(50 days)
The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system.
First, the kit is intended to improve the "fine adjustment" control of the compression sequence. The original design of the compression system uses the same control method for applying initial compression force and for "fine adjustment" force. The kit does not change the method to apply initial compression force. It modifies the control sequence to achieve smoother fine adjustment control. "Fine adjustment" control is required to slowly and incrementally add the last little bit of compression just prior to making the exposure.
The modification kit also repositions the compression paddle to be flat and parallel with the breast support plate. The original design elevates the chestwall edge of the compression paddle off of the breast support plate. The kit removes the 1.2-degree tilt of the original design.
The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. Finally, the kit does not change the safety or compression release features in any way.
The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. It is comprised of two parts:
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- Compression Control Module
The compression control module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force.
- Compression Control Module
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- Paddle Leveling Spacers
The leveling spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky.
- Paddle Leveling Spacers
Here's a breakdown of the acceptance criteria and study information for the Digitec Two Stage Compression Kit, based on the provided text:
Acceptance Criteria and Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by addressing specific improvements in functionality. While explicit pass/fail acceptance criteria (e.g., "must achieve X% improvement") are not detailed as they might be for a performance-based device, the document does describe the intended improvements and implies functionality relative to the predicate device's design.
Note: The 510(k) submission largely focuses on the description of the improvements and the intent to improve performance, rather than providing quantitative performance data from a specific study with defined acceptance thresholds. The "reported device performance" in this context refers to the described capabilities and intended improvements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Improve "fine adjustment" compression control | The Compression Control Module is a small electrical circuit added to the original compression control system. It modifies the system to give the technologist a smoother method for applying "fine adjustment" compression force. The kit modifies the control sequence to achieve smoother fine adjustment control, which is required to slowly and incrementally add the last bit of compression. |
| Reposition compression paddle to be flat and parallel | The Paddle Leveling Spacers are used to change the position of the compression paddles relative to the bucky surface. The spacers are small aluminum pieces designed to fit on the compression paddle mounting arms. The spacers remove the 1.2 degree tilt of the original design and reposition the paddles flat and parallel with the surface of the bucky. The kit removes the 1.2-degree tilt of the original GE Senographe 600T series design, which elevated the chestwall edge of the compression paddle off of the breast support plate. |
| Not change basic operation of compression system | The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. |
| Not change compression release features or safety | The kit does not change the compression release features in any way. The kit does not change the safety or compression release features in any way. |
| Compatibility with GE Senographe 600T series X-Ray Mammography | The kit is an accessory item designed for use in the GE Senographe 600T series X-Ray Mammography Systems. |
Study Information
The provided text does not describe a specific clinical study with a test set, ground truth, or statistical analysis to prove these acceptance criteria. Instead, the submission focuses on design modifications and intended improvements based on an understanding of the predicate device's functionality.
It appears to be a 510(k) submission for an accessory where the changes are considered minor enough not to require extensive clinical performance data for substantial equivalence. The "study" here is more of a description of the engineering modification and its intended effect.
Here's an attempt to answer the questions based on the absence of such information in the provided text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. No clinical test set seems to be described.
- Data Provenance: Not applicable, as no external data or test set is referenced.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. No ground truth establishment is described.
- Qualifications of Experts: Not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as no test set requiring adjudication is described.
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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:
- MRMC Study: No, an MRMC comparative effectiveness study was not described. This device is a mechanical/electrical accessory, not an AI or imaging interpretation device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, a standalone study was not described. This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable, as no ground truth is established for performance testing. The "ground truth" for the claims is the engineering design and its intended physical impact on the mammography system's operation.
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The sample size for the training set:
- Sample Size: Not applicable, as this is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable.
§ 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.