(90 days)
The CryoGen Cryosurgical System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.
The CryoGen Cryosurgery System consists of three components: the disposable Control Unit, the Cryoprobe and the Console, which contains the compressor system, microprocessor and user interface. The CryoGen Cryosurgery System is a cryosurgical device incorporating a gas cooled cryoprobe. Operation of the System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling. The device is intended to destroy tissue by the application of extreme cold. Temperatures of -100 to -120 ℃ are developed at the tip of the cryoprobe. These temperatures are within the range of the predicate devices and is sufficient to achieve the desired tissue effect. None of the coolant comes into contact with the patient or physician. In addition, none of the coolant gases are exhausted into the atmosphere, the system is closed. There is no coeling along the shaft of the probe nor at the handle that is held by the user during treatment.
The provided text describes a 510(k) premarket notification for the CryoGen Cryosurgery System, which focuses on establishing substantial equivalence to predicate devices rather than proving a new device's meeting of acceptance criteria through a dedicated study with performance metrics.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, and expert adjudication are not available in the provided document, as they are not typically required for a 510(k) submission where substantial equivalence to existing devices is claimed.
However, I can extract and infer some information based on the content related to substantial equivalence.
Here's a breakdown of what can be gleaned and what is explicitly not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices. It doesn't typically include a table of specific acceptance criteria (e.g., minimum temperature achieved, speed of freezing, lesion size) and a corresponding performance report from a novel study designed to meet those criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document discusses the technical characteristics and intended use in comparison to predicate devices, but it does not describe a "test set" in the context of a performance study with specific metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. There is no mention of a test set requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not provided. As there's no mention of a test set requiring adjudication, this method is not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
This information is not provided. The device is a physical cryosurgical unit, not an AI or imaging diagnostic tool. An MRMC study is irrelevant in this context.
6. If a Standalone (Algorithm only without human-in-the-loop) Performance Study was done
This information is not provided. This is not an AI or algorithmic device; therefore, a standalone performance study in that context is not applicable. The device's operation is based on the Joule-Thomson principle, a physical process.
7. The Type of Ground Truth Used
This information is not provided. As there's no mention of a performance study requiring ground truth, its type is not discussed.
8. The Sample Size for the Training Set
This information is not provided. The device is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided. Not applicable to this type of device.
What is available/inferable from the document regarding "acceptance criteria" and "proof":
While not framed as "acceptance criteria" in the traditional sense of a performance study, the entire 510(k) submission acts as a demonstration that the device acceptably performs similarly to predicate devices.
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Implicit Acceptance Criteria (Substantial Equivalence): The primary "acceptance criteria" for a 510(k) clearance is demonstrating substantial equivalence to legally marketed predicate devices. This means that the device must be as safe and effective as a legally marketed device in the same class and for the same indications for use.
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"Study" (Comparison to Predicates): The "study" that proves the device meets these implicit criteria is the comparison of its technological characteristics and intended use to predicate devices.
- Device Performance (as reported in the document):
- Principle of Operation: "Operation of the System is based on the Joule-Thomson principle in which pressurized coolants are expanded through a small orifice to produce cooling."
- Temperature Achieved: "Temperatures of -100 to -120 ℃ are developed at the tip of the cryoprobe."
- Sufficiency of Temperature: "These temperatures are within the range of the predicate devices and is sufficient to achieve the desired tissue effect."
- Safety Features: "None of the coolant comes into contact with the patient or physician. In addition, none of the coolant gases are exhausted into the atmosphere, the system is closed. There is no cooling along the shaft of the probe nor at the handle that is held by the user during treatment."
- Technological Characteristics Comparison: "The technological characteristics of the CryoGen Cryosurgical System 2 are the same as those of the CryoGen Cryosurgical System 1, and the other predicates listed elsewhere... These devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization."
- Intended Use Comparison: "The CryoGen Cryosurgical System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology. This intended use is identical to the intended use for the predicate cryosurgical devices."
- Device Performance (as reported in the document):
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Ground Truth (for Substantial Equivalence): The "ground truth" for determining substantial equivalence is the established safety and effectiveness of the identified predicate devices. The new device is evaluated against these known safe and effective precedents.
In summary, the provided document does not describe a study in the sense of a performance trial with specific calculated metrics against predefined acceptance criteria for a novel device. Instead, it details a 510(k) submission which relies on demonstrating the new device's equivalence to existing, already-cleared devices based on shared design, materials, principle of operation, product specifications, sterilization, and intended use. The "proof" is this detailed comparison allowing the FDA to conclude "substantial equivalence."
§ 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.