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Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular , ophthalmic and neurological procedures.
Nonabsorbable Polypropylene Suture with Needle is indicated for use in soft tissue approximation and/or ligation including use in general cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

The applicant devices of nonabsorbable silk suture with needle consist of a silk surgical suture made of natural silk and a stainless steel needle. It is EO sterilized, and prygon-free. Nonabsorbable silk suture is braided.
The applicant devices of nonabsorbable polypropylene suture with needle consist of a silk surgical suture made of polypropylene and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyester suture with needle consist of a polyester surgical suture made of polyester and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of nonabsorbable polyamide suture with needle consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is EO sterilized, and prygon-free.

The provided 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a submission for a medical device (surgical sutures) seeking substantial equivalence to predicate devices, not reporting performance against specific acceptance criteria.

The information primarily focuses on:

• Manufacturer and Contact Information: Foosin Medical Supplies Inc., Ltd.
• Device Identification: Nonabsorbable Silk Suture with Needle, Nonabsorbable Polypropylene Suture with Needle, Nonabsorbable Polyester Suture with Needle, and Nonabsorbable Polyamide Suture with Needle.
• Device Description: Composition (natural silk, polypropylene, polyester, polyamide, stainless steel needle), sterilization method (EO sterilized), and braided/not braided.
• Intended Use: General soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
• Predicate Devices: Citing K-numbers (K041514, K070243, K060165, K0060471).
• Substantial Equivalence Determination: A claim that the applicant devices are substantially equivalent to their respective predicate devices.
• FDA Correspondence: A letter from the FDA confirming the substantial equivalence determination and outlining regulatory requirements.
• Indications for Use Forms: Standard FDA forms specifying the intended use for each suture type.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies based on the provided text, as it is not present in this document. Such information would typically be found in a separate section detailing performance testing (e.g., tensile strength, knot security, biocompatibility, sterility assurance level) within a more comprehensive regulatory submission.

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Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

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

The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic acid surgical suture made of polyglycolic acid and a stainless steel needle. It is EO sterilized, and prygon-free.

The applicant devices of absorbable polydioxanone suture with needle consist of a polydioxanone surgical suture made of polyester and a stainless steel needle. It is unbraided. It is EO sterilized, and prygon-free.

The document describes the acceptance criteria and supporting studies for two types of absorbable surgical sutures with needles: Absorbable Polyglycolic Acid Suture with Needle and Absorbable Polydioxanone Suture with Needle.

Here's a breakdown of the requested information:

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

The document does not explicitly list "acceptance criteria" with numerical targets and then "reported performance" against those targets in a table format. Instead, it states that performance data was collected in accordance with recognized standards, implying that meeting these standards constitutes the acceptance criteria.

Absorbable Polyglycolic Acid Suture with Needle & Absorbable Polydioxanone Suture with Needle (both devices)

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 does not specify the sample size used for any of the tests (physical, biocompatibility, or in vivo strength).
The data provenance (country of origin, retrospective/prospective) is also not mentioned.

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

This information is not applicable as the studies are focused on material properties and biocompatibility, not diagnostic interpretations requiring expert ground truth establishment.

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

This information is not applicable for material performance testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for surgical sutures.

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 or AI-driven system.

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

The "ground truth" for the performance testing of these sutures is established through predefined, standardized test methods and specifications (e.g., USP 30, ISO 10993) which define the acceptable range or characteristics of the material. For in-vivo testing, it would be direct measurement of tensile strength and mass loss over time.

8. The sample size for the training set

This information is not applicable as the device is a manufactured medical product, 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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