FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Advanced Automatic Detector Selection (AADS) option is used with the automatic exposure control of the GLORY mammography system. With the AADS option, the legally marketed GLORY system can determine exposure parameters automatically from a detector located beneath the densest breast tissue.

AI/ML Overview

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The document describes an "Advanced Automatic Detector Selection (AADS) option for the GLORY Mammography System" and focuses on its substantial equivalence to a predicate device, rather than providing a detailed performance study with acceptance criteria.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (If Stated)	Reported Device Performance
Not explicitly stated	"the ADDS option does not result in any new potential safety risks and does not significantly change the effectiveness of the GLORY system."

Comment: The document does not define specific quantitative acceptance criteria (e.g., sensitivity, specificity, image quality metrics) for the AADS option's performance. Instead, it makes a qualitative statement about its safety and effectiveness relative to the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not provided.
Data Provenance: Not provided. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study.

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 as the document does not describe a performance study with a test set requiring ground truth established by experts.

4. Adjudication method for the test set

Not applicable as no performance study with a test set is described.

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 comparative effectiveness study is mentioned. The device is an "Advanced Automatic Detector Selection" option, implying an automated function during image acquisition, not necessarily an AI-assisted interpretation tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is an "option" for an existing mammography system, designed to "determine exposure parameters automatically from a detector located beneath the densest breast tissue." This implies a standalone algorithmic function within the system for exposure control. However, the document does not contain data to describe its standalone performance in terms of specific metrics. It's an enhancement to the existing automatic exposure control.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable as no performance study requiring "ground truth" to evaluate diagnostic accuracy is described. The device's function is exposure control, not diagnosis.

8. The sample size for the training set

Not applicable. The document describes a device option, not a machine learning model that would typically have a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this device is not presented as a machine learning model requiring a training set with ground truth.

Summary

Regulation Number and Section

§ 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.