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The iovera? system 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. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.

The ioveraº system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

The iovera system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block 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 is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® system 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:

1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)

Based on the provided text, the document is a 510(k) Premarket Notification for the Myoscience iovera® system, primarily focused on an extended Smart Tip configuration. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical outcome study in the traditional sense of proving clinical efficacy for a new indication.

Here's an breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this submission are primarily focused on demonstrating the safety and performance of the new Smart Tip configuration (1x90mm) as being substantially equivalent to existing predicate devices, particularly regarding its physical characteristics and operational performance within the iovera® system. The acceptance criteria are essentially implied by the "PASS" results for various tests.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify numerical sample sizes for each of the performance tests (e.g., number of Smart Tips tested for dimensional inspection, or number of cycles for temperature reproducibility).
   • Data Provenance: The tests were conducted by Myoscience, Inc. as part of their premarket notification for the device. The document does not specify a country of origin for the data or whether it was retrospective or prospective, but given it's a premarket submission, it would be prospective testing conducted for the purpose of the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For this type of device and submission (a 510(k) for a modification to an existing device, emphasizing engineering and material performance), "ground truth" is established through standardized engineering tests, material testing protocols (like ISO-10993), and software verification, rather than clinical expert consensus on complex diagnostic images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable. The "experts" would be qualified engineers, test technicians, and quality assurance personnel performing the described tests according to recognized standards.

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

   • Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving multiple human readers assessing medical images or outcomes. This document details engineering and biocompatibility testing, not a clinical reader study. Therefore, no such adjudication method was used or is relevant to the data presented.

4. 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, an MRMC comparative effectiveness study was not performed. This device is a cryogenic surgical system, not an AI-powered diagnostic or assistive tool for human readers. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.

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

   • No, this term typically applies to AI algorithms. The "software testing" mentioned is for the device's embedded software (e.g., for controlling treatment parameters), not a standalone AI algorithm for medical image analysis or diagnosis.

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

   • For the performance data provided, the "ground truth" is based on:
     • Standardized Test Specifications: For electrical safety, EMC, dimensional accuracy, temperature reproducibility, cryozone formation, and needle integrity, the ground truth is defined by pre-established engineering specifications and international standards (e.g., IEC 60601-1, ISO-10993).
     • Chemical/Biological Standards: For biocompatibility, the ground truth is determined by the results of specific standardized biological tests (Cytotoxicity, Sensitization, etc.) against accepted pass/fail criteria from ISO-10993.
     • Software Design Requirements: For software verification, the ground truth is the confirmed meeting of the software design requirements for the new Smart Tip descriptor.

7. The sample size for the training set:

   • This document describes performance testing for a 510(k) submission, not an AI model development. Therefore, there is no "training set" as understood in machine learning. The device itself (the iovera® system) has undergone extensive development and testing, but the term "training set" is not applicable here.

8. How the ground truth for the training set was established:

   • As there is no "training set" in the context of this 510(k) submission, this question is not applicable.

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The iovera? system 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. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.

The ioveras system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block 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 is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The ioveraº system 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:

1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)

The iovera Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece also contains LEDs for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery.

An assortment of Smart Tips is available for the iovera system. All Smart Tip needles are made of stainless steel and have a closed-end that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera° system. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.

The ioveras system uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N2O.

This document describes the FDA 510(k) clearance for the ioveraº system, a cryogenic surgical device, for an expanded indication related to the relief of pain and symptoms associated with osteoarthritis of the knee.

1. Table of Acceptance Criteria (Primary and Secondary Endpoints) and Reported Device Performance

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The myoscience ioveraº system 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 blocking of pain. The ioveraº system is not indicated for treatment of central nervous system tissue.

The iovera° system 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 is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. iovera° 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:

1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)

The provided text is a 510(k) Summary for the Myoscience iovera® system, a cryogenic surgical device. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study data for a novel device or AI algorithm.

Therefore, much of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes several bench tests and software tests with a pass/fail outcome. It doesn't explicitly state quantitative acceptance criteria beyond "PASS," but it implies meeting design requirements and pertinent standards.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the document. The tests performed are described but not the number of units or instances tested for each.
• Data Provenance: Not applicable in the context of this device's testing. The tests are primarily bench and software tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI/diagnostic device requiring expert ground truth for image interpretation or diagnosis. The ground truth for device performance is based on direct measurement and adherence to engineering specifications and standards.

4. Adjudication method for the test set:

• Not applicable. The tests are objective measurements or functional verifications, not subjective expert reviews.

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 is not an AI diagnostic device.

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

• Not applicable. This is not an AI algorithm. The device performance tests mentioned are standalone tests of the physical device and its software.

7. The type of ground truth used:

• The ground truth for the device's performance tests appears to be based on:
  • Engineering specifications and design requirements: For dimensional integrity, temperature reproducibility, cryozone size, and needle integrity.
  • International standards: Such as ISO 11135-1 for sterility and ISO-10993 for biocompatibility.
  • FDA guidance documents: For software verification testing.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model that requires a training set.

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

• Not applicable. No training set for an AI model.

Summary based on the Provided Text:

The provided document is a 510(k) summary for a medical device (Myoscience iovera® system) seeking substantial equivalence to a predicate device. It focuses on the safety and effectiveness of the device itself through bench testing, software verification, and biocompatibility evaluations, especially for the modified "Smart Tip" component. It explicitly states that "No preclinical testing was deemed necessary for this modification" and "No clinical testing was deemed necessary for this modification," indicating that the decision for substantial equivalence was based on non-clinical data. The document does not describe the evaluation of an AI algorithm or diagnostic performance.

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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.

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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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:

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.

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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

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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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

Detailed Information:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device; therefore, there is no "training set."

8. 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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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.

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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.

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