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The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.

The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.

The provided text describes a 510(k) submission for the KARL STORZ H1 Camera Head, which is an endoscope camera. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

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

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

The document lists several performance tests conducted for the subject device to ensure it meets its design specifications and is substantially equivalent to the predicate device. However, it does not explicitly state numerical acceptance criteria for each test or a direct comparison of the subject device's performance against those criteria in a table format. It generally states that the device "met all its design specification" and "performs as well as the predicate device."

Implied Acceptance Criteria Categories (from "Performance Testing" section):

• Color Reproduction and Color Contrast Enhancement
• Illumination
• Detection Uniformity
• Depth of field
• Spatial Resolution
• Dynamic Range & Detection Linearity
• Distortion
• Latency
• Signal-to-Noise Ratio (SNR) & Sensitivity
• Field of View

Reported Device Performance:

The document states, "The bench testing performed verified and validated that the H1 Camera Head has met all its design specification and is substantially equivalent to its predicate devices." It also concludes, "The conclusions drawn from the nonclinical tests demonstrate that the subject devices, the H1 Camera Head performs as well as the predicate device."

Without specific numerical acceptance criteria and performance data, a detailed table cannot be created.

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

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."

Therefore, there was no clinical test set in terms of human subjects or medical images. The testing was entirely non-clinical bench testing. The sample size for this non-clinical testing is not specified. The data provenance is also not applicable in the sense of country of origin for retrospective or prospective data, as it was bench testing.

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

As no clinical testing was performed and the ground truth was established through non-clinical bench testing against design specifications, no human experts were used to establish ground truth in the traditional sense of medical image interpretation.

4. Adjudication method for the test set

Since no clinical test set involving human experts was used for ground truth establishment, no adjudication method (like 2+1 or 3+1) was employed.

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 was done. The device is a camera head, not an AI-assisted diagnostic tool.

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

This question is not directly applicable. The device is a camera head, not an algorithm. The "standalone" performance was essentially the non-clinical bench testing of the device itself (hardware performance), which was done without human-in-the-loop in a clinical diagnostic context.

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

The ground truth for the non-clinical testing was based on design specifications and objective physical measurements during bench testing, ensuring the camera met its intended performance characteristics (e.g., spatial resolution measurements, color accuracy, brightness control functionality). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.

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

This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.

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The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

H100B Pulse Oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities. The sampled signal from finger sensor is processed in the main unit and transferred into electronic signal to display the SpO2 value, pulse rate value on the LCD at the form of numeral, plethysmogram, bar graph and waveform. Data management software (Oximeter Viewer) can transferred stored data into PC for storage, review and printing. The subject device is powered by 4 pieces 1.5V AA batteries or 4 pieces 1.2V Ni-H rechargeable AA batteries. Alarm capability including audio alarm and indicator is provided when the SpO2 value is lower than the limit setup or some technical reason.

The provided text is a 510(k) summary for the H100B Pulse Oximeter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance based on a new clinical trial.

Therefore, this document does not contain the detailed information required to fill out the requested table and answer many of the specific questions. The submission primarily discusses the intended use, device description, comparison with a predicate device (PM 60 Pulse Oximeter K072581), and a general statement about "Verification and validation testing." It explicitly states that "This premarket notification submission demonstrates that H100B Pulse Oximeter is substantially equivalent to the predicate device."

Here's what can be extracted based on the limited information provided:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The document does not specify quantitative acceptance criteria or report performance data.

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

This information is not present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

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

This information is not present and likely not applicable. The H100B Pulse Oximeter is not an "AI" device that assists human "readers" in a diagnostic context; it's a physiological monitoring device.

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

This information is not explicitly stated in the provided 510(k) summary. As it's a pulse oximeter, its primary function is standalone measurement and display. Performance would typically involve comparing its readings to a gold standard, not necessarily evaluating an "algorithm only" in the context of diagnostic AI.

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

This information is not present in the provided 510(k) summary. For pulse oximeters, ground truth for SpO2 measurements typically involves a co-oximeter or blood gas analyzer. The document does not specify how "verification and validation testing" was conducted.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This type of submission does not typically detail training sets for algorithms in the way an AI/ML device would.

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

This information is not present in the provided 510(k) summary.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence rather than a detailed scientific study report detailing acceptance criteria and performance data from a specific clinical or technical study. It lacks the granularity of information needed to answer most of your questions.

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The H12+ Holter recorder is intended to acquire, record and store up to 48 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.

Holter analysis is appropriate for the indications below:

• Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia. .
• Evaluation of adult patients for ST segment changes .
• Evaluation of adult patients with pacemakers .
• Reporting of time domain heart rate variability .
• Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or . cardiac surgery.)
• Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients .
• Clinical and epidemiological research studies .
• Infant patient evaluation is limited to QRS detection only .

The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H12+ recorder. The H12+ utilizes a 10-lead electrode hookup and placement that will result in three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keyboard is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keyboard can be used to enter event markers.

H12+ has a large LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various warning messages for the hook-up technician.

H12+ uses one AA battery, and a removable Compact Flash card as a memory support.

This document is a 510(k) premarket notification for the Mortara H12+ Holter Recorder. It describes the device's intended use, indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, ground truth establishment, or comparative effectiveness studies.

The document primarily focuses on establishing that the H12+ Holter Recorder is substantially equivalent to a legally marketed predicate device (Mortara PR4 Holter analysis Recorder (K9110977), later named H-12), based on its design, intended use, and indications for use.

Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for device clearance, not a performance study report.

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The H12+ Holter recorder is intended to acquire, record and store up to 24 hours of ECG data of patients that have been connected to the Mortara H12+ recorder and are undergoing Holter monitoring. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of 24 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis.

Holter analysis is appropriate for the indications below:

• Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia. .
• Evaluation of adult patients for ST segment changes •
• . Evaluation of adult patients with pacemakers
• . Reporting of time domain heart rate variability
• . Evaluation of a patients response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
• . Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
• . Clinical and epidemiological research studies
• . Infant patient evaluation is limited to QRS detection only

The Mortara H12+ is a Holter Recorder designed to be used in conjunction with the Mortara H-Scribe Holter Analysis system. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter System. The H12+ utilizes a 10-lead electrode hookup and placement to provide the H-Scribe system with three channels of full disclosure for Holter analysis. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

The H12+ Holter recorder stores 12 leads continuously for a 24-hour period. A keypad is available to set up system configuration, to enter patient's ID, to check lead quality during hook-up, and to start the recording. During the recording, the keypad can be used to enter event markers.

H12+ has a LCD screen to allow ECG display during the hook-up. lead quality check. system configuration and various messages for the hook-up technician.

H12+ uses one AA battery, and a removable memory card for data storage.

This document does not contain the information required to populate the requested tables and descriptions regarding acceptance criteria and study results. The provided text is a 510(k) summary for a Holter Recorder (H12+), which focuses on device description, intended use, indications for use, and regulatory substantial equivalence to a predicate device. It does not include:

• Specific acceptance criteria for device performance (e.g., accuracy metrics for ECG acquisition).
• Details of a study proving the device meets acceptance criteria.
• Information on sample size, data provenance, ground truth establishment, or expert involvement for any performance study.
• Mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.

The document states that the H12+ "performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017)." This indicates that the H12+ is a data acquisition device, and therefore, performance metrics related to cardiac analysis would likely be evaluated for the H-Scribe system, not the H12+ recorder itself.

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