(68 days)
PremiCron® Nonabsorbable PET Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue.
The subject device is an mutlifilament, nonabsorbable, sterile, flexible thread composed of 100% poly(ethylene terephthalate), or PET, and is indicated for soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological tissue. It is available uncolored, or colored with D&C Green No. 6. It is available uncoated, or with a silicone coating. It is available with or without standard or detachable stainless steel needles.
The provided text describes a 510(k) premarket notification for a surgical suture, not a device that would typically have acceptance criteria presented in the manner of diagnostic accuracy or performance metrics. Therefore, several sections of your request are not applicable.
Based on the provided document, here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or F1-score, as would be common for diagnostic AI/ML devices. Instead, it focuses on substantial equivalence to predicate devices by meeting established industry and regulatory standards for surgical sutures.
| Criterion Type (Implicit from document) | Acceptance Standard (from U.S.P. XXIV) | Reported Device Performance |
|---|---|---|
| Suture Diameter | Sutures -- Diameter | Conforms in all respects |
| Needle Attachment | Sutures -- Needle Attachment | Conforms in all respects |
| Tensile Strength | Tensile Strength | Conforms in all respects |
| Material Composition | 100% Poly(ethylene terephthalate) | 100% Poly(ethylene terephthalate) |
| Colorant Concentration | Conforms to 21 CFR, §74.3206 | Conforms to 21 CFR, §74.3206 |
| Sterilization Validation | (Not explicitly detailed, but implied) | Conducted |
| Sterilant Residues | (Not explicitly detailed, but implied) | Evaluated |
| Shelf-life | (Not explicitly detailed, but implied) | Tested |
| Biocompatibility | Assessed through in vitro and in vivo assays | Established |
| In vivo behavior | Assessed through in vitro and in vivo assays | Established |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing for a physical medical device (surgical suture). It does not involve a "test set" in the context of AI/ML models with data provenance. The testing would have involved physical samples of the suture, but specific sample sizes for each test are not provided. The data would be generated from laboratory and in vivo animal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI/ML device requiring expert ground truth for a test set. The "ground truth" for a surgical suture is its physical and biological performance against established standards.
4. Adjudication Method for the Test Set
Not applicable. There is no test set adjudication for this type of device. Performance is determined by standardized laboratory and biological testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is a physical medical device (surgical suture), not a diagnostic device or AI software that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device; there is no algorithm or AI component.
7. The Type of Ground Truth Used
The "ground truth" for verifying the performance of the PremiCron® Nonabsorbable PET Surgical Suture primarily relies on:
- Industry Standards and Regulatory Requirements: Conformance to the requirements of the Official Monograph for Nonabsorbable Surgical Suture in U.S.P. XXIV, including specific sections for diameter, needle attachment, and tensile strength.
- Biological Assessments: Results from "state-of-the-art in vitro and in vivo assays to establish biocompatibility and in vivo behavior."
- Material Specifications: Verification that the material is 100% poly(ethylene terephthalate) and colorant concentration meets 21 CFR, §74.3206.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or AI model involved.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.