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K Number
K092285
Device Name
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
Manufacturer
BEST MEDICAL CANADA LTD.
Date Cleared
2009-08-28

(30 days)

Product Code
IYE,TYE
Regulation Number
892.5050
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
K192196
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To provide dosimetry or to detect the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of radiation producing devices.

Device Description

Portable Dosimeter

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Portable Dosimeter". This letter does not contain the detailed technical information such as acceptance criteria, study details, and performance metrics that would be present in a 510(k) summary or the original submission itself.

Therefore,Based on the provided text, I cannot extract the requested information. The document is an FDA clearance letter and does not contain details about:

  1. Acceptance criteria and reported device performance: This letter states that the device is "substantially equivalent" to a predicate device, but it does not provide specific performance metrics or acceptance criteria used in the substantial equivalent determination.
  2. Sample size used for the test set and data provenance: No study details are included.
  3. Number of experts used to establish the ground truth for the test set and their qualifications: No study details are included.
  4. Adjudication method for the test set: No study details are included.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study: No study details are included, and given the nature of a dosimeter, an MRMC study is unlikely to be relevant.
  6. Standalone performance (algorithm only without human-in-the-loop performance): This is a hardware device (dosimeter), not an AI algorithm.
  7. Type of ground truth used: No study details are included.
  8. Sample size for the training set: This is a hardware device; a "training set" in the context of an AI algorithm is not applicable.
  9. How the ground truth for the training set was established: Not applicable.

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.