(30 days)
Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue
Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater.
Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease.
The three subject devices of this bundled submission share many of the same technological characteristics:
- Composed of multilayered sheets of processed porcine small intestinal submucosa (SIS).
- Packaged in a Tyvek/PE double pouch.
- Shelf-life of 18 months
- Sterilized using ethylene oxide.
The only differences between the three devices are the indications (and associated labeling) and the dimensional specifications (analogous to the indication and anatomic requirement for each device). Both the indications and the dimensional specifications of each subject device, however, are unchanged from the corresponding predicate device.
The provided text describes a 510(k) submission for three medical devices: Biodesign Tissue Graft, Biodesign Dural Graft, and Biodesign Peyronie's Repair Graft. The submission focuses on a technological modification to these devices, specifically the removal of a "sidedness indicator" (a small hole) that was present in the predicate devices. The document does not contain information about acceptance criteria for device performance, nor does it detail a study that proves the device meets such criteria in the way typically associated with diagnostic or AI-driven devices.
Instead, the submission aims to demonstrate substantial equivalence to predicate devices after a minor design change. The "evidence" presented is to show that the removal of the sidedness indicator does not alter the fundamental safety or effectiveness of the devices compared to their previously cleared versions.
Therefore, many of the requested elements for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission as the device is not an AI/ML or diagnostic device and the submission is focused on a minor design change for substantial equivalence.
Here's an analysis based on the information provided, highlighting the differences in the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance
This type of information is not present in the document. The submission is not about demonstrating performance against specific numerical benchmarks for a new device's function (e.g., sensitivity, specificity for a diagnostic tool). Instead, it argues that removing a mechanical indicator does not impact the device's original, established performance.
| Criterion Type | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Not Applicable to this 510(k) submission | This document concerns substantial equivalence after a minor design modification (removal of a sidedness indicator) for already cleared devices. It does not establish new performance criteria or report performance data in the typical sense of a diagnostic or AI device study. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no "test set" in the context of performance metrics for a new claim or an AI algorithm. The evidence relies on:
- Clinical feedback: Stated as confirming "functional differences between the sides were minimal and additionally reported that the presence of the sidedness indicator was confusing." (Page 7)
- Published peer-reviewed literature: Stated as confirming "that devices without the sidedness indicator performed as expected, giving evidence of substantial equivalence." (Page 7)
The document does not provide details on the sample size or provenance of this clinical feedback or the specific publications cited.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no concept of "ground truth" establishment in the context of this specific design modification. The "clinical feedback" mentioned is anecdotal or summarized, and no specific number or qualification of experts is provided.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process described for performance evaluation.
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 mesh/graft, not an AI-driven diagnostic tool, so an MRMC study related to AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not have an algorithm or standalone performance in the sense of AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable. For this type of submission, the "ground truth" of the device's functionality and safety is broadly accepted from its predicate devices. The modification (removal of a sidedness indicator) is supported by:
- Cell culture data (suggesting minimal functional differences).
- Clinician feedback (confirming minimal functional differences and reporting confusion with the indicator).
- Risk analysis (ISO 14971, which "did not identify sidedness of the material as a potential risk").
- Peer-reviewed literature (confirming performance of devices without the indicator).
These are not "ground truth" in the diagnostic sense but rather supporting evidence for substantial equivalence of a design change.
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.
Summary of the Study/Evidence Provided:
The "study" in this context is a collection of evidence supporting substantial equivalence for a minor design change, rather than a performance study for a new device or AI algorithm.
- Nature of the Change: Removal of a "sidedness indicator" (a small hole) from the Biodesign Tissue Graft, Biodesign Dural Graft, and Biodesign Peyronie's Repair Graft.
- Rationale for Removal:
- Cell culture data suggested minimal functional differences between sides.
- Clinician feedback confirmed minimal functional differences and indicated the indicator caused confusion.
- Risk management activities (ISO 14971) did not identify sidedness as a potential risk.
- Supporting Evidence for Substantial Equivalence (as described in the document):
- Review of FDA's 510(k) Guidance Document.
- Risk analysis performed in compliance with ISO 14971 (FMEA, residual risk review, post-production review).
- Summary of publications showing SIS (porcine small intestinal submucosa) performed as expected in versions of the device without the sidedness indicator.
This submission is a demonstration that the modified devices remain substantially equivalent to their predicate devices, and therefore do not require a new PMA. It is not a performance study as typically understood for diagnostic or AI devices.
§ 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.