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The purpose and function of the CLEO patient monitor is to monitor basic physiological parameters including

• NIBP (systolic and diastolic)
• SpO2
• ETCO2

The target population is for adults only.

It can be used in all hospital areas and hospital-type facilities. It may be used as bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The CLEO monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to three different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The CLEO Patient monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The associated accessories include:

• Sp02 Finger Sensors
• NIBP Monitor
• Blood Pressure Cuff
• ETCO2 Module

The provided document is limited to the FDA 510(k) summary for the CLEO Patient Monitor. This document outlines the device's regulatory status, intended use, and a summary of performance testing to support substantial equivalence to a predicate device.

It does not contain the detailed information needed to fully answer all aspects of your request, particularly regarding specific acceptance criteria values and a comprehensive study report with ground truth establishment and expert involvement, as would be expected for a comparative effectiveness study or a rigorous standalone algorithm performance study.

The information provided largely focuses on demonstrating compliance with recognized standards for medical devices rather than detailed clinical performance studies for a diagnostic algorithm.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Device Performance

The document describes various performance tests conducted to support the substantial equivalence of the CLEO Patient Monitor. However, it does not explicitly state numerical "acceptance criteria" for each parameter in the way one might expect for a diagnostic algorithm. Instead, it lists the standards of compliance that the device met. The "reported device performance" is implicitly that the device complied with these standards.

Table of Acceptance Criteria (as inferred from Standards of Compliance) and Reported Device Performance:

Missing Information:

The document does not provide the following information that would be necessary to answer the remaining parts of your request:

1. Sample size used for the test set and the data provenance: The document mentions "performance tests" for NIBP, SpO2, and ETCO2 but does not specify the number of subjects, the type of data (e.g., patient data, simulated data), or its origin (e.g., country, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. The testing described seems to rely on standardized methods and calibrated equipment rather than expert human assessment for ground truth.
3. Adjudication method: Not applicable/not mentioned, as there isn't a human-expert-based ground truth outlined.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No MRMC study is mentioned. This device is a physiological monitor, not a diagnostic imaging AI algorithm typically requiring MRMC studies.
5. If a standalone performance study was done: The document describes various performance tests ("Mechanical Testing," "SPO2 Performance Test," "NIBP Performance Test," "CO2 Measurement Accuracy and Drift") which could be considered standalone performance assessments against established standards. However, it's not a standalone algorithm performance in the sense of a machine learning model's output being compared to ground truth.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the physiological measurements would be derived from highly accurate reference instruments or test setups that simulate physiological conditions according to the respective standards (e.g., a calibrated pressure transducer for NIBP, a pulse oximeter simulator for SpO2, a gas analyzer for ETCO2). Expert consensus, pathology, or outcomes data are not relevant for establishing ground truth for these types of physiological measurements.
7. The sample size for the training set: This device is a traditional physiological monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" would be the engineering design, calibration, and validation against known physical and physiological principles.
8. How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device with a training set.

In summary: The provided document is a 510(k) summary for a traditional patient monitor. It focuses on demonstrating compliance with established medical device safety and performance standards for its physiological measurement capabilities (NIBP, SpO2, ETCO2). It does not describe an AI/machine learning algorithm or the types of studies (MRMC, expert consensus for ground truth, training/test sets for AI) that your request specifically asks about. The "acceptance criteria" are implied by compliance with the listed international and national standards.

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The purpose and function of the OMNI patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3, 5 or 12 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) .
• . SpO2
• Respiration .
• Temperature up to 2 channels (Dual Temperature) .
• . CO2
• IBP .
• Anesthetic agents .

The target population is for adult, neonate and pediatric patients.

It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI II patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3, 5 or 12 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) .
• SpO2 .
• Respiration .
• Temperature up to 2 channels (Dual Temperature) .
• . CO2
• . Cardiac Output
• IBP .
• . Anesthetic agents

The target population is for adult, neonate and pediatric patients with the exception of:

• · Cardiac Output for which the target population is adult only.
  It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3, 5 or 12 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) .
• SpO2 .
• Respiration .
• Temperature up to 2 channels (Dual Temperature) .
• CO2 .
• Cardiac Output ●
• . IBP
• Anesthetic agents .

The target population is for adult, neonate and pediatric patients with the exception of:

• · Cardiac Output for which the target population is adult only.
  It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The purpose and function of the OMNI Express patient monitor is to monitor basic physiological parameters including

• ECG waveform derived from 3 to 5 lead measurements .
• Heart Rate .
• NIBP(systolic, diastolic, and mean arterial pressure) ●
• . SpO2
• . Respiration
• . Temperature - up to 2 channels (Dual Temperature)
• CO2
• . Anesthetic agents

The target population is for adult, neonate and pediatric patients.

It may be used as bedside or portable monitor and be used in all hospitals and hospitaltype facilities such as clinics and emergency room facilities. It is to be used under the direct supervision of a licensed healthcare practitioner.

The OMNI monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, and processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability, Built-in battery facilitates transportation of patient.

The OMNI III can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The OMNI EXPRESS monitor is a comprehensive monitoring system with two or three traces compiling, and processing, analyzing and displaying data from up to eight different patient parameters, It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI EXPRESS monitor can be powered by an internal battery pack that provides 2 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

This document describes several patient monitors (OMNI, OMNI II, OMNI III, and OMNI Express) and their performance with respect to various physiological parameters. However, the provided text does not contain specific acceptance criteria, reported device performance values against these criteria, or a detailed study description with sample sizes, data provenance, ground truth establishment, or expert qualifications.

The document discusses substantial equivalence to predicate devices and lists performance tests conducted according to certain standards, but it does not explicitly state the quantitative acceptance criteria or the specific results obtained in numerical terms.

Therefore, I cannot fully complete the requested table and answer many of the questions directly. However, I can extract the available information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and corresponding reported device performance values are NOT explicitly stated. The document refers to compliance with performance standards rather than specific numerical targets.

The table below indicates the standards of compliance mentioned for certain parameters, which would imply that the device met the requirements of these standards.

Note: The document only states that testing was completed according to these standards and that "Based on the conclusions of each of these tests it is determined that the OMNI Patient Monitors are safe and effective." It does not provide the specific numerical results or tolerance limits (acceptance criteria) from these tests.

Study Details:

As the document primarily focuses on demonstrating substantial equivalence through compliance with recognized standards and non-clinical bench testing, it does not describe a clinical study in the conventional sense (e.g., with human subjects, test sets, ground truth panels, etc., for evaluating classification performance or diagnostic accuracy). The non-clinical data section references "bench testing" only.

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

   • Not explicitly stated. The document refers to "bench testing" and compliance with performance standards. These are typically laboratory tests using simulated signals or controlled environments, not human subject data sets as "test sets" in the context of AI/diagnostic algorithm evaluation.

2. 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):

   • Not applicable / Not stated. Since this is bench testing against performance standards, "ground truth" would be established by the characteristics of the test equipment or reference signals used to simulate physiological parameters, not by human expert consensus on clinical data.

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

   • Not applicable / Not stated. Adjudication methods are relevant for clinical studies where multiple experts interpret data. This document describes bench testing.

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. The document does not describe any MRMC study. These are patient physiological monitors, not AI-assisted diagnostic tools for image interpretation or similar.

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

   • Partially applicable, but for hardware/software performance, not an AI algorithm. The "bench testing" described evaluates the device (hardware and embedded software) in a standalone capacity against technical standards for performance (e.g., accuracy of ECG measurement, IBP measurement, etc.). It is not a standalone evaluation of an AI algorithm in the context of diagnostic decision-making.

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

   • Not explicitly stated in clinical terms. For bench testing against standards, the "ground truth" would be the known, controlled inputs provided by test equipment or calibrated sources, as defined by the respective performance standards (e.g., a signal generator producing a known ECG waveform or a pressure calibrator for IBP).

7. The sample size for the training set:

   • Not applicable / Not stated. The document describes a patient monitor that monitors basic physiological parameters. There's no indication of machine learning or an "AI algorithm" requiring a training set in the context of the information provided for this 510(k) summary. The device's functionality appears to be based on established signal processing and measurement techniques, not learned models.

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

   • Not applicable / Not stated. As above, no training set for an AI algorithm is mentioned.

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The purpose and function of the OMNI Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.

The OMNI patient monitor is a comprehensive monitoring system with three or six traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI patient monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

This 510(k) submission describes the Infinium Omni Patient Monitor, a device that measures various physiological parameters. The submission focuses on demonstrating substantial equivalence to a predicate device (Infinium OMNI II Patient Monitor, K103737) rather than providing a detailed clinical study demonstrating specific performance against acceptance criteria with associated numerical results.

Therefore, the requested information elements related to specific performance metrics, sample sizes, expert involvement, and ground truth for a clinical study are not explicitly present in the provided text. The submission relies on non-clinical data (electrical safety tests and software validation) and a comparison of technological characteristics to the predicate.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission does not contain specific acceptance criteria with corresponding numerical performance results for physiological measurements in the way a clinical study would typically present them. Instead, it relies on demonstrating compliance with recognized standards.

• ANSI/AAMI EC13:2002 Cardiac Monitors, Heart rate meters and alarms
• IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests
• ISO 9919:2005 Medical electrical equipment - particular requirements for the basic safety and essential performance of pulse oximeters.
• IEC 60601-2-27: (2005-08), Medical electrical equipment -- Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment.
• AAMI/ANSI SP10:2002 Manual, electronic or automated sphygmomanometers. (Cardiovascular) |
  | Software Validation | "Software Validation" was performed. |
  | Functional Equivalence | The device has the "same intended use and similar technological characteristics" as the predicate (Infinium OMNI II Patient Monitor K103737). Differences noted are physical (size, weight) and display characteristics (3-6 traces vs. 4, 6 or 8 traces). |

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

• Not explicitly stated. The submission focuses on non-clinical testing and comparison to a predicate, not a clinical test set with patient data.

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

• Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment.

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

• Not applicable. There is no clinical test set mentioned that would require adjudication.

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

• No. This is a patient physiological monitor, not an AI-assisted diagnostic device for human readers. No MRMC study was conducted.

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

• While the device functions as a "standalone" monitor in the sense it provides measurements, the submission does not detail standalone algorithmic performance against a defined ground truth or reference standard in the context of, for example, diagnostic algorithms. The performance is assessed by compliance with electrical safety and performance standards for each measured parameter.

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

• For the electrical safety and performance tests, the "ground truth" is often established by adherence to defined test protocols and reference measurements established by the specified standards (e.g., a known voltage/current for electrical safety, a calibrated pressure source for NIBP, a known oxygen saturation for SpO2, and a known heart rate for ECG testing). This is not "expert consensus" or "pathology" in the typical sense for clinical performance.

8. The sample size for the training set

• Not applicable. This submission does not describe a machine learning or AI algorithm that would require a training set.

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

• Not applicable. No training set is mentioned.

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The purpose and function of the OMNI II Patient monitor is to monitor ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature, for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital type facilities such as clinics and emergency room facilities.

The OMNI II monitor is a comprehensive monitoring system with four, six or eight traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient. The OMNI II monitor can be powered by an internal battery pack that provides 1 hour of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

The Infinium Omni II Patient Monitor is a physiological monitoring system that measures ECG, heart rate, NIBP, SpO2, respiration, and temperature for adult, neonate, and pediatric patients. It is intended for use as a bedside or portable monitor in various hospital-type facilities.

Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text doesn't specify numerical acceptance criteria for the device's performance (e.g., accuracy ranges for NIBP, SpO2, etc.). Instead, the device's performance is demonstrated by its compliance with recognized industry standards for safety and effectiveness.

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

The provided summary does not specify sample sizes for any test sets related to clinical performance data. The performance testing mentioned is primarily focused on compliance with recognized electrical safety and performance standards. These standards often have their own specific testing protocols, which may involve various samples or simulated environments, but details are not provided within this document.

The document does not mention any patient data or clinical data provenance. The testing appears to be primarily bench testing and software validation.

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

This information is not applicable or not provided in the given document. The "ground truth" for compliance with electrical safety and performance standards typically relies on standardized test methods and calibrated equipment rather than expert human evaluation to establish a clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or not provided as the performance testing described doesn't involve subjective expert review or adjudication of results. The tests are based on objective measurements against established standard requirements.

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

An MRMC comparative effectiveness study was not done or is not mentioned in this document. This type of study is typically performed for AI or diagnostic imaging devices to evaluate the impact of the device on human reader performance. The Omni II Patient Monitor is a physiological monitoring device, and its safety and effectiveness are established through compliance with technical standards, not typically through MRMC studies.

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

A standalone performance study, as typically understood for an AI algorithm without human intervention, was not performed or described in this document. The device itself is a physiological monitor that provides data for clinicians; it's not an AI analysis tool in the described context. Its "performance" is demonstrated by its adherence to the technical specifications outlined in the standards.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the Omni II Patient Monitor is established by meeting the requirements and parameters defined in the referenced industry standards. For example, an NIBP measurement system is considered "accurate" if its readings fall within the specified error margins when compared to a reference standard, as outlined in AAMI/ANSI SP10:2002. Similarly, the performance of the pulse oximeter is validated against the requirements of ISO 9919:2005, which typically includes comparison against co-oximetry reference values or simulated physiological conditions.

8. The Sample Size for the Training Set

This information is not applicable or not provided. Physiological monitors like the Omni II typically rely on established measurement principles and software algorithms, not machine learning models that require a "training set" of data in the AI sense.

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

This information is not applicable or not provided for the same reason as point 8. The device's functionality is based on established engineering principles and validation against industry standards, not on a machine learning training paradigm.

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The purpose and function of the Omni Express patient monitor is to monitor basic physiological parameters including, ECG, heart rate. NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals anf hospital-type facilities such as clinics and emergency room facilities.

The OMNI Express patient monitor is a comprehensive monitoring system with two or three traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI Express monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

This submission K103268 is a Special 510(k), which means it relies on the predicate device's performance data. The provided text does not contain a new study conducted to establish acceptance criteria or to prove the device meets these criteria. Instead, the submission asserts substantial equivalence to a previously cleared device.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm-only performance) study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Explanation of the Submission Type:

A Special 510(k) is used when a modification to an applicant's own previously cleared device does not affect the intended use or the fundamental scientific technology of the device. In such cases, the manufacturer generally relies on a comparison to their own predicate device and does not need to submit new clinical or performance data as extensively as a Traditional 510(k). The regulatory review focuses on whether the modifications introduce new questions of safety or effectiveness.

Information from the Provided Text Regarding Substantial Equivalence:

The document states:

"The proposed device is substantially equivalent to the Infinium OMNI III Patient monitor which has been cleared under K101052. The proposed device has the same intended use and similar technological characteristics as compared to the predicate device."

This means that the Omni Express Patient Monitor is considered to meet the same performance standards as its predicate device, the OMNI III Patient Monitor (K101052), due to their similar intended use and technological characteristics. The performance of the predicate device would have been established during its own clearance process.

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The purpose and function of the OMNI III patient monitor is to monitor basic physiological parameters including, ECG, heart rate, NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals and hospital-type facilities such as clinics and emergency room facilities.

The OMNI III monitor is a comprehensive monitoring system with eight traces compiling, processing, analyzing and displaying data from up to six different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria for the "Omni III Patient Monitor".

The document is a 510(k) summary and FDA clearance letter for the Omni III Patient Monitor. It primarily focuses on:

• Intended Use: Describing what the device monitors and for whom.
• Device Description: A general overview of the device's features.
• Predicate Device: Identifying a comparable existing device (Goldway UT4000F Patient Monitor).
• Substantial Equivalence: Stating that the proposed device is substantially equivalent to the predicate device in intended use and technological characteristics.
• FDA Clearance: The actual FDA letter granting clearance for the device.

There is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in design validation reports or clinical study summaries, which are not included in the provided 510(k) summary. The FDA clearance is based on the device being substantially equivalent to a predicate device, implying that the predicate device likely had studies supporting its performance, and the Omni III is considered to perform similarly without necessarily requiring extensive new clinical studies for this specific 510(k) clearance process.

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