(22 days)
The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system to produce a device that has specific application in first localizing, and then giving a physician the capacity of performing Fine Needle Aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.
The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system.
The provided text is a 510(k) summary for the MultiCare Platinum mammographic x-ray system. This document focuses on demonstrating substantial equivalence to predicate devices based on regulatory compliance and design specifications, rather than clinical performance studies using AI algorithms or human reader studies. Therefore, many of the requested elements are not present in the provided text.
Here is an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Design Standards) | Reported Device Performance |
|---|---|
| UL Standard 2601-1 (Electrical Safety) | Designed for classification to, and presumed to meet, this standard. |
| CSA Standard C22.2 No. 601.1-M9 (Electrical Safety - Canada) | Designed for classification by, and presumed to meet, this standard. |
| IEC-601-1 (Medical Electrical Equipment) | Designed for certification to, and presumed to meet, this standard. |
| Federal Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020) | Tested and conforms to these standards. |
| American College of Radiology (ACR) Accreditation Standards (Image Quality & Dose Limits) | Designed to meet the requirements for ACR accreditation. |
| User-Friendly and Comprehensive Operator's Manual (Ensuring Safe & Effective Operation) | A comprehensive Operator's Manual is provided, ensuring safe and effective operation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary focuses on engineering and regulatory compliance, not on clinical performance testing with a specific test set of images or patient data.
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)
This information is not provided in the document. Ground truth establishment with experts is typical for clinical performance studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that an MRMC comparative effectiveness study was done. The device described is a mammographic x-ray system, not an AI-powered diagnostic tool. The submission is a traditional 510(k) for a medical imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an imaging system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as there are no clinical performance studies detailed that would require a ground truth. The "ground truth" for this submission revolves around meeting technical and safety standards.
8. The sample size for the training set
This information is not provided. This concept is relevant for AI algorithms, which are not the subject of this 510(k) summary.
9. How the ground truth for the training set was established
This information is not provided. This concept is relevant for AI algorithms, which are not the subject of this 510(k) summary.
Summary of Device and Acceptance Criteria Pertaining to the Provided Text:
The K030666 510(k) submission for the MultiCare Platinum System and Accessories primarily establishes safety and effectiveness by demonstrating compliance with international and national electrical safety standards (UL 2601-1, CSA C22.2 No. 601.1-M9, IEC 601-1), federal radiation performance standards (21 CFR 1020), and design adherence to American College of Radiology (ACR) accreditation requirements for image quality and dose. The "study" proving these criteria are met consists of the design and testing processes undertaken by the manufacturer to ensure the device meets these established engineering and regulatory benchmarks, as well as the provision of a comprehensive operator's manual. No clinical performance studies with patient data, AI algorithms, or human reader evaluations are described in this summary. The FDA's substantial equivalence determination is based on this regulatory and design compliance against predicate devices.
§ 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.