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Intended Use: The truFreeze® System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196°C, requiring either active or passive venting during surgical procedures.

Indications for Use. VortexTM Radial Spray catheter: The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.

The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus.

The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube.

The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.

The provided text is a 510(k) Premarket Notification for the CSA Medical, Inc. truFreeze® System, specifically the Vortex™ Radial Spray Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device (K171626) by comparing technological characteristics and presenting performance testing results.

Crucially, this document does not contain a typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the format of a clinical trial designed with defined endpoints (like sensitivity, specificity, accuracy) for a diagnostic AI device.

Instead, this submission is for a cryosurgical treatment device, not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating the device's safety and effectiveness compared to a predicate device that performs a similar function.

Based on the provided text, here's an attempt to extract relevant information, adapting to the nature of the device:

1. Table of "Acceptance Criteria" (interpreted as performance specifications/comparisons to predicate) and Reported Device Performance:

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

• Bench Tests: "A number of bench tests were conducted to verify the product design met the predetermined product performance specifications." No specific sample sizes for these tests are mentioned.
• Pre-clinical (GLP Studies): "Three preclinical GLP studies were completed utilizing the Vortex™ Radial Spray catheter in swine." The exact number of swine used is not specified, only the number of studies.
• Clinical Data (Literature/RWD for Predicate Device):
  • Literature: "Three scientific, peer-reviewed literature articles have been published demonstrating the ability of the predicate device (i.e. linear spray) to achieve circumferential freezing of diseased tissue in the esophagus."
  • Patient Count from Literature: "73 patients have been treated with spray LN2 circumferentially since 2012 to ablate BE lesions."
  • Real-World Data (RWD) from Registry: "Real-World Data (RWD) has been extracted from an ongoing prospective, multi-center patient registry."
  • Patient Count from RWD: "Of the 112 patients identified in the registry as having Barrett's Esophagus, 49 of those patients received circumferential ablation."
  • Provenance: No specific country of origin is mentioned for the literature or RWD, but it can be inferred to be from regions where such studies are conducted (likely US/Europe). The RWD is "prospective, multi-center."

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

Not applicable in the context of this submission. This is not an AI diagnostic device requiring expert reading for ground truth establishment. The "ground truth" for this device's performance would be direct measurements (e.g., cooling power, depth of freeze in hydrogel) and histological assessment in animal models. Clinical outcomes cited from literature/RWD would be physician-documented.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study requiring adjudication of expert readings from a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study (MRMC) is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a medical device that performs a physical ablation.

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

Not applicable. This is a physical medical device, not an algorithm. Bench and preclinical data are provided for the device's standalone physical performance.

7. The Type of Ground Truth Used:

• Bench Testing: Engineering specifications and direct physical measurements (e.g., temperature, power density, dimensional measurements).
• Pre-clinical (Swine Studies): Histopathology data (e.g., assessment of lesion size, depth of injury) and survival/adverse event data.
• Clinical Data (from Literature/RWD for predicate): Clinical outcomes (ablation endpoint, adverse events like stricture), and physician observations.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device with a distinct training set. The "training" in this context refers to the development and iterative testing of the device throughout its design process.

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

Not applicable for the reasons stated above.

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The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196℃ requiring either active or passive venting during surgical procedures.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade and/or low grade dysplasia) and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an Artificial Intelligence (AI) or machine learning (ML) device. The document describes a 510(k) premarket notification for the "truFreeze® System," which is a cryosurgical tool.

The document discusses:

• The indications for use for the truFreeze system, including the addition of Barrett's Esophagus with low-grade dysplasia.
• A clinical study conducted to support the effectiveness and safety of the truFreeze system for ablating Barrett's Esophagus with low-grade dysplasia. This is a study of a physical medical device, not an AI/ML algorithm.
• Data on the safety and effectiveness of the device, focusing on patient response (complete eradication of dysplasia - CE-D) and adverse events.
• Comparison to predicate and reference devices to establish substantial equivalence.

Therefore, I cannot extract the information required for the requested table and study details related to an AI/ML device's acceptance criteria and performance as the provided document does not pertain to such a device.

Ask a specific question about this device

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

The truFreeze System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable Spray Kits:
Currently, there are 2 types of spray kits available. One kit is available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting Cryo Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

CryoDecrompression Tube (CDT):
Proposed changes involve the CryoDecrompression Tube (CDT) only. The CDT is a necessary part of the truFreeze Active Venting Kit to suction gas out of the patient when liquid nitrogen is sprayed.

The document provided describes modifications to the truFreeze System, specifically to the CryoDecompression Tube (CDT). The purpose of these modifications is to address user annoyance related to tube kinking and an orange indicator display during use, without changing the intended use or indications for use of the device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC, requiring either active or passive venting during surgical procedures.

Indications for Use: The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

The truFreeze System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console: The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable Spray Kits: Currently, there are 2 types of spray kits available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting CryoDecompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

This 510(k) introduces a third Spray Kit to the truFreeze System, referred to as the Rapid AV Spray Kit. These catheters provided with the proposed truFreeze System are only to be used for active venting procedures and have been modified to shorten the time it takes to pre-cool the catheter so it can achieve frost quicker.

The proposed Rapid AV Spray Kit consists of a carton with five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the Rapid AV Spray Kit includes a carton of five (5) sterile, single-use, dual-lumen Cryo- Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

This document describes the regulatory submission for the truFreeze® System with a new Rapid AV Spray Kit. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K162695). The changes primarily relate to the catheter design of the Rapid AV Spray Kit, which aims to shorten the pre-cooling time for faster frost formation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML performance metrics (e.g., target specificity, sensitivity, or AUC). Instead, the acceptance criteria are implicitly defined by a series of engineering and performance tests, all of which had a "Passed" result. The overall acceptance criterion for the submission is demonstrating substantial equivalence to the predicate device.

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

• Test Set Sample Size: "Sample size required for each test was guided by the risk index as determined by the DFMEA. Sample size considered both attribute data and variable data." However, specific numerical sample sizes for each test are not provided in the document.
• Data Provenance: The tests are described as "bench data collected" for the truFreeze System. This indicates that the data was generated in a controlled laboratory or testing environment, likely in the US (where the company is based). It is prospective data derived from product testing, not retrospective patient data.

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 applicable as the document describes a medical device (cryosurgical unit) performance validation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from images or clinical data. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.

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

This information is not applicable 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 as the document is about a hardware medical device (cryosurgical unit), not an AI/ML algorithm or system that assists human readers/clinicians.

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

This information is not applicable as the document is about a hardware medical device, not an AI/ML algorithm.

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

The "ground truth" for the tests described is the engineering specifications, design requirements, and regulatory standards for a medical device. For example, for "Measure Working Length," the ground truth is the specified design length. For "Biocompatibility," the ground truth is meeting established biocompatibility standards.

8. The sample size for the training set:

This information is not applicable as the document is about a hardware medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reasons as point 8.

In summary:

This document is a 510(k) summary for a hardware medical device (cryosurgical unit), not an AI/ML-driven device. Therefore, many of the requested categories pertaining to AI/MRMC studies, expert adjudication, or training/test sets for algorithms are not relevant to the information provided. The acceptance criteria are based on successful completion of a comprehensive set of engineering, mechanical, and safety tests, demonstrating that the modified device (Rapid AV Spray Kit) maintains the safety and effectiveness of its predicate, leading to a determination of substantial equivalence.

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The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction. The console is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised.

Disposable spray kit:
There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use. The disposable kit is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised.

Although the provided text heavily details the device and its testing, it does not contain acceptance criteria in the format of a table with specific metrics and thresholds. Instead, it presents a clinical study's results with the claim of "substantial equivalence" to predicate devices. Therefore, I cannot construct the requested table of acceptance criteria and reported device performance directly from the text.

However, I can extract and structure all other requested information about the study that proves the device meets its expanded indications.

Here's an analysis of the provided text, addressing your points:

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

The document does not provide a table of pre-defined acceptance criteria with specific numerical thresholds. It relies on a "substantial equivalence" argument, comparing the device's performance (safety and efficacy) to existing predicate devices and literature.

Implicit "Performance Metrics" and Reported Performance (derived from results):

Note on "Acceptance Criteria": The concluding statement in the "Discussion" section mentions: "This success rate is comparable to the success rate for the Barrx System and the Coldplay CryoBalloon™ Focal Ablation System among all phenotypes of BE patients, ranging from no dysplasia to early adenocarcinoma and across 3 different ablation doses." This suggests that the "acceptance criterion" was achieving a comparative efficacy and safety profile to these established devices, rather than a fixed numerical threshold.

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

• Test Set (Clinical Study Population):
  • Safety Population: 111 patients
  • Efficacy Population: 46 patients (a subset of the safety population, meeting specific inclusion/exclusion criteria for BE-HGD)
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the FDA submission suggests it's likely a US-based study given the regulatory context.
  • Retrospective or Prospective: "This post-marketing registry prospectively collected data on patients treated with the FDA-cleared cryotherapy device (truFreeze® System)." So, it was prospective.

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

The document does not specify the number or qualifications of experts used to establish the ground truth (e.g., histology results for Barrett's Esophagus with high-grade dysplasia). It merely states that there were "pre-therapy and post-therapy histology."

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

The document does not specify any adjudication method for the test set's ground truth assessment.

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 section is not applicable. The device is a cryosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance was not conducted.

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

This section is not applicable. The device is a physical surgical intervention tool, not an algorithm. Its performance is measured by clinical outcomes (ability to ablate lesions, safety profile), not by an algorithm's standalone performance.

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

The primary ground truth for efficacy was established through histology (pathology): "Patients without a pre-therapy and post-therapy histology" was an exclusion criterion for the efficacy population. The outcome measured was "Complete Eradication of Dysplasia (CE-D)," which relies on pathological confirmation.

8. The sample size for the training set

This section is not applicable. The truFreeze System is a cryosurgical device, not a machine learning algorithm that requires a "training set." The clinical data presented is for validation of its expanded indications.

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

This section is not applicable as there was no "training set" for an algorithm.

Ask a specific question about this device

Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC requiring either active or passive venting during surgical procedures.

Indications for Use: The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console: The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency stop button to be used in the event of user or technical malfunction.

Disposable spray kit: There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with a carton of five (5) individually packaged sterile. single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use. There is a proposed change to the active venting disposable spray kit. The proposed change reduces the Outside Diameter (OD) of the CDT from 20 French to 16 French without changing performance specifications, adds additional Marker Bands to the 16 French version of the CDT and makes the 16 Fr CDT and 20 Fr CDT available as a 5-pack box in addition to as a part of the active venting kit.

The provided text describes a 510(k) premarket notification for the truFreeze System, focusing on minor modifications to an already cleared device. Therefore, a full-scale clinical study with extensive acceptance criteria, ground truth establishment, and multi-reader comparative effectiveness studies as typically seen for novel diagnostic AI devices, is not applicable here.

Instead, the submission details a verification and validation process for specific physical changes to a component of the device (the Cryoablation Drug Delivery Tube, CDT). The "acceptance criteria" are essentially the performance specifications for these modified components.

Here's an analysis based on the provided text, structured to address your points where applicable, and noting when information is not present due to the nature of this submission:

Acceptance Criteria and Device Performance

The acceptance criteria are the "Test Specifications" and the "Reported Device Performance" is the "Result" column.

Note: (DV) indicates Design Validation Testing.

Study Details Addressing Your Points:

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 does not specify the sample sizes (e.g., number of CDTs tested) for the individual mechanical and material tests. These are typically internal verification tests.
• For the Design Validation tests:
  • User Survey / Simulated Use (PRO-R-17-00193): The sample size for the user survey/simulated use is not explicitly stated. It would likely involve a small number of users.
  • Animal Study (PRO-R-17-00198): The sample size (number of animals) for the animal study is not explicitly stated.
• Data provenance (country of origin, retrospective/prospective) is not mentioned, as these are internal design control activities for a physical device modification.

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)

• For the physical and functional tests, "ground truth" is established through engineering and material science standards and measurements. There are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy here.
• For the "User Survey / Simulated Use" and "Animal Study," the "experts" would be the participants in the survey/study and the veterinarians/surgeons conducting the animal procedures. Their number and specific qualifications are not detailed in this summary.

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

• Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic accuracy studies where there's subjectivity (e.g., interpreting medical images). This is not applicable here as the tests are for physical and functional properties of a medical device component. The "pass" results imply that the device met the predefined specifications, which is a form of objective assessment.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The truFreeze System is a cryosurgical tool, and this submission concerns a minor physical modification to an existing component, not an AI diagnostic algorithm.

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

• No, a standalone algorithm performance study was not done. This device is a physical cryosurgical system and does not involve a standalone algorithm for diagnostic or prognostic purposes.

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

• The ground truth for the physical and functional tests is based on engineering specifications, material science properties, and direct objective measurements.
• For the "User Survey / Simulated Use," the ground truth would be the subjective feedback and observed performance from the users.
• For the "Animal Study," the ground truth would be the physiological outcomes and observations documented during and after the animal procedures.
• None of these involve pathology or long-term outcomes data related to disease diagnosis, as the device is a therapeutic (surgical) tool.

8. The sample size for the training set

• There is no training set in the context of this 510(k) submission. Training sets are used for machine learning algorithms. This submission is for a physical medical device.

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

• Not applicable, as there is no training set.

Ask a specific question about this device

Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC requiring either active or passive venting during surgical procedures.

Indications for Use: The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, and general surgery, to ablate benign and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console: The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable spray kit: There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use.

This document describes a 510(k) premarket notification for the truFreeze® System (K161557), which is a cryosurgical unit. The submission focuses on modifications to the predicate device (K160273) and assesses if these changes introduce new questions of safety or effectiveness. The core of the evaluation is demonstrating that the modified device remains substantially equivalent to its predicate.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly defined as successful completion of various verification and validation tests, ensuring that the software and hardware modifications do not negatively impact the code, system performance, or functionality, and do not raise new questions of safety or effectiveness.

The "Verification Testing Summary Table" provides a good overview of the tests performed and their outcomes:

Reported Device Performance Summary: All tests, including software regression, software integration, system functional, and hardware stress tests, were successfully completed with a "Pass" result for the proposed truFreeze System, demonstrating that the modifications did not negatively affect the device's safety or functionality.

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

• Software Testing:
  • Regression Tests: The document states that "Regression testing was successfully completed and all tests passed," implying 100% pass rate for the tested code components (BIT, Fill, Procedure, Data, Service, Admin, Home Codes). The exact number of individual test cases within these categories is not specified.
  • Integration Tests: "All integration tests were completed and were considered acceptable." Again, the specific number of test cases or scenarios is not provided.
  • Unit Tests: "Unittests were used to verify the BIT and code revision updates... only one run on one console is required for this testing." This indicates a single run for these specific unit tests.
• Hardware and System Functional Testing:
  • Hardware Stress Testing: "Three production equivalent systems underwent stress testing."
  • System Functional Tests: "System functional testing was performed on three production consoles."
• Data Provenance: The testing appears to be internal to CSA Medical, Inc. or its contractors. No information is provided about the country of origin of data, or whether it was retrospective or prospective in the sense of patient data. This is a simulated/laboratory testing environment, not clinical data provenance.

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 type of information is not applicable to the testing described in this document. The truFreeze® System is a cryosurgical tool, and the testing outlined is focused on verifying software and hardware functionality and safety of modifications, not diagnostic accuracy requiring expert panel review. The "ground truth" for these tests would be the expected behavior of the system as defined by its design specifications.

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

This is not applicable as the testing primarily involves automated software verification, hardware stress tests, and functional checks against predetermined specifications, not subjective interpretation of results by multiple human adjudicators. The evaluation outcome (Pass/Fail) is based on objective criteria related to system performance and behavior.

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 is not applicable. The truFreeze® System is a physical medical device (cryosurgical unit) and its modifications are for internal system functionality, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists interpreting images). Therefore, an MRMC study or assessment of AI assistance effect size is irrelevant here.

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

This is not applicable in the context of an "algorithm only" performance as it relates to AI/diagnostic algorithms. The device itself is a standalone system with specific functionalities, and the testing implicitly evaluates its standalone performance relative to its design specifications. However, this is not a device whose performance would be measured in terms of classification, detection, etc., like an AI algorithm.

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

The "ground truth" for the tests described is the expected behavior and performance of the device's software and hardware as defined by its design specifications and requirements. For example:

• For software regression, the ground truth is that the updated code should produce the same correct output as the previous version for existing functionalities.
• For integration tests, the ground truth is that the software should correctly detect errors and display messages as designed.
• For hardware stress tests, the ground truth is that the hardware modifications should withstand simulated stress without failure.

8. The sample size for the training set:

This is not applicable. The document describes verification and validation of modifications to a physical medical device and its embedded software, not the development or training of a machine learning or AI model. Therefore, there is no "training set" in this context.

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

This is not applicable as there is no training set for an AI model. The ground truth for the testing was established through design specifications and requirements for the device's intended functionality and safety.

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The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.

The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable spray kit:
There are no proposed changes to the disposable spray kit. There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use.

This document describes the 510(k) premarket notification for the truFreeze® System. The information provided heavily focuses on the mechanical modifications and testing rather than clinical performance for diagnostic or prognostic purposes, which the requested questions seem to imply.

Based on the provided text, the device is a cryosurgical unit, not an AI-based diagnostic tool. Therefore, many of the requested elements (like MRMC studies, training sets, ground truth establishment by experts, etc.) are not applicable or described in this type of submission.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not present or not relevant to this type of device and submission.

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

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

• Test Set Sample Size: 4 samples of the Transfer Interface Assembly (2 at the low end of the depth specification, 2 at the high end of the depth specification). Each sample was subjected to 6 fill cycles for a total of 24 trials.
• Data Provenance: Not specified, but implied to be internal verification testing conducted by CSA Medical. No country of origin or retrospective/prospective nature is mentioned, but it's part of device verification.

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

• Not applicable/Not provided. The ground truth here is a physical characteristic (absence of leaking) observable during mechanical testing, not a clinical diagnosis or interpretation requiring expert consensus.

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

• Not applicable/Not provided. Adjudication methods are typically for subjective assessments (e.g., image interpretation), whereas this test is for a directly observable physical failure (leaking).

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 cryosurgical unit, not an AI-assisted diagnostic device for human readers.

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

• Not applicable. This device is a cryosurgical unit, not an algorithm.

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

• The "ground truth" for this engineering test was the direct observation of "no leaking" during multiple fill cycles, which is a physical performance characteristic of the device's redesigned components.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model that requires a training set. The descriptions are for modifications to existing hardware components.

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

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

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The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.

The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart, Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable spray kit:
There are no proposed changes to the disposable spray kit. The truFreeze disposable spray kit continues to consist of five (5) individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the onboard suction system.

The provided document describes a 510(k) premarket notification for a medical device called the truFreeze® System (K150920). This submission is for a software modification to an existing device (K143625). The document focuses on demonstrating that the updated device is substantially equivalent to its predicate.

Here's an analysis based on your request, extracting the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, it describes various tests performed to ensure the software modification did not negatively impact the device and added new safety features. The "acceptance criteria" can be inferred as successful completion of these tests without introducing new safety or performance concerns.

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

The document states:

• "Two sets of testing were performed for each of the load packages available to customers."
• "Three consoles were successfully loaded with the respective load packages."

This implies a very small sample size for the "test set" (e.g., 3 consoles). The data provenance is prospective in the sense that the testing was conducted specifically for this 510(k) submission on the modified device. The country of origin of the data is not explicitly stated, but the company is based in Lexington, Massachusetts, USA.

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

This information is not provided in the document. The testing described is primarily focused on software and system functionality, not on diagnostic accuracy requiring expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant for the type of software/system functional testing described. The "ground truth" for these tests would be the expected software behavior and system response to various inputs and error conditions.

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, an MRMC comparative effectiveness study was not done. The device is a cryosurgical tool, and the submission concerns a software update to improve safety by detecting communication errors, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

This is a standalone assessment of the software's functionality and its impact on the system. The "algorithm" (software control) was tested for its ability to detect and respond to communication interruptions. The performance is assessed without a human-in-the-loop in the context of the software's detection capability. However, the overall device (truFreeze® System) is a tool used by a clinician, so there is always a human-in-the-loop for its clinical application.

7. The Type of Ground Truth Used

The ground truth used for the software and system testing was based on:

• Software performance specifications: The expected design and functionality of the software.
• Intended system behavior: How the system is designed to operate, especially its response to error conditions (e.g., closing valves upon error detection).
• Predicate device's established performance: Ensuring the modified device maintained equivalence to the predicate for unchanged aspects.

It is not expert consensus, pathology, or outcomes data, as these are not relevant to the described software modification.

8. The Sample Size for the Training Set

The document describes software updates and validation, not a machine learning model that requires a "training set." Therefore, a training set sample size is not applicable.

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

As there is no training set for a machine learning model, this question is not applicable. The "ground truth" for the software development and testing was established through engineering specifications and design requirements.

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The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.

The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of (1) a console and (2) a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing. filling, pressure. cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable spray kit:
The truFreeze disposable spray kit consists of 5 individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer.) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing.). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for AI/ML medical devices. The document is a 510(k) premarket notification for a cryosurgical unit, which is a hardware device, not an AI/ML diagnostic or prognostic tool.

The text does mention "Testing" but states: "The truFreeze System was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, software testing, animal testing, biocompatibility and sterilization testing. Since the change does not involve any changes to the hardware or software of the truFreeze system, no additional testing was conducted to support demonstration of substantial equivalence in performance of the truFreeze system to its predicate device."

This indicates that the document is focused on demonstrating substantial equivalence to a predicate device based on minor labeling changes, not on establishing performance criteria for a new AI/ML algorithm or device.

Therefore, I cannot provide the requested information in the specified format from this text.

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