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The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The user can select from two nitrous oxide Canister (cryogen Canister) sizes.

To perform cryosurgery, the ClariFix Device is removed from the sterile packaging and the desired cryogen Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle, which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve that allows cryogen to flow down the Cannula into the Cryoprobe.

The Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, cryosurgery can start.

The Cryoprobe is held in contact with the target location during cryosurgery. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to

Here's an analysis of the provided text regarding the acceptance criteria and study for the ClariFix Device.

It's important to note that this document is a 510(k) summary for a medical device that has been re-classified with an expanded indication for use (cryosurgical tool including in adults with chronic rhinitis). It is not a standalone AI/software as a medical device (SaMD) submission. Therefore, some of the requested information, particularly around AI-specific elements like "test set," "training set," "ground truth establishment," and "MRMC studies," is not directly applicable or reported in the context of this traditional medical device submission.

The "device" in question is a cryosurgical tool, not an AI algorithm. The study described is a clinical trial to demonstrate the safety and effectiveness of the device for a specific clinical indication, not to prove the performance of an AI algorithm against acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a device and not an AI algorithm, the acceptance criteria are framed in terms of clinical safety and effectiveness for its intended use, rather than typical AI performance metrics like sensitivity, specificity, or AUC.

2. Sample Size Used for the Test Set and Data Provenance

Again, this is not an AI algorithm evaluation with a "test set" in the traditional sense.

• Test Set (Clinical Study Population): 27 subjects (total for safety evaluation). 24 subjects (for 90-day effectiveness follow-up).
• Data Provenance: Prospective, multicenter clinical study conducted in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not explicitly stated as "experts establishing ground truth" in the AI sense. However, the study involved "investigators" who performed endoscopic evaluations and rated ease of use, nasal congestion, bleeding, swelling, and crusting. These would be medical professionals (likely ENT specialists) who are experts in the field.
• Qualifications: Not explicitly stated, but assumed to be qualified clinicians (e.g., otolaryngologists) conducting the clinical trial.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable as it's not a study involving multiple interpretations for a "ground truth" establishment in the AI context. The study reports subjective patient outcomes (rTNSS, VAS, satisfaction) and objective investigator assessments (ease of use, endoscopic findings). Adverse events would typically be assessed by the study investigators.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance, especially when assisted by AI. This submission concerns a physical device, not an AI system.
• Effect Size of Human Readers with vs. without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No, a standalone algorithm performance study was not done. The device is a physical cryosurgical tool and inherently involves human-in-the-loop operation.

7. Type of Ground Truth Used

• Ground Truth: For this device, "ground truth" is established through:
  • Patient-Reported Outcomes (PROs): rTNSS and VAS scores.
  • Investigator Assessments: Endoscopic evaluations, ratings of ease of use, nasal congestion, bleeding, swelling, and crusting.
  • Adverse Event Monitoring: Clinical observation and reporting.
  • Literature Review: Comparison of device performance with published literature on cryosurgery in the nasal passageway.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The "training" for the device would be the extensive research and development prior to the clinical study, but not in the sense of a dataset used to train an algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI algorithm.

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The ClariFix Device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures.

The ClariFix Device is a handheld, single patient-use, disposable cryosurgical device used for the destruction of tissue during surgical procedures. The device consists of a Handle attached to a Cannula with a Cryoprobe at the distal end. The ClariFix Device is provided sterile to the user. The user can select the desired nitrous oxide Canister (a.k.a. cryogen Canister) size from two different options.

To perform a treatment, the ClariFix Device is removed from the sterile packaging and the desired cryogen Canister is inserted into the Handle. A Canister Cap is then tightened onto the Handle which pierces the Canister. The cryogen is held in the Handle until the user opens a mechanical valve which allows cryogen to flow down the Cannula into the Cryoprobe.

Prior to initiating a treatment, the Cryoprobe is placed into contact with the target tissue via direct visualization. The Cannula can be rotated to ensure proper positioning. Once the Cryoprobe is in the desired position, treatment can start.

The Cryoprobe is held in contact with the treatment area during the treatment. As cryogen flows into the Cryoprobe, the liquid partially evaporates and the inside of the Cryoprobe cools to

This document describes the ClariFix Device, a cryosurgical tool. It's a 510(k) premarket notification, which means it asserts substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria in the same way a new drug or high-risk device might.

Therefore, the requested information regarding acceptance criteria and a study proving a device meets them is not directly present in the context of this 510(k) summary. A 510(k) typically focuses on demonstrating that a new device is "as safe and effective as" a predicate device through comparison of indications for use, technological characteristics, and performance data from engineering tests, rather than clinical efficacy studies with the types of metrics usually associated with acceptance criteria tables (e.g., sensitivity, specificity, accuracy).

However, I can extract information related to performance testing that supports the substantial equivalence claim.

Here's a breakdown based on the provided document, addressing the closest relevant points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this 510(k) submission does not present "acceptance criteria" in the traditional sense of clinical performance metrics (like sensitivity/specificity) for a diagnostic AI device. Instead, it presents performance data to demonstrate the device functions as intended and is comparable to the predicate. The "acceptance criteria" would have been set internally by the manufacturer for these engineering and safety tests.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes for the performance tests (e.g., number of devices tested for temperature repeatability or mechanical integrity). These are typically internal engineering tests, and details about sample size (N) for each specific test are not usually provided in a high-level 510(k) summary.

Data Provenance: The data provenance is from Arrinex, Inc. (the manufacturer) as part of their internal testing and validation processes to support the 510(k) submission. These are prospective tests performed on the manufactured device. There is no information about country of origin for the data beyond being generated by Arrinex, Inc. in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The performance data presented are for engineering and safety characteristics (e.g., temperature, strength, biocompatibility), not for diagnostic or predictive accuracy that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This type of information is not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This type of study is not applicable to the ClariFix Device. This is a cryosurgical tool, not an AI-assisted diagnostic or imaging interpretation device. Therefore, there is no concept of human readers or AI assistance in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the ClariFix Device is a physical surgical tool and does not employ algorithms or AI in its operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be the established engineering specifications and regulatory standards (e.g., specific temperatures, tensile strengths, ISO 10993 standards for biocompatibility). For example, the ground truth for temperature performance would be the set temperature range the device is designed to achieve and maintain. For biocompatibility, the ground truth is compliance with the toxicological and biological safety requirements outlined in ISO 10993.

8. The Sample Size for the Training Set

This is not applicable. The ClariFix Device is a physical medical device, not a machine learning or AI model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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