(69 days)
These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.
The Jackson-Pratt® Hemaduct and the Jackson-Pratt Gold™ Hemaduct™ Wound Drains are made of silicone in a variety of sizes and are offered sterile in both flat and round configurations.
This document is a 510(k) summary for the Jackson-Pratt® Hemaduct™ and Jackson-Pratt Gold™ Hemaduct™ Wound Drains. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, much of the requested information regarding AI studies, expert consensus, and detailed ground truth establishment is not applicable to this 1997 medical device submission.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds typically associated with performance metrics for an AI device. Instead, it lists biological compatibility tests common for medical devices. The "Result" column serves as the reported performance, indicating successful compliance with these tests.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance (Result) |
|---|---|---|
| Cytotoxicity Test | Not elicit any toxic reactions | Drain does not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity | No reactivity was observed. |
| Hemocompatibility | Hemocompatible; no lysis | Drains are hemocompatible exhibiting no lysis. |
| Systemic Toxicity | No potential for irritation | Drain does not display potential for irritation. |
| Sensitization | No potential for irritation | Drain does not display any potential for irritation. |
| Pyrogen | No pyrogenic response | Drain does not illicit a pyrogenic response. |
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to predicate devices in terms of intended use, size, configuration, packaging, and material (silicone). The biological tests listed above support the safety aspect of this equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each of the biological compatibility tests. It generally refers to these as "testing" rather than a clinical study with a specific patient or sample count.
- Data Provenance: Not explicitly stated. These are laboratory-based biocompatibility tests, not clinical data from specific countries or retrospective/prospective studies.
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not applicable to this type of medical device submission. The ground truth for biocompatibility tests is established by standardized laboratory protocols and scientific evaluation, not by expert consensus in the way it would be for an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, primarily in AI or clinical trials. Biocompatibility tests have objective endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This submission is for a physical medical device (wound drain), not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
This is not applicable. There is no algorithm or software component for this physical wound drain device.
7. Type of Ground Truth Used
The ground truth used for the reported biological tests is based on standardized laboratory test methodologies and established biological safety parameters. For example, the cytotoxicity test follows a specific protocol to assess cellular toxicity, and the pyrogen test uses a method to detect fever-inducing substances. The results are objective measurements against defined biological endpoints, not expert consensus, pathology, or outcomes data in the clinical sense.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" as this is a physical medical device, not an AI model requiring machine learning.
9. How Ground Truth for the Training Set Was Established
This is not applicable. As there is no training set, there is no ground truth to establish for it.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.