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AtriCure's cryoICE® cryoXT™ cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

The cryoICE® cryoXT™ probe is a sterile, single-use device designed to enable cryoablation of target nerves by allowing surgeons to surround exposed peripheral nerves with its blunt prong-shaped distal tip, and in conjunction with an AtriCure cryoICE BOX (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. cryoXT is offered in one single probe length of approximately 11" (28 cm) long. The device has a flexible tubeset that consists of a gas supply tube and exhaust tube, a handle, a malleable probe which is covered by an insulating sheath and has a prong-shaped distal tip at the distal end.

The provided FDA 510(k) Clearance Letter for the cryoICE cryoXT cryoablation probe focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical bench testing. However, it does not contain information about clinical studies with human subjects, AI/algorithm performance, ground truth establishment, or human reader performance. Therefore, I cannot fully address all points in your request.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical bench tests performed to demonstrate performance. The acceptance criteria are stated as being "predetermined" and the device "met the predetermined acceptance criteria." However, specific quantitative acceptance criteria values and the reported quantitative performance data are not provided in this summary. Instead, a qualitative statement of meeting the criteria is given.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical bench testing. Therefore, there is no "test set" in the context of human data or image data. The "samples" would be individual cryoablation probes or components tested in a lab setting. The document does not specify the number of units/samples used for each of the listed bench tests.

Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, AtriCure, Inc., based in Mason, Ohio, USA. The document does not indicate if it's retrospective or prospective, as this distinction typically applies to clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device clearance is based on non-clinical bench testing and demonstration of substantial equivalence to existing predicate devices. It does not involve interpretation of medical images or diagnostic performance where expert ground truth would be established.

4. Adjudication Method for the Test Set

Not applicable. As stated above, this is non-clinical bench testing, not a study requiring adjudication of human data or expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes non-clinical bench testing and comparison of technological characteristics to predicate devices. There is no mention of a human-in-the-loop study or MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device (cryoablation probe), not an AI/algorithm.

7. The Type of Ground Truth Used

For the non-clinical bench tests, "ground truth" would be established by the engineering specifications and performance targets derived from the predicate devices and general safety/performance standards for cryosurgical devices. For example, the "Iceball Performance Test" would likely have a ground truth of a specific iceball size or temperature profile, which is determined by engineering and clinical requirements of the device's function. The results are compared against these predetermined specifications.

8. The Sample Size for the Training Set

Not applicable. This a physical device, and the clearance is based on substantial equivalence and non-clinical bench testing. There is no "training set" in the context of AI or machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is involved.

Summary of what the document does provide regarding acceptance criteria and proof:

The document focuses on demonstrating substantial equivalence of the new cryoICE cryoXT cryoablation probe to its predicate devices (CRYO2 and CRYOS) through a comparative analysis of technological characteristics and a series of non-clinical bench tests.

• Acceptance Criteria Approach: The acceptance criteria for the bench tests were "predetermined," and the device "met the predetermined acceptance criteria ensuring substantial equivalence." The specific quantitative values for these criteria are not disclosed in this summary.
• Proof: The "study" proving the device meets the criteria consists of the successful completion of the following non-clinical bench tests: Cryogenic Performance Test, Iceball Performance Test, Mechanical Reliability Test, Pressure Cycle Withstand Test, Drop Test, Dimensional Verification Test, Biocompatibility Test, and Sterility Test.
• Conclusion: The tests demonstrated equivalence in performance and did not raise any new safety issues, leading to the conclusion that the device is substantially equivalent in fundamental design, technology, function, materials, packaging, sterilization, operating principle, and intended use to the previously cleared predicate devices.

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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.

When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

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, NoO) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera8 System may be used in conjunction with standard of-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 ●
• An assortment of single-patient-use Smart Tips ●
• A Cartridge containing nitrous oxide ●

The provided text describes the iovera® System, a cryogenic surgical device cleared by the FDA (K243677). The document focuses on demonstrating substantial equivalence to predicate devices (K220656 and K211334) for a new Smart Tip configuration (STT21180STIM) that also facilitates nerve location.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on adherence to recognized standards and satisfactory completion of design verification testing. Specific quantitative acceptance criteria for each test (e.g., specific thresholds for biocompatibility, precise tolerances for mechanical tests) are not explicitly detailed in this summary, but the general outcome of "meets all ISO10993-1 and USP acceptance criteria" or "complied with standards" is stated.

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes design verification testing rather than a clinical study with a "test set" of patient data. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this regulatory summary. The testing focuses on engineering verification (e.g., number of units tested for mechanical properties, number of samples for biocompatibility, etc.), not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Again, this pertains to a clinical study with patient data and does not apply to the design verification testing described. The "ground truth" for the engineering tests would be the compliance with recognized standards and specified performance parameters.

4. Adjudication Method for the Test Set:

Not applicable, as this is design verification testing rather than a clinical study requiring consensus from experts on case interpretation.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, not on evaluating human reader performance with or without AI assistance. The device in question is a physical cryogenic surgical device, not an AI diagnostic tool that assists human readers with interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

Not applicable. The iovera® System is a physical medical device, not an algorithm. Performance is assessed through engineering tests of the device itself. While it facilitates nerve location, its primary function is direct tissue destruction via freezing, with a human operator always in the loop.

7. The Type of Ground Truth Used:

For the design verification testing, the "ground truth" used is:

• Compliance with recognized international and national standards (e.g., ISO 10993-1, IEC 60601-1, IEC 62366-1, ISO 11135, ASTM standards).
• Pre-defined product specifications and design input requirements for physical, electrical, mechanical, software, and biological properties.
• Laboratory test results (e.g., chemical analysis for extractables, temperature measurements for cooling performance, force measurements for bond strength).

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of medical device submission.

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The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.

The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F).

In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.

The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.

The provided text is a 510(k) summary for the AtriCure cryoICE BOX (ACM) and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.

However, based on the limited information available in the "V. Performance Data" section, here's what can be extracted and then what cannot be answered from the provided text:

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

The document provides a general statement in "V. Performance Data": "The AtriCure cryoICE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module."

It does not provide a specific table of acceptance criteria or detailed reported device performance. It only states that the device met the criteria.

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

This information is not provided in the document. The "Performance Data" section indicates "bench testing was conducted," but no details on sample size, data provenance, or whether it was retrospective or prospective are given.

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 document. The device is a "Cryosurgical Unit And Accessories" and the testing mentioned is "bench testing," which typically does not involve expert-established ground truth in the context of medical image analysis or diagnostic performance.

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

This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here for this device's performance testing.

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

This information is not provided in the document. A MRMC study is relevant for assessing diagnostic performance, especially of AI/CAD systems that assist human readers. This device is a cryosurgical unit, not an AI or diagnostic imaging device, so such a study would not typically be applicable.

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

This information is not provided in the document. This concept is typically relevant for AI/algorithm performance. The device is hardware (a cryosurgical unit), and its performance would be assessed through functional bench tests, not as an "algorithm only" product.

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

This information is not provided in the document beyond the general statement that "predetermined acceptance criteria" were met during "bench testing." For a cryosurgical unit, "ground truth" would generally involve objective measurements against engineering specifications (e.g., temperature achieved, power output, flow rates) rather than clinical ground truth like pathology or outcomes data, which are more applicable to diagnostic or therapeutic devices where a direct clinical outcome is being measured against a gold standard.

8. The sample size for the training set

This information is not provided in the document. This is only relevant for machine learning or AI models, which is not applicable to the AtriCure cryoICE BOX as described.

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

This information is not provided in the document for the same reason as point 8.

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FOR ADULT PATIENTS
AtriCure's cryolCE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).

FOR ADOLESCENT PATIENTS
The cryolCE cryoSPHERE+ and cryoSPHERE MAX cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization* in adolescent patients of at least 12 years of age.

*Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX cryoablation probes are sterile, single use devices that achieve cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The cryolCE cryoSPHERE+ and cryolCE cryoSPHERE MAX device is offered in two probe length configurations: approximately 11" and 17" long. At the distal end, the ryoICE cryoSPHERE+ and cryoICE cryoSPHERE MAX probe features an 8mm or 10mm diameter ball tip shape for each length configuration. The flexible region of the probe is malleable and is capable of being bent by the end user using an included forming tool.

The provided text is an FDA 510(k) clearance letter for the AtriCure cryoICE cryoSPHERE+ and cryoSPHERE MAX cryoablation probes. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria. As such, information regarding many of the requested points (like sample size for test sets, number of experts for ground truth, MRMC studies, or training set details) is not present.

However, I can extract the available information regarding acceptance criteria and the type of study conducted to support the equivalence claim.

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria were predetermined, and the device met these criteria, ensuring substantial equivalence. While specific numerical acceptance criteria are not detailed in the provided text, the criteria implicitly refer to demonstrating equivalence in performance, features, and safety compared to the predicate device.

Study Details Based on Provided Information:

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

   • Sample Size: Not specified. The document only lists "Reliability Testing," "Transit," "Shelf-life," "Cryogen Performance/Thermal Insulation," "Mechanical testing," "Biocompatibility," "Sterility," and "EMC" as types of tests.
   • Data Provenance: Not specified, but these are typically bench tests performed in a laboratory setting by the manufacturer. These are non-clinical bench testing.

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

   • Not applicable. This was a non-clinical bench testing study, not a clinical study involving experts defining a medical ground truth for diagnostic accuracy.

3. Adjudication method for the test set:

   • Not applicable. This was a non-clinical bench testing study.

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. This device is a cryoablation probe (surgical instrument), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

   • No. This is a medical device, not a software algorithm.

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

   • For the non-clinical bench tests, the "ground truth" would be established engineering specifications, performance standards, material properties, and regulatory requirements (e.g., sterilization efficacy, biocompatibility standards).

7. The sample size for the training set:

   • Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.

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

   • Not applicable. This information is not relevant to this device type.

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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.

When stimulation compatible components are used , the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

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. The iovera" System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.

The device comprises four main components:

• A reusable Handpiece
• A Charging Dock
• An assortment of single-patient-use Smart Tips
• A Cartridge containing nitrous oxide

The iovera® System 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 contains an LCD display 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 ioveraº system. All Smart Tip needles are made of stainless steel and have a closed-end design 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 its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment.

The iovera System uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.

This document is a 510(k) premarket notification for the iovera® System, a cryogenic surgical device. The purpose of this notification is to demonstrate that the modified iovera® System is substantially equivalent to previously cleared iovera® Systems (K211334 and K173763).

Based on the provided text, the device is evaluated against its product specifications. The document describes a series of engineering and performance tests rather than a clinical study evaluating diagnostic or prognostic performance with human readers. Therefore, several of the specific questions related to clinical studies (e.g., sample size for training/test sets, expert ground truth, MRMC studies) are not directly applicable or are not detailed in this submission.

Here's a breakdown of the acceptance criteria and the study (design verification testing) that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The subject iovera® System device met the design verification and validation inputs, passing all predetermined acceptance criteria." However, it does not provide a specific table with numerical acceptance criteria and corresponding reported performance values for each parameter. Instead, it lists categories of testing performed to demonstrate compliance.

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

The document describes "Design Verification testing" and "Verification and validation testing." These are engineering and performance validation tests, not clinical efficacy or diagnostic performance studies involving patient data. Therefore, the concept of a "test set" in the context of a dataset with patient outcomes or images is not applicable here. The "samples" would be units of the device or its components tested in a lab setting. The document does not specify the number of device units or components tested for each category.

• Data Provenance: Not applicable in the context of patient data. The tests are likely conducted in-house or by accredited testing laboratories.
• Retrospective or Prospective: Not applicable as it's not a clinical study involving patient data. These are design verification tests.

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

Not applicable. The ground truth for these engineering performance tests is established by product specifications, recognized standards (e.g., ISO, IEC, ASTM), and internal design requirements, not by expert consensus on clinical data.

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

Not applicable. This is for performance testing against established engineering specifications, not for interpretation of clinical data requiring expert adjudication.

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 submission is for a medical device (cryogenic surgical system), not an AI/CADe or CADx device that assists human readers in interpreting medical images.

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

Not applicable. The iovera® system is a physical device used by a human practitioner. It's not a standalone algorithm.

7. The type of ground truth used:

The ground truth for this device's performance is based on:

• Engineering Specifications: Pre-defined design requirements and performance parameters for the device and its components (e.g., temperature range, timing, electrical properties).
• Recognized Standards: Compliance with international and national standards (IEC, ISO, ASTM) for medical devices, software, electrical safety, biocompatibility, and sterility.
• Predicate Device Equivalence: The claim of substantial equivalence to previously cleared iovera® Systems (K211334 and K173763) implies that their performance characteristics serve as a benchmark.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning device, so there is no "training set." The performance verification relies on meeting established design specifications and adhering to relevant industry standards.

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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 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. The device comprises four main components: A reusable Handpiece, A Charging Dock, An assortment of single-patient-use Smart Tips, A Cartridge containing nitrous oxide.

The provided document K211334 is a 510(k) Premarket Notification for the Iovera System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving significant clinical efficacy or performing novel clinical trials to establish acceptance criteria for a new device's performance.

Therefore, the document does not contain the detailed information necessary to answer all parts of your request, especially regarding acceptance criteria for a new device's analytical performance, a groundbreaking study proving its independent performance, reader study details (MRMC), or specifics about training and test sets.

Here's an analysis of what can and cannot be extracted from the provided text:

Key Takeaway from the Document:
The Iovera System (subject device) is being cleared as substantially equivalent to a previously cleared Iovera System (predicate device, K161835). This means the focus of the submission is to show that any modifications to the device since its last clearance do not raise new questions of safety or effectiveness and that the core performance remains the same as the already approved predicate. It does not describe a new study to establish performance metrics against a novel set of acceptance criteria for a first-of-its-kind device.

Information Extracted/Deduced from the Document:

1. A table of acceptance criteria and the reported device performance:
   The document states:
   "Design Verification testing was performed for the iovera° system to demonstrate that the device meets product specifications."
   "The subject ioveraº system device met the design verification and validation inputs, passing all predetermined acceptance criteria."

   However, the document does not provide a specific table of acceptance criteria with numerical targets or the reported device performance outcomes for these criteria. It lists the categories of testing performed:

   • Functional Testing
   • Product Performance (Handpiece and Cartridge)
   • Smart Tip Testing
   • User Interface Testing
   • Electrical /EMC safety Testing

   Given this is a 510(k) for substantial equivalence based on modifications, the "acceptance criteria" likely refer to internal engineering and design verification specifications for the modified components to ensure they perform as intended and don't negatively impact the device's established safety and effectiveness. These are typically pass/fail for specific tests rather than statistical performance metrics like sensitivity/specificity for an AI or diagnostic algorithm.

2. Sample sizes used for the test set and the data provenance:
   The document does not provide information on sample sizes for any "test sets" in the context of clinical performance or algorithm evaluation. The testing described is design verification and validation, which often involves engineering tests on a defined number of units, but these are not typically referred to as "test sets" in the context of clinical data for performance evaluation.
   Data provenance (country of origin, retrospective/prospective) is also not mentioned as this type of clinical data is not the focus of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable and not provided. The device is a cryogenic surgical device, not a diagnostic or AI device that relies on expert interpretation to establish ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable and not provided for the same reasons as point 3.

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:
   This information is not applicable and not provided. The Iovera System is a therapeutic device (cryogenic surgical device), not a diagnostic device or AI software that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable and not provided. The Iovera System is a physical device used by a clinician, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As this is a physical therapeutic device, the concept of "ground truth" for performance evaluation in the context of diagnostic accuracy does not apply in the way it would for an AI or diagnostic device. The performance is assessed through meeting engineering specifications and demonstrating safe and effective tissue destruction/lesion creation as intended.

8. The sample size for the training set:
   This information is not applicable and not provided. The device is not an AI model that requires a "training set."

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.

In summary, the provided document relates to a 510(k) submission for a physical medical device (cryogenic surgical device) that is being cleared based on substantial equivalence to a predicate device after modifications. It does not contain the type of performance evaluation study details (e.g., test sets, ground truth methodology, reader studies) that would be relevant for an AI/diagnostic device.

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For Adult Patients
AtriCure's Cryo2 cryo2 cryoablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
The Cryo2 cryolCE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves.
For Adolescent Patients
The Cryo2 cryolCE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1 Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.
For Adult Patients
AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves.
For Adolescent Patients
The cryolCE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1 Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.

The cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac surgery; it is also intended for use in blocking pain by temporarily ablatinq peripheral nerves. The cryosurgical handpiece uilizes a high-pressure cryogen (nitrous oxide, N20) to freeze target tissues, creating an inflammatory response, and ultimately, cryonerosis. The cryosurgical handpiece provides below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitous oxide is supplied to the cryprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryolip, of the probe is malleable to allow access to varying anatomy and anatomical sites.
The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three infices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be cryotip into the desired form. The cryolip is attached to an insulated rigid shaft that allows the surgeon to adjust the exposed cryolip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).
The cryoICE PROBE is a sterile, single-use cryosurgical instrument.
The form tool facilitates bending of the malleable tip.
This PROBE was designed for treatment of cardieving controlled temperatures down to -50° to -70°C; it can also be used to temporarily block pain by ablating peripheral nerves in adolescent patients of at least 12 years of aqe.
The cryolCE cryoSPHERE cryoablation (CRYOS/CRYOS-L) probe is a single use cryablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.
The PROBE is a single-use device offered in two configurations: standard length probe shaft (CRYOS), and extended length probe shaft (CRYOS-L). The probe shaft is malleable and supports forming by the supplied TOOL. The PROBE features a spherical 8mm cryoablation tip.

This document is a 510(k) summary for AtriCure CryoICE cryo-ablation probes (Cryo2, CryoS, CryoS-L). It focuses on the expanded indication for use in adolescent patients aged 12 and above for temporary pain unique to its use in intercostal nerves under direct visualization.

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that clinical evidence demonstrated the use of the cryoablation probes in adolescent patients (≥ 12 years) for intercostal nerve ablation was "as safe and effective" as its use in adults. The evaluation was based on the following endpoints, implying these were the performance areas assessed:

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

The document states that AtriCure partnered with the UCSF Stanford Pediatric Device Consortium (PDC) to evaluate clinical evidence, which comprised clinical publications. The exact sample size from these publications is not specified in this summary. The data provenance (country of origin, retrospective/prospective nature) is also not explicitly stated in this summary.

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 510(k) summary. The evaluation relies on published clinical evidence rather than a dedicated expert panel for ground truth establishment within this specific submission.

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

This information is not provided in the 510(k) summary. Given that the evidence is based on clinical publications, any adjudication would have been part of the original studies, and details are not reiterated here.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a physical medical instrument (cryoablation probe) and not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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 cryoablation probe and not an algorithm.

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

The "ground truth" for the comparison of safety and effectiveness was based on outcomes data from the clinical publications. Specifically, it assessed "intraoperative or post-operative complications," "adverse events observed," and specific post-ablation conditions like "cryoablation associated numbness," "neuropathic pain," "chest wall numbness," and "post-operative pneumothorax." The comparison was against the known safety and effectiveness in adult patients.

8. The sample size for the training set

This document describes a premarket notification (510(k)) for a medical device and relies on existing clinical evidence. There is no "training set" in the context of machine learning for this type of device submission. The clinical evidence used for assessment is analogous to a validation set.

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

As there is no "training set" in the context of machine learning for this device, this question is not applicable. The clinical evidence used for evaluation was derived from existing clinical publications, where the "ground truth" (e.g., presence of complications, pain levels) would have been established within those individual studies.

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AtriCure's cryolCE cryoSPHERE cryoablation probes are sterile, single use devices intended for use in blocking pain by temporarily ablating peripheral nerves.

The cryolCE cryoSPHERE cryoablation (CRYOS) probe is a single use device that achieves cryoablation of peripheral nerves by allowing a surgeon to insert the probe through an incision to reach the target tissue, place the probe tip on the target site, and in conjunction with an AtriCure Cryo Module (ACM), temporarily freeze the tissue in contact with the probe tip by circulating a cryogenic agent, nitrous oxide, through the device. The CRYOS probe is offered in two probe length configurations: approximately 11" and 18" long. The probe is malleable, and is capable of being bent by the end user. At the distal end, the CRYOS device features an 8 mm diameter ball tip shaped probe.

The provided text describes a 510(k) premarket notification for a medical device, the AtriCure cryoICE cryoSPHERE cryoablation probe. It states that the device is substantially equivalent to a previously cleared predicate device based on bench testing. However, the document does not contain information about the device's performance in a study involving human or animal subjects, nor does it detail acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI/ML-based medical device.

The provided document focuses on demonstrating substantial equivalence for a physical medical device (a cryoablation probe) through non-clinical bench testing. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria and study data for an AI/ML device's diagnostic performance.

Specifically, the document states:

• Performance Data: "The following bench testing was conducted for design and performance elements deemed appropriate to demonstrate equivalence to the previously cleared CRYO2 device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared CRYO2 device. No new safety or performance issues were raising during testing."
• Non-clinical Bench Testing:
  • Reliability Testing
  • Transit
  • Shelf-life
  • Cryogen Performance/Thermal Insulation
  • Mechanical testing
  • Biocompatibility

Given this, I cannot construct a table of acceptance criteria and reported device performance for an AI/ML diagnostic device, nor can I provide details about sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided in this 510(k) summary for a physical cryoablation probe.

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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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AtriCure's cryolCE cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.

The cryosurgical handpiece, or cryo-ablation probe, utilized in the AtriCure Cryosurgical System is a hand held, single use, cryosurgical instrument intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery; it is also intended for use in blocking pain by temporarily ablating peripheral nerves. The cryosurgical handpiece utilizes a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpiece provides probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobe via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probe is malleable to allow access to varying and anatomical sites. The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler and three internal inlet orifices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be used to bend the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).

This document is a 510(k) premarket notification for a medical device called the AtriCure cryoICE cryo-ablation probe (CRYO2). It is a submission to the FDA for a modified version of an already cleared device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the performance of a new device against clinical acceptance criteria in the way AI/ML devices often require.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or available in this document for the following reasons:

• This is a 510(k) for a modified device, not a novel AI/ML device. The focus is on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, not on proving new clinical performance metrics against defined acceptance criteria.
• The device is a cryo-ablation probe, not AI/ML software. The performance data described is non-clinical bench testing (mechanical reliability, transit, shelf-life, cryogen performance/thermal insulation), which is standard for hardware modifications to medical devices. It does not involve algorithms, human readers, or clinical ground truth in the context of diagnostic or prognostic AI.
• "Acceptance criteria" here refer to regulatory requirements for demonstrating substantial equivalence, not performance metrics. The conclusion states that the modified device is "equivalent to the previously cleared AtriCure cryoICE cryoablation probe (CRYO2) as there is no change to intended use, operating principals, or function of the device." This "equivalency" is the primary acceptance criterion for a 510(k) of this nature.

Based on the provided document, I cannot generate the table or specific details requested because the information simply isn't present, as it pertains to a different type of device and regulatory submission.

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