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K Number
K993978
Device Name
PR3 ULTRASOUND SYSTEM
Manufacturer
CAROLINA MEDICAL, INC.
Date Cleared
2000-02-10

(78 days)

Product Code
IYO
Regulation Number
892.1560
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal (B and M mode of operation)

Device Description

PR3 Ultrasound System with 6.5 R11 Endocavity Probe

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for an ultrasound system and its transducers. It is primarily a regulatory document and does not contain information about acceptance criteria or a study proving device performance against such criteria for an AI/CADe device.

Therefore, I cannot provide the requested information from the given text.

The document discusses:

  • Substantial Equivalence: The device, PR3 Ultrasound System and its 6.5 R11 Endocavity Probe, is deemed substantially equivalent to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and safety and effectiveness profiles as existing devices.
  • Regulatory Classification: The device falls under Class II (21CFR892.1560/Procode: 90 TYO and 21CFR892.1570/Procode: 90 ITX).
  • Intended Use: The device is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Specific clinical applications for the PR3 Ultrasound System and the Endocavity 6.5R11 probe are listed, indicating new (N) clearances for Transrectal application in B and M modes.
  • Post-Clearance Requirement: A special report including acoustic output measurements based on production line devices is required prior to shipping the first device. This is a post-market requirement, not a pre-market performance study with acceptance criteria.

To directly answer your request based on the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
  2. Sample sized used for the test set and the data provenance: Not present. The document refers to a 510(k) submission, which typically summarizes performance data but doesn't detail the study design or data provenance in this clearance letter.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  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 present. This document is for a traditional ultrasound system, not an AI/CADe device.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present, as this is not an AI device.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.