(44 days)
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.
The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.
The provided 510(k) summary for the CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console does not contain information regarding detailed acceptance criteria or a specific study proving the device meets distinct performance thresholds.
Instead, the document states that the device is "substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics." It also mentions "Performance Testing" but provides no details about the tests performed, their results, or the acceptance criteria used.
Therefore, I cannot populate the requested table or provide the detailed information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Here's an analysis based on the provided text, indicating what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document. The document only states "Information submitted in this premarket notification...is substantially equivalent to the predicate devices listed." |
Explanation: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against pre-defined acceptance criteria for this particular device. It doesn't detail performance endpoints such as temperature reach, cryoablation zone size, success rate of blocking electrical conduction, or any other quantifiable metrics.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned.
Explanation: The document does not describe any specific "test set" or a study involving human subjects or data where performance was measured. The claim of "substantial equivalence" is typically supported by bench testing, non-clinical studies, and comparisons to the known performance of predicate devices, but the details of such tests are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
Explanation: Since no specific test set requiring expert ground truth is described, this information is absent. The regulatory approval process for these types of devices through 510(k) relies heavily on demonstrating similarity to already approved devices, rather than establishing new clinical effectiveness data requiring expert review of outcomes.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not mentioned.
Explanation: Without a described test set requiring human assessment or outcome review, an adjudication method is not relevant or not detailed in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: Not mentioned.
- Effect Size of Human Reader Improvement with AI vs. without AI: Not applicable (as no AI component is described).
Explanation: This device is a cryosurgical system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: Not applicable.
Explanation: As this is a physical medical device (cryosurgical system), the concept of "standalone (algorithm only)" performance does not apply. The device's performance is inherently linked to its physical operation and use by a clinician.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not mentioned.
Explanation: Because no specific "test set" with performance outcomes is detailed, the type of ground truth used to evaluate performance is not discussed. For cryosurgical devices, ground truth for effectiveness would typically involve histological confirmation of cryonecrosis, electrophysiological evidence of conduction block, or clinical outcomes, but these are not specified as part of a formal performance study in this summary.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable/Not mentioned.
Explanation: As this is not an AI/ML device, the concept of a "training set" is not relevant.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not applicable/Not mentioned.
Explanation: As this is not an AI/ML device, the concept of establishing ground truth for a "training set" is not relevant.
Summary of the Document's Approach:
The provided 510(k) summary document focuses on establishing substantial equivalence to already legally marketed predicate devices. This regulatory pathway typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive new clinical effectiveness studies with explicit acceptance criteria and performance statistics for the new device, unless significant technological differences or new intended uses are introduced. The statement "The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness" reinforces this approach.
§ 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.