(76 days)
The Squeeze-Ease™ Mammography Cushion provides padding for patient comfort during X-ray visualization of the breast.
The Squeeze-Ease™ Mammography Cushion is placed on both compression surfaces of the mammography machine. The pads can be cleaned with mild soap and water and disinfected with a hospital disinfecting solution, either Cavicide™ or T-Spray™ II. The Squeeze-Ease™ Mammography Cushion is mounted on the specified mammography machine, for which it was designed, using the included Velcro strips. First, the cushion is placed so that it is centered on the imaging area, and slightly overlaps the edge, which is directed toward the front of the machine, where the patient's chest wall will contact the machine. After placement on the machine, the cushion needs to be secured to the machine using the Velcro strips. The pads are cleaned/disinfected prior to use with the next patient. Any questions of cushion-induced artifact (or artifact caused by foreign body trapped between the cushions and the mammography machine) should be ruled out immediately by taking a test image using the cushions alone. The materials used in the Squeeze-Ease™ Mammography Cushions have been selected to be radiolucent and do not interfere with the mammography image. The cushion pad has been designed to be radiolucent at the energy levels used in mammography exams.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Squeeze-Ease™ Mammography Cushion:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Radiolucency (No interference with image) | "A study showing radiolucency of The Squeeze-Ease™ Mammography Cushion was conducted which demonstrated no difference in the image with the subject device in place." |
| Patient Comfort | Stated as the primary intended use: "The Squeeze-Ease™ Mammography Cushion provides padding for patient comfort during X-ray visualization of the breast." (No direct performance metric provided in terms of measurable comfort.) |
| Cleanability/Disinfection | "The pads can be cleaned with mild soap and water and disinfected with a hospital disinfecting solution, either Cavicide™ or T-Spray™ II." |
| Reusability | Device is described as "reusable" (compared to the predicate's "single-use, disposable"). |
| Material Compatibility (with mammography energy levels) | "The cushion pad has been designed to be radiolucent at the energy levels used in mammography exams." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only mentions "A study showing radiolucency... was conducted." No details about the number of images, tests, or subjects are provided.
- Data Provenance: Not specified. The document does not mention the country of origin of the data, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The study described is an engineering/technical test for radiolucency rather than a clinical study requiring expert interpretation of medical images. There is no mention of experts establishing a ground truth for image interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. As noted above, this was a technical radiolucency study, not a clinical trial involving expert adjudication of diagnostic findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." The study conducted was a non-clinical radiolucency test.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone performance study was not done. This device is a physical accessory (a cushion), not an algorithm or AI-driven software.
7. Type of Ground Truth Used:
- The ground truth used for the radiolucency study was an objective comparison of images with and without the device. The "ground truth" was effectively the baseline image without the cushion, against which images with the cushion were compared to determine if there was "no difference."
8. Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As this is not an AI/algorithm device, there is no training set or associated ground truth establishment process.
Summary of Study Information:
The provided document describes a non-clinical study primarily focused on demonstrating the radiolucency of the Squeeze-Ease™ Mammography Cushion. The key finding was that the device "demonstrated no difference in the image" when in place. No clinical studies were conducted or presented for this 510(k) submission, as stated explicitly in section 8: "Discussion of Clinical Tests Performed: Not Applicable." The comparison to the predicate device was based on intended use, material differences, and the non-clinical radiolucency study.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.