(27 days)
Biodesign Sling: For implantation to reinforce soft tissues where weakness exists in the urological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.
Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
The three subject devices of this bundled submission share many of the same technological characteristics:
- Composed of porcine small intestinal submucosa (SIS)
- Packaged in a Tyvek/PE pouch
- Labeled with a 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 (specific 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.
This document describes a 510(k) premarket notification for a medical device modification, specifically the Biodesign Sling, Biodesign Plastic Surgery Matrix, and Biodesign Anal Fistula Plug. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing clinical efficacy through a comparative effectiveness study involving human readers or AI assistance.
Therefore, the information regarding acceptance criteria and performance is related to the equivalence of the modified device to existing predicate devices, primarily through non-clinical performance testing and risk analysis, rather than a study proving new clinical effectiveness or an AI's diagnostic performance.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the sense of a numerical threshold for clinical performance metrics (like sensitivity, specificity, etc.) for a new device's efficacy. Instead, the acceptance criteria are implicitly met by demonstrating that the modified devices are substantially equivalent to their predicate devices and that the modifications do not introduce new risks or affect fundamental performance.
The "reported device performance" is demonstrated through various non-clinical tests and analyses to ensure the modified devices remain safe and effective for their intended use, comparable to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Determination) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Biocompatibility: No adverse biological reactions. | Biocompatibility analysis performed in accordance with ISO 10993. |
| Viral Inactivation: Effective inactivation of viruses. | Viral Inactivation verification performed in accordance with prEN 12442-3: 2000. |
| Risk Mitigation: All identified risks from modification are addressed. | Full design control (21 CFR 820.30) including risk analysis (ISO 14971) such as FMECA, residual risk review, post-production review. No change to device safety determined. |
| Mechanical Strength: Maintained burst force strength and suture retention strength. | Mechanical testing for burst force strength and suture retention strength. |
| Chemical Residuals: Acceptable levels of chemical residuals. | Chemical residuals testing. |
| Endotoxin Levels: Acceptable endotoxin levels. | Measurement of endotoxin levels. |
| Equivalence in Indications & Dimensions: Indications for use and dimensional specifications remain unchanged from predicates. | Confirmed in Table 5-1 and Table 5-2 that indications, common name, product code, device class, regulation number, and dimensions are unchanged or within acceptable ranges compared to predicates. |
| Fundamental Technology Equivalence: Modifications do not change the fundamental technology. | The document states, "The incorporation of the additional wash steps and the minor technological changes do not result in a change to the fundamental technology of the devices." |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes a premarket notification for device modification and focuses on non-clinical testing and risk assessment for substantial equivalence. It does not describe a clinical study with a "test set" in the context of data provenance (e.g., country of origin, retrospective/prospective). The "testing" refers to laboratory-based evaluations of the device's physical, chemical, and biological properties.
Therefore, sample size and data provenance in the context of a clinical test set are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for substantial equivalence based on non-clinical testing and risk analysis, there is no "ground truth for a test set" established by clinical experts (like radiologists). The "truth" is established by adherence to engineering standards, biocompatibility standards, and manufacturing quality controls.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study involving human adjudication of clinical outcomes or images.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This document concerns the substantial equivalence of a physical medical device (surgical mesh/plug) based on changes to its manufacturing process, not an AI or diagnostic imaging device requiring evaluation of human reader performance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This document is not about an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Adherence to recognized standards for biocompatibility (ISO 10993), viral inactivation (prEN 12442-3: 2000), and risk management (ISO 14971).
- Engineering and material science principles for mechanical properties (burst strength, suture retention), chemical residuals, and endotoxin levels.
- Regulatory definitions of "substantial equivalence" based on device characteristics, intended use, and safety/effectiveness profiles compared to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI context, 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 described.
§ 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.