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510(k) Data Aggregation
(64 days)
VERESURE, INC.
The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.
The VereSure Bell is a single-use device used during gynecologic laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate housing containing a sealable port for introduction of standard Veress needles and a stopcock for attachment to a sterile standard hospital vacuum line.
The provided text is a 510(k) summary for a medical device called the "VereSure Bell," and the FDA's clearance letter for it. This document focuses on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the detailed information a study proving acceptance criteria for an AI/CADe device would typically include.
Specifically, the "VereSure Bell" is a physical medical device (a single-use device for laparoscopic procedures), not an AI or software-as-a-medical-device (SaMD). Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/CADe performance metrics (like sensitivity, specificity, AUC) are not applicable here.
However, I can extract the information that is present regarding "test results" and "substantial equivalence" as it relates to this traditional medical device.
Here's a breakdown based on the provided text, highlighting what is present and what is missing due to the nature of the device and document:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) nor does it report specific numerical performance data against such criteria. This is because it's a physical device, and the evaluation for 510(k) clearance focuses on safety and substantial equivalence, not AI performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Intended Use (implied from 510(k) process for traditional devices) | "Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended use." (From 510(k) Summary) |
| Substantial Equivalence to Predicate Devices | "Based on the intended use, product, performance and clinical information provided in this notification the subject device has been shown to be substantially equivalent to the currently marketed predicate devices." (From 510(k) Summary) |
| "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (From FDA Clearance Letter) |
2. Sample size used for the test set and the data provenance:
The document mentions "animal and clinical testing" but does not provide specific sample sizes for these tests, nor does it detail data provenance (e.g., country of origin, retrospective/prospective).
- Sample Size (Test Set): Not specified.
- Data Provenance: "Animal and clinical testing" (retrospective/prospective not specified, origin not specified).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not present. Ground truth, in the context of AI/CADe, involves expert labeling of data. For a physical device, testing focuses on functionality, materials, and clinical outcomes, not expert-labeled datasets.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not present for a physical device.
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:
This information is not applicable and not present. The VereSure Bell is a physical device, not an AI or CADe system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not present. The device is a physical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this physical device, "ground truth" would relate to the successful establishment of pneumoperitoneum, safety outcomes (e.g., no adverse events), and effectiveness in facilitating the laparoscopic procedure. The document broadly states "animal and clinical testing" demonstrated safety and effectiveness, implying clinical outcomes data was assessed, but details are not provided.
8. The sample size for the training set:
This information is not applicable and not present. "Training sets" are relevant for AI/machine learning models, not for traditional physical medical devices.
9. How the ground truth for the training set was established:
This information is not applicable and not present.
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