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The Cryo-PaC™ systems are a series of cryoanalgesia devices intended for use in blocking pain by temporarily ablating the peripheral nerves.

The Cryo-PaCTM systems comprise a choice of three versions of a cryoanalgesia console: the base model Cryo-PaCTM, and the Cryo-PaCTM Plus and Cryo-PaCTM Ultra; all based on the same control module but providing a range of features for the control of the cryogen gas. The consoles are complemented by a range of cryoprobes that are used for freezing nerves to block pain by temporary ablation. The Cryo-PaC™ console is used to control the supply of gas to the cryoprobe and to provide an electrical nerve location device. A footswitch completes the system. A convenience procedure kit for probe placement is also provided as a single use disposable.

In the Cryo-PaC™ systems, compressed nitrous oxide or carbon dioxide is directed to the tip of the cryoprobe where it is allowed to expand through a fine annular space. The expansion of the gas to near atmospheric pressure causes cooling by the Joule Thompson effect. The design of the cryoprobes is such that the warmer incoming gas maintains the outer stem of the cryoprobe above freezing temperatures to prevent freczing up the stem of the cryoprobe and unwanted tissue damage. A peripheral nerve stimulator in the Cryo-PaC™ consoles facilitate the location of the peripheral nerve prior to freezing. Freezing of the nerve fibers creates a block which prevents the conduction of pain. The effect is usually non-permanent, and a repeat of the treatment may be necessary to deal with long term pain.

The Cryo-PaC™ consoles have been designed to provide a simple user interface, together with a series of error detection and warning systems to ensure proper operation. In the Cryo-PaCTM Plus and Ultra models the console includes a pedestal that provides a convenient small footprint mobile base for the system, and houses the gas tanks. A simple footswitch completes the system.

This 510(k) summary (K050272) describes a cryoanalgesia system for blocking pain by temporarily ablating peripheral nerves. It's important to note that this submission is from 2005, and regulatory requirements and the typical structure of performance studies have evolved significantly since then. For devices approved today, the level of detail regarding clinical study design, acceptance criteria, and statistical methods would be much more comprehensive.

Based on the provided document, there are no specific acceptance criteria or a detailed study description provided for this device that would typically be found in a modern 510(k) summary. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, intended use, and performance characteristics without explicitly detailing those performance characteristics or the studies used to demonstrate them.

Here's an attempt to answer your questions based only on the provided text, acknowledging the limitations due to the age and nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

No dedicated test set or clinical study with a specific sample size is described in the provided document. The submission relies on establishing substantial equivalence.

3. Number of Experts used to establish Ground Truth & Qualifications

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or ground truth adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned or implied in this submission. The device is a surgical tool, not an imaging or diagnostic device where human reader performance with and without AI assistance would be relevant.

6. Standalone Performance Study

No detailed standalone performance study (e.g., a clinical trial with efficacy endpoints) is described in the provided summary. The submission emphasizes substantial equivalence to predicate devices, implying that the performance of the new device is comparable to these established devices without requiring a full de novo performance study. The statement "There are now new issues of safety or effectiveness raised by the subject device" implies that no new safety or effectiveness concerns were identified, suggesting that direct comparative performance data might not have been deemed necessary beyond similarities to predicates.

7. Type of Ground Truth Used

Not applicable. No ground truth is described for a performance study.

8. Sample Size for the Training Set

Not applicable. The device is a surgical instrument, not an AI/ML driven diagnostic or assistive technology that would typically involve a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary of Limitations based on the Document:

The provided document is a 510(k) summary from 2005 for a cryoanalgesia system. It relies heavily on demonstrating substantial equivalence to previously cleared predicate devices (K031482, K781302, K854334). This type of submission, particularly from this era, often focuses on comparing design, materials, and intended use. Detailed clinical performance acceptance criteria, test set sizes, ground truth establishment methods, or studies demonstrating specific quantitative performance metrics (like sensitivity, specificity, accuracy) were not commonly included or required in the same depth for devices cleared through the substantial equivalence pathway as they are for novel devices or AI/ML-driven technologies today. The "study that proves the device meets the acceptance criteria" is implicitly the comparison to the predicate devices, rather than a formally described clinical trial with explicit endpoints and acceptance thresholds.

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