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Non absorbable Surgical Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.

The provided text describes the 510(k) summary for a Non Absorbable Surgical Polypropylene Suture (K230746). It focuses on demonstrating substantial equivalence to a predicate device (K080684) through non-clinical performance data.

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

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a single table listing "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists the standards the device complies with for various performance aspects and states that the test results met these requirements.

However, some specific acceptance criteria and general performance statements are given:

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

The document does not specify the sample sizes for any of the non-clinical tests mentioned.
The data provenance is also not specified, as these are bench tests and biological evaluations, not human data. It is implied these tests were conducted by the manufacturer or a contracted lab to meet international standards.

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 the provided information. The tests conducted are non-clinical (bench testing, biocompatibility). There is no "test set" requiring expert ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., USP, ISO, ASTM).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or diagnostic performance evaluations involving human interpretation. The reported tests are non-clinical lab tests and biocompatibility assessments, where results are typically objective measurements or observations against predefined criteria.

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 question is not applicable. The device is a surgical suture, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device.

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

This question is not applicable. The device is a surgical suture, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is established by adherence to recognized international standards and pharmacopeial monographs. For example:

• **USP , , **: These are pharmacopeial standards defining requirements for suture diameter, needle attachment, and tensile strength.
• ISO 10993 series: These are international standards for the biological evaluation of medical devices, covering aspects like cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, and hemolysis.
• ASTM standards: These are industrial standards covering material properties and packaging (e.g., seal strength, dye penetration, needle bend/penetration).

The ground truth is based on the objective criteria and methodologies outlined in these standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission focuses on verifying the physical and biological characteristics of a mechanical device against established standards.

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

This question is not applicable, as there is no training set for this device.

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Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.

The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached.

This document (K231183) is a 510(k) Premarket Notification for a Non-absorbable Surgical Polyester Suture. It seeks to demonstrate substantial equivalence to a predicate device (K172149). The information provided focuses on the physical and biological compatibility of the suture, rather than the performance of a software or AI-driven medical device in a diagnostic context. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO, USP, and ASTM standards. The "acceptance criteria" are implied by these standards, meaning the device must "Pass" or "Comply" with the requirements of each standard.

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

This information is not provided in the document. For non-clinical tests like those listed (USP, ASTM, ISO standards), specific sample sizes and testing methodologies are defined within the respective standards. The document only states that the tests were "conducted" and "complies" or "passed." The data provenance (country of origin, retrospective/prospective) is also not specified, as these are lab-based tests rather than patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This document describes the testing of a physical medical device (suture) against established performance and biocompatibility standards. "Ground truth" in the context of expert consensus, typical for diagnostic software or AI, is not relevant here. The "ground truth" for physical device performance is defined by the objective measurement criteria within the specified international and national standards (e.g., USP monographs for suture diameter, tensile strength).

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

Not Applicable. As described above, this is not a study involving human interpretation of diagnostic data that would require an adjudication method.

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

Not Applicable. An MRMC study is relevant for diagnostic software performance, particularly AI-driven tools. This submission is for a physical surgical suture.

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

Not Applicable. This is not an algorithm or software device.

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

The "ground truth" (or more accurately, the reference standard) for this device is based on established objective measurements and criteria defined by validated international and national standards (e.g., USP Monographs for physical properties, ISO 10993 series for biocompatibility). These standards specify methodologies and acceptance limits that the device must meet.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device that requires a training set. The device is a physical product.

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

Not Applicable. As this device does not use a training set, no ground truth needs to be established for it.

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The Surgical Face Mask is intended for single use by operation room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

The proposed device, Surgical Face Mask is a three-layer, single-use, flat-pleated mask. The mask body is made of 25g/m² PP non-woven cloth. The mask contains tie strings or ear loops to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of Nylon and Spandex, and tie strings are made of 25g/m² PP non-woven cloth. The nose clip which is made of high-density polyethylene and Galvanized wire. The device is provided in sterile.

This document is a 510(k) Premarket Notification for a Surgical Face Mask. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in AI/ML medical device submissions. However, this document is for a physical medical device (a surgical face mask), not an AI/ML device. Therefore, many of the requested categories (like number of experts for ground truth, MRMC studies, training set details, etc.) are not applicable and are not present in the provided text.

This document focuses on the performance of the surgical face mask based on established ASTM and ISO standards for biocompatibility and barrier protection.

Here's a breakdown of the available information based on your request, with a clear indication of what is not applicable for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides two tables: "Table 1 Summary of Biocompatibility Test Results" and "Table 2 Summary of Performance Testing".

Table 1: Summary of Biocompatibility Test Results

Table 2: Summary of Performance Testing (for Level 2 Mask - as per ASTM F2100-19)

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