Search Results

The MyoScience Cryo-Touch is used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch is nog indicated for treatment of central nervous system tissue.

The MyoScience Cryo-Touch is a hand-held, single patient-use disposable, cryogenic device used to destroy nervous tissue or produce lesions in peripheral nervous tissue by the application of cold to the selected site for the purposes of blocking pain. The Cryo-Touch has been developed for applications in cryoanalgesia. Cryoanalgesia for intractable pain involves the location and freezing of the nerve associated with the pain. The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide (N₂Q)) to the selected site and activation of the freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve. The Cryo-Touch may be used with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The MyoScience Cryo-Touch is a cryogenic surgical device intended to produce lesions in peripheral nervous tissue by applying cold to block pain. The submission, K100447, describes modifications to a previously cleared device (K083493), specifically the addition of a proprietary internal filter and an enhanced target treatment temperature of -65°C.

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state quantitative acceptance criteria in a table format with specific thresholds (e.g., "temperature must be -65°C +/- 2°C"). Instead, it describes general design requirements and performance goals. However, the key performance aspect highlighted for the modified device is its ability to achieve a specific temperature.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a distinct "test set" sample size for the verification testing. For the preclinical animal study, it mentions "a rat model" but does not provide the number of animals used.
• Data Provenance:
  • Verification testing: Performed internally by MyoScience. The country of origin is not specified, but MyoScience is based in Redwood City, CA, USA, suggesting the testing was likely conducted in the USA.
  • Preclinical animal study: Performed using a "rat model." The location of the study is not specified.
  • Nature of data: Both verification testing and the preclinical animal study were prospective in nature, designed specifically to evaluate the device.

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)

This information is not provided in the submission. The studies described are non-clinical (device performance verification and animal study) and do not involve human expert interpretation for "ground truth" in the way a diagnostic AI device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided as the described studies are non-clinical and do not involve human expert adjudication of a test set in the context of 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 performed. This submission is for a therapeutic cryogenic surgical device, not a diagnostic imaging AI algorithm that would typically involve human readers. The study focuses on the device's physical performance and biological effect, not on human interpretation or decision-making.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical surgical instrument, not a standalone algorithm. The device's performance is inherently "standalone" in terms of its mechanical and thermal operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Verification Testing: The "ground truth" for system performance and temperature profiling would be based on engineering specifications and established measurement standards, comparing measured physical parameters to pre-defined design requirements.
• Preclinical Animal Study: The "ground truth" for evaluating the impact of cryotreatment on peripheral nerves would be based on physiological function assessments and histological changes observed in the rat model. This involves direct observation and analysis of biological tissue and function.

8. The sample size for the training set

This information is not applicable/not provided. This device does not employ machine learning or AI that would require a "training set." The development relies on engineering design, physical principles, and biological testing.

9. How the ground truth for the training set was established

This information is not applicable/not provided as there is no training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device