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510(k) Data Aggregation
(180 days)
ReLeaf catheters are indicated for use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumens allow for application of anesthetic to relieve postoperative pain.
The ReLeaf catheter is comprised of a radiopaque multi-lumen catheter which bifurcates proximally into a single lumen wound drain line and a single lumen anesthetic infusion line. The distal tip of the device is composed of a thin film with one side for anesthetic infusion and the other for wound drainage. The anesthetic infusion and drainage sides of the catheter are clearly marked and mid-shaft depth markings are also present. Proximally the infusion and drain lines are both affixed to an insertion trocar.
The provided FDA 510(k) summary for the ReLeaf™ Catheter focuses on demonstrating substantial equivalence to a predicate device (Axiom Multipurpose Wound Drain, K993592) through bench-top and animal testing. It does not contain information about a study involving human readers, AI assistance, or the specifics of ground truth for a test set in the context of diagnostic accuracy. This is a medical device approval for a physical catheter, not a diagnostic imaging or AI-driven decision support system.
Therefore, many of the requested categories in your prompt are not applicable to the provided document.
However, based on the information provided, here's what can be extracted and inferred within the context of a medical device submission focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are generally qualitative (meets standards, no new safety/effectiveness issues) and demonstrate performance comparable to the predicate. The "reported device performance" are the results of various bench and animal tests.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | No new issues of safety or effectiveness introduced compared to predicate. | Performance testing results support a substantial equivalence determination. |
| Biocompatibility | Compliance with ISO 10993 standards. | Full battery of ISO 10993 testing passed. |
| Material Performance | Materials suitable for intended use; no impact on safety/effectiveness due to different materials/coatings. | Materials and coatings did not impact safety or effectiveness. |
| Design Performance | Distal tip design difference does not impact safety/effectiveness; performance confirmed for intended use. | Performance of the ReLeaf catheter confirmed for its intended use in bench testing and simulated use animal testing. |
| Mechanical Performance | (Implied) Device should function as intended without failure. | Performance testing included insertion force, removal force, leak testing, patency, lumen compression, fatigue strength, tensile strength, tissue adherence. (Results are not explicitly quantified in this summary, but implied to be acceptable). |
| Leachables | (Implied) No harmful substances leaching from the polymer. | Polymer leachables testing performed. (Implied acceptable results). |
| Simulated Use | Device performs as expected in a simulated environment. | Simulated use animal testing conducted. (Implied acceptable results). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "test set" here refers to the actual devices subjected to bench and animal testing. The document does not specify the number of catheters tested for each bench test or the number of animals used.
- Data Provenance: Bench-top testing and simulated use animal testing. No country of origin is specified for the animal testing, but the submission is to the U.S. FDA. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable as this is a physical medical device. "Ground truth" for device performance is established through objective measurements in laboratory and animal testing, not expert interpretation of diagnostic data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of diagnostic cases, not for assessing the physical performance of a catheter.
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 is a medical device for anesthesia and drainage, not an AI-assisted diagnostic tool. No human reader studies comparing AI vs. no AI assistance were conducted or are relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm or AI component in the ReLeaf™ Catheter.
7. The Type of Ground Truth Used
- For Bench Testing: Objective physical measurements, engineering standards, and performance specifications (e.g., tensile strength in Newtons, leak rate, patency flow rates, force measurements for insertion/removal).
- For Animal Testing: Physiological responses, tissue reactions, and the functional success of the catheter in a living system, often assessed by veterinary pathologists or researchers.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI algorithm for this device. The development of the catheter would involve iterative design, prototyping, and testing, but not in the machine learning sense of a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there's no training set for an AI, establishing ground truth for it is irrelevant in this context.
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