(38 days)
TephaFLEX braided 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 suture is a sterile, braided, surgical suture constructed of poly-4-hydroxybutyrate (P4HB). The suture consists of an inner core of multifilament fibers covered by a braided sheath made of multifilament fibers. The suture is provided dyed (D&C Violet No. 2) or un-dyed and is offered in a variety of cut lengths, with or without needles attached.
The provided document describes the acceptance criteria and the study that proves the TephaFLEX Braided Suture meets these criteria. Since this is a medical device (suture) and not an AI/ML device, many of the requested fields (e.g., sample size for training set, number of experts, MRMC studies, standalone performance) are not applicable.
Here's the information extracted from the document:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Characteristic | TephaFLEX Braided Suture Performance (Reported Device Performance) |
|---|---|
| Physical/Mechanical Properties | |
| Suture Diameter | Meets USP 33 requirements, except for diameter (specific deviation not precisely quantified, but noted to meet overall criteria). |
| Knot Pull Tensile Strength | Meets USP 33 requirements. |
| Needle Attachment Strength | Meets USP 33 requirements. |
| Biocompatibility | |
| Cytotoxicity | Non-toxic response. |
| Intracutaneous Irritation | Non-toxic response. |
| Sensitization | Non-toxic response. |
| Acute Systemic Toxicity | Non-toxic response. |
| Pyrogenicity | Non-toxic response. |
| Genotoxicity | Non-toxic response. |
| Subcutaneous Implantation (12, 26, 52, 78 weeks) | Non-toxic response. |
| In Vivo Performance | |
| Tensile Strength Retention | Equivalent to the published strength retention of predicate devices with the same clinical indications over the critical healing period. (Specific approximate % strength remaining (BSR) is given for Size 2: "2 - 4 weeks:", "8 - 12 weeks:", "26 weeks:", but the percentages are blank in the table. However, a general statement of equivalence to predicates is made.) |
| Mass Loss Rate | Demonstrated. (Specific rates not detailed, but results supported equivalence.) |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Biocompatibility: Not explicitly stated as "sample size" but involved "12, 26, 52 and 78 week Subcutaneous Implantation studies in rabbits." This implies a cohort of rabbits used over these time points.
- In vivo implantation for strength/mass loss: Conducted in "rabbits." The exact number of rabbits is not specified in the provided text.
- Physical/Mechanical testing: Not specified, but generally follows standardized testing procedures for medical devices.
- Data Provenance: The studies were conducted by Tepha, Inc. and are retrospective in nature, as they involve testing of a manufactured device. The origin of the animal subjects (rabbits) is not specified but is assumed to be within a controlled lab environment.
- Test Set Sample Size:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (suture) and the assessment criteria are based on standardized physical, mechanical, chemical, and biological tests, rather than expert interpretation of images or clinical data. The "ground truth" is defined by compliance with USP and ISO standards and observed biological responses.
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Adjudication method for the test set:
- Not Applicable. As the assessment is based on objective laboratory and in vivo testing against established standards, an adjudication method for conflicting expert opinions is not relevant.
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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 is a medical device, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm involved; this is a physical medical device.
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The type of ground truth used:
- Laboratory Testing and Standards Compliance: The ground truth is established by meeting predefined threshold values for physical and mechanical properties as outlined in USP 33 ( Suture Diameter, Knot Pull Tensile Strength, and Needle Attachment Strength) and demonstrating non-toxic responses and equivalent in vivo performance according to ISO-10993 for biocompatibility studies and in vivo strength retention studies.
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The sample size for the training set:
- Not Applicable. This is a medical device for which "training set" is not a relevant concept. The device's characteristics are inherent to its design and manufacturing process, not learned from a dataset.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).