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The intended use and the indications of use of the GLORY mammography system are identical to those of the MAM-CH22S mammography system. Radiography of the breast

The GLORY mammography system describes a modification of the legally marketed MAM-CH22S mammography system (K960381). Compared to the MAM-CH22S mammography system, additional radiation (or mAs) is provided for very thick or dense breasts and higher mA values are provided with the small focal spot for magnification procedures.

Here's an analysis of the provided text regarding the GLORY mammography system, focusing on acceptance criteria and supporting studies:

Based on the provided documents, it's important to note that this is a 510(k) premarket notification for a modification of an already legally marketed device (MAM-CH22S). The submission focuses on demonstrating substantial equivalence rather than presenting an entirely new device with novel performance studies against specific acceptance criteria for a new indication.

Therefore, many of the typical elements of a detailed performance study proving a device meets acceptance criteria (like specific sensitivity/specificity thresholds, MRMC studies, or detailed ground truth establishment for a test set) are not present in these documents. Instead, the focus is on comparing the modified device's technical specifications and safety to the predicate device.

Here's the information extracted from the provided text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for a modification, the "acceptance criteria" is primarily demonstrating substantial equivalence in safety and effectiveness to the predicate device (MAM-CH22S). The performance metrics reported are primarily in terms of technical capabilities rather than clinical outcomes.

Study Details

Given the nature of a 510(k) for a modification focused on substantial equivalence, a traditional "study proving the device meets acceptance criteria" in the sense of a large clinical trial with predefined performance metrics is not described here. The "study" is more of an engineering and comparative analysis.

1. Sample Size Used for the Test Set and Data Provenance:

   • Not applicable / Not specified. The document does not describe a clinical "test set" of patient data used to evaluate diagnostic performance. The comparison is primarily at a technical specification level.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not applicable. No clinical test set with expert-established ground truth is mentioned.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical test set.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is not mentioned or described.

5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

   • No. This device is a mammography system (hardware), not an AI algorithm. Standalone algorithm performance is not relevant here.

6. Type of Ground Truth Used:

   • Not applicable. For this type of 510(k), the "ground truth" for demonstrating equivalence largely relies on technical specifications, safety standard compliance, and the established performance of the predicate device.

7. Sample Size for the Training Set:

   • Not applicable. This is a hardware system, not a machine learning model that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, no training set.

Summary of Approach:

The regulatory strategy for the GLORY Mammography System was to demonstrate substantial equivalence to a previously cleared predicate device (MAM-CH22S). The primary evidence for this was:

• Identical Intended Use and Indications: The device performs the same diagnostic function.
• Technical Enhancements: The modifications (additional mAs for dense breasts, higher mA for magnification) were presented as improvements for specific scenarios, not changes that altered the fundamental safety or effectiveness negatively.
• Safety Compliance: Adherence to international safety standards (IEC 601-1) and an analysis of the modifications to ensure no new significant risks.

This type of submission relies on the established safety and effectiveness of the predicate device and the argument that the modifications do not introduce new questions of safety or effectiveness, effectively piggy-backing on the prior clearance. It does not involve de novo clinical studies to establish new performance metrics against specific acceptance thresholds.

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