(48 days)
The CryoShape is intended to destroy tissue during surgical procedures by applying extreme cold.
The CryoNeedle Cryoprobe manufactured by Etgar Group H.M.Y.A. Ltd. (U.S Patent 6.503,246) is a hand-held cryosurgical instrument for destroving tissue during surgical procedures by intralesional application of extremely cold cryoprobe. The device is based on intralesional application of a needle cooled by the cryogenic fluid (liquid nitrogen with boiling temperature -196℃ (-320.8ºF)) to a selected area to effect cellular destruction. . The needle is cooled by the cryogenic fluid (liquid nitrogen - boiling temperature -196°C (-320.8°F)) is applied intralesionally to a selected area to effect cellular destruction. By forcing liquid nitrogen to circulate through the needle an ice ball around the CryoNeedle developed causing the abutted HSK tissue to be completely frozen. As this iceball grows, its leading edge advances through tissue. Tissue that comes into contact with the iceball is destroyed. Temperatures of -25℃ to -50℃ (-139F to -58°F) are achieved within 30 seconds.
The provided text describes a medical device, the CryoNeedle (also referred to as CryoShape in the FDA letter), and its intended use, but it does not contain information about a study that proves the device meets specific acceptance criteria.
The document is primarily a 510(k) premarket notification summary and an FDA clearance letter. It establishes substantial equivalence to a predicate device and states the intended use. It mentions that the device "meets all the declared requirements of its intended use" and "presents no adverse health effect or safety risks," but it does not provide any specific quantitative acceptance criteria or evidence from a study to back these claims.
Therefore, I cannot populate the table or answer many of the questions as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what is explicitly missing:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria are provided in the text. | The device achieves temperatures of -25℃ to -50℃ (-139F to -58°F) within 30 seconds. This is a functional description, not a performance metric against a stated acceptance criterion. |
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not describe any specific clinical or performance test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication process is 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:
- No. This device is a cryosurgical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical cryosurgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No ground truth for any study is mentioned. The clearance is based on substantial equivalence to a predicate device and adherence to a consensus standard (ASTM F882-84(2002)).
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. No training set is mentioned.
§ 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.