(148 days)
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.
| Acceptance Criteria Category | Specific Criteria (Implicit from study design) | Reported Device Performance (Summary) | Met? |
|---|---|---|---|
| Safety | Frequency of device/procedure-related Serious Adverse Events (SAEs) | No device or procedure-related SAEs reported within 90 days. | Yes |
| Frequency of device/procedure-related Adverse Events (AEs) | One moderate nasal bleeding (remotely related, controlled, healed by Day 7). Other transient/mild AEs resolved by Day 90. | Yes | |
| Effectiveness | Improvement in subject-reported Total Nasal Symptom Score (rTNSS) | Average rTNSS improved 56% (from 6.2 to 2.7) at 90 days. | Yes |
| Improvement in subject-reported Visual Analog Scale (VAS) | Average VAS improved 53% (from 7.6 to 3.7) at 90 days. | Yes | |
| Investigator evaluation of ease of use | Rated "easy" to "moderately easy" in 89% (24/27) of subjects. | Yes | |
| Investigator evaluation of nasal congestion score | Average nasal congestion score improved 67% (from 1.5 to 0.5) at 90 days. | Yes | |
| Investigator rating of bleeding, swelling, crusting | Average rating of 0 at 90 days. | Yes | |
| Subject Experience | Subject satisfaction/comfort with cryosurgery. No explicit pass/fail, but reported. | 59% reported uncomfortable (53% somewhat, 6% very), 41% reported comfortable (29% somewhat, 12% very). | N/A |
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.
§ 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.