(147 days)
Sutrazorb Absorbable Surgical Sutures USP / EP are indicated for use in general soft tissue approximation and / or ligation in ophthalmic procedures. The safety and effectiveness of Sutrazorb sutures in cardiovascular and neurological procedures have not been established.
The Sutrazorb Absorbable PGA Suture (Sutrazorb Suture) is a sterile, surgical suture composed of monofilaments and braids of polyglycolic acid. The suture is dyed violet. The violet sutures are dyed with D&C Violet #2 in accordance with CFR Title 21 Part 74.3602, reference Section 6.0.
The Visionary Medical Supplies' Sutrazorb Suture meets all requirements established by the United States Pharmacopoeia for absorbable surgical sutures. Testing to the following USP 32:2009 Monographs for Absorbable Sutures is discussed in Section 6.0:
- Sutures - Diameter
- Sutures Needle Attachment
- Tensile Strength
The provided text describes a 510(k) summary for the Sutrazorb Absorbable PGA Sutures. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.
Here's an analysis of the acceptance criteria and the study as described in the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (USP Monograph) | Reported Device Performance |
|---|---|
| Sutures - Diameter | Meets USP standards |
| Sutures Needle Attachment | Meets USP standards |
| Tensile Strength | Meets USP standards |
| Absorption profile | Meets USP standards |
| Shelf life | Meets USP standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the performance tests (diameter, tensile strength, needle attachment, absorption profile, shelf life). It only states that tests were conducted according to USP monograph methods.
The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be conducted by or for Visionary Medical Supplies, Inc. and are retrospective analyses against established USP standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for this device is based on objective, standardized physical and chemical properties defined by the United States Pharmacopoeia (USP) monographs, not on expert interpretations of medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable, as ground truth is established by objective USP standards, not by expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically performed for AI-driven diagnostic or screening devices to assess how AI assistance impacts human reader performance. The Sutrazorb Absorbable PGA Sutures are a medical device (surgical sutures), and their evaluation focuses on physical and material properties, not diagnostic accuracy or human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence. The performance tests (diameter, tensile strength, etc.) are conducted directly on the device itself, without human interpretation as part of the primary measurement. The evaluation of the results against USP standards is a human process, but the performance data itself is intrinsic to the device.
7. Type of Ground Truth Used
The ground truth used is objective, standardized criteria defined by the United States Pharmacopoeia (USP) Monographs for absorbable surgical sutures. These monographs provide specific methods and acceptance limits for material properties like diameter, tensile strength, and needle attachment, as well as characteristics like absorption profile and shelf life.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The tests are direct measurements of the product's physical and chemical properties against established standards.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The standards against which the device is evaluated are established by the United States Pharmacopoeia.
§ 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.