(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.
§ 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.