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The intended uses of the BVI 6100 System, as defined by FDA quidance documents, is for Abdominal (Adult and Pediatric) applications.

The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound's predicate devices. The BladderScan BVI 6100 is contraindicated for fetal use and for use on pregnant patients.

The BladderScan™ BVI 6100 Ultrasound System is a hand-held, batterypowered, software-controlled ultrasound system used to acquire and display real-time B-mode images of the bladder. The System is intended to non-invasively monitor bladder volume on an intermittent basis. The System is an effective, low cost, simple option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

The provided text describes the BladderScan™ BVI 6100 Ultrasound System, an ultrasound device for non-invasively monitoring bladder volume. However, the document does not contain information about specific acceptance criteria related to device performance (e.g., accuracy, precision of bladder volume measurement) or a study proving it meets those criteria.

The document primarily focuses on:

• Device Description and Intended Use: The device is a hand-held, battery-powered ultrasound system for acquiring real-time B-mode images of the bladder and measuring urinary bladder volume in non-pregnant patients.
• Compliance with Standards: A list of international and national standards the device is designed to comply with (e.g., EN 60601-1, IEC 61000-4-2, CISPR11). These standards relate to safety, EMC, and acoustic output, not clinical performance metrics.
• Predicate Devices: Identification of similar legally marketed devices (BladderManager™ BVI 5000 System, BladderScan™ BVI 2500 System, and SonoSite™ Hand-Carried Ultrasound System).
• FDA Clearance: Notification of FDA's determination of substantial equivalence (K022153) to predicate devices, allowing it to be marketed. A post-clearance special report for acoustic output measurements based on production line devices was requested.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study proving it meets those criteria, as this information is not present in the provided text.

Specifically, the following points from your request cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics (like accuracy or precision for volume measurement) are mentioned along with their acceptance criteria or achieved values.
2. Sample size used for the test set and the data provenance: No performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described.
4. Adjudication method for the test set: No performance study is described.
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 such study is mentioned. This device is a standalone measurement device, not an AI assistance tool for human readers in the context of the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While the device is "standalone" in that it performs the measurement, no specific study evaluating its standalone performance against a ground truth is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No performance study is described.
8. The sample size for the training set: No information is provided about any training sets for an algorithm.
9. How the ground truth for the training set was established: No information is provided about any training sets for an algorithm.

The only "study" mentioned is the compliance with various standards related to safety and electromagnetic compatibility, and a general statement that the device "meets the FDA's pre-amendment acoustic output limits." These are not performance studies in the sense of clinical accuracy or precision.

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