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DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.

DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table.

Here's an analysis of the provided text regarding the DemeQUICK (Rapid Absorbable) Surgical Suture, structured to address your requested points about acceptance criteria and the study proving compliance:

The document provided is a 510(k) summary, which is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device. For this type of submission, extensive clinical trials with human subjects as we typically associate with "AI studies" are generally not required. Instead, the focus is on non-clinical testing to demonstrate performance equivalence to established standards and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DemeQUICK Absorbable Suture are based on conformance to the requirements of the United States Pharmacopeia (USP) for absorbable sutures and demonstrating substantial equivalence to the specified predicate devices (Riverpoint's Vilet Quick® and Ethicon's Vicryl Rapide®). The reported device performance is consistently stated as "Same" relative to the predicate devices, implying that DemeQUICK meets or exceeds these criteria.

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

The document does not explicitly state specific sample sizes for each non-clinical test conducted (e.g., number of sutures tested for tensile strength or diameter). It mentions "Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture..." This implies that standard methods outlined in the USP were followed, which would have specified sample sizes for such tests.

• Test Set Sample Size: Not explicitly stated for individual tests, but implied to follow USP guidelines.
• Data Provenance: The testing was conducted in a non-clinical setting to conform to USP requirements and establish biocompatibility (ISO 10993-1). The nature of these tests (e.g., physical property measurements, in-vitro/in-vivo resorption studies) suggests laboratory-based data, not necessarily tied to a specific country of origin in the way clinical data would be. The data is retrospective in the sense that it's generated from manufactured product for regulatory submission.

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

This request is not directly applicable to this type of device submission. For surgical sutures, "ground truth" is not established by expert clinical consensus in the way seen with diagnostic AI studies. Instead, the "ground truth" for acceptance is defined by:

• USP Monograph Requirements: These are objective, measurable physical and chemical properties (e.g., minimum tensile strength, diameter tolerances) established by a pharmacopeial authority.
• Biocompatibility Standards: ISO 10993-1 provides a framework for evaluating biological responses to medical devices via standardized tests, not expert opinion.
• Performance of Legally Marketed Predicate Devices: The DemeQUICK suture is compared against two existing, approved sutures. Their performance serves as a benchmark for equivalence.

Therefore, no clinical experts are involved in establishing the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for this type of device is based on objective, standardized physical, chemical, and biological tests, not on subjective assessment or consensus among clinical experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-powered) where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. For a surgical suture, the effectiveness is proven through physical performance, biocompatibility, and absorption characteristics, not through human reader interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The testing conducted for the DemeQUICK suture is analogous to "standalone" performance. The device's physical and chemical properties, as well as its biocompatibility and absorption profile, are evaluated independently against specified standards and predicate devices, without involving a human practitioner's real-time interaction or interpretation in a clinical setting as part of the primary equivalence demonstration.

7. The Type of Ground Truth Used

The ground truth used for DemeQUICK's assessment is primarily:

• Standardized Specifications: The official Monograph of the United States Pharmacopeia (USP) requirements for absorbable surgical sutures, including specific tests for diameter, tensile strength, needle attachment, and length.
• Biocompatibility Standards: ISO 10993-1 guidelines for biological evaluation of medical devices.
• Performance Data from Predicate Devices: The established performance characteristics of Riverpoint's Vilet Quick® and Ethicon's Vicryl Rapide® sutures act as a comparative "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This concept is not applicable here. A "training set" is used for machine learning or AI models. This submission is for a physical medical device (suture) and does not involve AI.

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

Not applicable, as there is no training set for an AI model.

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