(90 days)
TephaFLEX absorbable 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.
TephaFLEX sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The TephaFLEX 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.
Here's an analysis of the provided text regarding the TephaFLEX Absorbable Suture, addressing your requested information:
Analysis of Acceptance Criteria and Study for TephaFLEX® Absorbable Suture (K082178)
This document describes a 510(k) submission for a medical device (TephaFLEX® Absorbable Suture), which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel efficacy through a clinical trial with specific acceptance criteria in the context of AI/diagnostic devices. Therefore, many of your requested points regarding AI device studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (an absorbable surgical suture), the "acceptance criteria" are typically defined by recognized standards and benchmarks for physical properties and biocompatibility. The "reported device performance" refers to the results of testing against these standards.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Physical Properties | USP 28 Suture Diameter: To ensure consistent thread width and proper surgical handling. | Performed; Conformed to USP 28 standards. |
| USP 28 Suture Needle Attachment: To evaluate the secureness of the suture to the needle, preventing detachment during surgery. | Performed; Conformed to USP 28 standards. | |
| USP 28 Tensile Strength: To measure the breaking strength of the suture, ensuring it can withstand surgical tension during approximation and ligation. | Performed; Conformed to USP 28 standards. | |
| Biocompatibility | ISO 10993 (Biocompatibility): A series of standards evaluating the biological response to medical devices, ensuring the material is not toxic, allergenic, or otherwise harmful to tissue. | Performed; Conformed to ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, systemic toxicity). |
| In Vivo Performance | Implant Studies (Tensile Strength Loss Rate): To demonstrate the rate at which the suture loses its strength over time when implanted in living tissue, which is critical for absorbable sutures. | Performed; Demonstrated acceptable rates of tensile strength loss in vivo. |
| Implant Studies (Mass Loss Rate): To demonstrate the rate at which the suture material is absorbed and degrades in living tissue. | Performed; Demonstrated acceptable rates of mass loss in vivo. | |
| Substantial Equivalence | Comparison to Predicate Devices (TephaFLEX Absorbable Suture, ENTrigue Surgical BioElast™ Absorbable Suture, Ethicon PDS II Absorbable Suture): Demonstrated that the device has similar indications for use, technological characteristics, and safety and performance as legally marketed predicate devices. | Concluded to be substantially equivalent based on testing and characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of sutures, number of animal subjects) used for each individual test. It generally states that "Physical testing was performed" and "Animal testing was performed."
- Data Provenance:
- Country of Origin: Not explicitly stated, but assumed to be from studies conducted under US regulatory oversight for submission to the FDA.
- Retrospective or Prospective: These types of tests (physical and animal implant studies) are generally considered prospective experiments specifically designed and conducted to evaluate the device against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to the evaluation of a surgical suture in this context. The "ground truth" for suture performance is established by:
- Standards bodies: (e.g., USP, ISO) defining the acceptable limits for physical properties.
- Industry best practices and scientific understanding: Guiding the design and interpretation of biocompatibility and in-vivo degradation studies.
- Qualified laboratory personnel and veterinarians/researchers: Conducting the tests and evaluating the results against established scientific protocols. No specific "experts" for ground truth adjudication in the sense of image interpretation for AI are mentioned.
4. Adjudication Method for the Test Set
Not applicable. This concept (e.g., 2+1, 3+1 for clinical disagreement) is relevant to studies involving human interpretation or clinical outcomes where there might be subjectivities. For physical and animal tests, the results are typically quantitative and objective measurements or histological assessments compared directly against predetermined criteria, not subject to adjudication in this manner.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a surgical suture, not an AI diagnostic or assistance device. Therefore, no MRMC study involving human readers and AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this device evaluation is primarily:
- Standardized Measurement: Quantitative results from physical tests (e.g., suture diameter, tensile strength) compared against USP 28 specifications.
- Histopathological and Clinical Observation: For biocompatibility and implant studies, assessing tissue response, inflammation, strength loss, and mass loss over time based on established biological and pathological criteria.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of evaluating a physical medical device like a surgical suture. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).