Search Results

The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-the-wire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise Multi-Use RF Adapter Cable (packaged separately – Model CW-1001) and a commercially available Electrosurgical Pencil.

This 510(k) clearance letter details the substantial equivalence of new models of the CrossWise RF Transseptal Access System to a previously cleared predicate device. It specifically states that the new models have minor modifications and leverage most of the performance data of the predicate device.

Therefore, the acceptance criteria and study details discussed below refer to the bench testing conducted for these minor modifications, as this is the only performance data explicitly mentioned for the subject device. The document does not contain information about clinical studies with human participants, expert ground truth adjudication, or AI performance, as it is related to a medical device's physical and functional equivalence, not an AI or diagnostic tool.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The provided 510(k) clearance letter details the acceptance criteria and the non-clinical performance data for the CrossWise RF Transseptal Access System line extensions (Models CW-1085C, CW-1085V, and CW-1013F). The study conducted to prove the device meets these criteria was a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

The letter explicitly states that the new models leverage most of the performance data of the predicate device. The following table summarizes the specific tests conducted for the minor modifications of the new models and the implied performance criteria based on the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated in terms of a number of devices or units. The testing refers to "minor modifications" to the dilator hub and compatibility with new introducer sheaths. For bench tests like these, a statistically representative sample size would have been used for each test (e.g., n=3, 5, or 10 units per test configuration), but the exact numbers are not provided.
• Data Provenance: The data is non-clinical bench testing conducted by the manufacturer, Circa Scientific, Inc. The location of the testing is not specified, but it would have been conducted in a laboratory setting under controlled conditions. This is not retrospective or prospective in the clinical sense, as it does not involve patient data.

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

• Not applicable. This document describes the clearance of a medical device (a transseptal access system), not an AI or diagnostic tool that relies on expert interpretation of data to establish ground truth. The acceptance criteria are based on objective engineering and performance standards demonstrated through bench testing.

4. Adjudication Method for the Test Set

• Not applicable. As this is non-clinical bench testing of a physical medical device against engineering standards, there is no expert adjudication process in the manner of medical image interpretation or clinical outcomes. Test results would have been analyzed and verified by qualified engineering and quality personnel.

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

• No. An MRMC study is typically conducted for diagnostic devices or AI systems where human readers interpret patient cases. This clearance is for a physical medical device used in interventional cardiology.

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, so the concept of standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering and Performance Standards: The "ground truth" for the bench tests would have been established by predefined engineering specifications, internationally recognized standards (e.g., ISO 80369-7, ISO 10993-1, ISO 11070-1), and the performance characteristics of the predicate device. For example, the ground truth for "Dilator Leak Test" would be "no leakage observed under specified pressure," and for "ISO 80369-7 Luer Testing" would be "full compliance with all requirements of the standard."

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The PeriCross™ Epicardial Access Kit is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies in adult patients.

The PeriCross™ Epicardial Access Kit is designed to provide safe and reliable access to the epicardium. The kit is supplied sterile and is designed to deliver a .018" guidewire to the pericardial space.

The PeriCross™ Epicardial Access Kit consists of the following components:

• One (1) PeriCross™ Tunneler Assembly
• One (1) PeriCross™ Access Device
• One (1) Guidewire – 0.018" OD × 80cm Long
• One (1) Coaxial Introducer – 5F × 18cm

The PeriCross™ Tunneler assembly consists of a cannula and a removable blunt obturator that, together, create an atraumatic assembly, which is utilized to gain access to the pericardium via the subxiphoid approach. When the tip of the PeriCross™ Tunneler Assembly reaches the pericardial surface, the obturator is removed, leaving a path to the pericardial surface through the open cannula. The PeriCross™ Access Device is inserted into the cannula and secured via a snap connection. The PeriCross™ Access Device incorporates a thumb slide that deploys tines to engage and retract the pericardium away from the surface of the epicardium. The space created allows for the deployment of an integrated 21ga needle to puncture the pericardium in a location away from the heart. The PeriCross™ Access Device prevents inadvertent deployment of the needle and retraction of the tines via an interlock mechanism. A .018" guidewire can then be deployed through the PeriCross™ Access Device. A 5F x 18cm coaxial introducer is provided to allow for subsequent dilation and guidewire exchange to a .032" guidewire.

The provided FCC 510(k) clearance letter and summary for the PeriCross™ Epicardial Access Kit discuss its design, comparison to predicate devices, and general non-clinical and clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific details required to fully address all aspects of acceptance criteria and the study that proves the device meets them as requested in the prompt.

Specifically, the document states:

• "The primary efficacy endpoint of achieving guidewire access to the pericardial space using the PeriCross Epicardial Access Kit, confirmed by standard X-ray technique, was achieved in all subjects."
• "There were two non-serious cardiac perforations (≤ 80 mL of bleeding) and one serious cardiac perforation (≥ 80 mL of bleeding), with no surgery required for closure."

This information is related to the outcome of the study, but it does not provide a table of acceptance criteria (e.g., minimum success rate, maximum complication rate) or explicitly state how these specific results meet predefined acceptance criteria. It also lacks details about the test set, ground truth experts, adjudication, MRMC studies, or training set specifics.

Therefore, I will provide a response based on the inference of typical medical device study reporting and what might be implied by the passing results, acknowledging the limitations of the provided text.

Acceptance Criteria and Study Proving Device Performance: PeriCross™ Epicardial Access Kit

Based on the provided 510(k) summary, the primary efficacy endpoint for the PeriCross™ Epicardial Access Kit was the successful achievement of guidewire access to the pericardial space. Safety endpoints related to cardiac perforations were also assessed. While explicit numerical acceptance criteria are not detailed in the provided document, the successful clearance implies that the study results met the FDA's requirements for demonstrating substantial equivalence and safety/efficacy.

Inferring from the "Pass" results and the successful clearance, the implied acceptance criteria were met.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula (K241414) to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the CrossWise™ RF Transseptal Cannula to facilitate septal puncture. The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory. The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels. Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU. The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

The provided document is a 510(k) Pre-Market Notification for a medical device called the "CrossWise™ Multi-Use RF Adapter Cable." This document primarily focuses on demonstrating the substantial equivalence of the new device to a previously cleared predicate device, especially regarding its reusability and materials.

The request asks for information typically found in studies validating an AI/ML medical device, specifically regarding acceptance criteria and performance data for an algorithm. However, this 510(k) submission does not describe an AI/ML device or algorithm. Instead, it describes a physical medical device (an adapter cable) and the bench testing performed to ensure its safety and effectiveness, particularly its reprocessing capabilities.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," and "sample size for the training set," are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, reinterpreting the request for a physical device rather than an AI/ML algorithm.

Device Description:
The CrossWise™ Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the cannula to facilitate septal puncture. The primary difference from the predicate device is its ability to be reprocessed (cleaned and re-sterilized) for up to 10 uses, and minor material modification to the connector shroud to withstand autoclave temperatures.

1. Table of Acceptance Criteria and Reported Device Performance

For this multi-use physical device, the "acceptance criteria" revolve around its ability to maintain its functionality and safety after repeated reprocessing cycles, showing substantial equivalence to the predicate device.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., "n=X cables tested"). It mentions "Devices" were tested and "testing was conducted on devices at 2 aging points: after manufacturing (T=0) and after 6 months of accelerated aging (T=6M AA)." It also states that devices were "subsequently conditioned to reflect the intended reusability of the devices after reprocessing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Circa Scientific, Inc., to support the 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer's location (Englewood, CO, USA). The testing is prospective as it's specifically designed to validate the new device's capabilities prior to market clearance.

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

• This concept is not applicable to this type of device validation. "Ground truth" established by experts (e.g., radiologists interpreting images) is relevant for AI/ML diagnostic tools. For this physical device, the "ground truth" is defined by established engineering and medical device standards for performance, sterilization, and material properties. The engineers and quality assurance personnel conducting and overseeing these tests are inherently acting as the "experts" whose work ensures compliance with these standards.

4. Adjudication Method for the Test Set

• This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic or prognostic AI/ML studies. For bench testing of a physical device, results are typically objectively measured against pre-defined engineering specifications, not subject to subjective interpretation and 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

• This is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. The device here is a physical adapter cable, not an AI/ML algorithm.

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

• This is not applicable. A standalone performance evaluation is performed for AI/ML algorithms. The device submitted is a physical product. Its "standalone" performance is assessed via the bench tests (e.g., electrical resistance, tensile strength) without human interaction being part of the performance metric itself, but this is a fundamentally different type of evaluation from an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this physical device is based on engineering specifications, material science properties, and established medical device performance standards (e.g., ISO 11135, ISO 17665, AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI ST98, IEC 60601-2-2). The physical and functional characteristics of the cable are objectively measured and compared against these pre-defined benchmarks to ensure safety and effectiveness for its intended use. There is no "pathology" or "outcomes data" in the sense of clinical study that establishes efficacy for this specific component; rather, component performance ensures the overall system works.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

• This is not applicable as there is no "training set."

Ask a specific question about this device

The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.

The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.

This document does not describe a study involving device performance metrics relevant to AI/ML, such as sensitivity, specificity, or F1 score, or any human reader studies using AI assistance. The provided text is a 510(k) summary for a medical device (CrossWise RF Transseptal Access System) to demonstrate substantial equivalence to predicate devices, focusing on non-clinical performance data like biocompatibility, sterilization, electrical safety, and bench testing.

Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies cannot be populated from the given text.

Here's a breakdown of the information that can be extracted:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the device was tested to conform with various international standards and that "The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions."

The types of tests performed and the general findings are:

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

• Test Set Sample Size: Not specified in terms of number of devices or number of tests for each type, other than "Devices were subjected to 2X sterilization and distribution simulation". The document states "Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA)."
• Data Provenance: Not explicitly stated, however, the testing appears to be internal validation performed by the manufacturer, Circa Scientific, Inc., or a contract lab on their behalf. It is non-clinical (bench).

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

• Not applicable. This is a non-AI/ML medical device submission based on physical and electrical performance. Ground truth would be based on instrument readings, standardized methods, and expert evaluation of physical properties, not clinical expert consensus.

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

• Not applicable for this type of device and 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:

• No. This is not an AI/ML device.

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

• No. This is not an AI/ML device.

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

• For the non-clinical performance data, the "ground truth" is based on:
  • Validated test methods outlined in international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 11135 for sterilization).
  • Objective measurements from laboratory equipment and physical inspection.
  • Functional verification against design specifications.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The CIRCA Scientific CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the interatrial septum.

The CardioCurve™ Steerable Sheath from CIRCA Scientific is an 8.5 Fr sterile, single-use catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40cm, 61cm, 71cm, or 82cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, marketed cleared guidewire (K935170). A side port with a 3-way stopcock allows air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle equipped with two linked rotating dials is used to deflect the tip clockwise and counterclockwise 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, and a lubricious coating on the outer surface.

The CardioCurve™ Steerable Sheath shaft is made from Pebax and Nylon. The shaft includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy.

The CardioCurve™ dilator can be used with a curved transseptal Abbott BRK™ type needle with stylet if indicated on the package label.

This Special 510(k) is submitted to support the changes made to the predicate device: the Tuohy Borst adapter in the CardioCurve Steerable Sheath is replaced with a cap; as a result of this change, the dilator shaft usable length is shortened, and the Instruction for Use (IFU) is updated.

This document describes the premarket notification for the CardioCurve™ Steerable Sheath (K240004), which is a modification of a previously cleared device (K210185). The key changes are the replacement of a Tuohy Borst adapter with a cap and a resulting shortening of the dilator shaft usable length, along with an updated Instruction for Use (IFU).

Based on the provided text, the device in question is a physical medical device (a catheter introducer), not an AI/software-based device. Therefore, the questions related to AI/algorithm performance (e.g., ground truth, training set, MRMC study, standalone performance, experts for ground truth) are not applicable to this submission. The validation for this medical device focuses on physical performance testing to demonstrate that the design changes do not raise new questions of safety or effectiveness.

Here's the information that can be extracted relevant to the physical device's acceptance criteria and study, followed by an explanation of why AI-specific questions are not applicable:

Acceptance Criteria and Device Performance (for a physical medical device):

The document references a "Summary of Performance Testing" which includes a list of tests. It states: "The methods and acceptance criteria were the same or equivalent to the predicate device and are relevant to the changes under review. The testing identified in the list below was based on well-established test methods and requirements."

Since specific numerical acceptance criteria and reported performance values are not explicitly provided in the text for each test, the table reflects the types of tests conducted and infers that the device met the criteria, as it received clearance.

Study Details (for a physical medical device):

1. Sample sizes used for the test set and data provenance:
   The document states "Verification testing has been conducted to support that the subject device meets the design specifications and is substantially equivalent to the predicate device." It also mentions "Design verification tests were performed to demonstrate that the subject device...met predetermined performance specifications."
   However, the exact sample sizes for each test (e.g., number of units tested for fatigue, leak, etc.) and the data provenance (e.g., specific country of origin for test materials or retrospective/prospective nature of the physical tests) are not specified in the provided text. These tests would typically be performed in a lab setting rather than on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not Applicable. This is a physical medical device. "Ground truth" in the context of physical medical devices typically refers to engineering specifications, material properties, and established test methods, not expert consensus on medical images or clinical outcomes. The testing is based on "well-established test methods and requirements," implying engineering and quality control expertise, but not necessarily a panel of medical experts for "ground truth" establishment in the way it's understood for AI.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not Applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This device undergoes physical performance testing against engineering specifications, not human interpretation against a medical standard.

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:
   Not Applicable. An MRMC study is relevant to AI-assisted diagnostic devices. This is a physical catheter introducer, not a diagnostic AI tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not Applicable. This refers to AI algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As explained in point 2, "ground truth" for this physical device refers to engineering specifications, design requirements, and established testing standards. The document mentions an FMEA (Failure Modes and Effects Analysis) and that testing "met critical design specifications as well as performance attributes for its intended use."

7. The sample size for the training set:
   Not Applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:
   Not Applicable.

Summary of Device, Study, and Why AI-specific Questions are Not Applicable:

The CardioCurve™ Steerable Sheath is a Class II medical device, specifically a catheter introducer. The submission is a Special 510(k) to support changes to a previously cleared predicate device. The changes are physical design modifications (replacement of a Tuohy Borst adapter with a cap and resulting dilator length adjustment).

The "study" described is a series of design verification tests conducted to ensure that these physical changes do not negatively impact the device's safety and effectiveness. This is a standard process for physical medical device modifications.

The questions regarding "ground truth," "training set," "experts," "adjudication," and "MRMC studies" are typically applied to diagnostic AI/machine learning devices where the output is an interpretation of data (e.g., medical images), and human performance or algorithmic performance needs to be evaluated against a clinical standard. Since the CardioCurve™ Steerable Sheath is a physical, interventional device, these AI-centric questions do not apply to its regulatory clearance process as described in this document. The "acceptance criteria" relate to engineering and performance specifications, and the "study" involves physical bench testing.

Ask a specific question about this device

The CIRCA Temperature Monitoring System is composed of CIRCA Temperature Monitor and CIRCA MATRIX12 M Probe and is intended for the continuous detection, measurement and visualization (in ℃) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The CIRCA Monitor must be used in conjunction with the CIRCA MATRIX12 M Probe.

The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation-related esophageal injury has not been established. The performance of the CIRCA Temperature Monitoring System in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

The CIRCA Scientific Temperature Monitoring System consists of a touch-screen monitor, interconnect cables, and an esophageal temperature probe.

The monitor displays 12 temperature probe sensor readings (°C), the minimum and maximum temperature of all sensors, and contains an alarm system with userselected levels. The measured temperatures can be stored in the internal memory of the device and examined at a later time on an external personal computer (after exporting the corresponding data file to an USB flash drive).

The MATRIX12 M Esophageal Temperature Probe provides continuous temperature measurement (°C) and operates in direct mode (operating mode of a clinical thermometer where the output temperature is an unadiusted temperature that represents the temperature of the measuring site to which the probe is coupled). The probe contains 12 thermistor sensors located in a 3 x 4 sensor array. The sensors measure temperature by a thermistor that is sensitive to temperature changes. The probe is connected to the CIRCA Scientific monitor by using an interconnect cable. The 14Fr diameter probe is placed inside the esophagus.

The Probe is also equipped with 4 electrode sensors. By connecting the MATRIX12 M Probe to a 3D cardiac mapping system through the optional component Mapping Interconnect Cable, the probe can be visualized inside a 3D model of the patient's body for placement.

The provided text is a 510(k) summary for the CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System. It describes the device, its intended use, and comparative testing against a predicate device (CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System, K200943).

However, the information provided does not describe a study involving an algorithm or AI that would require the in-depth data requested regarding sample sizes, expert ground truth, MRMC studies, or training/test sets. The device is a clinical electronic thermometer and sensing probe, and the testing described focuses on hardware performance, electrical safety, biocompatibility, and software system tests for an embedded system, not a diagnostic AI/algorithm.

Therefore, I cannot fully answer the request as the context of the input document is for a medical device that does not rely on an AI/algorithm based on the typical sense of machine learning models for diagnosis or prediction.

However, I can extract the acceptance criteria and performance data for the device itself from the provided tables, as well as information about the non-clinical testing.

Here's the information extracted concerning the device's acceptance criteria and proven performance:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Device Specifications (from Comparison Table, acting as implicit acceptance criteria):

• Temperature Measurement Range: 0 - 55 °C (subject device rated higher than predicate 0 - 45 °C, but still meets consensus standard ISO 80601-2-56 range of 34-43 °C).
• Number of Temperature Sensors: 12
• Temperature Sensor Type: NTC Thermistor (system accuracy ±0.3℃)
• Measurement Presentation / User Interface: LCD monitor, Touch screen monitor
• Alarm Temperature Range: Upper threshold (Alarm and Warning High), Lower Threshold (Alarm and Warning Low); Low threshold cannot be set higher than upper threshold.
• Alarm Signal: Visual (flashing yellow, blue, or red on LCD), Audible (intermittent sound).
• Power Requirements: 100 - 240 Vac
• Monitor Classification: Class I Medical Electrical Equipment, Type CF Applied Part, Defibrillation-Proof.
• Introduction: Esophageal (nose/throat)
• Signal Processing and Display: Actual temperature is a function of thermistor resistance; Temperature displayed in 0.1℃ increments; 1 input (single probe) available; 12 sensors per probe measurements and user-selected alarm limits displayed on LCD monitor.
• Operating Conditions: 0°C to 40°C; Non-condensed relative humidity: 30% to 75%.
• Precision and Repeatability: 0.1 °C
• Probe Sterilization: ETO Sterilized; Single-use only.
• Biocompatibility of Patient Contacting Part: Compliance to ISO 10993-1; Surface-contacting device, mucosal membrane; Limited exposure (A) – up to 24 h.
• Software: Compliance to IEC 62304.
• Electrical Safety: Compliance to IEC 60601-1.
• EMC: Compliance to IEC 60601-1-2.
• Performance Bench Testing: Compliance to ISO 80601-2-56.

Regarding points 2-9 (Sample sizes, experts, MRMC, training/test sets, ground truth):

These points are highly relevant to AI/ML software as a medical device (SaMD) clearances. However, the provided document describes a hardware medical device (a clinical electronic thermometer and probe). The "software system tests" mentioned refer to verification of embedded control software, not diagnostic AI algorithms. Therefore, the concepts of "test set," "training set," "experts for ground truth," "adjudication," and "MRMC comparative effectiveness studies" do not apply to the type of device and testing described in this 510(k) summary.

The non-clinical performance data provided focuses on:

• Biocompatibility
• Sterility
• Software (embedded system verification, not AI/ML)
• Electrical Safety and EMC
• Accuracy and Response Time (met standards for thermometers)
• Mapping Cable validation
• Performance in working environment (immunity to noise, compatibility with mapping systems)

There is no mention of any AI or machine learning component in the device's functionality, nor any clinical study involving human readers or comparative effectiveness in the way typically required for AI/ML SaMDs. This submission outlines a traditional medical device premarket notification based on substantial equivalence to a predicate device.

Ask a specific question about this device