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510(k) Data Aggregation
(147 days)
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes.
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory is intended to provide automated data acquisition of ultrasound breast imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers the reflected ultrasound signal which is displayed on a computer screen. The accessory includes a mechanical apparatus for breast image acquisition, a video monitor to display the images, and related software. The patient stands next to system and mammography-like plates compress the breast. Tissue is electronically and mechanically scanned using linear array transducer through thin layer of water and sono-lucent film.
The provided documentation for K022517 (U-Systems Ultrasound System USI-2000 with automated scanning accessory) includes a 510(k) summary and FDA clearance letter. However, it does not contain detailed information regarding acceptance criteria and a study proving the device meets those criteria, as typically expected for robust clinical performance validation.
The available information indicates a "substantial equivalence" pathway for clearance, meaning the device's technical characteristics and intended use are comparable to legally marketed predicate devices. This pathway often relies on demonstrating that the new device performs similarly to existing ones without necessarily requiring extensive new clinical performance studies with predefined acceptance criteria.
Based on the provided text, here's what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
- Not explicitly stated: The document does not define specific performance metrics or thresholds (e.g., sensitivity, specificity, accuracy) that the device must meet to be considered effective.
Reported Device Performance:
- The document states: "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures." This is a very general statement and does not provide specific performance results.
- The FDA clearance letter confirms that the device is "substantially equivalent" to predicate devices, implying its performance is considered acceptable based on this comparison.
| Performance Metric | Acceptance Criteria | Reported Device Performance Statement |
|---|---|---|
| Clinical Performance | Not explicitly defined | "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures." (No specific metrics or values provided.) |
| Substantial Equivalence | Device is equivalent to predicate devices with regard to intended use and technological characteristics. | The FDA determined the device is substantially equivalent to the LABSONICS Ultrasound Breast Scanner and the Sonopsy LA System. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: It is not mentioned that an MRMC comparative effectiveness study was done.
- Effect size of human reader improvement: Not applicable, as no MRMC study is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: It is not mentioned that a standalone (algorithm only) performance study was done. The device is described as an "accessory" to an existing ultrasound system, and the clearance largely hinges on its equivalence to existing technologies.
7. Type of Ground Truth Used for the Test Set
- Type of Ground Truth: Not specified.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not specified. (It's unclear if a traditional "training set" in the context of machine learning was even used, given the age of the document and the nature of the device as an ultrasound system accessory relying on known B-mode technology.)
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): Not specified.
Summary of Missing Information:
The provided 510(k) summary and FDA letter for K022517 primarily focus on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics. It lacks detailed clinical performance data, specific acceptance criteria, information about test or training sets, expert involvement, or adjudication methods that would be common in submissions for novel diagnostic algorithms or devices requiring extensive de novo clinical validation. The statement "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures" is the closest the document comes to describing performance validation, but it provides no specifics.
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