(87 days)
The Courier™ Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, In addition, certain sizes of the Diamond ballown catheter are indicated for stent deployment / optimization of the J&J Palmaz Biliary Stent into the biliary ducts.
The proposed Courier™ Balloon Dilatation catherer is an over-the-wire catherer designed to be placed over guidewires which have outer diameters of .035" or smaller.
The provided text is a summary of safety and effectiveness for a medical device (Medi-tech Courier™ Balloon Dilatation Catheter) submitted for premarket notification (K963691) in 1996. It primarily focuses on demonstrating substantial equivalence to predicate devices through functional, integrity bench testing, and biocompatibility testing. This type of submission (510(k)) generally does not include extensive clinical studies with human performance data or AI algorithm evaluations as these are modern requirements for AI/ML-based devices.
Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this document. I will fill in what can be gleaned from the provided text.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for clinical performance in the way a modern AI device submission might. Instead, it relies on demonstrating substantial equivalence through bench testing. The "performance" described is that the functional and integrity bench testing supported the substantial equivalence of the device to its predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (PEMT-5 Balloon Dilatation Catheter) | Functional bench testing performed. Data supported substantial equivalence. |
| Integrity Equivalence to Predicate Device (PEMT-5 Balloon Dilatation Catheter) | Integrity bench testing performed. Data supported substantial equivalence. |
| Biocompatibility in accordance with FDA guidance (ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993) | Biocompatibility testing performed to the specified FDA guidance. Data supported substantial equivalence. |
| Safety and Effectiveness for Intended Use | Based on Indication for Use, technological characteristics, and safety and performance (bench) testing, the device has been shown to be safe and effective for its intended use. (This is a conclusion based on the above tests, not a direct measurement of "effectiveness" in a clinical trial sense as would be expected for an AI device). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not applicable in the context of human or clinical data for performance evaluation. The "test set" here refers to the actual physical devices (Courier™ Balloon Dilatation Catheter) undergoing bench testing. The number of devices tested is not specified, but it would have been a sample from a production lot.
- Data Provenance: Not applicable in the context of clinical data. The data is generated from bench testing (laboratory-based physical and chemical tests) of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. Ground truth in the context of this submission typically refers to established engineering standards, material science properties, and comparison to the predicate device's known characteristics, rather than expert clinical consensus on image interpretation or diagnoses.
- Qualifications of Experts: Not applicable. The "ground truth" for bench testing is determined by engineering specifications and established test methodologies.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Bench testing results are typically objectively measured and compared against specifications or predicate device data, not through human adjudication of differing 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:
- MRMC Study: No. This document predates the widespread development and regulatory submissions of AI/ML devices, and this type of study is not relevant to a traditional balloon dilatation catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the "safety and performance" section, the ground truth is based on established engineering specifications, material science, and performance characteristics of the predicate device (PEMT-5 Balloon Dilatation Catheter). Biocompatibility ground truth is established by international standard ISO-10993 and FDA guidance.
8. The Sample Size for the Training Set:
- Sample Size (Training Set): Not applicable. This refers to a physical device, not an AI model.
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth was Established: Not applicable. This refers to a physical device, not an AI model.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.