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510(k) Data Aggregation
(133 days)
CRYO-TOUCH III
The Myoscience Cryo-Touch III is used to destroy tissue during surgical procedures by applying freezing cold. It can also be 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 III is not indicated for treatment of central nervous system tissue.
The Myoscience Cryo-Touch III is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a needle probe, "Tip" cooled by the cryogenic fluid (liguid nitrous oxide, N₂O) to a selected area. The Tip is cooled by the Joule-Thomson effect and/or Latent Heat of Vaporization. The Cryo-Touch III may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The provided text describes the Myoscience Cryo-Touch III, a cryogenic surgical device. Since this is a medical device and not an AI/ML-based system, many of your requested criteria (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable. The device's performance is demonstrated through various engineering and preclinical tests, not through studies involving human or imaging data analysis.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria Implicitly Met | Reported Device Performance |
|---|---|---|
| Temperature reproducibility | Device consistently achieves target temperatures for cryoablation. | PASS, Substantially equivalent to predicate |
| Mechanical Integrity for system | Device components maintain structural integrity during use. | PASS, Substantially equivalent to predicate |
| Disable valve reliability | Safety mechanism reliably prevents unintended operation. | PASS, Substantially equivalent to predicate |
| Thermal fuse testing | Thermal fuse functions correctly to prevent overheating. | PASS, Substantially equivalent to predicate |
| Nitrous exposure | N₂O leakage or exposure is within safe limits. | PASS, Substantially equivalent to predicate |
| Cryozone size | The size and shape of the cryoablation zone are consistent and predictable. | PASS, Substantially equivalent to predicate |
| Needle Integrity | The needle probe maintains structural integrity and functionality. | PASS, Substantially equivalent to predicate |
| Device Durability | Device withstands repeated use and sterilization procedures. | PASS, Substantially equivalent to predicate |
| Sterilization and Shelf Life Testing | Device can be effectively sterilized and maintains sterility and functionality over its shelf life. | PASS, Substantially equivalent to predicate |
| Electrical Safety Testing | Device meets electrical safety standards (e.g., preventing shock, electromagnetic compatibility). | PASS, Substantially equivalent to predicate |
| Software Testing | Device software functions as intended and does not introduce hazards. | PASS, Substantially equivalent to predicate |
| Safety Testing | Overall device operation is safe for patients and users. | PASS, Substantially equivalent to predicate |
| Biocompatibility Testing | Device materials are compatible with biological tissues to minimize adverse reactions. | PASS, Substantially equivalent to predicate |
Implicit Acceptance Criteria: The phrase "Substantially equivalent to predicate" indicates that the Cryo-Touch III met the same performance standards and safety profiles as the previously cleared Cryo-Touch and Cryo-Touch II devices. This implies that the acceptance criteria are based on the established performance of the predicate devices and relevant industry standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84).
2. Sample size used for the test set and the data provenance
Since this is a physical medical device and not a data-driven AI system, there is no "test set" in the context of data. The "tests performed" refer to laboratory and engineering evaluations. The sample size for these tests would typically involve a predefined number of devices or components to be tested according to design verification and validation protocols (e.g., a certain number of units for durability testing, or a specific number of cycles for reliability tests). This specific number is not provided in the summary. Data provenance is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant for this type of medical device's performance evaluation. The "ground truth" for the device's technical specifications and safety would be established through engineering specifications, regulatory standards, and established scientific principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for resolving discrepancies in expert labeling or diagnoses, which is not relevant for the technical performance testing of this device.
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 cryogenic surgical tool, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Engineering Specifications: The design parameters and target performance metrics defined by the manufacturer.
- International Standards: Adherence to recognized medical device standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84).
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (Cryo-Touch and Cryo-Touch II).
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(60 days)
CRYO-TOUCH II
The MyoScience Cryo-Touch II 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 II is not indicated for treatment of central nervous system tissue.
The MyoScience Cryo-Touch II is a hand-held, single patient-use disposable, cryogenic device used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide) to the target nervous tissue and controlled by the user via a freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve. The Cryo-Touch II may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of three main components: a control unit (controller), probe assembly, and a cryogen cylinder assembly (Nitrous Oxide). The entire device is hand-held and for single patient-use. The Cryo-Touch II controller is battery operated; the battery powers electronics within the controller and provide feedback to the user when the device is ready to use. An assortment of needle assemblies is available for the Cryo-Touch II, ranging from a single to a triple needle, from 25 gauge to 30 gauge and 6mm in length. All needle assemblies are made of stainless steel and have a closed-tip that fully contains the cryogen so that it does not enter the target tissue. The needle assembly is the sterile patient contacting component of the Cryo-Touch II. The user removes the needle assembly from the sterile packaging and attaches it to the controller by inserting the needle hub end into the distal end of the controller. The cryogen is provided as a nitrous oxide cylinder. The cartridge is filled with liquid N₂O (83%) and the cylinder treats for approximately 180 seconds. The cylinder, once empty, may be replaced with a new cylinder by the user.
The provided 510(k) summary for the MyoScience Cryo-Touch II is for a cryosurgical unit and accessories, which is a Class II device. This type of device relies on established physical principles for its operation (cryotherapy) rather than complex algorithms or AI for diagnostic/interpretive functions. Therefore, many of the requested categories related to algorithm performance, ground truth, expert consensus, and comparative effectiveness studies with AI are not applicable to this type of medical device submission.
The "acceptance criteria" for a device like the Cryo-Touch II are typically its ability to function as intended, consistently apply the specified temperature, and meet safety and performance standards. The "study" mentioned refers to verification testing to ensure these criteria are met.
Here's the breakdown based on the provided text, with "N/A" for categories not applicable to this type of device submission:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from submission) | Reported Device Performance |
|---|---|
| Device meets design requirements for accurate temperature profiling | Verification testing demonstrated the product met the design requirements for accurate temperature profiling during simulated use conditions. |
| Consistent application of cold to selected site for blocking pain | (Demonstrated through functional testing, consistent with predicate device) |
| Operational reliability (e.g., battery operation, cryogen flow, iceball formation) | (Demonstrated through functional testing, consistent with predicate device) |
| Patient-contacting materials are biocompatible | (Confirmed as identical to predicate, implying biocompatibility established) |
| Treatment Temperature Range of -55° C to -75° C | (Confirmed as identical to predicate) |
Detailed Information:
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Sample size used for the test set and the data provenance:
- The document mentions "Verification testing was performed on the Cryo-Touch II device to demonstrate that the product met the design requirements for accurate temperature profiling during simulated use conditions." It does not specify a sample size for this testing nor the data provenance (country of origin, retrospective/prospective). This type of non-clinical testing typically involves a set number of devices or components tested under controlled laboratory conditions to ensure manufacturing and functional specifications are met.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device does not involve diagnostic interpretation or AI algorithms that require expert-established ground truth for a test set in the traditional sense. The "ground truth" for a cryosurgical device is its physical performance (e.g., temperature output, iceball size, durability), which is assessed through engineering and functional testing against design specifications, not expert interpretation of outputs.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically used in studies where human interpretation (e.g., reading medical images) is being evaluated and discrepancies exist. For performance testing of a physical device like this, results are objective measurements against specifications.
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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:
- N/A. This device is a surgical tool, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study comparing human reader performance with or without AI assistance would have been conducted or is relevant for its 510(k) clearance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm-only device. It is a handheld surgical instrument operated by a medical professional.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" or reference standard for its performance is its engineering specifications and functional requirements (e.g., achieving a specific temperature range, proper cryogen flow, iceball formation). These are objective, measurable parameters, not subjective expert consensus, pathology, or outcomes data.
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The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
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