criteria.

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

The document does not explicitly state the sample sizes used for the physical and mechanical testing of the sutures (e.g., number of sutures tested for tensile strength, diameter, or needle attachment).

• Sample Size: Not explicitly stated (e.g., "n=" not provided for each test). The text only mentions "Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture PDO USP 0 to USP 29".
• Data Provenance: Not specified regarding country of origin. The data is derived from physical performance testing of the manufactured device components. It is inherently "prospective" in the sense that the tests are conducted on manufactured products to verify design.

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

This question is not applicable to this physical device submission. Ground truth, in the context of AI/software, refers to expert interpretations or labels. For a surgical suture, the "ground truth" is defined by the objective, quantitative measurements against established USP physical and mechanical standards. No human expert interpretation is involved in establishing the "ground truth" for suture diameter, tensile strength, or needle attachment.

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

Not applicable. Adjudication methods are typically used for expert consensus in labeling or interpreting data, common in AI/software performance studies. For physical testing of a medical device like a suture, results are quantitative and objective, eliminating the need for 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

Not applicable. MRMC studies are specific to evaluating the clinical impact of AI or imaging devices on human reader performance. This submission is for a physical surgical suture, which does not involve "human readers" in the context of interpretation.

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

Not applicable. This device is a physical suture, not an algorithm.

7. The type of ground truth used

The "ground truth" for the Suture-TOOL System's performance is based on pre-defined, objective, quantitative physical and mechanical standards set by the United States Pharmacopeia (USP) for surgical sutures. Specifically, USP standards for Suture Diameter, for Suture Attachment, and for Tensile Strength.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The device is manufactured and tested based on established engineering and materials science principles.

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

Not applicable. There is no concept of "ground truth for the training set" for this physical device. The device's design and manufacturing rely on established material properties and engineering standards.

Summary regarding the nature of this 510(k) submission:

This 510(k) submission for the Suture-TOOL System is for a physical medical device (surgical suture). The "study" proving it meets acceptance criteria for FDA clearance predominantly involves physical and mechanical performance testing against recognized industry standards (USP). The questions related to AI/software performance studies (human experts, ground truth adjudication for interpretative tasks, MRMC, standalone algorithm performance, training sets) are therefore not relevant to this specific device and the information provided in the clearance letter. The substantial equivalence claim is primarily based on the device being identical to a previously cleared predicate device, with the addition of a new size (USP 0) that also demonstrated conformance to the same physical and mechanical standards.

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The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(0-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602) and are available in size 2. The Suture-TOOL System includes the following: - Polydioxanone resorbable suture pre-mounted on the needle -1020S (Suture&Needle). - Suture-TOOL 1018S (suture applicator) Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.

The provided text describes the regulatory clearance of a medical device, the "Suture-TOOL System," and compares it to predicate and reference devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.

This document focuses on the substantial equivalence of a physical surgical device (suture and applicator) based on material properties, performance testing (tensile strength, diameter, needle attachment), biocompatibility, and human factors testing related to its physical use. It does not describe an AI medical device or a study involving human readers and AI assistance for diagnostic or interpretative tasks.

Therefore, I cannot provide the requested information from the given text. The text does not provide:

1. A table of acceptance criteria and reported device performance: While it mentions USP criteria were met or exceeded for physical tests, it doesn't present these as specific acceptance criteria in a table format.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study effect size, standalone performance, type of ground truth, training set size, or how ground truth for training was established. These are all concepts relevant to AI/diagnostic studies, which are not described in this regulatory submission for a physical surgical device.

The study referenced ("Börner and Montgomery, 2020; and Börner et al., 2022") appears to be a nonclinical performance study related to the physical surgical technique (SL/WL ratio, reducing needle stick injuries), not an AI performance study measuring diagnostic accuracy.

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Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only.

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. PDO Sutures are characterized by their bidirectional barbs along axis of the monofilament. The bidirectional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot. As a result, the barbed suture improves the effectiveness of treatment.

The provided document is a 510(k) premarket notification for a medical device called "Secret Line up" and "i-Thread," which are absorbable polydioxanone sutures with needles. The document asserts that the subject device is substantially equivalent to a previously cleared predicate device (K240389).

However, the document does not contain any acceptance criteria or study results that prove the device meets specific performance criteria related to AI or algorithm-only performance. This is because the device described is a physical surgical suture, not an AI/algorithm-driven device.

Therefore, I cannot fulfill the request for information regarding AI/algorithm acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these types of studies are not applicable to the non-AI medical device described in the input.

The document primarily focuses on demonstrating substantial equivalence of the subject suture to a predicate suture based on material, manufacturing, sterilization, and physical performance tests, not on any AI or software-related functional performance.

Therefore, many parts of your request for information related to AI/algorithm performance studies cannot be answered based on the provided document.

Here’s what can be extracted and inferred from the document regarding the physical medical device:

Acceptance Criteria and Device Performance (Not for AI, but for the physical suture)

The document does not present a formal table of "acceptance criteria" for the device's main performance as a suture with corresponding "reported device performance" in a quantitative manner as one might expect for an AI algorithm. Instead, it lists the types of performance tests conducted and states that they "Pass." The acceptance criteria are implicitly the successful completion of these tests as per relevant standards.

Table of Acceptance Criteria (Inferred from standards and tests listed) and Reported Device Performance (Summary)

Information Not Applicable or Not Found (Relevant to AI/Algorithm Studies):

1. Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided as the tests are for a physical device, not an AI algorithm. The document mentions "in vivo testing in Sprague-Dawley Rat" for animal studies, but doesn't specify sample sizes for these, nor does it detail human subject data for an AI test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical suture's performance (e.g., tensile strength) is established by direct measurement and compliance with engineering standards, not by expert consensus on interpretations of data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review for AI ground truth.
4. 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 assistance tool for human readers. The document explicitly states "no Clinical Studies were performed nor required."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by bench testing against ISO, USP, and ASTM standards, and animal studies for in-vivo performance (absorption, barb holding, tensile strength over time).
7. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) submission for a traditional physical medical device (a surgical suture) and, therefore, does not contain any of the specific information requested regarding acceptance criteria and study designs pertinent to AI/algorithm performance. The 'acceptance criteria' for this device are implicitly derived from the successful execution of a range of standard physical, chemical, biological, and sterilization tests.

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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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Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and is intended for dermatological use only.

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.

This document is a 510(k) Pre-market Notification for a medical device, specifically absorbable polydioxanone surgical sutures. The purpose of this document is to demonstrate that the new device, "Secret Line up / i-Thread," is substantially equivalent to existing legally marketed predicate devices.

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

The document implicitly uses the performance of the predicate devices as its acceptance criteria and demonstrates that the subject device meets or is similar to these criteria through various tests. Explicit numerical acceptance criteria are not presented in a direct table with reported performance. However, the "Substantially Equivalent (SE) Comparison Chart" (page 6) serves this purpose by comparing various attributes of the subject device to the predicate device. All "SE" remarks indicate that the device meets the implied acceptance criteria.

Key performance tests and their outcomes (reported device performance):

Differences noted and justified:

• Suture Size (USP): Predicate: 4-0, 3-0, 2-0, 0. Subject: 2-0, 2, 0. (Similar - predicate has more sizes but subject still equivalent).
• Suture Length: Predicate: 90, 110, and 150 mm. Subject: 150, 160 mm. (Similar - predicate has various lengths but subject still equivalent).
• Barb Angle: Predicate: 2 - 45 degrees. Subject: 50 - 80 degrees. (Justified by barb holding performance test).

The overall conclusion states: "Despite the differences, the test results submitted in this 510k show that the subject device is substantially equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device." (Page 7)

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

The document references several performance tests, but it does not explicitly state the sample sizes used for each test. The tests include:

• Bench Tests (Non-clinical):

  • Suture measurements (Length, Diameter, Hub)
  • Bending test
  • Barb Holding strength
  • Flexural test
  • Pulling out (or) Extraction Test
  • USP standards: Sutures Diameter (), Sutures Needle Attachment (), Sutures Tensile Strength ().
  • ASTM F1874-98 9 bending test.

• Biocompatibility Tests (in vitro and in vivo):

  • ISO 10993 series tests for various aspects (cytotoxicity, hemolysis, systemic toxicity, irritation, sensitization, local effects after implantation, genotoxicity).
  • Ethylene Oxide Sterilization Results (ISO 10993-7, ISO 11135).

• Animal Study (In Vivo):

  • Biodegradability evaluation in Sprague-Dawley Rats.
  • Comparing "absorption", "Tensile strength test" and "Barb holding strength test" over time.

Data Provenance: The document does not explicitly state the country of origin of the data. The studies and tests appear to be retrospective, conducted in support of the 510(k) submission.

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

This information is not provided within the document. The document describes laboratory and animal studies, not studies involving human experts establishing ground truth for a diagnostic interpretation.

4. Adjudication method for the test set:

This information is not applicable as the studies described are laboratory, animal, and biocompatibility tests, not studies requiring expert adjudication of results like image interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is a surgical suture, not an AI-powered diagnostic device, and no MRMC studies are mentioned.

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

This information is not applicable as the device is a surgical suture, not an algorithm.

7. The type of ground truth used:

For the performance and biocompatibility studies, the "ground truth" is established by adherence to recognized international and FDA standards, and comparison to the performance of legally marketed predicate devices.

• Bench Test Ground Truth: Defined by the specifications and performance characteristics of the predicate device, as well as established industry standards (USP, ASTM). The goal is to show the subject device performs similarly or within acceptable limits.
• Biocompatibility Ground Truth: Defined by the requirements of the ISO 10993 series of standards, which assess the biological safety of medical devices.
• Animal Study Ground Truth: The observed biological response in the Sprague-Dawley Rat model (absorption, tensile strength, barb holding strength) is compared against the expected performance based on the predicate device and established knowledge of polydioxanone sutures.

8. The sample size for the training set:

This information is not applicable as the device is a surgical suture, not a machine learning model that requires a training set.

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

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

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MINT Product Family (Including MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate.

These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.

MINT Product Family Sutures are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. These sutures are available in a range of lengths and thicknesses and have bi-directional barbs which hold the suture in position and exert tension throughout the length of the suture. These sutures are provided sterile. They degrade and reabsorb over time.

The provided text is a 510(k) summary for the MINT Product Family of absorbable polydioxanone surgical sutures. It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it does not contain the type of AI/ML device performance data, acceptance criteria, or study details (sample sizes, expert consensus, MRMC studies, etc.) that would typically be found for an AI/ML powered medical device.

The document is for surgical sutures, a physical medical device, not an AI/ML software device. Therefore, the requested information about acceptance criteria for an AI/ML device, details of diagnostic performance studies, expert involvement in ground truth, etc., are not present in this document.

The document discusses "non-clinical performance data" and "clinical performance data" related to the physical sutures, but these are for the material properties and safety/effectiveness of the suture itself, not for an AI/ML algorithm's diagnostic performance.

Therefore, I cannot provide the requested information because the provided text is about a physical surgical suture device, not an AI/ML software device.

The document does not describe:

• Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC)
• A test set size for an AI/ML model
• Data provenance for AI/ML training/testing
• Number/qualifications of experts for AI/ML ground truth
• Adjudication methods for AI/ML ground truth
• MRMC studies for AI/ML assistance
• Standalone AI algorithm performance
• Type of ground truth for an AI/ML model
• Training set size for an AI/ML model
• How ground truth for a training set was established for an AI/ML model.

What the document does discuss (related to the physical suture device):

• Non-Clinical Performance Data: Bench testing confirming compliance with USP standards for tensile strength, barb holding strength, suture-needle attachment strength, needle corrosion resistance, needle flexural stress, cannula pull testing, and needle penetration testing. Biocompatibility testing per ISO 10993.
• Clinical Performance Data: A review of published clinical literature (10 relevant articles) from regions where the product is available. This literature involved over 500 patients with a minimum of 3 months follow-up (some 22+ months) supporting the safety and effectiveness of the sutures for face suspension surgery. The literature addressed complications associated with the sutures and procedure, not an AI algorithm.

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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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The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

The synthetic barbed Sutures are made of polydioxanone (PDO) with needles attached to each end of the suture. The needles are straight and pre-loaded onto each end of the suture filament. The pigment for the violet dye is D&C Violet No.2. The sutures are inserted into the tissue using the needles. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament. The suture is barbed into two sections and each section are in opposite direction. The device is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The Synthetic Absorbable suture with needle, approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 2-0, 0 and 1, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The needles are 50mm in length (each) and are reverse cutting type.

This document pertains to a 510(k) premarket notification for a medical device called "PDO Max Suture with Dual Needle." It assesses the substantial equivalence of the new device to a legally marketed predicate device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The document describes a medical device (surgical sutures) and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It details the device's characteristics, indications for use, and various performance tests conducted (or leveraged from previous submissions) to demonstrate its safety and effectiveness.

Key points from the document:

• Device Name: PDO Max Suture with Dual Needle
• Regulation Number: 21 CFR 878.4840 (Absorbable Polydioxanone Surgical Suture)
• Regulatory Class: Class II
• Product Code: NEW
• Indications for Use: Soft tissue approximation on the skin for dermatological applications only. Not for interior body cavity applications or lifting/supporting tissues.
• Predicate Device: Angiotech Quill™ PDO Knotless Tissue-Closure Device (K120827)
• Reference Device: PDO MAX, Inc. PDS Barbed Suture, PDO MAXX Threads (K190245)
• Performance Testing: Includes biocompatibility, sterilization validation, shelf-life, USP suture and needle performance, and in vivo animal testing. A barb holding strength test was also conducted comparing the subject device to the predicate device in porcine tissue.
• Clinical Testing: Not required to support substantial equivalence.

Therefore, I cannot answer the specific questions about acceptance criteria and a study proving an AI/ML device meets them, as this document does not describe such a device or study.

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WEGO-PDO Barbed Suture is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The propose device, WEGO-PDO Barbed Suture, is monofilament, absorbable surgical suture. It is intended for soft tissue approximation where use of an absorbable suture is appropriate. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The sutures with no needle attachments are only available with bi-directional barbs of 77 cm, 1010 cm, 2424 cm and 3030 cm, the diameter of which are USP 2-0, USP0, USP1 and USP2. The suture is made of poly(p-dioxanone). The suture is uncoated. The suture is available undyed and dyed. The suture is designed with small unidirectional and bidirectional barbs along the length of the device. Barbs allow for tissue approximation without the need to tie surgical knots. The needle is made of stainless steel. The needles are available in six types: Taper, Reverse Cutting, Cutting, Taper Cutting, Blunt and Diamond. The Arc (Circle) of needle has 5/8 circle, 1/2 circle and Straight. The proposed devices are provided in various combinations of suture length, barb, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10t and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided document is a 510(k) Summary for a medical device (WEGO-PDO Barbed Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or standalone study.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning performance metrics for an AI or imaging device.

The document describes pre-market notification for a surgical suture, not an AI or imaging device. The "Non-Clinical Test Conclusion" and "Clinical Test Conclusion" sections clearly state the types of tests performed (primarily material and sterility standards, with no clinical study included). The "SE Comparison" table compares the proposed suture device to predicate suture devices based on physical characteristics, material properties, and regulatory standards, not diagnostic performance.

To answer your prompt, you would need a document related to the clearance or approval of an AI/imaging medical device, which would detail its performance study, acceptance criteria (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, and expert involvement. This document does not provide such information.

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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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