(90 days)
The Beamer™ Argon Probes are indicated for argon enhanced coagulation of tissue.
The Beamer Argon Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The proximal end of the stainless steel wire is soldered into the connector body. The distal end of the wire is crimped to an electrode located at the distal end of the probe. The distal end of the Beamer Argon Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The electrode remains recessed in the ceramic tip such that there is no tissue contact during the procedure. There are several configurations of the Beamer Argon Probe. The probes vary in length and outside diameter to accommodate the procedure performed by the physician. The Beamer Argon Probes are provided sterile by ethylene oxide and are single use only.
The provided text describes a 510(k) summary for the ConMed Beamer™ Argon Probe. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than novel clinical performance studies with specific statistical acceptance criteria.
Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets specific acceptance criteria for performance, especially in the context of AI or diagnostic systems.
However, based on the available information, here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Assessment |
|---|---|---|
| Technological Characteristics | Substantially equivalent to predicate devices (ConMed ABC Probes, ERBE Straight Fire & Side Fire Probes, Canady Plasma Probes for Flexible Endoscopy) | Met (stated as "substantially equivalent") |
| Intended Use | Substantially equivalent to predicate devices (argon enhanced coagulation of tissue) | Met (stated as "substantially equivalent") |
| Biocompatibility | All testing passed the predetermined performance specifications. | Met |
| Bench Testing | All testing passed the predetermined performance specifications. | Met |
2. Sample size used for the test set and the data provenance
- Not applicable for a clinical study. The document refers to "bench testing" and "biocompatibility testing" but does not provide details on the sample sizes or data provenance for these engineering-focused tests. It's a 510(k) submission, so the "test set" in the context of clinical performance (like for an AI device) is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is for clinical studies, especially those involving human interpretation or diagnostic ground truth. The submission focuses on device equivalence through engineering/bench testing.
4. Adjudication method for the test set
- Not applicable. This is relevant for clinical studies involving multiple reviewers or ground truth establishment.
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
- No. This is not an AI device, and no MRMC study was performed or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI device.
7. The type of ground truth used
- For biocompatibility and bench testing, the "ground truth" would be established by engineering specifications, regulatory standards (e.g., ISO for biocompatibility), and internal product requirements. The document states "predetermined performance specifications" were used.
8. The sample size for the training set
- Not applicable. This is not an AI device, therefore no training set was used.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
Summary of what the document focuses on:
The ConMed Beamer™ Argon Probe's 510(k) submission primarily relies on demonstrating substantial equivalence to existing predicate devices (ConMed ABC Probes, ERBE Straight Fire & Side Fire Probes, Canady Plasma Probes for Flexible Endoscopy) in terms of:
- Intended use: Argon enhanced coagulation of tissue.
- Technological characteristics: Described as having a stainless steel wire, electrode, ceramic tip, and varying configurations (length/diameter).
- Materials: Implied to be equivalent through the substantial equivalence claim.
The "Performance Testing" section states that biocompatibility and bench testing were performed, and all testing "passed the predetermined performance specifications." However, the specific details of these tests, methodologies, and the exact specifications are not provided in this summary. The FDA's acceptance of the 510(k) indicates that they found sufficient evidence of substantial equivalence based on these tests and comparisons to predicates.
§ 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.