(62 days)
Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
MonodermTM suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ Synthetic Absorbable Surgical Suture:
This 510(k) summary describes a surgical suture, which is a medical device. The regulatory pathway for such devices often relies on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive human studies. Therefore, the information provided focuses on material properties and performance characteristics, aligning with physical and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance | Comments |
|---|---|---|
| Physical Testing (USP 27 Standards) | To ensure the suture meets established quality and performance standards for surgical materials. | |
| Suture Diameter | Performed | Device demonstrated conformance. |
| Suture Needle Attachment | Performed | Device demonstrated conformance. |
| Tensile Strength | Performed | Device demonstrated conformance. |
| Biocompatibility (ISO 10993 Standards) | Performed | To ensure the material is safe for implantation in the human body. |
| Implant Studies (ISO 10993 Standards) | Performed | To demonstrate rates of tensile strength retention and mass loss, which are crucial for absorbable sutures. |
| Absorption Time | Dissolves essentially in 91 days | This is a key performance characteristic for absorbable sutures, indicating how long the material provides support before being absorbed by the body. Compared favorably to predicate device. |
| Material Composition | Copolymer of glycolide and e-caprolactone | This defines the fundamental nature of the device. Confirmed to be similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Physical testing was performed on Monoderm™ Synthetic, Absorbable sutures" and "Animal testing was performed," but does not specify the number of sutures or animals used for these tests.
- Data Provenance: The document implies prospective testing conducted by the manufacturer, Surgical Specialties Corporation. The origin of the data is internal to the company (Reading, PA, USA) and refers to standardized testing methods (USP, ISO). No country of origin for specific human patient data is mentioned as such studies are not described for this type of device submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information is not applicable to this submission. For physical and material performance testing like those described (suture diameter, tensile strength, biocompatibility, absorption rates), "ground truth" is established through standardized laboratory measurements and scientific protocols, not expert consensus on interpretations of imagery or clinical cases.
4. Adjudication Method for the Test Set
- Not applicable. As the "test set" involves physical and animal testing, there is no need for expert adjudication in the way it would be applied to, for example, diagnostic image interpretation. Results are generated through objective measurements and adhere to specified test methods (USP, ISO).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. This type of study assesses human reader performance with or without AI assistance, which is irrelevant for a surgical suture and its 510(k) submission based on manufacturing and material performance data.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Not applicable. This device is a physical surgical suture, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.
7. Type of Ground Truth Used
- The "ground truth" for the performance criteria described is established through:
- Standardized Laboratory Measurements: For physical properties like suture diameter, tensile strength, and needle attachment, the ground truth is the numerical value obtained from calibrated instruments following USP protocols.
- Animal Studies/Biological Assays: For biocompatibility and absorption rates (tensile strength and mass loss over time), the ground truth is derived from the biological responses observed in in vivo animal models and in vitro assays according to ISO 10993 standards.
8. Sample Size for the Training Set
- Not applicable. This submission does not involve an AI algorithm that requires a "training set" in the machine learning sense. The device is a manufactured product whose performance is evaluated against established physical and biological standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, there is no ground truth to be established for it. The ground truth for the device's performance relates to its compliance with USP and ISO standards, as outlined in item 7.
§ 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.