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Intended Use: The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.

Indications for Use: The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.

The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.

The provided text describes a medical device, the DVS (Dose Verification System), and its regulatory submission. However, it does not contain specific information about acceptance criteria for performance, a study proving those criteria were met, or details related to an AI/ML device.

The document is a 510(k) summary for a patient radiation dosimeter. It focuses on:

• Device Description: What the DVS is and how it works (MOSFET technology for in vivo radiation dose measurement).
• Intended Use/Indications for Use: To verify treatment planning and radiation dose in radiation therapy, specifically for breast and prostate cancer to measure photon beam therapy.
• Comparison to Predicate Device: Stating that the intended use and technological features are largely the same as a predicate device, with an additional indication for prostate cancer.
• Regulatory Information: Submitter details, FDA communication, and classification.

Therefore, I cannot provide the requested information about acceptance criteria, performance study details, or AI/ML-specific metrics because these details are not present in the provided text.

To address the prompt directly with the information available:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document describes the device, its intended use, and its equivalence to a predicate device, but does not detail specific performance metrics, acceptance criteria, or results from a performance study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. No test set or data provenance is mentioned.

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)

This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.

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

This information is not provided in the document. There is no mention of adjudication or a test set.

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

This information is not provided in the document. The DVS is a patient radiation dosimeter, not an AI/ML-assisted diagnostic device. Therefore, an MRMC study related to human reader improvement with AI assistance would not be applicable to this device and is not mentioned.

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

This information is not provided in the document. The DVS is a physical implantable device with a reader and software, not an algorithm in the sense of AI/ML. Its performance is inherent to its physical measurement capabilities.

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

This information is not provided in the document. For a radiation dosimeter, ground truth would typically refer to a known, accurately measured radiation dose from a reference instrument. However, the document does not elaborate on how this was established for validation.

8. The sample size for the training set

This information is not provided in the document. As this device is not described as an AI/ML device, a "training set" in that context would not apply.

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

This information is not provided in the document. (See point 8).

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