(191 days)
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.
The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.
The USI Needle Guide accessory is intended for small parts use for breast biopsy.
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.
The provided FDA 510(k) summary for the U-Systems Ultrasound System USI-2000 with Needle Guide does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or information commonly found in AI/ML device studies.
The document states:
- "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures." This is a very generic statement and does not provide specific performance data, methodology, or results.
Therefore, I cannot extract the detailed information requested in your prompt based on the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device and indicating new uses for the existing ultrasound system with the addition of a needle guide accessory.
The concepts of "acceptance criteria," "test set sample size," "ground truth experts," "adjudication methods," "MRMC studies," and "standalone performance" are typical for regulatory submissions of AI/ML-driven medical devices. This document predates the widespread regulatory consideration of such devices (JUN 0 5 2002).
To explicitly address your request, here's what the document shows (or, more accurately, doesn't show regarding performance studies):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures." (No specific performance metrics provided) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified. The concept of "ground truth" as it relates to expert consensus for a test set is not discussed in this submission regarding device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified.
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 study was mentioned. The device is an ultrasound system with a needle guide accessory, not an AI-driven interpretation tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- This is not an AI/ML algorithm; it's a physical accessory that displays graphics on an ultrasound screen. Thus, the concept of "standalone performance" for an algorithm isn't applicable or discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the context of a performance study for the needle guide.
8. The sample size for the training set
- Not applicable/not specified. This submission is for a physical ultrasound accessory, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/not specified.
Summary of what is available:
- Device: U-Systems Ultrasound System USI-2000 with Needle Guide accessory.
- Purpose of Accessory: Displays graphics depicting the position and future path of a rigid interventional instrument (e.g., biopsy needle, aspiration needle) on a computer monitor screen alongside the ultrasound image.
- Intended Use: Clinical interventions and anatomical structures where ultrasound is currently used for visualizing such procedures, specifically for small parts use (breast biopsy).
- Predicate Device: UltraGuide 1000 System.
- Performance Claim: "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures," but no specific data or metrics are provided in the public summary. The FDA granted clearance based on substantial equivalence and a required post-clearance special report on acoustic output measurements.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.