(87 days)
The Giotto Image X-ray Mammographic System is intended to provide filmscreen X-ray imaging of the breast that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto Image can also be used as the imaging device for stereotactic needle biopsy.
The Giotto Image is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film using an x-ray source designed specifically for mammography. It incorporates a state-of-the-art microprocessor controlled high frequency single phase x-ray generator and automatic exposure control, molybdenum rotating anode x-ray tube with 0.3 and 0.1 mm focal spots, gantry, compression device and film holder. The unique open design of the Giotto Image allows positioning of the patient with the operator facing the patient. This face-to-face positioning allows the operator to carefully center the breast and compress it quickly and efficiently. Optional accessories allow both prone and seated breast needle biopsy.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
Key Takeaways:
- This 510(k) summary is for a conventional film-screen X-ray mammographic device, not an AI-powered system.
- The primary method for demonstrating equivalence is by showing the device meets or exceeds existing regulatory and accreditation standards for mammography equipment and that its performance is substantially equivalent to a predicate device (Giotto HT).
- The text does not describe a study involving an AI algorithm or human readers interpreting images with or without AI assistance. Therefore, most of the requested AI-related information (MRMC study, standalone AI performance, training set details) is not applicable or cannot be extracted from this document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (What the device must meet) | Reported Device Performance (How the device performs) |
|---|---|---|
| Overall Performance & Standards | Meet or exceed all requirements set forth by the ACR (American College of Radiology) accreditation program, which is adopted by the FDA's MQSA program. | "The Giotto Image has been designed to meet or exceed all the ACR requirements." (Implies it does perform at this level, though specific numbers aren't provided). |
| Image Resolution | ACR requirements for image resolution. | "The Giotto Image has been designed to meet or exceed all the ACR requirements." |
| Contrast Resolution | ACR requirements for contrast resolution. | "The Giotto Image has been designed to meet or exceed all the ACR requirements." |
| Dose | ACR requirements for patient dose. | "The Giotto Image has been designed to meet or exceed all the ACR requirements." |
| kV Accuracy | ACR requirements for kV accuracy. | "The Giotto Image has been designed to meet or exceed all the ACR requirements." |
| Functionality | Generate high-resolution images of the breast on film using an x-ray source. | "The Giotto Image is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film..." |
| Technological Characteristics | Substantially compare in materials, technology, and functional methodology to the predicate device (Giotto HT). | "The characteristics of the Giotto Image system compare substantially with the Giotto HT, in both materials used, technology applied, and functional methodology." |
| Safety and Effectiveness Impact | Differences from predicate device do not affect safety and effectiveness, intended use, or application methods. | "Differences of note do not affect safety and effectiveness of the device, intended use, or application methods." |
| Patient Contact Materials | Components in direct contact with the patient are of the same materials as the predicate device. | "The components of the Giotto Image that come in direct contact with the patient... are of the same materials as the Giotto HT predicate device." |
Study Information (Based on provided text)
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Sample size used for the test set and the data provenance:
- The document does not describe a specific "test set" in the context of an algorithm or human reader study. It refers to meeting ACR accreditation standards for mammography equipment. These standards generally involve phantom imaging and calibration tests, not a clinical study with a patient dataset.
- No data provenance (country of origin, retrospective/prospective) is mentioned, as a clinical study with a patient test set isn't detailed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth for an image-reading test set is described. The "ground truth" here is adherence to engineering and performance specifications defined by the ACR.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication is described.
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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. This is a conventional X-ray mammography device, not an AI-powered system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed (and is not mentioned).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device for image acquisition, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth in this context is the adherence of the device's physical and performance characteristics (image resolution, contrast, dose, kV accuracy, etc.) to established industry and regulatory standards (ACR requirements adopted by MQSA) for mammography equipment. This is assessed through physical measurements and phantom tests, not clinical outcomes or expert consensus on patient images.
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The sample size for the training set:
- Not applicable. This document describes a physical imaging device, not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is described.
§ 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.