(115 days)
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
The MyoScience Cryo-Touch device is a hand-held, single patient-use disposable, cryosurgical instrument used for destroying tissue by subcutaneous insertion of a needle during general surgical procedures. The device is based on introduction of a needle cooled by the cryogenic fluid (liquid nitrous oxide (N₂O)) to a selected area. The needle is cooled by the Joule-Thompson effect. The Cryo-Touch comes with a variety of stainless steel closed-tip needle assemblies for use in various applications. The Cryo-Touch uses a commercially available nitrous oxide cylinder.
The provided document is a 510(k) summary for the MyoScience Cryo-Touch device. It describes the device, its intended use, and comparison to predicate devices, and a high-level summary of supporting data. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a specific study that proves the device meets those criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully answered. The document states, "Performance testing has demonstrated that the device is in compliance with pertinent standards, the medical community's expectations and the product labeling." This is a general statement and does not provide specific acceptance criteria (e.g., minimum freeze time, temperature achieved, etc.) nor does it report specific device performance metrics against those criteria. It only indicates that performance testing was done and compliance was achieved.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be answered. The document mentions "Performance testing" but does not provide any details about the sample size used for this testing or the provenance of any data generated (e.g., country of origin, retrospective/prospective).
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)
- Cannot be answered. The document does not describe any test set that would require expert-established ground truth. The performance testing mentioned likely relates to engineering and functional performance of the device itself (e.g., cooling capabilities), not an assessment of diagnostic accuracy or treatment efficacy by experts on a patient dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be answered. As there's no mention of a test set with expert-established ground truth, an adjudication method is not applicable and therefore not described.
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
- Cannot be answered. This device is a cryosurgical unit, not an AI-assisted diagnostic or therapeutic tool for "human readers." Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant to this device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be answered. This device is a physical cryosurgical instrument, not an algorithm. Therefore, "standalone algorithm" performance is not applicable and not discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be answered. As discussed in point 3, the nature of the device (cryosurgical unit) implies that "ground truth" as typically defined for diagnostic or AI-driven devices (like pathology or expert consensus on images) is not relevant for its performance testing in this context. Performance testing would likely involve physical measurements (e.g., temperature, freeze size, consistency).
8. The sample size for the training set
- Cannot be answered. This device is a physical cryosurgical unit, not a machine learning model. Therefore, there is no "training set."
9. How the ground truth for the training set was established
- Cannot be answered. As there is no training set for this type of device, this question is not applicable.
Summary of available information regarding compliance:
The document states that:
- "Biocompatibility data demonstrates that the device is in compliance with ISO 10993."
- "Performance testing has demonstrated that the device is in compliance with pertinent standards, the medical community's expectations and the product labeling."
These statements indicate that some form of testing was conducted to show compliance with relevant standards and expectations, but the specific details of these tests, including acceptance criteria, sample sizes, and detailed results, are not present in this 510(k) summary. Such details would typically be found in the full 510(k) submission, which is not provided here.
§ 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.