Jupiter PTA Catheters are designed for dilating stenotic lesions in peripheral arteries (renal, popliteal, infra popliteal, femoral, and illio femoral) and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

Jupiter PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

AI/ML Overview

This document is a 510(k) premarket notification for Jupiter PTA Catheters and does not contain the type of acceptance criteria and study information typically found for AI/ML-driven medical devices.

The provided text focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (a catheter), not on the performance of a diagnostic algorithm or AI system. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to the content provided.

Specifically, the document discusses:

General Provisions: Common and proprietary names of the device.
Predicate Devices: Lists similar catheters from Cordis and Medi Tech.
Classification: Class II device.
Performance Standards: States that FDA performance standards have not been established under Section 514 of the Food, Drug and Cosmetic Act. This explicitly indicates that there are no predefined performance criteria from the FDA for this device discussed in the document.
Intended Use and Device Description: Explains what the catheter is used for.
Biocompatibility: Refers to previous testing on K955886 and compliance with ISO Standard 10993, but this relates to material safety, not diagnostic performance.
Summary of Substantial Equivalence: Asserts similarity in design, construction, indications for use, and performance characteristics to commercially available PTA Catheters.

To answer your request, if this were an AI/ML device submission, I would expect to see sections detailing:

Acceptance Criteria/Performance Targets: Specific metrics like sensitivity, specificity, AUC, F1-score, or agreement rates.
Clinical Study Design: Information on how the device's performance was evaluated, including reader studies, standalone studies, etc.
Dataset Details: Size, provenance, and characteristics of training and test sets.
Ground Truth: How the definitive diagnosis or outcome was established (e.g., pathology, clinical follow-up, expert consensus).
Expert Review: Number and qualifications of experts involved in establishing ground truth or reading studies.

Since these elements are absent in the provided text, I cannot fulfill your request as formulated for evaluating an AI/ML medical device.

Summary

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000048

APR 24 1997

PREMARKET NOTIFICATION 510(k) Cordis Corporation Juniter PTA Catheters January 24, 1997

K970299

Attachment 1 SUMMARY OF SAFETY AND EFFECTIVENESS

General Provisions: l,

Common Name:

Percutaneous Transluminal Angioplasty Catheters

Jupiter PTA Catheters Proprietary Name:

Name of Predicate Devices: 9.

Juniter PTA Catheters Trade Name: a. Manufacturer: Cordis Corporation
Trade Name: Opta 5 PTA Catheters b. Cordis Corporation Manufacturer:

ﻤﺴ

Ultra Thin PTA Balloon Catheter Trade Name: C. Manufacturer: Medi Tech'

111. Classification:

Class II

IV. Performance Standards:

Performance standards have not been established by the FDA under Section 514 of the Food. Drug and Cosmetic Act.

Intended Use and Device Description: V.

1 A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA has stated"... A determination of substantial equivalence under the Federal Food. Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without ore-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits" 42 Fed. Reg. 42, 520 et seq. (1977).

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PREMARKET NOTIFICATION 510(k) Cordia Corporation Jupiter PTA Catheters January 24, 1997

Blocompatibility VI.

Since no new materials are being introduced in this submission, no additional biocompatibility testing was performed. All appropriate biocompatibility tests were successfully performed on Cordis Corporation's Jupiter PTA Catheters. Biocompatibility test results can be found in K955886. Biocompatibility testing was performed in compliance with ISO Standard 10993.

Summary of Substantial Equivalence: VII.

Jupiter PTA Catheters are substantially equivalent to the predicate devices. Jupiter PTA Catheters are similar in design, construction, indications for use, and performance characteristics as compared to commercially available PTA Catheters.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).