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510(k) Data Aggregation
(166 days)
The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including:
- the partial or complete ablation of non-resectable liver lesions and
- the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.
The RITA System (RF Generator and electrosurgical devices) is designed to create coagulative necrotic lesions in soft tissue, and allow localized delivery of fluid to the lesion. The RF Generator is specifically designed for use with RITA Electrosurgical Devices (Accessories). The RF Generator provides multiple temperature sensors, impedance, and power monitoring to assist the user in delivering the desired energy to the target tissue. The electrosurgical devices consist of monopolar electrosurgical devices that include disposable electrosurgical probes with deployable needle arrays that deliver RF power with temperature and impedance monitoring to ablate predictable volumes of tissue.
The provided text describes the RITA® System, an electrosurgical device, and its intended use and performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria (e.g., target specificity, sensitivity, or similar metrics for a diagnostic device). Instead, it describes a clinical study and its observed outcomes as a measure of effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in terms of specific performance metrics for this device, which is a therapeutic device for ablation and pain palliation) | Effectiveness for Pain Palliation (Worst Pain): 75% of patients experienced at least a two-point reduction in "worst pain" from baseline to week four. |
| Effectiveness for Pain Palliation (Average Pain): 80% of patients experienced at least a two-point reduction in "average pain" from baseline to week four. | |
| Safety/Morbidity: Low attendant morbidity (no reports of death related to use of the devices). | |
| Adverse Events: Three adverse events potentially related to RF ablation. | |
| (Bench study findings on ablation characteristics/parameters) | Bench studies determined the effect of the bone environment on ablation characteristics and parameters. (Specific quantitative results not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of patients in the clinical study. It refers to percentages of "patients" (75% and 80%) but not the base number.
- Data Provenance: The study was conducted on "patients with lesions that had metastasized to one or more locations in the skeleton." It is a prospective clinical study assessing safety and effectiveness. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a therapeutic device like this, "ground truth" would typically relate to clinical outcomes rather than expert-derived labels on images.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of pain palliation as an endpoint, "adjudication" in the sense of expert consensus on image interpretation is less relevant. The effectiveness was measured using a "validated instrument for evaluating cancer pain," suggesting a standardized assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not provided. The study described is a clinical study evaluating the device's effectiveness in alleviating pain, not a comparative effectiveness study involving human readers with/without AI assistance. The device itself is an RF ablation system, not an AI diagnostic tool that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This question is not applicable to the RITA® System as described. It is a physical medical device (RF generator and electrosurgical devices) that requires direct human operation, not a standalone algorithm. The "performance" refers to the device's clinical efficacy and safety when used by a clinician.
7. The Type of Ground Truth Used
The "ground truth" for the effectiveness of the RITA® System's pain palliation indication was based on:
- Outcomes Data: Specifically, patient-reported pain levels assessed using an "instrument validated for evaluating cancer pain."
- Safety Data: Observed adverse events and mortality related to the device's use.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The RITA® System is a physical electrosurgical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "bench studies" mentioned would involve laboratory testing, not a data training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8. There is no "training set ground truth" in the context of this device.
In summary, the provided text describes a clinical study demonstrating the RITA® System's effectiveness in pain palliation and its safety profile. However, it does not detail specific, quantitative acceptance criteria in a tabular format, nor does it address aspects related to AI/algorithm performance (like training sets, expert adjudication, or MRMC studies) as the device is a therapeutic electrosurgical system.
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