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Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using standard dental software used for tooth alignment, Blue Sky Bio then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Blue Sky Bio produces trays, which are formed of clear, then, thermoformed plastic. The trays are sent back to the dental health professional who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

The provided text describes the 510(k) premarket notification for Blue Sky Bio Aligners, establishing its substantial equivalence to predicate devices. It focuses on the device's characteristics, indications for use, and comparison to existing aligner systems. However, it explicitly states that no performance testing was conducted for the device itself or its materials (Essix) because the material already has 510(k) clearance as an aligner material, and the aligner production technology is considered "essentially identical" to the predicate.

Therefore, the specific information requested about acceptance criteria, study data, sample sizes, expert involvement, and ground truth for performance evaluation is not available in the provided document. The submission relies on the established safety and effectiveness of the existing predicate devices and materials.

Below is a table summarizing the requested information that can be extracted or derived from the text, with an explicit mention where information is not provided:

Acceptance Criteria and Device Performance Study Information

• Indications for Use equivalence: To be substantially equivalent to predicate devices.
• Technological Characteristics equivalence: Design, technology, materials, and composition must be substantially equivalent to predicate devices.
• Mechanism of Action equivalence: Similar to predicate devices.
• Material properties: Essix material (the aligner material) must demonstrate "sufficient tensile strength, elasticity, ductility, chemical resistance, and clarity for use as a clear tray aligner," as per its existing 510(k) clearance (K062828).
• Software functionality: Software must facilitate ordering and processing of aligners and maintain safety and effectiveness compared to predicates, without changing the functions of Blue Sky Bio Plan. | No specific quantifiable device performance metrics are reported. The submission asserts substantial equivalence based on the following:
• Indications for Use: Blue Sky Bio Aligners have "substantially equivalent Indications for Use" to the 3M Clear Tray Aligner (predicate).
• Technological Characteristics: "The results of this comparison demonstrate that the design, technology, materials, and composition of Blue Sky Bio Aligners are substantially equivalent to the predicate devices." The technology is described as "essentially identical to that used by a number of sequential aligner systems including the predicate device, 3M Clear Tray Aligners."
• Mechanism of Action: "The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence."
• Material: The aligners use Essix from Dentsply, which "has a 510k clearance as an aligner material (K062828, MQC unclassified)." Therefore, it is assumed to meet the necessary material properties.
• Biocompatibility: No separate biocompatibility testing was performed as the material already has 510(k) clearance.
• Software Verification and Validation: "Software verification and validation testing of the aligner showed that the addition of the aligner module did not change the functions of Blue Sky Bio Plan." The software was considered a "moderate" level of concern and documentation was provided as per FDA guidance.

Crucially, the document states: "Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting." And "no performance tests were done on it [Essix material]." |
| 2. Sample size and data provenance for test set | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. |
| 3. Number and qualifications of experts for ground truth | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 4. Adjudication method for test set | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 5. MRMC comparative effectiveness study? | No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with AI assistance (as this is an aligner, not an AI diagnostic device). | Not applicable. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 6. Standalone (algorithm only) performance study? | No. The document states that "Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting." Performance is assumed through substantial equivalence to existing devices and materials. | Not applicable. |
| 7. Type of ground truth used | Not applicable, as no performance testing was performed on the device or its materials. | Not applicable, as no performance testing was performed on the device or its materials. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 8. Sample size for the training set | Not applicable, as this is a physical dental aligner product, not an AI algorithm that requires a training set. The software module mentioned facilitates ordering and processing, but its development does not involve a "training set" in the machine learning sense. | Not applicable. |
| 9. How ground truth for the training set was established | Not applicable. | Not applicable. |

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Blue Sky Plan is intended to be used as conversion software for Computed Tomography (CT) generated DICOM images into a format that allows a dentist to assess the anatomic topography of the maxilla and mandible as well as location of important structures. It allows the information to be used for pre-surgical treatment planning of dental implant procedures. The Blue Sky Plan software is deployed on standard personal computer hardware using a Windows operating system.

Blue Sky Plan™ is dental imaging software which loads DICOM images and provides 3D visualization. 2D image reformation for surgical implant planning and stent fabrication, which allows the virtual position of implants from the images supplied by computerized tomography.

The provided text is a 510(k) summary for the medical device "Blue Sky Plan," a 3D Dental Image Processing Software. It outlines the device's description, indications for use, and a comparison to predicate devices, ultimately concluding substantial equivalence.

However, the document does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria. It states that "Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission," implying a comparison to predicate devices was performed, but no specifics of this comparison or any standalone performance study are provided.

Therefore, I cannot populate the requested table and sections with information directly from the provided text.

Based on the absence of explicit information in the provided document, the following points cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance metrics are mentioned.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
4. Adjudication method for the test set: No test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is described. The device is software for image visualization and planning, not explicitly "AI" in the modern sense or assistance to human readers in a diagnostic capacity beyond providing 3D views.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is described.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set is described.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological compatibility, without detailing specific performance studies or acceptance criteria for a new device evaluation.

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The device is intended to acquire and transmit electrocardiograph (ECG) data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.
The device is to be used on ambulatory adult populations where monitoring is prescribed while undergoing exercise rehabilitation.
Multiple central receivers may be used and connected to a local area network.
Specified wireless data entry devices may be connected to the system via a wireless access point and be used as a station for entry of patient session data.
Optional workstation(s) may be connected to the system via a network for entering and viewing patient demographic and rehab session data. The workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms.
ECG analysis may include 12-lead ECG interpretation.
Patient demographics, exercise prescription, scheduling information, and collected data can be ported to an outcomes management program.

The Q-Tel RMS telemetry system measures the electrical activity of a patient's heart during an exercise class and transmits it via radio frequency to a central monitoring station. The core features of the O-Tel RMS system include telemetry monitoring, ECG displays, full disclosure of vital signs, printing and reporting, and rehabilitation program management, such as scheduling classes and seminars and patient enrollment.

The monitoring station displays the patient's real-time ECG waveforms and uses programmable alarms to indicate the presence of pre-selected medical or technical conditions, such as arrhythmia or loss of signal. When alerted by the alarm, the clinician determines whether the event causing the alarm is clinically significant or benign. The Q-Tel RMS system enables the clinician to view, edit, record ECG strips, and use a printer to print reports.

Optional workstation(s) may be connected to the Q-Tel RMS via a network for the purpose of entering and viewing patient demographic and session data, which is stored on the Q-Tel RMS system. A workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms. Workstation(s) may be supplied as a turnkey device or as software only to be installed on specified hardware platform supplied by the customer. The software only workstation provides the same functions as the turnkey workstation except viewing of session data in "read-only" mode.

An optional wireless data entry device, such as a PDA, may act as a station for entry of patient session data which is saved on the Q-Tel RMS system. The wireless entry device has access only to patient session data.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device (Q-Tel RMS) seeking substantial equivalence to a previously cleared device. It focuses on comparing the technological characteristics and intended use of the new device with its predicate device to demonstrate that it is equally safe and effective.

Therefore, I cannot provide the requested table or study details based on the input.

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This device is designed to connect an intravascular electrode to a monitor through a standard EKG patient lead for the purpose of displaying an intravascular signal in real time. Only the black pinjack is "active". The red pinjack is electrically blind and designed to isolate the proximal electrode from inadvertent stimulation.

In essence, the subject device provides an electrically safe connection between the proximal pin of an intravascular electrode and a patient EKG lead , the signal ultimately traveling retrograde along a standard EKG cable to a bedside monitor. It would be used to facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance rather than the more cumbersome (and expensive) fluoroscopic approach. The device entirely consists of a pin jack (to accept the proximal pin of the electrode) connected in series via a 1000 ohm resistor to a standard EKG eyelet all encased in an appropriate housing. The snap-fit connection between the EKG lead and device eyelet completes the connection to the monitor.

The provided text does not contain information about acceptance criteria or a study that demonstrates the device meets such criteria. The document is a 510(k) summary for a "Transvenous Pacemaker Placement Assist Device" (formerly "PACER ASSIST DEVICE"), indicating FDA clearance based on substantial equivalence to predicate devices, rather than performance testing against specific acceptance criteria.

The information primarily describes:

• Device Description: An accessory to an EKG cable, consisting of a pin jack, a 1000 ohm resistor, and an EKG eyelet, encased in a housing. Its purpose is to provide an electrically safe connection between an intravascular electrode and a patient EKG lead for displaying an intravascular signal.
• Intended Use: To facilitate placement of a transvenous pacemaker or appropriately designed intravenous catheter with EKG guidance.
• Regulatory Information: Classification as Class II with product codes LDF and DRR, and the FDA's determination of substantial equivalence.
• Key Features: One "active" black pinjack for the signal and one "electrically blind" red pinjack for isolation.

Since no performance study or acceptance criteria are discussed in the provided text, I cannot complete the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.

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MAC-LAB System: The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Medical Systems Information Technologies TRAM modules (K01 1000), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

CardioLab EP System: The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have archythmia detection capabilities.

The ComboLab System: The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLabEP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or anthythmias, and does not have arrhythmia detection capabilities.

The MAC-LAB/CardioLab EP/ComboLab Systems do not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure.

Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization. Intended for use in catheterization and related cardiovascular specialty labs.

The MAC-LAB System is a microprocessor based data acquisition system used during cardiac catheterization procedures. The MAC-LAB system, via various models of the GE Medical Systems Information Technologies TRAM module (K011000) and amplifier module, acquires patient data which may include surface ECG, invasive and non-invasive blood pressure, blood oxygen saturation via pulse oximetry, respiration, and temperature, The TRAM module is housed in a dedicated front end chassis called the remote acquisition case (RAC). The MAC-LAB System joins together the TRAM module and amplifier module with computer processors, software, high resolution display monitors, power supply, laser printer, keyboard and mouse. Digital data is transmitted, via cable, from the TRAM module and/or amplifier module to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via L.A.N.

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to acquire ECG, intracardiac signals, and pressure signals via amplifier module. Digital data is also acquired from other devices such as RF generators, fluoro video systems and the GE Medical Systems Information Technologies TRAM module. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.

The product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or a combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only' configuration only allows the user to run the CardioLab EP modes. The 'MAC-LAB only' configuration only allows the user to run the MAC-LAB mode. The combination of both CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiological lab cases and MAC-LAB for catheterization lab cases).

This document is a 510(k) summary for the MAC-LAB/CardioLab EP/ComboLab System Version 6.0. It describes the device's intended use and states that it employs the same functional technology as a predicate device (K021366). However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the given input.

Here's a breakdown of what can be stated based on the provided text, and what cannot:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) for any aspect of the device's performance. It also does not report performance metrics against such criteria.

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

• Cannot be provided. The document states that the new device employs the "same functional technology as the predicate device" but does not describe any specific testing or clinical study for this 510(k) submission that would involve a test set, sample size, or data provenance. 510(k) submissions often rely on substantial equivalence to a predicate device rather than new clinical trials, especially for Class II devices like this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No test set or ground truth establishment is described.

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

• Cannot be provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Cannot be provided. This document describes a cardiac catheterization and electrophysiology system for data acquisition and display, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI assistance effect size is not applicable to the device as described.

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

• Cannot be provided. The device is a data acquisition system for use "under the direct supervision of a licensed healthcare practitioner." It explicitly states it "does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure." This strongly indicates it's not a standalone diagnostic algorithm but rather a tool for practitioners.

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

• Cannot be provided. No ground truth is described.

8. The sample size for the training set

• Cannot be provided. The document describes a medical device system, not an AI or machine learning algorithm that would typically involve a training set.

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

• Cannot be provided. No training set or ground truth establishment is described.

Summary based on the document:

The 510(k) submission for the MAC-LAB/CardioLab EP/ComboLab System Version 6.0 relies on demonstrating substantial equivalence to a predicate device (K021366), rather than presenting new performance data against specific acceptance criteria. The document states:

• Technology: "The proposed MAC-LAB/CardioLab EP/ComboLab System Version 6.0 employs the same functional technology as the predicate device."

This implies that the device is considered to meet implicitly acceptable performance levels because its technology and intended use are the same as a device already cleared by the FDA. Such submissions typically do not include detailed performance studies with acceptance criteria, ground truth, or sample sizes unless there are significant technological differences or new intended uses that raise new questions of safety or effectiveness.

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The device is intended to monitor, analyze, document, and report hemodynamic data acquired during a cardiac catherization procedure.
The system contains an acquisition subsystem and an analysis subsystem.
The system acquires non-invasive and invasive data parameters. The data is received, displayed, stored, and analyzed in the Q-Cath.
The device is to be used on adult and pediatric patients while undergoing a cardiac catherization procedure.
Patient demographics, registration, patient assessment, procedure log notes, collected physiological and other Q-Cath data can be exported to an information management system.
A Q-Cath remote workstation may be used to access patient files off-line or for the entering of additional patient information or editing of existing patient files. Additionally, the workstation may be used as a means of recording non-invasive vital signs data through the use of qualified third party peripheral monitoring devices.
Multiple Q-Cath systems and workstations may be used and connected to a local area network.
The Q-Cath system is not intended to be the sole means for monitoring a patient's status.

The Q-Cath system is a monitoring and analysis system that is used by Physicians, nurses, technicians and administrators associated with the cardiac catherization (cath) lab. The Q-Cath is a Microsoft Windows® based system with 32-bit architecture. The system contains an acquisition subsystem and an analysis subsystem. The O-Cath organizes patient signals (invasive & non-invasive), and non-physiological signals from external devices. The Signal Conditioning System (SCS) acquisition subsystem contains connectors for the 12 lead surface ECG, four pressure inputs, three HIS inputs, two DC inputs, two types of synchronization waveform outputs and ECG simulator outputs. The optional Vital Statistical System (VSS) acquisition system contains module connections for the non-invasive blood pressure, the SPO2 and two auxiliary modules. The analysis system generates data based upon pressure site locations, ECG data and the entry of information such as cardiac output, oximetry results, and the patient physiological condition. The system stores Full Disclosure data of all waveform data to the O-Cath local computer or can be stored off-line to a file server.

The provided document, a 510(k) summary for the Quinton Q-Cath System, does not contain information regarding acceptance criteria, a specific study proving device performance against such criteria, or details typically found in performance evaluation sections for AI/ML-driven devices.

The document describes a medical device for monitoring and analyzing hemodynamic data during cardiac catheterization procedures. Its purpose is to demonstrate substantial equivalence to a predicate device (Quinton Q-Cath, K862740), focusing on technological comparison, intended use, and safety/effectiveness aspects. The improvements mentioned are primarily related to system architecture (Windows-based, co-resident image analysis, integration of external data) and workflow efficiency, rather than a new analytical algorithm requiring rigorous performance metric evaluation against defined acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document does not include details on:

1. Acceptance criteria table and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for an analytical task) or acceptance thresholds are mentioned.
2. Sample size for the test set and data provenance: No test set is described.
3. Number of experts and qualifications for ground truth: No ground truth establishment is described as there's no analytical model being evaluated.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating that the Q-Cath System is "substantially equivalent in safety and effectiveness" to its predicate device through a comparison of technological characteristics, intended use, and compliance with general safety standards (like IEC 60601-1 and electromagnetic compatibility). It states, "Both devices perform equivalently," and "Generated data is identical," implying that the core functionality related to data generation and initial analysis remains the same as the predicate device, with enhancements primarily in user experience, data integration, and system architecture.

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MAC-LAB System:
The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Medical Systems Information Technologies TRAM modules (K921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

CardioLab EP System:
The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

The ComboLab System
The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

The MAC-LAB / CardioLab EP and ComboLab systems do not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure.

The MAC-LAB System is a microprocessor based data acquisition system used during cardiac catheterization procedures. The MAC-LAB system, via various models of the GE Medical Systems Information Technologies TRAM module (K921669) and amplifier module, acquires patient data which may include surface ECG, invasive and non-invasive blood pressure, blood oxygen saturation via pulse oximetry, respiration, and temperature. The TRAM module is housed in a dedicated front end chassis called the remote acquisition case (RAC). The MAC-LAB System joins together the TRAM module and amplifier module with computer processors, software, high resolution display monitors, power supply, laser printer, keyboard and mouse. Digital data is transmitted, via cable, from the TRAM module and/or amplifier module to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to acquire ECG, intracardiac signals, and pressure signals via amplifier module. Digital data is also acquired from other devices such as RF generators, fluoro video systems and the GE Medical Systems Information Technologies TRAM module. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.

The product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only' configuration only allows the user to run the CardioLab EP mode. The 'MAC-LAB only' configuration only allows the user to run the MAC-LAB mode. The combination of both CardioLab EP and MAC-LAB allows the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases).

The provided document is a 510(k) Summary for the GE Medical Systems Information Technologies MAC-LAB/CardioLab EP/ComboLab System from 2002. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific quantitative performance acceptance criteria through a detailed study comparing its performance to a defined ground truth.

Therefore, the document does not contain the specific information requested regarding acceptance criteria, a detailed study proving the device meets those criteria, or the methodology of such a study (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, or training set details).

Instead, the document focuses on demonstrating that the new device is as safe, as effective, and performs as well as predicate devices through:

• Technology Equivalence: Stating that the proposed system employs "the same functional technology as the predicate device."
• Compliance with Voluntary Standards: Mentioning that the systems comply with voluntary standards (details not provided in this excerpt).
• Quality Assurance Measures: Listing general quality assurance activities applied to development: requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

The "Test Summary" section explicitly states: "The results of these measurements demonstrate that the MAC-LAB/CardioLab EP/ComboLab System are as safe, as effective, and perform as well as the predicate devices." This is a general statement of equivalency rather than a presentation of data against specific, quantifiable acceptance criteria.

In summary, none of the requested information (points 1-9) about acceptance criteria, study design, and performance metrics can be extracted directly from this 510(k) summary.

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The intended use of the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision) is the acquisition, amplification, display, recording, and transmission of electrical signals of biological origin obtained during electrophysiology studies and related procedures. Such signals include ECG, intracardiac ECG, and blood pressure. Physiological parameters as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from these signals and displayed numerically, recorded, and/or transmitted.

Additionally, the EPXpress System (Timberwolf Revision) may acquire, transpose, amplify, display, record and transmit measurement data received from other medical devices typically used during these procedures, such as oximeters, RF generators, or electronic thermometers.

The EPXpress System (Timberwolf Revision) is an integrated catheter switching amplification and display system that can be installed at the patient table in the electrophysiology lab or moved to other locations where particular procedures may require its use. The system is made up of the EPAmp, Real-Time Controller, and monitor that are usually mounted on a cart. The EPAmp unit amplifies and conditions electrical signals from intracardiac catheters and displays these signals on a real-time monitor and/or prints these results to a chart recorder. The Timberwolf Revision added the capability of numerically displaying diastolic, systolic and mean blood pressures, as well as heart rate, cycle length, and certain measurement data received from other instruments.

Here's a summary of the acceptance criteria and study details for the Quinton Electrophysiology Corporation's EPXpress System (Timberwolf Revision), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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As for the current HP Cathstation, the added NBP module is intended for use in the cardiac cath lab on adult, pediatic, and nonatal patients undergoing cardiac cath procedures. The intended use for the HP Cathstation NBP module is the same as the intended use for the legally marketed predicate device and several other products currently on the market.

The HP Cathstation is modified by the addition of the HP M1008B Noninessive Blood Pressure (NBP) plug-in moduled by the HD M1008) Noninvasive Blood Pressure (NBP) plug-in module for display and recording of NBP numerics on the HP Cathstation.

The provided text describes a 510(k) submission for a modification to the Hewlett-Packard Model M1264B Cathstation, specifically the addition of an HP M1008B Noninvasive Blood Pressure (NBP) plug-in module.

However, the document is a Summary of Safety and Effectiveness, which typically outlines the device and its intended use, but does not contain the detailed acceptance criteria and study results for performance validation. It states that "Performance specifications for this modification have been validated," but it does not provide the specifics of those validations.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The document explicitly mentions:

• No detailed acceptance criteria.
• No reported device performance figures.
• No information on sample sizes for test or training sets.
• No details on data provenance.
• No mention of experts or ground truth establishment.
• No adjudication method is described.
• No MRMC or standalone study details are provided.
• No information on how ground truth was established for training or testing.

The document focuses on:

• Identifying the device and predicate device.
• Stating its intended use.
• Claiming substantial equivalence based on technological characteristics and the general statement that performance specifications have been validated, along with compliance to safety standards.

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