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510(k) Data Aggregation
(106 days)
Atricure Cryo Module System; cryoICE cryoablation probe
AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation probes.
cryolCE™ Indication for Use Statement: AtriCure's cryoICE™ 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 AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to the AtriCure cryo-ablation probes. The AtriCure's cryo-ablation probe (CRYO2) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or ACC2 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The cryolCE™ probe can also be used to temporarily ablate peripheral nerves.
The information provided in the document focuses on the substantial equivalence of the AtriCure Cryosurgical System to predicate devices, rather than establishing specific acceptance criteria and detailed study results for a new medical device's performance. The document describes the system and its indications for use, and then lists various non-clinical bench tests that were conducted. However, it does not provide the specific acceptance criteria for these tests, nor does it present detailed performance data that would allow for a direct comparison against such criteria. The "Results" column in the "Non-clinical Bench Testing" table simply states "Passed" for all tests, without quantitative or qualitative metrics.
Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and sample sizes for effectiveness studies (especially related to human-in-the-loop or standalone AI performance) cannot be extracted from the provided text. This document is a 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed devices rather than presenting novel performance studies in the way a PMA application might.
Based on the provided text, here is what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria for the various tests. The 'Performance Data' section only lists the types of tests performed and states "Passed" as the result, without providing specific metrics or targets that define "Passed".
| Acceptance Criteria (Inferred/Not Provided) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | "Passed" for all listed Non-clinical Bench Tests |
| CRYO2 Comparison testing (Bench testing) | Passed |
| CRYO2 Mechanical Reliability (Bench testing) | Passed |
| CRYO2 Performance testing (Bench testing) | Passed |
| CRYO2 Acute Animal Verification Lab (Bench testing) | Passed |
| CRYO2 ASTM Testing (Bench testing) | Passed |
| Evaluation Against Similar Product (Bench testing) | Passed |
| ACM Software Validation (Software testing) | Passed |
| ACM Display Board Verification (Bench testing) | Passed |
| ACM Controller Board Verification (Bench testing) | Passed |
| Handpiece Connector Board Verification (Bench testing) | Passed |
| ACM Power Board Verification (Bench testing) | Passed |
| ACM Reliability Testing (Bench testing) | Passed |
| ACM Simulated Use (Bench testing) | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for any of the non-clinical bench tests or studies. It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective nature). The "Acute Animal Verification Lab" test implies animal data, but no specifics 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. Given that the studies are non-clinical bench tests and a single "Acute Animal Verification Lab" test, it's unlikely that 'experts for ground truth' in the context of clinical interpretation (like radiologists) would be relevant. The "ground truth" for these types of engineering tests would typically be established by established test methodologies and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 such study is mentioned or implied. The device described, the AtriCure Cryosurgical System, is a cryo-ablation device, not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of "ground truth" used for any of the tests. For bench testing, the "ground truth" would typically be defined by engineering specifications, physical measurements, and adherence to validated test protocols. For the "Acute Animal Verification Lab," this would involve physiological measurements and potentially histological examination, but no specifics are provided.
8. The sample size for the training set
Not applicable. The device is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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(14 days)
ATRICURE CRYO MODULE SYSTEM
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a nonsterile, reusable device-used with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or AtriCure ACC2 (Frigitronics CCS-200) Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
This looks like a 510(k) summary for a medical device (AtriCure Cryo Module System), not a study demonstrating that a device meets acceptance criteria. A 510(k) submission generally aims to prove "substantial equivalence" to a predicate device, rather than meeting specific performance acceptance criteria through clinical or rigorous standalone studies as you might see for novel devices or AI/ML-based systems.
Here's a breakdown based on the provided text, indicating what information is not present because this is a substantial equivalence submission, not a study demonstrating performance against acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable - This submission focuses on substantial equivalence to predicate devices rather than specific performance acceptance criteria for the modified device. | Not Applicable - No specific performance metrics or acceptance criteria are provided in the document. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) for a modified cryosurgical system seeking substantial equivalence. The document describes product testing for conformance to product specifications, design verification and validation, software validation, and electrical safety testing. These are engineering and safety tests, not clinical or performance studies with a "test set" in the context of AI/ML or comparative clinical device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert consensus are relevant for studies evaluating device performance against a clinical "truth," often in diagnostic or prognostic AI/ML applications. This document concerns a physical cryosurgical system and its modifications.
4. Adjudication method for the test set
Not applicable. No test set or clinical performance adjudication is mentioned.
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. An MRMC study is relevant for evaluating diagnostic performance, particularly for AI-assisted image interpretation. This device is a cryosurgical system, not a diagnostic AI tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical cryosurgical device, not an algorithm. The testing mentioned (design verification, software validation, electrical safety) is for the device's functionality and safety, not for standalone algorithmic performance.
7. The type of ground truth used
Not applicable. No clinical ground truth (e.g., pathology, outcomes data) is mentioned as part of the submission for validating the modified device's performance. The "truth" here relates to compliance with engineering standards and existing predicate device characteristics.
8. The sample size for the training set
Not applicable. Training sets are relevant for AI/ML models. This document describes a physical medical device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary based on the provided text:
The document describes a 510(k) premarket notification for the AtriCure Cryo Module System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K111042, K112072, and K121507) for the cryosurgical treatment of cardiac arrhythmias.
The "study" described is a series of product tests to evaluate conformance to product specifications and substantial equivalence, including:
- Design verification and validation
- Software validation
- Electrical safety testing
These tests were performed to show that the modified device is substantially equivalent and conforms to international standards and device specifications. The standards referenced include:
- UL 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
The basis for substantial equivalence relies on similarities to predicate devices in:
- Intended use
- Operating principle
- Fundamental scientific technology
- Cryo-ablation probes used
- Materials used
- Module design
- Electronic solenoid valves
The document does not contain information about clinical trials, performance studies with specific acceptance criteria, or the use of AI/ML algorithms that would necessitate ground truth establishment, expert adjudication, or MRMC studies. The focus is on demonstrating that the modified device maintains the safety and effectiveness characteristics of its predicates through engineering and safety testing.
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(16 days)
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Crvo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or crvolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
The provided text describes the AtriCure Cryo Module System, a Class II medical device intended for the cryosurgical treatment of cardiac arrhythmias. However, the document focuses heavily on the regulatory approval process (510(k) submission) and substantial equivalence to a predicate device. It does not contain specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for a device that relies on such metrics, nor does it describe a study designed to validate such performance.
Instead, the "Testing" section refers to product testing for conformance to specifications, substantial equivalence, and international standards. This suggests that the device's acceptable performance is defined by its adherence to engineering and safety standards, rather than clinical performance metrics typically associated with AI-driven diagnostic or prognostic devices.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical cryosurgical device rather than an AI/ML-based system.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from submission) |
|---|---|
| Conformance to Product Specification | "Appropriate product testing was conducted to evaluate conformance to product specification." |
| Substantial Equivalence | "The modified AtriCure Cryo Module System proposed in this submission is considered substantially equivalent to the AtriCure Cryo Module System cleared via K112072." |
| International Standards Compliance | Demonstrated conformance to standards including: |
- UL 60601-1 (Medical Electrical Equipment Safety)
- EN 60601-1 (Medical Electrical Equipment Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- EN 55011 (Electromagnetic Disturbance Characteristics)
- ISTA Procedure 3A (Packaged Product for Parcel Delivery Shipment)
- ASTM F882-84 (Cryosurgical Medical Instruments Performance and Safety)
- FDA Guidance for Software Contained in Medical Devices (if applicable) |
| Biocompatibility | "Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure crvo-ablation probes (Cryo1 and cryolCE)." (Note: ACM is not intended for patient contact). |
| Software Validation | "Software validation, etc. were completed." |
| Transit Testing | "Transit testing... were completed." |
| Design Verification and Validation | "Design verification and validation... were completed." |
Note on Acceptance Criteria: For this type of device (a cryosurgical system), acceptance criteria are primarily related to safety, electrical performance, material compatibility, and manufacturing quality, rather than diagnostic or predictive accuracy metrics. The 510(k) process primarily assesses "substantial equivalence" to a predicate device, meaning it performs similarly and is as safe and effective.
2. Sample size used for the test set and the data provenance
Not applicable. The document describes engineering and regulatory testing, not a clinical study involving a "test set" of patient data for performance evaluation in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of "ground truth" establishment by experts in the context of performance metrics for an AI/ML system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not an AI/ML system requiring adjudication of results based on a test set.
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 a physical surgical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of AI/ML performance. The "ground truth" for this device's approval relates to its adherence to engineering specifications, safety standards, and performance benchmarks established for the predicate device.
8. The sample size for the training set
Not applicable. This device does not use a training set as it is not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set or ground truth in the AI/ML context.
Summary regarding AI/ML context: This 510(k) submission describes a traditional Class II medical device (a cryosurgical system) and its regulatory path. It does not involve artificial intelligence or machine learning, and thus the acceptance criteria and study descriptions are focused on engineering, safety, and substantial equivalence rather than performance metrics typically associated with AI/ML systems.
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(14 days)
ATRICURE CRYO MODULE SYSTEM
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
The provided text describes the AtriCure Cryo Module System (ACM, Cryo1, and cryolCE), which is intended for cryosurgical treatment of cardiac arrhythmias. However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI-powered device are not applicable or cannot be extracted from this document, as it describes a non-AI medical device and its regulatory submission.
Here's an attempt to answer the questions based only on the provided text, with explicit notes about what information is missing or not relevant for this type of submission:
Acceptance Criteria and Device Performance for AtriCure Cryo Module System
This 510(k) submission focuses on demonstrating substantial equivalence of the AtriCure Cryo Module System to its predicate device (AtriCure Cryo Module System [K111042]). As such, the "acceptance criteria" are primarily related to conforming to product specifications, relevant safety standards, and demonstrating equivalent performance characteristics to the predicate device, rather than specific clinical performance metrics with predefined thresholds typical for novel AI/ML device evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on 510(k) summary interpretation) | Reported Device Performance (based on 510(k) summary) |
|---|---|
| Safety: Conformance to electrical safety standards (e.g., UL 60601-1, EN 60601-1) | Testing completed; indicated conformance to product specifications and international standards. |
| Electromagnetic Compatibility: Conformance to EMC standards (e.g., IEC 60601-1-2, EN 55011) | Testing completed; indicated conformance to product specifications and international standards. |
| Material Biocompatibility: Materials safe and suitable for intended use, biocompatibility of probes (ISO 10993-1) | "All materials used in the manufacture of the AtriCure Crvo Module System are safe and suitable for their intended use... Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure cryo-ablation probes." |
| Packaging/Transit Safety: Conformance to transit testing standards (e.g., ISTA Procedure 3A) | Testing completed; indicated conformance (transit testing was completed). |
| Cryosurgical Performance: Conformance to cryosurgical instrument standards (e.g., ASTM F882-84) | Testing completed; indicated conformance to product specifications and international standards. |
| Software Validation: Conformance to FDA Guidance for Software in Medical Devices | Software validation completed. |
| Substantial Equivalence: Equivalent intended use, method of operation, construction, and materials to predicate device. | "The AtriCure Cryo Module System is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products." |
| General Product Specifications: Conformance to internal design specifications. | "Appropriate product testing was conducted to evaluate conformance to product specification..." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/not provided in the context of this 510(k) submission. The testing described primarily involves bench comparison testing, transit testing, electromagnetic compatibility, design verification, and software validation of a physical electro-mechanical medical device, not a data-driven AI/ML system tested on a clinical "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. Ground truth in the context of clinical data for AI/ML models is not relevant to this submission for a hardware medical device. The "ground truth" for this device would be its ability to perform its intended cryoablation function and meet engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies to establish a consensus ground truth from expert readers for a dataset, which is not described 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
This information is not applicable/not provided. An MRMC study is designed for evaluating the impact of AI on human reader performance, which is not relevant for this non-AI medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is not an algorithm; it is a physical cryosurgical system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not refer to "ground truth" in the manner relevant to AI/ML devices. For this device, the "truth" is established through:
- Conformance to engineering specifications and design validation.
- Compliance with safety and performance standards (e.g., UL, EN, IEC, ASTM).
- Demonstration of biocompatibility (ISO 10993-1).
- Proof of functional performance in bench testing.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As there is no training set, there is no ground truth to establish for one.
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(41 days)
ATRICURE CRYO MODULE
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)—a non-sterile, reusable device-used with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to a cryosurgical handpiece to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias.
Here's an analysis of the provided text regarding the AtriCure Cryo Module, focusing on the acceptance criteria and study details:
Analysis of Acceptance Criteria and Study Information for AtriCure Cryo Module (K111042)
Based on the provided 510(k) summary, the AtriCure Cryo Module is a Class II device intended for the cryosurgical treatment of cardiac arrhythmias. The submission primarily relies on demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Overall) | Device is substantially equivalent to predicate devices. | "The AtriCure Cryo Module is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products." |
| Conformance to Product Specifications | Device meets its defined product specifications. | "Appropriate product testing was conducted to evaluate conformance to product specification..." |
| Bench Comparison Testing | Performance comparable to predicate devices in bench tests. | "Bench comparison testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific metrics or thresholds for comparison are not provided in the summary.) |
| Transit Testing | Device withstands transportation stresses. | "Transit testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific tests or outcomes are not provided in the summary.) |
| Electromagnetic Compatibility (EMC) | Device meets EMC standards. | "Electromagnetic compatibility...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific standards or test results are not provided in the summary.) |
| Reliability | Device operates reliably over time. | "Reliability, reliability testing...were completed to show that the ACM is substantially equivalent and in conformance international standards and device specifications." (Specific reliability metrics, duration, or outcomes are not provided in the summary.) |
| Conformance to International Standards | Device adheres to relevant international standards. | "...in conformance international standards and device specifications." (Specific standards are not listed in the summary, but common ones for medical devices would include those related to electrical safety, quality management, etc.) |
| Materials Suitability | Materials are appropriate for intended use. | "All materials used in the manufacture of the AtriCure Cryo Module are suitable for their intended use and suitable for use with pressurized nitrous oxide." (This is a statement of suitability rather than a specific test outcome, implying internal material qualification presumably met prior established criteria.) |
| Safety (No Patient Contact) | Device has no direct patient contact. | "The AtriCure Cryo Module is not intended for patient contact." (This is a design characteristic that influences the level of safety testing required, rather than a test result. It implicitly means that acceptance criteria related to biocompatibility for direct patient contact were not applicable.) |
| Intended Use (Cryosurgical Treatment) | Device effectively performs cryosurgery. | "The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias." (The "substantially equivalent" assertion implies that its ability to perform cryosurgery is comparable to the predicate devices, which are already cleared for this purpose. No specific performance metrics for cryosurgery (e.g., lesion depth, temperature achieved) are provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in the context of clinical data or patient samples. The testing described ("bench comparison testing, transit testing, electromagnetic compatibility, reliability") appears to refer to engineering and functional verification/validation, rather than a clinical study with a patient test set.
- Data Provenance: Not applicable in the context of a clinical test set, as no clinical studies with patient data are described for the primary submission. The data provenance is from internal engineering and bench testing conducted by AtriCure, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the provided 510(k) summary does not describe a clinical study requiring expert-established ground truth for a test set (e.g., image interpretation, disease diagnosis). The testing performed is primarily focused on engineering and functional aspects of the device.
4. Adjudication Method for the Test Set:
- This question is not applicable as no clinical test set requiring adjudication (e.g., for diagnostic accuracy or outcome assessment) is described.
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 substantial equivalence based on engineering and bench testing, not clinical comparative effectiveness with human readers or AI assistance. No mention of AI is made in the document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. The AtriCure Cryo Module is a physical medical device (cryosurgical system), not an algorithm or AI software. Therefore, "standalone" algorithm performance is not relevant to this submission.
7. The Type of Ground Truth Used:
- For the engineering and bench testing described, the "ground truth" would be defined by engineering specifications, industry standards, and the performance characteristics of the predicate devices. For example:
- For EMC, the ground truth would be conformance to specific electromagnetic compatibility standards.
- For reliability, the ground truth would be predetermined failure rates or operational lifespan targets.
- For bench comparison, the ground truth would be the established performance parameters of the predicate devices.
- For material suitability, the ground truth would be material specifications and safety data for use with nitrous oxide.
8. The Sample Size for the Training Set:
- This question is not applicable as there is no mention of an algorithm or AI model requiring a training set in this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no training set for an algorithm or AI model mentioned in this 510(k) submission.
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