(82 days)
The intended use of the LANTIS TREATSTATION is to allow the radiation therapist to deliver treatment to the patient using the MEVATRON and all available accessories. This entails selecting a patient, selecting today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, LANTIS TREATSTATION supports intensity modulation (IM), a process of shaping, modifying, and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures. The intended use is the same as the predicate device.
LANTIS TREATSTATION is a direct replacement for the sequencing/VMI module of the Impac Sequencer Record and Verify Radiation Treatment System. The TREATSTATION coexists with the LANTIS Commander application on the target platform to allow the user access to the information system's other functions and provide the complete spectrum of required functionality.
The provided text describes a 510(k) submission for the "LANTIS TREATSTATION," a Record and Verify Radiation Treatment System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or details about standalone or MRMC studies that would typically be found in a detailed device performance evaluation section.
The document states:
- "Performance tests were conducted and the results indicated that the device consistently performed within the design parameters and equivalently to the predicate device." This is a high-level statement without specific data.
- "The LANTIS TREATSTATION software does not have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it." This emphasizes equivalence rather than specific, new performance targets.
Given the limitations of the provided text, I can only create a table and response based on the information explicitly stated or implied about equivalence. Most sections below will indicate that the information is "Not provided in the text."
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device (Impac Medical Systems' Sequencer, K913612) and consistent performance within "design parameters."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1. Substantial equivalence to predicate device (K913612) | Device is substantially equivalent to the predicate device. |
| 2. Consistent performance within design parameters | Device consistently performed within the design parameters. |
| 3. No significant changes in performance characteristics | Performance characteristics are the same as the predicate device. |
| 4. Intended use is same as predicate device | Intended use is the same as the predicate device. |
| 5. Supports auto sequencing | TREATSTATION supports auto sequencing. |
| 6. Supports Intensity Modulation (IM) | LANTIS TREATSTATION supports intensity modulation (IM). |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the text. The document refers generally to "performance tests."
- Data Provenance: Not provided in the text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided in the text. The type of "performance tests" conducted doesn't suggest a human-expert-driven ground truth process for a software system that records and verifies radiation treatment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the text.
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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 study was mentioned. The device described (a "Record and Verify Radiation Treatment System") is a software system for treatment delivery and recording, not an AI diagnostic or assistive tool that would typically involve human "readers" in the context of improving diagnostic accuracy.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "performance tests" described would be considered a form of standalone testing of the software's functionality, as it assesses the device's ability to "consistently perform within the design parameters" and equivalence to the predicate. However, specific methodology and results for such standalone performance beyond the general statement are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given the nature of the device (a record and verify system for radiation treatment delivery), the "ground truth" for performance tests would likely involve comparisons against expected computational outputs, physical measurements of delivered radiation fields (if applicable), and human observation of correct system functionality, rather than medical ground truths like pathology or expert consensus on a diagnosis. Details are not provided.
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The sample size for the training set:
- Not applicable/Not provided. This device is a software system for recording and verifying treatment delivery, not a machine learning or AI model that requires a "training set" in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable/Not provided, for the same reasons as above.
§ 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.