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K Number
K052001
Device Name
MODEL SR-115 PORTABLE X-RAY SYSTEM
Manufacturer
SOURCE-RAY, INC.
Date Cleared
2005-08-11

(17 days)

Product Code
IZL
Regulation Number
892.1720
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

Device Description

X-Ray System, Portable

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study related to device performance. The document is an FDA 510(k) clearance letter for the "Model SR-115 Portable X-Ray System," which states that the device is substantially equivalent to legally marketed predicate devices.

The letter primarily focuses on:

  • Device identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code, Date Received.
  • Regulatory status: Substantial equivalence determination to predicate devices.
  • Post-market requirements: General controls, additional controls for Class II/III devices, good manufacturing practices, labeling, electronic product radiation control provisions.
  • Contact information: For specific advice and general information.
  • Indications for Use: The Model SR-115 Portable X-Ray System is intended for General Purpose Portable Radiographic Applications.

There is no mention of:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes or data provenance for any test sets.
  3. Number or qualifications of experts for establishing ground truth.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance studies.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This document is a regulatory approval, not a scientific study detailing performance metrics or clinical trial results. Therefore, I cannot fulfill your request for that specific information based on the text provided.

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.