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The SprayGenix™ Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

The SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system. The SprayGenix™ Cryo Ablation System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

The provided text is a 510(k) safety summary for the SprayGenix™ Cryo Ablation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria or a study proving the device meets them.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided document. The document describes the device, its intended use, and lists predicate devices, but lacks details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement for evaluating specific acceptance criteria.

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The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for use in dermatology, gynecology and general surgery.

The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and cryogen tank, The Cryo-Ablator System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a crvo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

The provided text is a 510(k) premarket notification for the CryMed Cryo-Ablator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria or extensive study results that would be typical for novel devices or AI solutions.

Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of regulatory submission and device.

Here's what can be extracted and why other parts cannot be:

1. A table of acceptance criteria and the reported device performance

• Cannot be extracted: This document does not specify quantitative acceptance criteria or provide performance data (e.g., accuracy, precision, or success rates) for the CryMed Cryo-Ablator. The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted: The document does not describe any specific test set or clinical study data used to evaluate the device's performance. The basis for clearance is substantial equivalence to predicates, not new clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be extracted: No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be extracted: No test set or adjudication method 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

• Cannot be extracted: This device is a cryosurgical unit, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant, and no such study was conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Cannot be extracted: This device is a manual cryosurgical tool, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be extracted: No ground truth associated with a performance study is mentioned, as the clearance is based on substantial equivalence to existing devices.

8. The sample size for the training set

• Cannot be extracted: This device is not an AI/ML algorithm that would undergo a training phase with a specific dataset.

9. How the ground truth for the training set was established

• Cannot be extracted: Not applicable, as there's no AI/ML training set.

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