(31 days)
The Baylis Medical RF Perforation Probe V2.0 is indicated for use to cut and/or coagulate soft tissue.
The Baylis Medical RF Perforation Probe V2.0 is a sterile, single-use device that delivers radiofrequency power in a monopolar mode to its distal electrode. The device consists of an insulated core nitinol wire with a rounded tip. The distal active tip is uncoated to deliver radiofrequency energy. The device connects to a separately cleared Baylis Medical Company Radiofrequency Puncture Generator at its proximal end through a compatible BMC Connector Cable.
Here's an analysis of the provided text regarding the Baylis Medical RF Perforation Probe V2.0, focusing on the acceptance criteria and supporting studies.
Important Note: The provided text is a 510(k) summary and FDA clearance letter. This type of document is a submission for substantial equivalence to a previously cleared device, not typically a report of a de novo clinical trial with detailed acceptance criteria and performance metrics for a novel technology demonstrating clinical efficacy. Therefore, many of the requested points, particularly those related to human reader studies, ground truth establishment for AI models, and explicit performance metrics against clinical acceptance criteria, will not be present in this type of submission.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify explicit numerical acceptance criteria for clinical performance that would typically be seen in a clinical trial for a new, non-substantially equivalent device. Instead, the "acceptance criteria" for this submission are rooted in demonstrating substantial equivalence to a predicate device and meeting applicable engineering and safety standards.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance against Criteria |
|---|---|
| Intended Use (Identical to predicate) | Met – "Identical" |
| Indications for Use (Identical to predicate) | Met – "Identical" |
| Fundamental Scientific Technology (Identical to predicate) | Met – "Identical" |
| Operating Principle (Identical to predicate) | Met – "Identical" |
| Mechanism of Action (Identical to predicate) | Met – "Identical" |
| Materials (Similar to predicate) | Met – "Similar" (implies no new safety/effectiveness concerns) |
| Dimensions (Similar to predicate) | Met – "Similar" (implies no new safety/effectiveness concerns) |
| Compatible Devices & Accessories (Identical to predicate) | Met – "Identical" |
| Packaging Configuration (Identical to predicate) | Met – "Identical" |
| Sterility Assurance Level & Sterilization Method (Identical to predicate) | Met – "Identical" |
| Biocompatibility (Compliance with standards) | Met – "Performed" and implicit compliance |
| Mechanical Integrity (Compliance with standards) | Met – "Performed" and implicit compliance |
| Electrical Safety (Compliance with standards) | Met – "Performed" and implicit compliance |
| Arc Integrity (Compliance with standards) | Met – "Performed" and implicit compliance |
| General Physical Properties (Compliance with standards) | Met – "Performed" and implicit compliance |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (of substantial equivalence and safety/performance) is documented as "Performance Testing."
-
Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the "verification tests." These tests typically involve a defined number of units or test articles run through a protocol. For example, biocompatibility might involve specific animal models or in-vitro tests, and mechanical tests would involve a set number of devices. The document states "the following verification tests were performed," implying the standard sample sizes and methodologies for these engineering and biological tests were followed.
- Data Provenance: The tests were conducted internally or by contracted labs by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada. The nature of these tests (biocompatibility, mechanical, electrical, etc.) means they are prospective engineering and biological evaluations, not retrospective clinical data analysis.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission details engineering and biocompatibility testing for a medical device. There is no "ground truth" in the sense of clinical interpretations or diagnoses requiring expert consensus. The "truth" is established by adherence to recognized standards and protocols for device testing.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As there's no "ground truth" derived from expert interpretation, there is no adjudication method like 2+1 or 3+1. Test results are typically compared against pre-defined engineering specifications and standards.
-
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:
- No. This is a medical device for tissue cutting and coagulation, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance metrics are not applicable to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical, electrosurgical device, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the clinical sense. The "ground truth" for the device's performance is established by engineering specifications, recognized national and international standards for medical device safety and performance (e.g., electrical safety, biocompatibility, mechanical durability), and comparison to the characteristics of the legally marketed predicate device. For example, the "ground truth" for biocompatibility is whether the materials meet ISO 10993 standards.
-
The sample size for the training set:
- Not Applicable. As this is not an AI/ML device, there is no "training set."
-
How the ground truth for the training set was established:
- Not Applicable. No training set exists.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.