(88 days)
Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Sutures, Undyed are indicated for use in general soft tissue approximation and/or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissues. The Modified ETHICON Absorbable poly(1-lactide/glycolide Surgical Suture, is particularly useful where extended wound support (up to 6 months) is desirable.
Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a braided absorbable surgical suture prepared from a copolymer of lactide and glycolide and coated with a copolymer of caprolactone and glycolide.
The acceptance criteria and study details for the Modified ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Composition | - Made from homopolymers and copolymers of glycolide and/or L-lactide. | - Composed of a copolymer of lactide and glycolide, coated with a copolymer of caprolactone and glycolide. |
| Intended Use | - General soft tissue approximation and/or ligation. |
- Orthopedic uses, including tendon and ligament repairs and reattachment to bone.
- Not for use in ophthalmic, cardiovascular, or neurological tissue. | - Intended for use in general soft tissue approximation and/or ligation.
- Indicated for orthopedic uses, including tendon and ligament repairs and reattachment to bone.
- Not for use in ophthalmic, cardiovascular, or neurological tissue. (Initially, the FDA letter mentioned use in ophthalmic procedures, but the "Indications for Use" statement explicitly excludes it, aligning with the "but not for use in ophthalmic, cardiovascular or neurological tissues" wording.) |
| Technological Characteristics | - Same as the predicate device (existing ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed). | - The modified device has the same technological characteristics as the predicate device (existing ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed). |
| Biocompatibility | - Biocompatible. | - Results indicated that the device was highly biocompatible. |
| Functionality | - Functional within its indicated uses. | - Results indicated that the device was functional within its indicated uses. |
| Breaking Strength Retention | - Performance comparable to predicate in terms of strength retention. | - Nonclinical laboratory testing was performed to determine breaking strength retention to assess safety and effectiveness. (Specific numerical values for retention are not provided in this summary, but the general finding of effectiveness suggests it met internal criteria.) |
| Wound Support | - Desirable for extended wound support (up to 6 months). | - Particularly useful where extended wound support (up to 6 months) is desirable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided documents. The studies performed were "Nonclinical laboratory testing," "Biocompatibility and Functionality testing." The exact number of sutures or test subjects (if any animal models were used for some aspects) is not detailed.
- Data Provenance: The document does not specify countries of origin for the data. The studies are described as "Nonclinical laboratory testing" by ETHICON, Inc., which implies internal corporate testing.
- Retrospective or Prospective: Not explicitly stated, but typically, these types of laboratory and biocompatibility tests are conducted prospectively as part of product development and pre-market submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The studies were nonclinical laboratory and functionality tests, implying scientific and engineering experts involved in the testing and evaluation of material properties and performance.
4. Adjudication Method for the Test Set
- No information on adjudication methods is provided, as the studies are "Nonclinical laboratory testing" and "Biocompatibility and Functionality testing," not studies that would typically involve expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The approval is for a medical device (suture), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a surgical suture, not a software algorithm.
7. The Type of Ground Truth Used
- For the nonclinical laboratory testing (e.g., breaking strength retention) and functionality testing, the "ground truth" would be established through objective physical and chemical measurements according to established scientific and engineering standards and protocols.
- For biocompatibility, the "ground truth" would be established through standardized in vitro and/or in vivo biocompatibility assays as per regulatory guidance (e.g., ISO 10993 series), comparing results against pre-defined safety limits or established biocompatible materials.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the device refers to its manufacturing and processing.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As noted above, this is not an AI/machine learning device. The "ground truth" for the device's development and manufacturing would relate to material specifications, manufacturing process controls, and quality assurance, which are established through engineering design, material science, and quality management systems.
§ 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.