(48 days)
The VariSource iX is indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote-controlled high dose-rate Brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.
The VariSource iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 20 channels for treatment.
The provided text is a 510(k) Summary for the VariSource iX HDR Brachytherapy Afterloader. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information about acceptance criteria and a study proving the device meets those criteria in the typical format of a performance study with specific metrics, sample sizes, and expert adjudications.
The document primarily focuses on establishing substantial equivalence to the predicate device (VariSource K061582) based on technological characteristics, as indicated in section "6. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 9 of the submission."
Therefore, based only on the provided text, I cannot complete all sections of your request. I will fill in what is available and explicitly state where information is missing.
Acceptance Criteria and Device Performance Study Analysis for VariSource iX HDR Brachytherapy Afterloader
The provided 510(k) summary (K071467) does not contain a detailed performance study with explicit acceptance criteria and corresponding reported device performance metrics in the format requested (e.g., sensitivity, specificity, accuracy for a classification task, or specific quantitative performance measures for other device types).
The submission focuses on demonstrating substantial equivalence to a predicate device (VariSource K061582) based on technological characteristics. This typically means that the new device performs in a manner that is as safe and effective as the predicate device, often without requiring extensive new clinical or performance studies if the technological changes are minor. The "acceptance criteria" in this context would implicitly be that the device functions as intended and meets the safety and performance standards of the predicate.
Given the absence of a specific performance study in the provided text, the table below will reflect that information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available - Document focuses on substantial equivalence based on technological characteristics rather than a new performance study with specific metrics. | Not Available - No specific quantitative performance metrics are provided in the summary. |
Detailed Study Information (Based on provided text, or marked as Not Available if absent):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Available. The document does not describe a performance study with a test set of data.
- Data Provenance: Not Available.
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)
- Number of Experts: Not Available. No test set or ground truth establishment process is described.
- Qualifications of Experts: Not Available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Available. No test set or adjudication process is 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
- MRMC Study: Not applicable. The VariSource iX is a brachytherapy afterloader, a medical device for delivering radiation, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study related to human reading improvement with AI is not relevant to this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not Available. The device is a physical electro/mechanical system. Its performance evaluation would typically involve tests of its mechanical accuracy, radiation delivery precision, software functionality, and safety features, rather than "standalone algorithm performance" in the AI sense. The 510(k) focuses on substantial equivalence of its technological characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not Available. No performance study requiring ground truth is described. For a device like this, the "ground truth" for its safety and effectiveness would be established through engineering tests, adherence to design specifications, and comparison to the predicate device's established performance and safety profile.
8. The sample size for the training set
- Sample Size for Training Set: Not Available. This device is an electro/mechanical system. The concept of a "training set" in the context of machine learning is not applicable here. Its software and firmware would be developed and tested through traditional software engineering and verification/validation processes.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not Applicable. See explanation for point 8.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.