(34 days)
The Canady Plasma Probes' intended use is for the delivery of argon gas plasma energy for argon enhanced coagulation of tissue.
The Canady Plasma Probes are tubular instruments and are flexible. They are provided in various lengths and diameter sizes to accommodate the various size/types of endoscopes for a variety of applications (i.e. the treatment of various target tissues inside a patient). The Probes have applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas.
The device consists of a connector which acts also as a handle for maneuvering the probe inside the working channel of an endoscope. Via an inner lumen of the Canady Plasma Probe argon gas is delivered to the operative site as well as an internal wire to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during coagulation procedure.
The provided text describes a 510(k) premarket notification for the Canady Plasma Probes for flexible Endoscopy, specifically the Canady Plasma GIT Probe and Canady Plasma TBS Probe. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.
Therefore, many of the requested sections cannot be filled from the given text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance results from a study. It states that "Canady Plasma Probes are substantial equivalent in its Intended Use, Dimensions, Used Materials, Construction, Safety, Electrical Characteristics, and Operational Principles..." to predicate devices. This implies that the 'acceptance criteria' are met by demonstrating equivalence to established predicate devices rather than independent performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided. The document outlines a regulatory submission process based on substantial equivalence, not a clinical trial or performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth establishment is not described for a clinical or performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication is not described.
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
Not applicable. This device is an electrosurgical probe, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The applicant is asserting that their device is equivalent.
8. The sample size for the training set
Not applicable. This document is not describing an AI model development.
9. How the ground truth for the training set was established
Not applicable. This document is not describing an AI model development.
Summary based on the provided text:
The document is a 510(k) premarket notification for the Canady Plasma Probes for flexible Endoscopy. The primary method for gaining regulatory clearance is demonstrating substantial equivalence to already cleared predicate devices.
The "acceptance criteria" are implicitly met by comparing the device's characteristics to those of the predicate devices. The study proving this involves a direct comparison of:
- Intended Use: Argon enhanced coagulation of tissue.
- Dimensions: Lengths (1.6 m to 3.4 m), diameters (1.5 mm to 3.2 mm).
- Used Materials: Mentioned as "mantling" (may be a typo for "mantle" or similar) and Teflon.
- Construction: Tubular, flexible, connector/handle, inner lumen, internal wire, tungsten electrode tip, ceramic tip.
- Safety: Provided sterile by ethylene oxide, disposable (single use).
- Electrical Characteristics: Compatible with HF generators, max HF voltage and power specified (e.g., 4.0 kVp/50W for TBS; 4.3 kVp/90W for GIT 2.3mm; 4.3 kVp/120W for GIT 3.2mm).
- Operational Principles: Delivers argon gas and HF electrosurgical current for coagulation.
The "study" is the 510(k) submission itself, which details these comparisons. No specific clinical trial or analytical performance study with defined acceptance criteria and reported numerical performance metrics for the new device are described in this summary. The conclusion is that "The differences do not affect safety and effectiveness," thus proving the device meets the implicit acceptance criteria of being substantially equivalent to the predicate devices.
§ 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.