Search Results

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.

Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa
Endometrial ablation

The Loop Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.

This document describes an electrosurgical electrode and does not contain information related to AI/ML device performance or studies with acceptance criteria as typically found in medical imaging AI submissions. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies.

The provided text focuses on:

• Device Name: Versapoint Electrosurgery Loop Electrode Accessory
• Predicate Device: Scuba Electrosurgical System and Versapoint Electrosurgery G-VAP Electrode Accessory
• Device Description: Bipolar Electrosurgical Electrode used with the Scuba Electrosurgical Generator.
• Intended Use: Gynecologic hysteroscopic electrosurgical procedures.
• Indications Statement: Tissue cutting, removal, and desiccation in gynecologic hysteroscopic electrosurgical procedures for treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
• Technological Characteristics: Stated to have the "same technological characteristics as the predicate device" with similar form, fit, function, and method of operation.
• Preclinical Testing: "Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively."

Summary of what is present and what is missing based on your request:

• Acceptance Criteria & Reported Device Performance: The document states that "Preclinical testing has been performed to verify that the product meets the Performance Data performance requirements described. It was determined that the device performs safely and effectively." However, it does not list specific acceptance criteria (e.g., in a table) or quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) as would be expected for an AI/ML device. It's a general statement of compliance for a traditional medical device (electrosurgical electrode).
• Sample size: Test set: Not applicable/not provided. This is not a study involving a test set of data points in the AI/ML context.
• Data provenance: Not applicable.
• Number of experts and qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

This document serves as a 510(k) summary for a traditional medical device, specifically an electrosurgical electrode, emphasizing substantial equivalence to a predicate device based on technological characteristics and preclinical testing. It does not provide the type of performance evaluation details (like those related to AI/ML algorithms and their test sets) that your questions are designed to cover.

Ask a specific question about this device

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa.
Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
Incision of uterine septa

The G-VAP Electrode is an Bipolar Electrosurgical Electrode. It is used in conjunction with the Scuba Electrosurgical Generator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Versapoint Electrosurgery G-VAP Electrode Accessory:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The provided text is a 510(k) summary for a medical device accessory. For such devices, a detailed list of specific, quantifiable acceptance criteria and performance metrics is generally not included in the summary itself. Instead, the summary refers to a broader assessment of "performance requirements described" that are met through pre-clinical and bench-top testing. The actual detailed criteria would be in the full submission, which is not provided here.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include information on the sample size or data provenance (such as country of origin or retrospective/prospective nature) for any test set. The performance data section only states, "Pre-clinical as well as bench top testing has been performed to verify that the product meets the performance requirements described." This implies laboratory-based testing rather than studies involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The provided text does not include information on the number or qualifications of experts used to establish ground truth. As noted above, the testing described appears to be pre-clinical/bench-top, not clinical, rendering this type of ground truth establishment less relevant for this submission.

4. Adjudication Method for the Test Set

The provided text does not include any information on an adjudication method for a test set. This would typically be relevant for clinical studies or studies involving expert assessment of outputs, neither of which are described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in the provided 510(k) summary. The summary focuses on pre-clinical and bench-top testing to demonstrate substantial equivalence, not a comparison of human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device is an "Electrosurgical Electrode" and an "Bipolar Electrosurgical Electrode" that is used "in conjunction with the Scuba Electrosurgical Generator." It is a physical accessory used by a surgeon. Therefore, no standalone (algorithm only) performance study was relevant or performed, as the device itself is not an algorithm or AI.

7. The Type of Ground Truth Used

Based on the description of "Pre-clinical as well as bench top testing," the ground truth would likely be established through engineering specifications, physical measurements, and possibly simulated tissue models to verify the device's functional integrity, power delivery, tissue effects (cutting, desiccation), and safety features (e.g., electrical insulation, temperature control). It would not involve expert consensus, pathology, or outcomes data in the typical sense for an AI/algorithm-based device.

8. The Sample Size for the Training Set

The provided text does not mention a training set or any machine learning/AI components. This device is a physical electrosurgical electrode, not an AI software.

9. How the Ground Truth for the Training Set Was Established

As the device is a physical electrosurgical electrode and not an AI software, there is no training set and therefore, no process for establishing ground truth for a training set.

Ask a specific question about this device