(34 days)
The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.
The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosiments, (2) a hand held, battery powered reader, (3) a reader calibration test strip and (4) reader download software. The dosimeters use a MOSFET, metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and zeroed, then positioned onto a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The liner is removed and the adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The patient's records are stored on the dosimeter for future reference and in the Reader's memory.
The provided text states that "verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications." However, specific details about the acceptance criteria, the study design, and the reported device performance are not explicitly provided in the furnished document.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets the acceptance criteria with the information given. The document mentions that the primary difference between the predicate and modified device is a "change in the accuracy specification," which implies that accuracy was an acceptance criterion, but the exact target and achieved performance are not listed.
Despite this, I can extract the following relevant information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed in the provided document. The text mentions "pre-determined acceptance criteria based on performance specifications" and a "change in the accuracy specification" as the primary difference from the predicate device, but no specific values or metrics are given. | Not explicitly detailed in the provided document. The text states "The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device," but no specific performance metrics are provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set 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 applicable as this is a dosimetry device, not an imaging analysis device requiring expert interpretation for ground truth. The ground truth would typically be established by physical measurements or established radiation dosimetry standards. Details of such ground truth establishment are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and study as 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
- Not applicable. This is a radiation dosimetry system, not an AI-assisted diagnostic imaging device requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a "standalone" dosimetry system in the sense that it measures dose directly. The testing mentioned in the document would have evaluated the device's accuracy and performance independently.
- The document states: "Furthermore, verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness and demonstrated that the device met pre-determined acceptance criteria based on performance specifications." This implies standalone testing of the device's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for a radiation dosimeter, the ground truth would typically be established through physical measurements using calibrated reference dosimeters or by calculations based on known radiation fields, rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable. This device is a measurement system, not a machine learning algorithm that requires a "training set" in the conventional sense. Its calibration and performance are based on physical principles and engineering, not data training.
9. How the ground truth for the training set was established
- Not applicable for the same reason as in point 8.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.