(204 days)
The Pacific Surgical Patties are intended for use in neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.
To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.
A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding.
This document describes the marketing authorization for the Pacific Surgical Patties, a surgical cotton pad. The authorization is based on a finding of substantial equivalence to a predicate device, the Codman Surgical Patties.
Here's an analysis of the acceptance criteria and the study presented:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance |
|---|---|
| Equivalent materials to predicate device | Manufactured from equivalent materials meeting the same or similar standards. |
| Similar standards to predicate device | Manufactured from materials meeting the same or similar standards. |
| Dimensional specifications similar to predicate device | Meets similar dimensional specifications. |
| Quality conditions similar to predicate device | Meets similar quality conditions. |
| X-ray detectable | X-ray detectable. |
| Sterile | Sterile patties. |
| Absorb fluids | Absorbs fluids at 6.5 times its dry weight. |
| Functions in the same manner as the predicate | Functions in the same manner as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not explicitly describe a "test set" in the context of an algorithmic or AI-based device. The approval is for a physical medical device (surgical patties). The performance data cited appears to be based on an internal assessment or comparison of the Pacific Surgical Patties to the predicate device, focusing on material and functional equivalence. There is no mention of a traditional "test set" as would be used for evaluating the performance of a diagnostic or predictive algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set in the context of diagnostic performance. The evaluation is based on the physical and functional characteristics of the surgical patties compared to a predicate device.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no described test set requiring adjudication in the context of diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No. This type of study is not relevant to the described medical device (surgical patties). MRMC studies are typically used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No. This is not an AI-based device, so standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used for this device is the performance and characteristics of the legally marketed predicate device (Codman Surgical Patties). The key argument for acceptance is that the Pacific Surgical Patties are "as safe and effective" and "meets all regulatory requirements to be found substantially equivalent" to this predicate. The performance data focuses on demonstrating this equivalence through properties like material composition, dimensional specifications, quality, sterility, X-ray detectability, and fluid absorption capacity.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device that requires a training set.
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).