(35 days)
The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte" Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices 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® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 7cm and 10cm Cryosurgical Devices 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® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and 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® 7cm and 10cm Cryosurgical Probes 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CryoCath Technologies Inc. SurgiFrost® devices:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative or qualitative manner, nor does it present a table of device performance against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a pre-defined performance against specific, novel acceptance criteria.
The core of the submission is that: "The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness."
Therefore, the "acceptance criteria" are implicitly the characteristics and performance demonstrated by the predicate devices, and the "reported device performance" is a claim of equivalence to those predicates.
2. Sample size used for the test set and the data provenance
The document does not describe any specific clinical test set data (e.g., patient samples, data from a clinical trial). The approval is based on a demonstration of substantial equivalence through design and technological characteristics, not on a clinical performance study with a defined test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no specific test set or clinical study is described, there is no information provided on experts establishing ground truth.
4. Adjudication method for the test set
Similarly, since no test set is discussed, there is no adjudication method mentioned.
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 section is not applicable as the device is a cryosurgical system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the device is a cryosurgical system, not an algorithm. Its performance is inherent in its physical function and design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the submission (substantial equivalence for a physical medical device) and the absence of a defined clinical performance study, there is no mention of a specific ground truth methodology being applied to establish device performance for this particular 510(k) submission. The "ground truth", if it can be called that, is effectively the established safety and efficacy of the predicate devices.
8. The sample size for the training set
This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
§ 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.