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510(k) Data Aggregation
(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.
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(83 days)
TephaFLEX® Surgical Film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing 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.
TephaFLEX surgical film is intended for temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential tissue attachment to the device in case of direct contact with the viscera.
The provided text describes the regulatory clearance of a medical device, TephaFLEX® Surgical Film, through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving a device meets specific, quantitative acceptance criteria through a standalone study with a test set.
Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document. The document focuses on demonstrating that TephaFLEX® Surgical Film is as safe and effective as existing legally marketed devices.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present quantitative acceptance criteria (e.g., a specific tensile strength value that must be met) in the way one might find for a software algorithm or a diagnostic test. Instead, the "acceptance criterion" for 510(k) clearance is "substantial equivalence" to predicate devices. The performance is reported in terms of this equivalence:
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical strengths substantially equivalent to predicate devices under indication for use conditions. | "Physical and in vivo animal testing was performed on the TephaFLEX surgical film which determined the film to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions." |
| Safety and effectiveness comparable 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..." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "Physical and in vivo animal testing." The exact number of films tested or animals used is not provided.
- Data Provenance: The testing appears to have been conducted by Tepha, Inc. ("Physical and in vivo animal testing was performed on the TephaFLEX surgical film"). The country of origin and whether it was retrospective or prospective are not specified, though in vivo animal testing would be prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The "ground truth" in this context is the performance characteristics of the predicate devices, which were established prior to this submission. The comparison is against those established characteristics, not against a newly generated expert-derived ground truth for the TephaFLEX film itself.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" in the sense of a set of cases requiring adjudication. The comparison was based on physical and animal tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. TephaFLEX® Surgical Film is a physical implantable device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, in a sense. The "physical and in vivo animal testing" represents standalone performance evaluation of the device itself, separate from any human-in-the-loop interaction for its evaluation. It's not an algorithm, so "algorithm only" isn't the right terminology, but the device's inherent properties were tested directly.
7. The Type of Ground Truth Used
The "ground truth" used for comparison was the established mechanical strengths and safety/effectiveness profiles of the predicate devices:
- MAST Biosurgery, Inc. - Surgi-Wrap Film
- OsteoBiologics, Inc. -- PlastiFIIm
- Tepha, Inc. - TephaFLEX Absorbable Mesh
The TephaFLEX Surgical Film's performance was measured and compared against these existing devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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