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K Number
K063274
Device Name
ACCULOC BREAST LOCALIZATION SYSTEM
Manufacturer
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
Date Cleared
2006-12-12

(43 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 indications for use of ACCULOC Breast Localization System (formerly MAMMOLOC) are lesions requiring extracranial stereotactic radiotherapy or radiosurgery to the breast.

The software is used to determine the precise location of the target with respect to implanted fiducials.

Device Description

Not Found

AI/ML Overview

The input provided is a 510(k) clearance letter from the FDA for a medical device called the "ACCULOC Breast Localization System (formerly MAMMOLOC)".

Based on the content of the provided document, no information about acceptance criteria or a study that proves the device meets those criteria is available.

The document is primarily an FDA clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines:

  • The trade/device name.
  • Regulation number and name.
  • Regulatory class.
  • The date of the review and receipt.
  • General controls provisions of the Act that apply.
  • Contact information for FDA offices.
  • Indications for Use for the device.

There is no mention of:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This type of information is typically found in a clinical study report or a premarket submission (510(k) or PMA) summary, which is not included in the provided FDA clearance letter. The letter itself does not contain the detailed technical or clinical performance data.

§ 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.