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CHISON 8300 is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, obstetric, gynecology, cardiology and small parts etc. This device is intended to adult, pregnant woman, pediatrics.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (B, M, Combined (B/M))
Abdominal (B, M, Combined (B/M))
Pediatric (B, M, Combined (B/M))
Small Organ (B, M, Combined (B/M))
Cardiac (B, M, Combined (B/M))
Transvaginal (B, M, Combined (B/M))
Peripheral Vascular (B, M, Combined (B/M))

Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa

CHISON 8300 is a portable digital ultrasonic diagnostic B/W system.
Display mode: B, B/B, 4B, B/M, M. In the B or M mode, 128 frames of real-time image can be stored in Cine-memory.
The Standard configuration of the applicant device includes Main unit, probes, relative accessories.
There's no unique feature or technological characteristics for the applicant device.
Accessories include Video Printer and Trolley.
Applicant Probe types: C60613S (Convex, 3.5 MHz), L40617S (Liner Probe, 7.5 MHz), C12616S (Micro-convex, 6.0 MHz).

The provided document, a 510(k) Summary for the CHISON 8300 Digital Ultrasonic Diagnostic Imaging System, focuses on demonstrating the device's technical performance and safety rather than a clinical study involving human subjects or AI algorithms. Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or available in this specific document.

The "acceptance criteria" discussed in the document are primarily related to the measurement accuracy of the ultrasonic imaging system itself, using various probes.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these accuracy tests were "conducted" and "display the measurement accuracy," implying the reported performance matches or is better than the acceptance criteria given in the "Accuracy" column.

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

The document describes "Accuracy Test was conducted for the effectiveness". However, it does not specify the sample size used for these accuracy tests. It also does not provide data provenance (e.g., country of origin, retrospective/prospective). This appears to be a technical validation of the device's measurement capabilities, likely using phantoms or controlled objects, rather than a clinical study on patient data.

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 in the document. Given the nature of an "accuracy test" on an ultrasonic system's measurements, the ground truth would likely be established using highly precise physical measurements on test objects or phantoms, not necessarily by medical experts interpreting images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the type of technical accuracy testing described here.

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 was done as described in the document. The device is a diagnostic ultrasound imaging system, and the filing primarily focuses on its fundamental technical performance and safety, not on the performance of an AI algorithm or human reader improvement with AI assistance. The document predates widespread AI integration in medical devices (2007).

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

No standalone algorithm performance study was done. The device itself is an imaging system; it does not feature an independent algorithm requiring standalone performance evaluation in the context of this 510(k) submission.

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

The ground truth used for the "Accuracy Test" would most likely be physical measurements or calibrated reference values from test phantoms or controlled objects. The document implicitly indicates this by listing accuracy specifications for axial distance, lateral distance, circumference, area, and heart rate within specific measurement ranges. These are quantifiable technical performance metrics.

8. The sample size for the training set

This is not applicable as the document describes a traditional diagnostic ultrasound imaging system and its technical performance, not an AI/ML-based device that would require training data.

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

This is not applicable for the same reasons as in point 8.

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