(43 days)
The Glotto RT is intended to provide film-screen X-ray imaging of the breast and other soft-tissue organs that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto HT can also be used as the imaging device for sterotactic needle biopsy.
The Giotto HT 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 HT 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.
The provided document, K973d56, describes a 510(k) submission for a conventional film-screen x-ray mammographic device named Giotto HT. As a premarket notification for a medical device cleared through the 510(k) pathway, it primarily focuses on demonstrating substantial equivalence to a predicate device, not on specific clinical study results proving performance against acceptance criteria in the way a new, high-risk device might.
Therefore, the information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, as requested, is largely not present in this type of 510(k) summary. This document operates under the assumption that if the device is substantially equivalent to a legally marketed predicate device, its safety and effectiveness are established.
However, based on the provided text, I can infer some aspects related to acceptance criteria and the "study" (which in this context refers to the substantial equivalence comparison).
Here's the breakdown of the requested information, with acknowledgements of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance |
|---|---|---|
| Safety | No adverse effect on patient/operator | Same materials (paddles, supports, holders, Bucky) as predicate Giotto HF, which is considered safe. Differences do not affect safety. |
| Effectiveness | Produce high-resolution images of the breast; Detect non-palpable lesions. | Operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Giotto HF. Designed to meet or exceed all ACR requirements (e.g., image resolution, contrast resolution, dose, kV accuracy). |
| Technological Characteristics | Substantial equivalence to predicate in materials, technology, functional methodology. | All characteristics of Giotto HT compare substantially with Giotto HF. |
| Intended Use | Identical to predicate device | Intended uses are identical to the Giotto HF predicate device. |
| Regulatory Compliance | Meet MQSA and ACR requirements | Designed to meet or exceed all ACR requirements. |
Explanation:
The document doesn't list explicit "acceptance criteria" in a quantitative, measurable format as might be found in a clinical trial protocol. Instead, for a 510(k) device like this, the primary "acceptance criterion" is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device. The "reported device performance" is essentially the claim of substantial equivalence and adherence to established standards (like ACR).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not mentioned. This document describes a comparison to a predicate device and adherence to industry standards, not a specific clinical study with a defined test set of patients or images.
- Data Provenance: Not applicable/Not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not mentioned. The 510(k) process for this type of device does not typically involve independent expert review of a clinical test set for ground truth establishment.
- Qualifications: Not applicable/Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not mentioned. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- MRMC Study Done? No. This device is a conventional mammographic x-ray system, not an AI-powered diagnostic aid. The concept of "human readers improve with AI" is not relevant to this device.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study Done? No. This device captures images; it is not an algorithm that performs a standalone diagnostic function.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the predicate device and the ACR accreditation program requirements. The claim is that the Giotto HT meets or exceeds these established standards.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is a conventional imaging device, not an AI/machine learning product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable, as there is no training set for this type of device.
Summary regarding the "study that proves the device meets the acceptance criteria":
The "study" in this 510(k) submission is the comparison to the predicate device (Giotto HE, K901558) and the demonstration of compliance with ACR requirements and the MQSA program. The manufacturer asserts that:
- The Giotto HT's function, scientific concepts, physical and performance characteristics are substantially equivalent to the predicate device.
- The device is designed to meet or exceed all ACR requirements for mammography equipment (e.g., image resolution, contrast resolution, dose, kV accuracy).
- The materials in patient contact are the same as the predicate, ensuring biocompatibility.
- The intended uses are identical to the predicate.
The FDA's allowance to market the device signifies their agreement that sufficient evidence was provided to demonstrate substantial equivalence, thus inherently accepting that the device meets the necessary safety and effectiveness criteria as established by the predicate device and relevant standards in 1997.
§ 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.