(190 days)
The Arrow Epidural Catheter kit permits access to the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.
This document describes the Teleflex Medical, Inc. Arrow Epidural Catheter Kit (K143581) and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies for an AI device.
However, I can extract the information provided about the device's performance testing, which serves a similar purpose of demonstrating that the device meets certain criteria for its intended use.
Here's the closest possible interpretation of your request based on the provided document:
Description of Device: The Arrow Epidural Catheter Kit is intended to permit access to the epidural space for the administration of epidural anesthetic for up to 72 hours. It contains an epidural catheter and various accessory components, including a 0.2 Micron In-Line Flat Anesthesia Conduction Filter.
No AI/ML Powered Device: Please note that this document is a 510(k) summary for a medical device (an epidural catheter kit) and does not describe an AI/ML powered device. Therefore, sections related to AI/ML specific criteria (like human reader improvement with AI, standalone performance, training data, etc.) are not applicable and are not present in the document.
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests and met internal requirements or relevant industry standards. The specific quantitative acceptance criteria are generally "Internal Requirement" or compliance with the specified standard.
| Test | Acceptance Criteria (Principle of Test) | Reported Device Performance |
|---|---|---|
| Luer Strength Test | Force is applied to the male and female luer tapers until failure. | Meets internal requirement (implies satisfactory strength) |
| Housing Burst Pressure Test | Hydrostatic pressure is applied until part bursts. | Meets internal requirement (implies satisfactory burst integrity) |
| Flow Rate Test | Water is passed through the filter at a pressure of 10 psi and collected in a graduated cylinder for 60 seconds. The volume of water is recorded. | Meets internal requirement (implies satisfactory flow rate) |
| Filter Luer Slip | To test unscrewing gauging, liquid leakage, air leakage, separation force (ISO 594-1). | Complies with ISO 594-1 (implies satisfactory luer slip performance) |
| Filter Luer-Lock | To test unscrewing torque, ease of assembly, resistance to overriding, stress cracking (ISO 594-2). | Complies with ISO 594-2 (implies satisfactory luer-lock performance) |
| Bacterial Retention and Bubble Point Test | To test bacterial retention of membrane filter (ASTM F838). | Complies with ASTM F838 (implies 100% bacterial retention and appropriate bubble point) |
| Biocompatibility | Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic systemic toxicity, genotoxicity, implantation, and extractables & leachables (ISO 10993). | Complies with ISO 10993 (implies biocompatibility) |
| EO Residuals | EO residual testing for prolonged contact devices (ISO 10993-7). | Complies with ISO 10993-7 (implies acceptable EO residual levels) |
| LAL Bacterial Endotoxin | LAL bacterial endotoxin testing for medical devices that have contact with CSF (AAMI ST72). | Complies with AAMI ST72 (implies acceptable endotoxin levels) |
| Packaging | Packaging stability, Distribution simulation testing (ISO 11607-1, ASTM D4169). | Complies with ISO 11607-1 and ASTM D4169 (implies satisfactory packaging integrity and stability) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the specific sample sizes used for each of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, not in the 510(k) summary. The tests appear to be laboratory-based rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring adjudication of interpretations.
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
This is not applicable. The device is an epidural catheter kit, not an AI/ML system, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance tests described, the "ground truth" would be the established scientific principles, engineering specifications, and validated measurement techniques as outlined in the referenced ISO, ASTM, and AAMI standards, or the internal requirements. These are not types of ground truth typically associated with AI/ML systems.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).