(63 days)
The PTW DAVID is a transparent multiple wire or multiple segment ionization chamber with attached electronics. It is intended to be used as an IMRT QC check device to make verification measurements and provide documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation bear data, consistency, over time as part of a quality assurance program.
The PTW DAVID system MLC-29 is a transparent, segmented, multi-wire ionization chamber with 37 wires or segments. It is designed for operation in medical hierar accelerators with 29 multi-leaf collimator pairs.
The PTW DAVID system MLC-80 is a transparent, segmented, multi-wire ionization chamber with 40 wires or segments. It is designed for operation in medical hiear accelerators with 40 multi-leaf collimator pairs.
The PTW DAVID system MLC-120 and MLC-80 are transparent, segmented, multiwire ionization chamber with 80 and 40 wires or segments. They are desioned for operation in medical linear accelerators with 60 or 40 multi-leaf collimator pairs.
The software for the PTW DAVID is for recording or logging measurement data only.
This document is a 510(k) premarket notification for the PTW DAVID, an IMRT QC check device. The device is intended for quality control verification measurements and documentation of leaf positions and doses from medical accelerators used for IMRT radiotherapy.
Based on the provided document, the following information regarding acceptance criteria and the study that proves the device meets them can be extracted:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance General Compliance with IEC 60601-1 Met Compliance with IEC 60601-1-2 Met Compliance with UL 60601-1 Met Compliance with ISO 9001 certification (manufacturing, testing, process, procedures) Met CE marked Met (CE 0124) Technological Characteristics Meet or exceed predicate device specifications (PTW QC6Plus, K972211) Met (stated that it "meet or exceed that of the predicate device since both devices are produced by the same manufacturer") Safety and Effectiveness No issues with regard to safety and effectiveness compared to predicate device Met (based on compliance with standards and technological characteristics) -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details on a specific test set sample size or data provenance for proving the device's performance directly. The basis for acceptance is stated as compliance with relevant medical device standards and a comparison of technological characteristics to a predicate device. -
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. The acceptance is based on adherence to recognized standards and comparison to a predicate device, rather than a clinical trial with expert-established ground truth. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. -
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 PTW DAVID is an IMRT QC check device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study demonstrating human reader improvement with AI assistance would not be applicable. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document describes the PTW DAVID as an ionization chamber for QC verification measurements. Its performance evaluation, as described, is based on meeting technical specifications and compliance with standards, rather than an "algorithm-only" performance study in the context of diagnostic AI. The software is "for recording or logging measurement data only" (page 0), implying it processes raw data from the chamber. No specific standalone algorithm performance study is described in the document in the way it would be for an AI diagnostic device. The device's performance is intrinsically linked to the physical measurement capability of the ionization chamber. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically used in AI diagnostic studies (e.g., pathology for cancer detection) is not directly applicable or mentioned here. The "ground truth" for this device's performance would be the physically accurate measurement of leaf positions and doses from medical accelerators, verified by established calibration methods and adherence to industry standards for dosimetry devices. -
The sample size for the training set:
This information is not provided in the document. The PTW DAVID is a physical measurement device, not a machine learning model that requires a training set in the conventional sense. -
How the ground truth for the training set was established:
This information is not provided in the document, as it is not a machine learning device requiring a training set with established ground truth.
Summary of the study/evidence presented for acceptance:
The approval of the PTW DAVID device by the FDA (K062817) is based on a Substantial Equivalence (SE) determination to a legally marketed predicate device, the PTW QC6Plus (K972211). The manufacturer's argument for substantial equivalence is primarily founded on:
- Comparison of Technological Characteristics: The PTW DAVID is stated to "meet or exceed that of the predicate device" because both are produced by the same manufacturer.
- Compliance with Recognized Standards: The device is designed in full accordance with IEC 60601-1, IEC 60601-1-2, and UL 60601-1 for medical electrical equipment safety and electromagnetic compatibility.
- Quality System Compliance: The manufacturing, testing, process, and procedures comply with ISO 9001 certification.
- CE Marking: Both the device and its predicate are CE marked (CE 0124).
- Intended Use Equivalence: The intended use of the PTW DAVID is consistent with its function as an IMRT QC check device for verification measurements and documentation, comparing treatment dose to prescribed dose, and compiling radiation beam data for quality assurance.
The document implicitly relies on the predicate device's established safety and effectiveness, and the PTW DAVID's adherence to relevant standards and equivalent or superior technological characteristics, to demonstrate its own safety and effectiveness. It does not present a de novo clinical trial or performance study with a specific test set, ground truth acquisition by experts, or AI-specific performance metrics.
§ 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.