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Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Device Description

Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Grams Absorbable Surgical Gut Suture (Plain and Chromic):

This document describes a 510(k) premarket notification for a medical device (surgical suture), not an AI/ML device. Therefore, many of the requested categories related to AI/ML specific studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable. The device's "performance" is based on conformity to established physical and chemical standards for surgical sutures.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Comparison Items (Acceptance Criteria)	Grams American Suture Inc. (Reported Device Performance)	Notes
Absorbable Surgical Gut Suture (Plain & Chromic) is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine.	Same	Grams suture is composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines, aligning with the predicate devices.
Absorbable Surgical Gut Suture (Plain & Chromic) is "Intended for Use" in soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.	Same	Grams suture shares the same intended use as the predicate devices.
Absorbable Surgical Gut Suture (Plain & Chromic) supplied for single use only, with or without needles attached, uncoated or coated with a glycerol solution.	Same	This characteristic matches the predicates (with one predicate being "Similar" for coating).
Absorbable Surgical Gut Suture (Plain & Chromic) is packed with a packet fill solution of 90% Isopropyl Alcohol, 0.5% Diethylethanolamine 0.5% Sodium Benzoate and water q.s ad 100%.	Same	This characteristic matches the predicates (with two predicates being "Similar").
Absorbable Surgical Gut Suture (Plain & Chromic) packaged in the same or equivalent manner, and has the same or equivalent labeling claims as the predicate devices including indications, contraindications, warnings, cautions, and precautions.	Same	The packaging and labeling claims are equivalent.
Finished suture material meets or exceeds the performance requirements for "Absorbable Surgical Suture" as defined in the Official Monograph of the United States Pharmacopeia 23 and the current edition USP 24.	Same	The suture material meets or exceeds the general performance requirements of USP 23 and USP 24.
Finished suture material meets the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Diameter" .	Same	The suture meets USP 23 and USP 24 requirements for diameter.
Finished suture material meets or exceeds the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Tensile Strength" .	Same	The suture meets or exceeds USP 23 and USP 24 requirements for tensile strength.
Finish suture material meets or exceeds the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Needle Attachment" .	Same	The suture meets or exceeds USP 23 and USP 24 requirements for needle attachment.
Finished suture material meets the performance requirements defined in the United States Pharmacopeia 23 and the current edition USP 24 for "Finish suture Length Requirement" (95% of stated label length).	Same	The suture meets USP 23 and USP 24 requirements for length.
Finished suture material packaged in a same or equivalent manner with sterile single or double package having labeling conforming to 21 CFR and USP XXIV.	Same	The packaging conforms to 21 CFR and USP XXIV.
Grams Absorbable Gut Suture (Plain & Chromic) is composed of the same material and has the same design as predicate devices, being a sterile, flexible, monofilament-like thread meeting all USP requirements.	Same	Explicitly stated in the conclusion. The device is made from the same raw materials and manufactured in a similar manner to the predicate devices.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "performance testing data" but does not give specific numbers of sutures tested.
Data Provenance: Not specified, but implied to be from a manufacturing and testing process adhering to USP standards. Given the applicant's address (Grafton, Wisconsin, USA), it's highly likely the testing was conducted in the USA or by a facility adhering to US regulations. The testing methodology would be prospective based on current manufacturing batches.

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

Number of Experts: Not applicable. The "ground truth" for suture performance is established by objective, standardized physical and chemical tests defined in the United States Pharmacopeia (USP Monograph). This does not involve expert consensus in the way an AI diagnostic tool would.
Qualifications of Experts: Not applicable for establishing ground truth; however, the testing would be performed by qualified laboratory personnel following USP protocols.

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

Adjudication Method: Not applicable. The performance is based on objective measurements against USP standards, not subjective assessment 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

MRMC Study: No. This is a traditional medical device (suture), not an AI/ML device.

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

Standalone Study: Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and chemical characteristics of the suture itself.

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

Type of Ground Truth: The ground truth is defined by objective, standardized measurements against the specifications and test methods outlined in the United States Pharmacopeia (USP 23 and USP 24) for "Absorbable Surgical Suture", "Diameter" , "Tensile Strength" , "Needle Attachment" , and "Finish suture Length Requirement".

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device. The "training" for a physical device is its manufacturing process and quality control, which is implicitly ongoing.

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

How Ground Truth for Training Set was Established: Not applicable. For a manufactured product like a suture, ongoing quality control and adherence to manufacturing specifications ensure consistency. The "ground truth" for the manufacturing process is its ability to consistently produce sutures that meet the USP standards, which are verified through the performance testing mentioned in the document.

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