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K Number
K062141
Device Name
MAMMOPAD RADIOLUCENT CUSHION
Manufacturer
BIOLUCENT, INC.
Date Cleared
2006-09-13

(48 days)

Product Code
IYX
Regulation Number
892.1100
Type
Traditional
Panel
RA
Reference & Predicate Devices
K003795
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.

Device Description

MammoPad is a radiolucent foam cushion used during radiologic visualization of the breast. MammoPad is non-sterile and is a single use device.

AI/ML Overview

The provided text is a 510(k) summary for the MammoPad Radiolucent Cushion, which is a medical device intended to provide comfort and aid in positioning during breast imaging. This document describes the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/algorithm-based device.

The MammoPad is a physical accessory (a foam cushion) rather than an AI or algorithm. Therefore, the questions related to AI/algorithm performance (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are not applicable to this device submission.

The "Technological Characteristics/Performance Data Summary" section (excerpt {1}) explicitly states that "MammoPad is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics." The conclusion is that it is "substantially equivalent to an existing legally marketed device." This highlights that the approval pathway for this device was based on substantial equivalence, not on meeting specific performance metrics derived from a clinical study for a diagnostic algorithm.

Therefore, I cannot provide the requested table and study details because the provided document does not contain that type of information for this specific device.

For clarity, here's what the document does indicate about the device and its regulatory pathway:

  • Device Name: MammoPad Radiolucent Cushion
  • Intended Use: "Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology."
  • Device Type: A physical, non-sterile, single-use foam cushion.
  • Regulatory Pathway: 510(k) Pre-market Notification, approved based on substantial equivalence to predicate devices (MammoPad® (K003795), Scintimammography Pad Set, PineStar Technology, Scintimammography Pad, Cone Instruments).
  • Performance Data: The submission relies on demonstrating that the device has "the same principles of operation and overall technological characteristics" as the predicate devices. There is no mention of a formal clinical performance study with defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., as would be expected for an AI diagnostic device.

§ 892.1100 Scintillation (gamma) camera.

(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).