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510(k) Data Aggregation
(46 days)
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
The Patch reinforces the soft tissue of the lung thereby sealing or reducing air leaks that occur during pulmonary surgery.
• Reinforce soft tissue of the lung
• Seal or reduce air leaks in thoracic surgery
The Patch is a bioresorbable film containing gelatin. Each Patch is supplied sterile and non-pyrogenic in a single-use package.
Thin film
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fusion Medical Technologies, Inc. "The Patch" device:
The provided text does not explicitly define specific, quantitative acceptance criteria for the device's technical performance. Instead, it offers a general statement about the successful closure of air leaks.
Here's the breakdown based on your requested information, extracting what's available and noting what's not:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly defined as a quantitative metric for "success". The closest is "successful closure." | 96% of 52 treated air leaks were deemed to have "successful closure." |
| Biocompatibility requirements (Implicit from testing) | Passed all specified biocompatibility tests. |
| No product related adverse effects | No product related adverse effects were noted during the study. |
Study Details
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 26 patients. A total of 52 air leaks were treated.
- Data Provenance: Multi-center, open-label study. The country of origin is not specified but is implicitly within the regulatory scope of the FDA given the 510(k) submission. It is a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications used to establish the "successful closure" ground truth for the air leaks. It's implied that the clinical investigators participating in the multi-center study made these determinations.
4. Adjudication method for the test set
The document does not specify any explicit adjudication method (e.g., 2+1, 3+1). The assessment of "successful closure" was likely made by the treating physicians/investigators at each study center.
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, an MRMC comparative effectiveness study was not done. This device is a surgical patch, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (surgical patch), not an algorithm.
7. The type of ground truth used
The ground truth for the "successful closure" of air leaks was based on clinical assessment by the investigators/treating physicians during the pulmonary surgery and follow-up.
8. The sample size for the training set
The document does not mention a training set. This is a physical medical device, and the concept of a "training set" as understood in AI/ML contexts does not apply here. The "clinical tests" described are considered the pivotal study for performance evaluation.
9. How the ground truth for the training set was established
Not applicable. As above, no training set in the AI/ML sense was used or described.
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