Search Results
Found 6 results
510(k) Data Aggregation
(132 days)
The myoscience ioveral device 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 selected site for the blocking of pain. The iovera® device is not indicated for treatment of central nervous system tissue.
The myoscience iovera® device 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 Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip has the added functionality of having the treatment parameters being preprogrammed into its secure processor. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® device 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 four main components:
- A reusable Handpiece 1.
- A Charging Dock 2.
- A single-patient use Smart Tip 3.
- A Cartridge (Nitrous Oxide)
The provided text describes a 510(k) submission for the myoscience iovera® cryogenic surgical device. This document focuses on the substantial equivalence of the new device to a predicate device based on non-clinical performance testing. It does not include information about acceptance criteria and clinical study results in the format typically used for AI/ML device submissions, such as detailed performance metrics, ground truth establishment, or human reader studies.
Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance
For this device, the "acceptance criteria" are implicitly meeting the design requirements and demonstrating substantial equivalence to the predicate device through non-clinical testing. The "reported device performance" is a simple pass/fail for each test, indicating it met the criteria for substantial equivalence.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Result) |
|---|---|
| Temperature reproducibility | PASS, Substantially equivalent to predicate |
| Mechanical Integrity for System | PASS, Substantially equivalent to predicate |
| Nitrous Exposure | PASS, Substantially equivalent to predicate |
| Cryozone Size | PASS, Substantially equivalent to predicate |
| Needle Integrity | PASS, Substantially equivalent to predicate |
| Sterilization and Shelf Life Testing | PASS, Substantially equivalent to predicate |
| Electrical Safety Testing | PASS, Substantially equivalent to predicate |
| Software Testing | PASS, Substantially equivalent to predicate |
| Safety Testing | PASS, Substantially equivalent to predicate |
| Biocompatibility Testing | PASS, Substantially equivalent to predicate |
Study Details:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document states "Verification testing was performed on the Nonclinical myoscience iovera® device to demonstrate that the product met the design requirements for system performance." It does not specify sample sizes for these non-clinical tests (e.g., number of devices tested, number of cycles performed).
- Data provenance is not explicitly mentioned but would be from internal lab testing at myoscience, Inc. The nature of the tests (e.g., temperature reproducibility, cryozone size) implies prospective testing in a lab setting.
-
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/Not provided. The "ground truth" for non-clinical performance tests like temperature reproducibility or mechanical integrity is typically established by engineering specifications and objective measurements, not by expert human reviewers.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for subjective human interpretations, often in clinical or image-based studies. These non-clinical tests rely on objective measurements against predefined engineering specifications.
-
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. The document explicitly states: "Clinical Testing Submitted: None." This is a non-clinical submission, and therefore, no MRMC study or AI-related effectiveness study was performed or required for this 510(k). The device is a surgical tool, not an AI diagnostic/interpretive tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical, cryogenic surgical device, not a software algorithm. Therefore, "standalone algorithm performance" is not applicable. The device's "performance" is its ability to meet specified engineering parameters (e.g., temperature, mechanical integrity) during its operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on engineering specifications and objective measurements (e.g., specific temperatures, physical dimensions, material properties, electrical safety standards). It is not dependent on expert consensus, pathology, or outcomes data, as these are not clinical tests.
-
The sample size for the training set:
- Not applicable/Not provided. As this is not an AI/ML device, there is no "training set" in the machine learning sense. The device's design and functionality are based on established physical principles (Joule-Thomson Effect, Latent Heat of Vaporization) and engineering.
-
How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no training set for an AI/ML device.
Ask a specific question about this device
(57 days)
The Myoscience Cryo---Touch IV 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 IV is not indicated for treatment of central nervous system tissue.
The Myoscience Cryo-Touch IV 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 Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N-O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The Cryo-Touch IV 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 four main components: A reusable Handpiece, A Charging Dock, A single-patient use Smart Tip, and A Cartridge (Nitrous Oxide).
The Myoscience Cryo-Touch IV is a cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through the application of extreme cold. The provided document describes nonclinical testing performed to demonstrate that the product met design requirements for system performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Temperature reproducibility | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Mechanical Integrity for System | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Nitrous Exposure | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Cryozone Size | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Needle Integrity | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Device Durability | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Sterilization and Shelf Life Testing | In compliance with pertinent standards (ISO 11137-1) and substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Electrical Safety Testing | In compliance with pertinent standards (IEC 60601-1, IEC 60601-1-2) and substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Software Testing | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Safety Testing | Substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
| Biocompatibility Testing | In compliance with pertinent standards (ISO 10993-1) and substantially equivalent to predicate devices | PASS, Substantially equivalent to predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Verification testing was performed on the Cryo-Touch IV device," but does not specify the sample size used for the test set. The data provenance is not explicitly stated. These were nonclinical tests, likely performed in
a laboratory setting, rather than on human subjects or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. Given that these are nonclinical device performance tests, the "ground truth" would likely be established by engineering specifications, validated measurement techniques, and comparison to predicate device performance, not clinical expert consensus.
4. Adjudication Method for the Test Set:
This information is not provided in the document. As these are nonclinical tests, an adjudication method in the human-in-the-loop sense is not applicable. The assessment would be based on meeting predefined engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. The tests described are nonclinical performance validations of the device itself, not studies comparing human reader performance with and without AI assistance. The Cryo-Touch IV is a physical surgical device, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The concept of a "standalone" algorithm performance is not applicable to the Cryo-Touch IV. It is a physical medical device. The "standalone" evaluation would refer to its own functional standalone performance as measured by the nonclinical tests listed, which were indeed performed.
7. The Type of Ground Truth Used:
The ground truth for these nonclinical tests appears to be based on:
- Engineering specifications and design requirements: The document states the tests "demonstrate that the product met the design requirements for system performance."
- Pertinent consensus standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and ISO 11137-1 serves as a form of ground truth or benchmark.
- Performance of legally marketed predicate devices: The "substantially equivalent to predicate" outcome for many tests indicates that the performance of existing, approved devices served as a critical benchmark or ground truth for acceptable performance.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The Cryo-Touch IV is a physical cryogenic surgical device. There is no mention or indication of any AI/ML components that would require a "training set" in the context of machine learning. The nonclinical tests described are for device validation, not algorithm training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the same reasons as point 8.
Ask a specific question about this device
(133 days)
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.
Ask a specific question about this device
(60 days)
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:
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
Ask a specific question about this device
(128 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| System Performance (General) | Met design requirements for system performance. |
| Temperature Profiling during Simulated Use Conditions | Met design requirements for temperature profiling. |
| Target Treatment Temperature within Range of Predicate Devices | Delivers a target treatment temperature of -65°C. This temperature is within the range of the other predicate devices (Cryo-PaC, Painblocker WA5000, and Neurostat), which target -55°C to -80°C. |
| Cryolesioning Effects on Peripheral Nerves | Evaluated impact on physiologic function and histologic changes in a preclinical rat model. |
| Safety (Biocompatibility) | Identical to predicate device, implying biocompatible patient-contacting materials. |
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
(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.
Ask a specific question about this device
Page 1 of 1