(64 days)
TephaFLEX® Surgical Film is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
NOTE: The TephaFLEX Surgical Film is not intended to be placed transvaginally. The film should be placed abdominally when being used to reinforce soft tissues in the urological, gynecological or gastrointestinal anatomy.
TephaFLEX surgical film is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Note: The TephaFLEX surgical mesh is not intended to be placed transvaginally The film should be placed abdominally when being used to reinforce soft tissues in the urological, gynecological or gastrointestinal anatomy
This looks like a 510(k) summary for a medical device (TephaFLEX® Surgical Film). Based on the provided text, the device is not an AI/ML powered device. Therefore, many of the requested fields (such as acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the safety and performance testing conducted for a traditional medical device prior to its 510(k) clearance by the FDA, demonstrating substantial equivalence to a predicate device.
Here's the information extracted from the provided text, focusing on the safety and performance aspects:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific numerical acceptance criteria for each test. Instead, it states that "Mechanical testing, in vivo animal testing, and biocompatibility testing, were performed based on recommendations identified in the FDA surgical mesh guidance document." The reported performance is implicitly that the device met these recommendations and was found to be "substantially equivalent" to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA surgical mesh guidance document | Mechanical testing, in vivo animal testing, and biocompatibility testing were performed as recommended in the FDA guidance document. |
| Comparative burst strength comparable to predicate(s) | "Comparative burst strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| Suture pull-out strength comparable to predicate(s) | "Suture pull-out strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| Tensile strength comparable to predicate(s) | "Tensile strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| Tear resistance strength comparable to predicate(s) | "Tear resistance strength...was characterized." (Implied to be comparable or equivalent to predicate devices to achieve substantial equivalence). |
| In vivo strength retention (via subcutaneous implantation study) | "In vivo strength retention was characterized via a subcutaneous implantation study." (Implied to be comparable or equivalent to predicate devices or acceptable for the intended use to achieve substantial equivalence). |
| Biocompatibility | "Biocompatibility testing...were performed based on recommendations identified in the FDA surgical mesh guidance document." (Implied to be acceptable for the intended use to achieve substantial equivalence). |
| Substantial Equivalence to Predicate Devices | "Based on the indications for use, technological characteristics, and safety and performance testing, the TephaFLEX surgical film has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text for any of the tests (mechanical, in vivo animal, or biocompatibility).
- Data Provenance: Not specified in the provided text. The in vivo study is described as a "subcutaneous implantation study" which implies a prospective animal study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This pertains to an AI/ML device where expert consensus is often used for ground truth. This is a traditional medical device submission based on physical and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to expert assessment for AI/ML performance.
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
- No. This is not an AI-powered device, and therefore no MRMC study with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical tests: The "ground truth" would be the direct measurements of burst strength, suture pull-out strength, tensile strength, and tear resistance, likely compared against a known standard or the predicate device's characteristics.
- For the in vivo animal study: The "ground truth" for strength retention would be the direct measurement of the device's remaining strength after a certain implantation period. Observations related to biocompatibility would likely be assessed through histological examination and other biological markers.
- For biocompatibility testing: The "ground truth" is established by standard biological assays and tests guided by ISO 10993 standards and FDA guidance, assessing phenomena like cytotoxicity, sensitization, irritation, genotoxicity, etc.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth associated with it in this context.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.