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K Number
K974703
Device Name
CARBON FIBER BREAST BOARD
Manufacturer
MEDTEC, INC.
Date Cleared
1998-03-10

(84 days)

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

The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.

Device Description

Carbon Fiber Breast Board

AI/ML Overview

I am sorry, but based on the provided documents, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The documents are a 510(k) clearance letter and an Indications for Use statement for a "Carbon Fiber Breast Board." These documents confirm the regulatory clearance of the device but do not contain detailed study information such as:

  • Acceptance criteria: There's no mention of specific performance metrics or thresholds the device needed to meet.
  • Reported device performance: No data on the device's performance is provided.
  • Study details: Information regarding sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set sizes is absent.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria for a novel device.

§ 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.