(81 days)
THE PROFILE 2000 MAMMOGRAPHY SysTEM, MODEL PRO-2000, 15 A DEDICATED MANMOGRAPHIC IMAGING SysTEM USED FOR MAMMOGRAPHIC EXAMINATIONS.
The Bennett Profile 2000 Mammographic System, Model PRO-1. 2000, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations. The PRO-2000 is adaptable to performing screening and/or biopsy procedures with the addition of either a film-based or digital-based image receptor device attached. It consists of the following components; an x-ray generator cabinet, Model M-2000G (single-phase input) or Model M-2000G-3P (three-phase input); a tube stand with a non-tilting c-arm; mammographic collimator (DM-2000) and tube; an operator control panel, Model M-2000C; and image receptor (film cassette holder or bucky).
The Profile 2000 Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz or three-phase 208-440 VAC, 50/60 Hz for operation. The Profile 2000 system's c-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The c-arm has a fixed source-to-image distance (SID) of 76 cm.
The provided text describes a 510(k) submission for a mammography system, not an AI/algorithm-based device. Therefore, the questions related to AI/algorithm performance (such as sample sizes for test and training sets, ground truth establishment for AI, MRMC studies, or standalone performance) are not applicable.
The submission focuses on demonstrating substantial equivalence of the Bennett Profile 2000 Mammography System to predicate mammography systems. The acceptance criteria for this type of device are primarily related to safety, operational performance, and functional equivalence compared to existing devices.
Here's an attempt to answer the relevant questions based on the provided text, while acknowledging the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of basic features, operation, and functionality, and meeting safety functions. The document does not provide specific quantitative acceptance criteria or detailed performance metrics in a tabular format as one might find for an AI algorithm's sensitivity/specificity.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Bennett Profile 2000 Mammography System is substantially equivalent to currently marketed devices in terms of basic features, operation, and functionality." |
| Conformance to Safety Requirements | "The safety functions of the Profile 2000 Mammography System have been rigorously tested and analyzed for conformance to requirements. In each case, these functions have performed as required, ensuring that each identified hazardous condition would not occur under simulated conditions." |
| Fulfillment of Design Requirements | "The Profile 2000 Mammography System fulfills its design requirements by providing the operator with the ability to perform safe and effective mammographic examinations." |
| Intended Use | "dedicated mammographic imaging system used for mammographic examinations." (Same as predicate devices). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical imaging hardware device (X-ray system), not an algorithm or AI. There is no "test set" of clinical images as there would be for an AI diagnostic device. The "testing" referred to is related to the hardware's safety and functional performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as there is no "test set" or "ground truth" to establish in the context of an AI/algorithm for this device. The evaluation would involve engineering tests and potentially clinical performance assessments by users, but not ground truth establishment for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" requiring adjudication of diagnostic findings.
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
Not applicable. This is a standalone imaging system, not an AI-assisted diagnostic tool designed to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone mammography system. "Standalone performance" in the AI context would refer to an algorithm making a diagnosis without human intervention. This device is the imaging equipment, which serves as a component in a diagnostic process that involves a human reader (radiologist).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for the submission of an X-ray hardware device.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device, not an AI algorithm.
§ 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.