(36 days)
The ACell UBM Surgical Mesh is intended for implantation to reinforce soft tissues. The device is intended for one-time use.
The ACell UBM Surgical Mesh is composed of porcine collagen and is supplied sterile in single sheet sizes ranging from 16 cm squared to 360 cm squared.
Here's an analysis of the provided text regarding the ACell UBM Surgical Mesh, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification summary for the ACell UBM Surgical Mesh. It largely focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or results from a rigorous clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria are not explicitly stated. The document broadly claims that the device "passed the requirements of all tests and was shown to be safe and effective." Without specific metrics (e.g., tensile strength, biocompatibility indices, degradation rates), a table of acceptance criteria and reported performance cannot be generated.
The "Discussion of tests and test results" section states:
- Acceptance Criteria (Implicit/General): To "assess the biocompatibility and the performance of the material."
- Reported Device Performance: "It passed the requirements of all tests and was shown to be safe and effective as a surgical mesh for soft tissue reinforcement."
This statement is a high-level summary without any detailed, quantifiable results.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for any specific tests or the provenance of the data (e.g., country of origin, retrospective/prospective). It only mentions "a number of tests" were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. The document doesn't describe the use of experts to establish a "ground truth" for test sets. The tests mentioned appear to be material and biological assessments, not expert-adjudicated clinical outcomes.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests mentioned are not clinical trials requiring human expert review with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is more common for diagnostic imaging devices involving interpretation by multiple readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The ACell UBM Surgical Mesh is a physical medical device (surgical mesh), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) is not explicitly detailed for this submission. The "tests" mentioned are likely in-vitro, in-vivo (animal), and potentially some form of biocompatibility assessments, where "ground truth" would be the results of standard laboratory analyses rather than clinical outcomes or expert consensus on patient data.
8. The Sample Size for the Training Set
This question is not applicable. The ACell UBM Surgical Mesh is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as above.
Summary of Device-Specific Information from the Text:
- Device Trade Name: ACell UBM Surgical Mesh
- Device Common Name: Surgical mesh
- Classification Name: Mesh, Surgical (FTM, 21 CFR 878.3300)
- Predicate Devices: K021637 (ACell, Inc., ACell UBM Lyophilized Wound Dressing), K980431 (Cook Biotech, Inc., SurgiSIS®)
- Device Description: Composed of porcine collagen, supplied sterile in single sheet sizes ranging from 16 cm² to 360 cm².
- Intended Use/Indications for Use: Implantation to reinforce soft tissue, intended for one-time use.
- Conclusion: Substantially equivalent to predicate devices with respect to material composition, device characteristics, and intended use.
- Tests Performed: "A number of tests to assess the biocompatibility and the performance of the material." Details of these tests and their specific results are not included in this summary.
Key takeaway: This document is a 510(k) Premarket Notification summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It typically provides an overview of testing rather than the granular detail of a full clinical study report, especially concerning specific acceptance criteria and detailed quantitative results. The criteria outlined in the input prompt are more relevant to AI/diagnostic device submissions than for a physical surgical mesh device like this one.
§ 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.