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The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatic populations. The basic system delivers three (3), six (6) or twelve (12) channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate). The device is indicated in situations where an instantaneous display of ECG information or a hard copy record may be required. The device is intended to be used under the direct supervision or a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph is meant to acquire and record cardiac action potentials from patients. The device is design to be used in Recovery areas of the hospital or clinic. Patient ages from neonates to adults can all be applied. Waveforms, heart rate and analysis data from these patients are available to the diagnostic or may be recorded.

The FX-8322 is an Electrocardiograph. The main part consists of the Main Control Board (model: PCB-7285), the Operation Board (model: PCB-7234), the AMP Board (model: PCB-6731), the LCD Module (model: TX17DO1VM2CAA / FD-42-3D), the Power Supply Unit (model: APAU003-07), the Recorder Unit. In addition, the Patient Cable (model: CP-105L), the Chest Electrode (model: TEE-01 / TEE-01RA) and the Limb Electrode (model: TEE-43 / TEE-43RG). Furthermore, the device is designed so it can be connected to USB, LAN cable, Serial cable, SD Card and an external monitor. There are two (2) types of the external monitors depending on the display size desired:

17 inch LC monitor L-560T-C: 19 inch LC monitor MX-191:

The user interfaces, touch screen panel and key panel are located on the top surface of the device. The touch screen display has a variable number of keys that are activated by software and depends on the display/function that the user selects. In addition, there are sixty-five (65) fixed keys on the bottom of the LCD display.

The Fukuda Denshi Model CardiMax FX-8222 provides acquiring and recording ECG (standard 12 lead), heart rate along with the standard 12-Lead ECG analysis software module.

The Fukuda Denshi Model CP-105L Patient Cable provides the ECG signal through Electrocardiograph Electrodes.

Additional standard features include the LAN connection, which is a proprietary network system through either a built in Ethernet LAN connector for connection to the hospital system. Standard features include a USB connection and SD Card connection, which is intended to store the ECG data and connect the USB Wireless LAN adaptor, and the Serial Connection, which is intended to connect to an External Monitor connection and the R-sync connection available when an R-Wave synchronized signal is needed.

The provided document is a 510(k) summary for the Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph. It describes the device, its intended use, and its technological characteristics, stating that it incorporates identical technology to predicate devices. It also mentions compliance with various safety and performance standards.

However, the document does not provide details about acceptance criteria, specific device performance metrics, or study designs that would enable the completion of the requested table and information points. The summary only broadly states that the device has been "subjected to extensive safety, environmental and performance testing" and that "Final testing for the device included various performance tests for the device designed to insure that all functional and performance specifications were met."

Therefore, based solely on the provided text, I cannot fill out the requested table or answer most of the specific questions.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document only mentions the device's ability to provide "interpretation" but doesn't detail the ground truth establishment process for testing this interpretation.

4. Adjudication method for the test set

• 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

• Not specified. The document states the device performs "interpretation" but does not detail human reader studies or AI assistance. This device is an electrocardiograph, and the "interpretation" likely refers to automated ECG interpretation, not an AI assisting human readers.

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

• The document implies standalone performance for the "12-Lead ECG analysis software module" by stating it's the "same as that used in the Fukuda Denshi CardiMax model FX-4010 Multi Channel Electrocardiograph cleared under 510(k) # K981066 and the Nihon Kohden Cardiofax model ECG-1350A cleared under 510(k) #K072217." However, it does not detail a specific standalone study for this particular 510(k) application.

7. The type of ground truth used

• Not specified. For ECG interpretation, common ground truths might include expert cardiologist over-reads, clinical outcomes, or pathology reports for specific conditions. This information is not present.

8. The sample size for the training set

• Not specified.

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

• Not specified.

Summary of Document Information:

• Device Name: Fukuda Denshi CardiMax Model FX-8322 Electrocardiograph
• Intended Use: To acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Delivers 3, 6, or 12 channels of ECG parameters (waveform, arrhythmia and rhythm measurements, interpretation and heart rate).
• Predicate Devices: Fukuda Denshi Cardiograph Model FX-4010 Electrocardiograph (K981066) and Nihon Kohden Cardiofax model ECG-1350A (K072217). The "12-Lead ECG analysis software module" is noted as being the same as in the predicate devices.
• Testing Mentioned: "Extensive safety, environmental and performance testing." Compliance with IEC 60601-1, IEC 62304, IEC 62366, ISO 14971, ANSI/AAMI EC53, IEC 60601-2-25, ISO 15233-1, and IEC 60601-1-2. These are general and particular safety and performance standards for medical electrical equipment and software, not specific clinical performance studies.
• Conclusion: The device is substantially equivalent to predicate devices based on laboratory testing, validation, and risk analysis.

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The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. Device features include as follows:

• Portable, lightweight design .
• Easy data input and operation .
• Alphanumeric keyboard and one-touch operation .
• Built-in rechargeable battery, AC/DC power supply .
• Automatic analysis and diagnostic software (SEMIP) for . adults
• Heart rate variability (HRV) analysis
• Internal thermal printer and external printer
• Support external archiving: USB flash disk, card reader .
• Data transmission to PC via Ethernet or serial port .

The provided text does not contain detailed information about specific acceptance criteria for the SE-601 Series Electrocardiograph, nor does it describe a detailed study proving the device meets particular performance metrics. The summary focuses on regulatory compliance, outlining the device description, intended use, and substantial equivalence to a predicate device.

However, based on the limited information available and making some inferences about standard regulatory practices for ECG devices, I can construct a response. Please note that many fields will be marked as "Not provided" because the document does not offer that level of detail.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Acceptance Threshold" and specific "Specific Metric" are largely inferred based on typical regulatory requirements for ECG devices seeking 510(k) clearance, as the document only generally states that "Verification and validation testing was done" and that the device is "substantially equivalent."

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

• Sample Size for Test Set: Not provided. The document mentions "Verification and validation testing" but does not specify the number of patients or ECGs used in any performance evaluation.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.

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

• Number of Experts: Not provided.
• Qualifications of Experts: Not provided.
  • Inference: For ECG interpretation software, ground truth is typically established by board-certified cardiologists or physicians experienced in ECG reading.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided.
  • Inference: If multiple experts were used, common methods include 2-out-of-3 consensus, 3-out-of-5 consensus, or a lead expert adjudicating disagreements.

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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The submission focuses on substantial equivalence, implying a comparison to a predicate device rather than an evaluation of human reader improvement with AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was described.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Study: Yes, an implicit standalone performance evaluation of the "Automatic analysis and diagnostic software (SEMIP)" was likely performed as part of the "Verification and validation testing" and "Performance test." The document states this software provides "analysis and diagnostic software (SEMIP) for adults" and that the "interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only." This suggests the algorithm's output was evaluated, even if the specific metrics are not detailed.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated.
  • Inference: For ECG interpretation software, ground truth is typically established by:
    • Expert Consensus: Independent review by a panel of cardiologists.
    • Clinical Outcomes/Follow-up: Though less common for individual ECG features, clinical correlation might be used for certain diagnoses.
    • Pathology: Not directly applicable to ECG interpretation.
    • Given the "advisory basis only" statement, it's highly probable that expert consensus was the primary method for establishing ground truth for the interpretive statements.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not provided. The document does not describe the development or training of the SEMIP algorithm, only its existence and intended use.

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

• Ground Truth Establishment for Training Set: Not provided.
  • Inference: Similar to the test set, ground truth for training data would typically be established by expert cardiologists reviewing ECG waveforms and clinical data.

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