(92 days)
This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system providen creatial and head and neck fixation and stereotactic localization with automatic software fiducial location. It is intended to be used during both Computed Tomography (acquisition of the imagiong series used for the patient's treatment plan) and each of the patient radiation free on ants.
The Aktina Head and Neck Stereotactic Localizer, Part Number 50-100, is used for the localization and fixation of patients undergoing stereotactic radiotherapy and radiosurgery of the cranial area, as well as radiotherapy of the head and neck area. Fixation is accomplished via two components: a customized Dental Tray that with the aid of slight vacuum suction fixes to the roof of the patient's mouth, and a customized head and neck support. Localization is accomplished via two components: a hardware component which comprises of a Stereotactic Fiducial Frame that is positioned over the patient's treatment area while being accurately interfaced to the Dental Tray, and a software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame. The Fiducial Frames are used during the patient's initial CT and then as a setup target box for each treatment thereafter.
The provided text, K081935, describes a medical device, the Stereotactic Head and Neck Localizer. However, it does not contain the detailed study information required to fill out all aspects of your request regarding acceptance criteria and device performance studies.
The document primarily focuses on:
- General provisions of the device (trade name, owner).
- Classification and predicate devices.
- Description and intended use.
- Technological characteristics and comparison to predicate devices.
- Biocompatibility information.
- A summary of substantial equivalence to predicate devices, asserting no new safety or effectiveness issues.
- A letter from the FDA confirming substantial equivalence and market authorization.
Crucially, under "7. Performance Standards and Data", it states: "Hardware and software specification testing have been performed on the Stereotactic Head and Neck Localizer to show that the verification, validation and safety requirements have been met." However, it does not report the specific acceptance criteria, quantitative results, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.
Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies as this information is not present in the given text.
Below is a partial response based on the information available in the document, along with explicit notes about what information is missing.
Acceptance Criteria and Device Performance Study Details for K081935
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from study) | Reported Device Performance (from study) |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the document.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the document. The device is a physical localization and fixation system with a software component for fiducial localization, rather than an AI-assisted diagnostic tool that typically involves human reader performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document states that "Hardware and software specification testing have been performed... to show that the verification, validation and safety requirements have been met." This strongly suggests standalone testing of the software's ability to determine "the coordinate system of the patient within the fiducial frame" and "automatic software fiducial localization." However, specific results, metrics, or details of these standalone tests are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified for the software's localization capabilities. For a device of this nature, ground truth would likely involve precise physical measurements from a phantom or highly accurate imaging modalities to verify the software's calculated coordinates against known physical positions. However, this is not explicitly stated.
8. The sample size for the training set
- Sample Size (Training Set): Not specified in the document.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not specified in the document.
§ 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.