(102 days)
The IceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology. The IceSense3 may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
The IceSense3 device is used to destroy unwanted tissue by application of extreme cold to the selected sites. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The device consists of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction.
The device discussed is the IceCure Medical IceSense3.
Summary of Acceptance Criteria and Device Performance:
The provided text does not specify quantitative acceptance criteria in terms of clinical outcomes (e.g., specific percentages of lesion shrinkage, recurrence rates, etc.) for the IceSense3 device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that its performance is considered acceptable if it is comparable to already cleared devices.
The primary performance metric explicitly stated for the IceSense3 is its ability to create an iceball of a certain size within a specific timeframe.
| Acceptance Criteria (Implied by Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Function as intended (similar to predicate devices) | "In all instances, the IceSense3 functioned as intended and the performance observed was as expected." |
| Capable of creating an iceball of at least 40mm diameter | "in the range of up to 15 minutes freeze, the IceSense3 system probes can create an iceball of at least 40mm diameter." |
| Shaft temperature within specifications during freeze, thaw, warm | "Results demonstrated that temperatures along the shaft remained within the device's specifications during all phases." |
| Similar iceball formation and tip temperatures as predicate device | "Performance testing of IceSense3 versus the Sanarus Visica2 system that are both based on liquid nitrogen technology were conducted and gave very similar metrics of iceball formation versus time; the temperatures at the tip of the probe were very similar as well." |
Study Details:
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Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the context of a clinical study with a defined sample size of patients/cases. The performance data presented appears to be from bench testing or engineering validation studies comparing the IceSense3 to predicate devices.
- There is no information about the country of origin or whether the data is retrospective or prospective, as it does not appear to be human clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is based on physical measurements of iceball size and temperature, not expert interpretation of clinical images or outcomes.
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Adjudication method for the test set:
- Not applicable, as there is no human interpretation involved in establishing the performance metrics.
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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 imaging or diagnostic device with an AI component requiring MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a cryosurgical unit, not an algorithm. Its performance is inherent in its physical operation. The "performance data" provided evaluates the device's function directly.
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The type of ground truth used:
- The ground truth used for the performance evaluation appears to be physical measurements of iceball diameter, freezing time, and temperature, likely against established engineering specifications or the performance of predicate devices.
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The sample size for the training set:
- Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. This is a medical device, not a machine learning algorithm.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.