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The indications for use of the product is to remove the cold from the bucky by placing this sheet between patient's breast and the image receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Comfort Cover is a single-use disposable cover placed between the patient's breast and the image receptor plate during mammography. The purpose of this product is to allow the patient to feel more comfortable and less cold during the mammographic examination without interfering with image quality. Comfort Cover will allow for artifact-free images in both Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT), patient radiation dose is equivalent to that when using no Comfort Cover and the Image quality is equivalent to images exposed without Comfort Cover.

Comfort Cover is designed to fit small and large image receptor plates of all leading mammographic equipments. The product is constructed of a fabric material with a purple printed design and has adhesive backing with a paper liner. Both the material and adhesive backing of the product do not affect imaging.

The product is directly applied wrinkle free to the image receptor plate of the mammographic machine by the adhesive backing exposed by peeling off the liner. After the patient's mammogram, the product is peeled off the image receptor plate and disposed. As the product removes cleanly without leaving behind any residue, the image receptor plate does not need to be cleaned between Comfort Covers nor between patients.

The provided document, a 510(k) Premarket Notification for the "Comfort Cover," describes the device, its intended use, and comparative testing against a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a regulatory submission for a device involving AI or complex performance metrics. The Comfort Cover is a disposable cover for mammography plates to enhance patient comfort without affecting image quality.

Below is an attempt to extract and synthesize the requested information based on the document, noting where specific details are not provided or are not applicable to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

• Irritation and Skin Sensitization: Pass ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). | - The subject device passed all tests (ISO 10993-5 and ISO 10993-10). |
  | Mechanical/Physical Performance | - Visual and Dimensional: No visible defects, correct dimensions.
• Thermal Conductivity: Performance in line with material properties (implied comparison to predicate).
• Ink Smear: No ink smearing as per ASTM D5264-98.
• Peel Adhesion: Adequate peel adhesion as per ASTM D6252-98 (90° Angle).
• Removes Cleanly: Product removes cleanly without leaving residue (in-house method). | - The subject device passed all visual and dimensional examinations.
• Thermal Conductivity Test was performed.
• Ink Smear Test was performed and passed.
• Peel Adhesion Test was performed and passed.
• Removes Cleanly Test was performed and passed (removes cleanly from mammographic equipment without leaving residue). |
  | Radiological Performance | - Artifact-free images: Allow for artifact-free images in both Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) when using Comfort Cover.
• Patient Radiation Dose: Equivalent to that when using no Comfort Cover.
• Image Quality: Equivalent to images exposed when using no Comfort Cover.
• Radiolucent: Does not image, no artifacts, quality of images not affected. | - Comfort Cover allows for artifact-free images in both FFDM and DBT.
• Patient radiation dose is equivalent to that when using no Comfort Cover.
• Image quality is equivalent to images exposed when using no Comfort Cover.
• The device is radiolucent. |
  | Usability | - Fulfill design requirements of making mammography examination more comfortable.
• Not negatively impact patient positioning. | - The Comfort Cover fulfilled its design requirements of making the mammography examination more comfortable.
• The Comfort Cover did not negatively impact patient positioning. |
  | Comparison to Predicate (Overall) | - Similar Indications for Use, Target Population, Where Used, Product Size, Packaging and Labeling, Biocompatibility, Sterility, Dispensing Method, and Environment Compatibility.
• Minor material differences (fabric type, ink color) do not affect safety and effectiveness.
• Provides comfort and removes cold without affecting image quality.
• Allows for artifact-free images and image quality equivalent to images exposed without Comfort Cover.
• Removes cleanly without residue.
• Printed ink does not smear.
• Remains where placed.
• Radiolucent. | - All "None" in the "Significant Differences" column of Table 5-1 indicate similarity.
• Stated: "Safety and performance testing results have shown that the slight differences in material composition do not affect safety and effectiveness."
• Stated: "Provides comfort and removes cold during a mammographic examination without affecting quality of the images."
• Stated: "Allows for artifact-free images and image quality equivalent to Comfort Cover."
• Stated: "Removes cleanly from the mammographic equipment without leaving behind any residue."
• Stated: "Printed ink does not smear."
• Stated: "Remains where placed."
• Stated: "Does not image, no artifacts, quality of images not affected, radiolucent." |

2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes (e.g., number of covers, images, or participants) for the test sets. It states that "a number of non-clinical performance tests" were completed.

• Biocompatibility: Testing was conducted per ISO 10993-5 and ISO 10993-10 on the subject device.
• Mechanical Testing: Performed on "both the subject and the predicate devices."
• Radiological Studies: Phantom image testing was performed "as per MQSA regulations and with relevant International Electro technical Commission (IEC) standards (62220-1-2:2007 and 61223-3-2)." This implies the use of standardized phantoms, not patient data.
• Usability Studies: Included "radiologists, radiology technologists and patients." The number of each group is not specified.

Data provenance (country of origin, retrospective/prospective) is not specified, but given the nature of the tests (lab-based, phantom studies, usability feedback), it is likely all internal data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For the usability studies, "radiologists" and "radiology technologists" were involved, but their number and specific qualifications (e.g., years of experience) are not detailed. For radiological studies, phantom images were used, implying objective measurements rather than expert human interpretation for ground truth.

4. Adjudication method for the test set
Not applicable or not described. The tests are primarily objective measurements (e.g., passing a specific ISO standard, conforming to ASTM methods, measuring radiation dose, image quality metrics from phantom images). For usability, it simply states that user needs were fulfilled, but no adjudication method for consensus is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, nor is this device related to Artificial Intelligence (AI). The Comfort Cover is a physical accessory for patient comfort during mammography.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

• Biocompatibility: In-vitro and in-vivo (skin irritation/sensitization) test results against ISO standards.
• Mechanical Testing: Objective measurements (e.g., ASTM standards, in-house developed test for residue).
• Radiological Studies: Objective measurements from phantom images (e.g., presence/absence of artifacts, radiation dose measurements, image quality metrics) compared to baselines (without Comfort Cover) and regulatory/IEC standards.
• Usability Studies: User feedback (radiologists, technologists, patients) on comfort and impact on positioning.

8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and does not have a "training set."

9. How the ground truth for the training set was established
Not applicable.

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