(119 days)
The truFreeze® System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.
The truFreeze® System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of (1) a console and (2) a disposable spray kit. The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and the touch panel. A controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the procedure room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency shut-off button. The truFreeze spray kit consists of sterile single-use catheters and cryogen decompression tubes (CDTs). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.
The provided text is a 510(k) summary for the truFreeze® System. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to existing devices, rather than detailed performance studies and acceptance criteria in the way a clinical trial report would.
Therefore, the input does not contain the specific information required to complete the detailed table and answer all questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
However, I can extract what is available and highlight what is missing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Conformance to Product Specifications | The truFreeze System must conform to product specifications. | "Test results demonstrated that the truFreeze System meets its specifications." |
| Safety Issues | The truFreeze System should not raise any new safety issues compared to predicate devices. | "Test results demonstrated that the truFreeze System... does not raise any new safety and/or effectiveness issues." |
| Effectiveness Issues | The truFreeze System should not raise any new effectiveness issues compared to predicate devices. | "Test results demonstrated that the truFreeze System... does not raise any new safety and/or effectiveness issues." |
| Ease of Use | Improvements in ease of use compared to predicate devices. | "The minor differences and additional features improve the overall ease of use..." |
| Robustness | Improvements in robustness compared to predicate devices. | "...robustness and serviceability..." |
| Serviceability | Improvements in serviceability compared to predicate devices. | "...robustness and serviceability..." |
| Electrical Safety | Compliance with applicable electrical safety standards. | "Electrical safety and electromagnetic compatibility testing... were conducted in accordance with applicable standards." |
| Electromagnetic Compatibility (EMC) | Compliance with applicable EMC standards. | "Electrical safety and electromagnetic compatibility testing... were conducted in accordance with applicable standards." |
| Software Testing | Adherence to software requirements. | "software testing... were conducted in accordance with applicable standards." |
| Biocompatibility | Compliance with applicable biocompatibility standards. | "biocompatibility and sterilization testing... were conducted in accordance with applicable standards." |
| Sterilization | Compliance with applicable sterilization standards. | "sterilization testing... were conducted in accordance with applicable standards." |
Missing Information for Table: The document states that the device "meets its specifications" but does not explicitly list the quantitative or qualitative acceptance criteria themselves (e.g., "Cryogen flow rate must be X L/min +/- Y%"). It also doesn't provide specific numerical performance results for most categories.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "a comprehensive test program" and "user validations using animal models." It does not provide the number of animal models or specifics of other testing samples.
- Data Provenance: Not specified. "User validations using animal models" suggests prospective testing, but the country of origin or specific study sites are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The study focuses on device performance against specifications and predicate devices, not on diagnostic accuracy requiring expert panel ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable and not provided for the type of testing described (device function and safety, not diagnostic accuracy).
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a cryosurgical tool, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the "Summary of Testing" section implies standalone testing: "The truFreeze System was subjected to a comprehensive test program to evaluate conformance to product specifications... Electrical safety and electromagnetic compatibility testing, software testing, biocompatibility and sterilization testing were conducted in accordance with applicable standards." These tests evaluate the device's inherent functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the testing appears to be engineering specifications, recognized industry standards, and pre-defined functional performance criteria for a medical device (e.g., electrical safety, EMC, software functionality, biocompatibility, sterilization efficacy). For the animal model user validations, the "ground truth" would likely relate to the observed physiological effects of cryoablation in the animal tissue, as expected for the intended use.
8. The sample size for the training set
- This concept is not applicable as the truFreeze System is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable (see point 8).
§ 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.