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CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.

CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

• Patient Population: Male/Female, Adults .
• Environment of Use: Hospital and Clinic .
• Prescription Device by a Physician ●

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office.

CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

The provided document describes a 510(k) premarket notification for the CardioView 32 Review Module, an ECG interpretive software. The focus of the submission is to demonstrate substantial equivalence to a previously cleared predicate device, the CardioView 3000.

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

The document does not explicitly present a table of "acceptance criteria" with quantitative performance metrics for diagnostic accuracy (e.g., sensitivity, specificity for specific ECG abnormalities) for the device. Instead, the "Performance Standards" section indicates compliance with a general standard:

The submission relies on demonstrating that the modified CardioView 32 Review Module is as safe and effective as the unmodified CardioView 3000 predicate device, largely by showing that the fundamental interpretation algorithm (Cardionics Algorithm) remains the same, and that other modifications are related to software functionality, display, and operating system compatibility, rather than core diagnostic performance.

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

The document does not provide any specific information regarding a test set (e.g., ECG recordings used for validation), its sample size, or the provenance of the data (e.g., country of origin, retrospective or prospective). The "Summary of Performance Testing" only states that the device "has been tested or found otherwise to comply with applicable sections of the following standards: AAMI EC11-1991 (R/2007)." This suggests compliance through technical evaluation against the standard's requirements rather than a clinical performance study using a medical dataset.

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

Since no specific test set or clinical performance study is described, there is no information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Again, given the absence of a described test set or clinical performance study, there is no information regarding an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technical specifications and adherence to a general standard, rather than a clinical comparison of human readers with and without AI assistance.

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

The document states that the CardioView 32 Review Module "provides interpretive statements for which the physician renders his/her own medical opinion." This indicates that the software is not intended for standalone diagnostic use; it produces interpretations that are reviewed by a physician. While the underlying "Cardionics Algorithm" performs the primary interpretation, the submission does not detail a standalone performance study where the algorithm's output alone was assessed against a ground truth without human review. The claim is that the algorithm itself is the same as the predicate.

7. The Type of Ground Truth Used

As there is no detailed performance study described, there is no explicit mention of the type of ground truth used. If the predicate device's algorithm was validated, it would likely have been against expert consensus or possibly outcomes data, but this submission does not provide those details for the modified device.

8. The Sample Size for the Training Set

The document does not provide any information about the training set sample size. The "Cardionics Algorithm" is a pre-existing component, and no details regarding its development or training are included in this 510(k) summary.

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

Similar to the above, the document does not provide any information on how the ground truth for the algorithm's training set was established, as the algorithm itself pre-dates this submission and is considered a "Same" component as the predicate device.

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The BPCard is a Non-Invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, adult subjects. The BPCard also measures heart rate.

• Patient Population: Male/Female, Adults .
• Environment of Use: Hospital, Clinic and Home Use .
• Prescription Device by a Physician .

Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the ausculatory method. The BPCard also measures heart rate.

• . Patient Population: Male/Female Adults
• . Environment of Use: Hospital, Clinic and Home Use
• . Prescription Device by a Physician

The provided text focuses on the 510(k) summary for the QRS Diagnostic BPCard, a blood pressure monitor. It compares the modified device to a previously cleared predicate device and lists compliance with various standards. However, it does not contain the detailed study information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically found when describing acceptance criteria and a study that proves a device meets those criteria.

The document primarily states that the device complies with the ANSI/AAMI SP10:2002 standard. This standard itself defines acceptance criteria for automated sphygmomanometers.

Based on the provided text, here's what can be extracted:

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

The document explicitly states that the device "Meets AAMI SP10:2002". Therefore, the acceptance criteria are implicitly those defined by the AAMI SP10:2002 standard for manual, electronic, or automated sphygmomanometers. The reported performance is that the device meets this standard.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not mentioned or implied. This device is a measurement system (blood pressure monitor), not an AI-assisted diagnostic tool for image interpretation, so an MRMC study is not applicable in this context.
• Effect Size of AI assistance: Not applicable.

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

• Standalone Performance Study: The document implies standalone performance testing by stating compliance with "ANSI/AAMI SP10:2002, Manual, Electronic or Automated Sphygmomanometers". Such standards define requirements for the automated device's accuracy. However, specific details of such a study are not provided. The device measures blood pressure using an "auscultatory method," which traditionally involves listening, but in an automated context, it refers to the device detecting Korotkoff sounds.

7. The type of ground truth used:

• Type of Ground Truth: The AAMI SP10 standard typically requires comparison against a reference method, often auscultation by trained observers using a mercury sphygmomanometer as the gold standard for blood pressure measurement. The document doesn't explicitly state this but implies it through compliance with the standard.

8. The sample size for the training set:

• Sample Size: Not applicable/Not specified. This device is a blood pressure monitor, not a machine learning model that requires a training set in the conventional sense. Its algorithms are based on established physiological principles and signal processing, not statistical learning from a labeled dataset.

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

• Ground Truth Establishment for Training Set: Not applicable/Not specified. (See point 8).

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The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard.

The BPCard™ is a non-invasive Blood Pressure Monitor. The patient population is for both male and female, pediatric and adult. The BP Card has been tested to the following standards: AAMI SP10-1992-Electronic or Automated Sphygmomanometers I FDA-1997-NIBP Monitor Guidance EN1060-1-Non-Invasive Sphygmomanometers General Requirements EN1060-3-Non-Invasive Sphygmomanometers Supplementary Requirements EN980-Symbols EN46001-Quality EN1441-Risk Analysis EN60601-1-2-EMC EN60601-1-Electrical Safety 93/42/EEC-MDD 89/336/EEC-EMC Directive 92/37/EEC-Product Safety 93/465/EEC-Conformity Assessment and CE Marking UL 2601-1-Safety US ISO 10993-1-Biological Evaluation ISO 9001:1994-Quality ISO 9001:2000-Quality ISO 13485:1996/1998-Medical Devices 21CFR Part801-Labeling 21CFR Part820-QSR FDA Blue Book Memorandum G95-1-Biocompatibility The BPCard is a non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method in both male and female, pediatric and adult subjects. The BPCard also measures heart rate. It is to be used by health care professionals in a hospital, clinic or home environment. It is contraindicated in patients who are not ambulatory, have heart failure, arrhythmia, or cardiac valve abnormality. It is not to be operated in an explosive atmosphere nor in proximity to any equipment that has the potential to generate a sufficiently large electromagnetic field as to interfere in any manner with the operation of the BPCard. The BPCard is a Prescription Device, not life supporting or live sustaining, not an implant, supplied non-sterile with a cuff, valve and microphone that requires a Personal Computer with the following requirements: Windows 2000 Operating System 32 MB RAM 1 GB Free Hard Disc Space 133 MHz Processor

The provided text describes the BPCard™ Blood Pressure Monitor and its comparison to a predicate device for 510(k) clearance. However, it does not contain a detailed study report that would include specific acceptance criteria with reported device performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.

The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (Accutracker DX) by demonstrating conformance to the AAMI SP10 Standard for electronic or automated sphygmomanometers.

Here's a breakdown of the requested information based on the provided text, with explicit notes where information is not available:

Acceptance Criteria and Device Performance

The core acceptance criterion implicitly stated is conformance to the AAMI SP10 Standard. The document explicitly states:

"Thus, even though the BPCard is not identical to Accutracker DX, it does comply with the SP10 Standard and we at QRS believe it should be granted substantial equivalence by its conformance to SP10."

The document also directly compares the BPCard to the Accutracker DX on the "Accuracy" row, indicating "SP10 - Trained Observer" for both, implying the BPCard also meets the accuracy requirements of SP10.

Study Details

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

   • Sample Size: Not specified in the provided text. The document refers to "conformance to the SP10 Standard," which outlines testing methodologies, but the specific sample size used for the BPCard's SP10 conformance test is not reported here.
   • Data Provenance: Not specified.

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

   • Number of Experts: Not specified. The comparison table mentions "SP10 - Trained Observer," suggesting that trained personnel were involved in generating the data for the SP10 conformance, but specific numbers or qualifications are not detailed.
   • Qualifications of Experts: Only "Trained Observer" is mentioned, which is generic. Specific qualifications (e.g., years of experience, medical specialty) are not provided.

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

   • Not specified in the provided text.

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

   • No. This device is a Blood Pressure Monitor, not an AI-assisted diagnostic tool for "readers." This type of study is not applicable.

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

   • The BPCard is described as a "non-invasive Blood Pressure Monitor that measures blood pressure (systolic and diastolic) using the auscultatory method." It is a measurement device operated by healthcare professionals. It is not an "algorithm only" device in the context of AI performance studies. Its performance is inherent to its mechanical and electronic measurement capabilities. The "trained observer" mentioned for SP10 conformance implies human involvement in the measurement validation.

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

   • For blood pressure monitors, the "ground truth" or reference measurement in SP10 conformance testing typically involves simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or another validated reference method. The document mentions "auscultatory method" as the technique and "trained observer" for accuracy testing, strongly suggesting this type of ground truth was used.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense. Its performance is based on its engineering design and adherence to physical measurement principles.

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

   • Not applicable, as there is no "training set" for this type of device.

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Diagnostic ECG for 12 Channel Resting ECG Patient Population: Male/Female, Pediatric to Adult Environment of Use: Hospital, Clinic and Home Use Prescription Device by a Physician

The EKGCard™ System is a diagnostic electrocardiograph (ECG or EKG) for 12 channel resting ECG's. The patient population is for both male and female, pediatric and adult. The System requires a Type II PC Card Slot and Windows CE Pocket PC 2002 and is a Prescription Device.

The provided K030535 filing describes the EKGCard™ System, a diagnostic electrocardiograph. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a dedicated study with defined acceptance criteria and statistical analysis.

Based on the provided document, there is no detailed information describing acceptance criteria and a study dedicated to proving the device meets those criteria. Instead, the submission relies on a comparison to legally marketed predicate devices (Biolog 3000 and ECG Interface) to establish substantial equivalence.

Here's a breakdown of the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated or presented in a table format within the provided document. The submission details the features and specifications of the EKGCard™ System and compares them to the predicate devices. The "performance" assessment is implicitly based on matching or being similar to the predicate devices' capabilities.

Note: The "acceptance criteria" here are inferred to be "being substantially equivalent to the predicate device" in each listed characteristic or demonstrating compliance with relevant industry standards. The reported performance is the EKGCard™ System's stated feature/capability.

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

The document does not describe a specific "test set" of patient data for evaluating the EKGCard™ System's performance in a clinical or analytical study. The comparison is feature-based against predicate devices and compliance with standards. Therefore, information on sample size and data provenance is not available in this filing related to performance validation.

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

As no specific test set or clinical study to establish performance is described, there is no information on experts used to establish ground truth.

4. Adjudication Method for the Test Set

Since no specific test set or clinical study for performance evaluation is detailed, there is no information on an adjudication method.

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

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical comparisons and compliance with standards, not on human reader performance with or without AI assistance.

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

The EKGCard™ System is a diagnostic electrocardiograph, which is a device for acquiring ECG signals. It does not appear to incorporate an AI algorithm for interpretation, as explicitly stated under "Differences" that "The EKGCard does not have interpretation, whereas the Biolog 3000 does or can." Therefore, a standalone algorithm performance study is not applicable and not reported.

7. The Type of Ground Truth Used

Given the nature of the device (an ECG acquisition system) and the type of submission (substantial equivalence based on technical features and standards compliance), the "ground truth" implicitly refers to the established technical specifications and validated performance of the predicate devices and/or compliance with recognized industry standards (e.g., IEC 601-1, ANSI/AAMI EC11). There's no mention of expert consensus on specific cases, pathology, or outcomes data being used as ground truth for performance validation of the EKGCard™ System itself.

8. The Sample Size for the Training Set

The document does not mention any training set as there is no indication of an AI or machine learning component being developed or trained for this device. The device is for ECG acquisition.

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

As there is no training set mentioned, this question is not applicable.

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Diagnostic Spirometry. Patient Population: Male/Female, Podistric to Adult. Device Functionality: Diagnostic Spirometry. Spirometric Parameters: FVC, MVV, SVC, and FEF. Environment of Use: Hospital, Clinical and Home Use. Prescription device by a physician.

The SpiroCard is a spirometery diagnostic device that measures the breathing functions of The volume and rate of exhalation and inhalation is measured and calculated by the patients. spirometer. Information provided by the spirometer assists the physician in diagnosing and treating respiratory diseases. The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device so that no new materials are introduced to the patient. The SpiroCard measures and calculates the results the same as the predicate device using the pressure produced by the pneumotachometer, the same correction factors and formulas for final results. The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy. The main difference is that the SpiroCard is in a PC Card package and that the reporting and user interface will be completely handled by a host computing device whereas the PFM-7000 was a desktop standalone device with a keypad, processor and displays built in.

Here's an analysis of the provided text regarding the SpiroCard device, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Study Details for SpiroCard

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the SpiroCard. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (PFM Professional 7000) and meeting "specifications" through testing.

However, based on the description, we can infer the primary performance expectation:

2. Sample Size for the Test Set and Data Provenance

The document states: "The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms."

• Sample Size for Test Set: Not specified. The exact number of waveforms generated or the duration/number of tests performed is not mentioned.
• Data Provenance: Not applicable in the traditional sense, as it was a simulated study using a Pulmonary Waveform Generator, not human patient data.

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

Not applicable. The ground truth for this study was established by the American Thoracic Society Standard waveforms generated by the Pulmonary Waveform Generator. There were no human experts involved in establishing the "ground truth" for the test set of waveforms.

4. Adjudication Method for the Test Set

None. Since the "ground truth" was derived from standardized waveforms, there was no need for human adjudication. The device's output was compared directly against the known, standardized waveform parameters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focused on the technical performance of the device itself against standardized waveforms, not on how human readers interact with or are influenced by the device's output. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Yes, a standalone performance study was done. The description of the testing against the Pulmonary Waveform Generator directly evaluates the device's (SpiroCard's) ability to measure and calculate spirometric parameters without human intervention or interpretation as part of the core measurement. The output of the device (measurements and calculations) was compared to the known values of the standard waveforms.

7. Type of Ground Truth Used

The type of ground truth used was standardized scientific waveforms (American Thoracic Society Standard waveforms).

8. Sample Size for the Training Set

Not applicable/Not specified. The SpiroCard is described as a diagnostic spirometer that measures and calculates breathing functions based on physical principles (pressure produced by a pneumotachometer, correction factors, and formulas). It does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. Its "knowledge" is embedded in its design, specific sensors, and pre-programmed algorithms/formulas.

9. How Ground Truth for the Training Set Was Established

Not applicable. As the device does not appear to use a machine learning model requiring a training set, the concept of establishing ground truth for a training set does not apply here. The device's functionality is based on established physiological principles and measurement techniques.

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