(36 days)
Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.
The subject device is an absorbable, flexible multifilament suture thread which is supplied sterile. It is composed of a synthetic polyglycolic acid polymer and it is indicated for soft tissue approximation where only short term wound support is required. It will be offered dyed or undyed with the FDA approved colorant D&C Violet No.2 or D&C Green No.6 in accordance with Title 21 CFR, §74.3206. The modified device is coated with an absorbable polyclyconate.
The provided document is a 510(k) summary for the Safil and Safil Quick Synthetic Absorbable Surgical Suture. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a detailed clinical study in the way AI/ML devices often do.
Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML context. Instead, it focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices.
Here's why the requested information cannot be extracted from this document:
- Type of Device: The device is a surgical suture, a physical medical device. The concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "standalone performance" are typically applied to AI/ML software or diagnostic devices that generate a result based on data analysis.
- Regulatory Pathway: A 510(k) submission primarily relies on demonstrating "substantial equivalence" to existing legally marketed devices. This usually involves:
- Comparing technological characteristics (materials, design, intended use).
- Bench testing to ensure physical properties (e.g., tensile strength, absorption profile) are comparable.
- Sometimes, biocompatibility testing.
It generally does not involve clinical studies with the kind of structured "acceptance criteria" and "ground truth" assessment seen for AI/ML algorithms.
- Absence of Data: The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This reinforces that there aren't formal, quantitative acceptance criteria for clinical performance that the manufacturer needs to meet and prove through a study for this specific device type and regulatory pathway.
- Focus on Predicate Devices: The "Performance Data" section simply states that no performance standards exist, and the "Substantial Equivalence" section lists predicate devices. This implies that the 'proof' of safety and effectiveness comes from its similarity to devices already on the market, rather than a novel study demonstrating adherence to new performance metrics.
In summary, the provided text describes a medical device (surgical suture) pursuing a 510(k) clearance based on substantial equivalence, which does not involve the detailed performance study and acceptance criteria typically associated with AI/ML devices.
§ 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.