(140 days)
The device is used to destroy unwanted tissue by application of extreme cold to the selected site.
The CMS AccuProbe® 600 series consists of two components including: i) a console which holds three dewars of liguid nitrogen (LN-) (one dewar is filled at a time; one dewar is a receptacle for the circulating LN, and the third dewar contains the supercooling chamber); and ii) one to eight (models 610 through 680) cryoprobes with tips extending from the console. The console includes an optional on-board computer which is used as a redundant display system and an archival system to store information from the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes to be utilized as necessary.
This is a cryosurgical unit (CMS AccuProbe 600 series) for destroying unwanted tissue by applying extreme cold. The provided text doesn't contain information about acceptance criteria or a study proving the device meets them in the way typically discussed for AI/ML devices, such as performance metrics like sensitivity, specificity, or accuracy.
The document is a 510(k) premarket notification summary for a medical device submitted to the FDA in 1996. For devices of this nature and era, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device, and the "study" would be focused on technical specifications, safety, and functionality rather than performance against a clinical ground truth with statistical metrics.
Here's a breakdown based on the provided text, using the structure requested but noting where information is not available due to the nature of the device and document:
1. A table of acceptance criteria and the reported device performance
| Feature/Criterion | Acceptance Criteria (Implied) | Reported Device Performance (as described relative to predicate) |
|---|---|---|
| Intended Use & Principle of Operation | Substantially equivalent to CMS AccuProbe® 550/530. | "The intended use and principal of operation are the same" as the predicate device (AccuProbe® 550/530). The device is used to destroy unwanted tissue by application of extreme cold (LN2) and may be monitored by imaging. |
| Liquid Nitrogen Capacity | Appropriate range of capacities to meet clinical needs. | AccuProbe® 600 SERIES: Ranges from 15 liters (Model 610) to 115 liters (Model 680). This offers a wider range than the predicate's 85 liters. |
| Normal Operating Pressure | Safe and effective operating pressure. | AccuProbe® 600 SERIES: 65psi (compared to 55psi for the predicate). This represents a design change that would require verification. |
| Regen Time | Efficient regeneration time. | AccuProbe® 600 SERIES: Two minutes (compared to four minutes for the predicate). This suggests an improvement in efficiency. |
| Regen Mode | Safe and effective LN2 handling during regeneration. | AccuProbe® 600 SERIES: Depressurizes supply dewar and pressurizes return dewar to capture LN2 flow back to supply dewar. This is a different mechanism from the predicate, implying a re-design and requiring safety and functional verification. |
| Dimensions | Appropriate physical size for clinical use. | AccuProbe® 600 SERIES: Offers a range of dimensions based on model, generally smaller for lower capacities (e.g., Model 610 is 45"x 24"x 29" vs predicate 54"x 29"x 47"). |
| Nitrogen Gas Supply | Reliable supply for probe heating/thawing. | AccuProbe® 600 SERIES: Internally Generated (compared to External Supply for the predicate). This is a significant design change for self-sufficiency. |
Study Proving Acceptance Criteria:
The "study" described in this 510(k) summary is a declaration of substantial equivalence to a previously cleared predicate device, the CMS AccuProbe® 550/530 (K953637). The basis for this is a comparison of features and the assertion that "The intended use and principal of operation are the same." The modifications (various liquid nitrogen capacities, normal operating pressure, regen time, regen mode, dimensions, and nitrogen gas supply) would have been supported by internal testing and engineering assessments to demonstrate that these changes do not raise new questions of safety or effectiveness and that the new device is as safe and effective as the predicate. This is typical for traditional (non-AI/ML) medical devices seeking 510(k) clearance.
The following questions are not applicable to this type of device and submission (a cryosurgical unit from 1996) as they pertain to the evaluation of AI/ML algorithms and their diagnostic performance. There is no AI/ML component mentioned in the description of the AccuProbe 600 series.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: There is no "test set" in the context of an AI/ML algorithm for this traditional medical device. Performance is assessed through engineering testing and substantial equivalence to a predicate.
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)
- Not Applicable: No ground truth in the AI/ML sense (e.g., diagnoses, annotations) is being established for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No ground truth adjudication process relevant to AI/ML performance.
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
- Not Applicable: This device is a physical cryosurgical unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: There is no algorithm to evaluate in a standalone capacity.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable: No ground truth data of this type is mentioned or required for this device's regulatory pathway. The "ground truth" for a cryosurgical device's effectiveness would be its ability to destroy tissue, which is assessed through bench testing and clinical experience, not through diagnostic accuracy metrics.
8. The sample size for the training set
- Not Applicable: There is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
- Not Applicable: No AI/ML model or training set.
§ 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.