(83 days)
Atramat ® Polyglycolic Acid Sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
sorb-FAST ® Polyglycolic Acid Sutures are indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. These sutures are not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid are synthetic absorbable sterile surgical sutures composed of a synthetic polyglycolic acid polymer.
Atramat® Polyglycolic acid and sorb-FAST® Polyglycolic Acid meet all requirements as described in the United States Pharmacopeia (USP) monograph for Absorbables Surgical Sutures. These products are offered as monofilament or multifilament and it is offered uncoated or coated with polycaprolactone and calcium sterarate, it could also be undyed or dyed with D&C Violet No. 2.
Sizes offered are U.S.P. 8-0 through 2 ( metric equivalent 0.4 through 5).
Materials: Polyglycolic acid. USP & Polycaprolactone and Calcium Stearate
The provided text describes a 510(k) summary for Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid surgical sutures. This submission is for a medical device and therefore the acceptance criteria and study information provided are related to demonstrating substantial equivalence to a predicate device, rather than the performance of a diagnostic or AI-driven device. As such, the typical structure for reporting on acceptance criteria for diagnostic devices (like those involving AI) does not directly apply here.
However, I can extract the information relevant to device performance and the "study" conducted to demonstrate equivalence, framed within the context of a 510(k) submission for a non-AI surgical suture.
Acceptance Criteria and Reported Device Performance
For both Atramat® Polyglycolic Acid and sorb-FAST® Polyglycolic Acid, the core acceptance criteria revolve around meeting or exceeding the performance requirements of the United States Pharmacopeia (USP). This is the key "performance" standard for these devices.
| Acceptance Criteria Category | Criteria for Atramat® Polyglycolic Acid | Reported Device Performance for Atramat® Polyglycolic Acid | Criteria for sorb-FAST® Polyglycolic Acid | Reported Device Performance for sorb-FAST® Polyglycolic Acid |
|---|---|---|---|---|
| General Performance Standard | Meet or exceed the performance requirements for "Absorbable Surgical Suture" as defined in the official Monograph of the United States Pharmacopoeia (USP) 24. | Meets or exceeds the performance requirements for "Absorbable Surgical Suture" as defined in the official Monograph of the United States Pharmacopoeia (USP) 24. | Meet or exceed the performance requirements for "Absorbable Surgical Suture" as defined in USP 26 monographs. | Meets or exceeds the performance requirements for "Absorbable Surgical Suture" as defined in USP 26 monographs. |
| Tensile Strength Retention | Implicitly defined by USP 24, but specific percentages are given as characteristic for comparison to predicate. | Retains approximately 70% of its original tensile strength at two weeks post implantation, with approximately 50% remaining at three weeks. | Implicitly defined by USP 26, but specific percentages are given as characteristic for comparison to predicate. | Sorb-FAST® retains approximately 50% of its original tensile strength at one week post implantation. |
| Absorption Rate | Implicitly defined by USP 24, but specific timeframe is given as characteristic for comparison to predicate. | Absorption of the suture is essentially complete between 60 and 90 days. | Implicitly defined by USP 26, but specific timeframe is given as characteristic for comparison to predicate. | Absorption of the suture complete in 42 days. |
| Suture Diameter | Meet USP requirements. | Meets or exceeds the performance requirements (USP 24). | Meet USP requirements. | Meets or exceeds the performance requirements (USP 26). |
| Suture Length | Meet USP requirements. | Meets or exceeds the performance requirements (USP 24). | Meet USP requirements. | Meets or exceeds the performance requirements (USP 26). |
| Knot Pull Tensile Strength | Meet USP requirements. | Meets or exceeds the performance requirements (USP 24). | Meet USP requirements. | Meets or exceeds the performance requirements (USP 26). |
| Needle Attachment Strength | Meet USP requirements. | Meets or exceeds the performance requirements (USP 24). | Meet USP requirements. | Meets or exceeds the performance requirements (USP 26). |
Study Information (Non-Clinical Testing for Substantial Equivalence)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Non-clinical testing was conducted on the subject devices to prove conformance to the requirements of USP standards". It does not specify the exact sample sizes used for each test (e.g., how many sutures were tested for tensile strength or absorption rate).
- Data Provenance: Not specified, but generally, such non-clinical testing would be performed by the manufacturer (Internacional Farmaceutica S. A. de C.V.) in Mexico, or by a contract testing laboratory. It is retrospective in the sense that the testing was completed before the 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts is relevant for diagnostic performance studies, often comparing human interpretation to a definitive answer. For medical devices like surgical sutures, "ground truth" is defined by established engineering and material science standards (e.g., USP monographs) rather than expert consensus on a diagnostic outcome. The "experts" involved would be those performing the standardized physical and chemical tests according to USP guidelines.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used to resolve discrepancies among multiple expert readers in diagnostic studies. Here, the "test results" are objective measurements against defined standards.
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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 a 510(k) submission for a surgical suture, not a diagnostic device or an AI-powered system that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "performance" is the physical and chemical properties of the suture itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" is adherence to United States Pharmacopeia (USP) standards for absorbable surgical sutures. These are objective, quantitative specifications for material composition, physical dimensions, tensile strength, and absorption rates. For Atramat® Polyglycolic Acid, the standard is USP 24, and for sorb-FAST® Polyglycolic Acid, it is USP 26.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The product development and manufacturing processes would involve internal testing and quality control, but this is distinct from a "training set" in an algorithm development context.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the device's performance is established by the well-defined and published USP monographs.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.