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The SpiroSphere is a compact device inspiratory and expiratory lung function parameters in adults and children aged 4 years and older. It can be used by physicians in the office or hospital.

With the option ECG, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reassess all ECG measurements. An interpretation by SpiroSphere ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the SpiroSphere ECG represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The SpiroSphere ECG is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

It can be used by physicians in the office or hospital.

With the CardioSphere, electrocardio measurements can be made under resting conditions. For this purpose a 12channel surface electrocardiogram can be measured and recorded. The acquired ECG can be displayed on the screen or printed on paper. The interpretation software is intended to support the physician in evaluation of the resting ECG in terms of morphology and rhythm. Automatic interpretation of the ECG is not possible for pediatric subjects with an age below 16 years and for pacemaker subjects. It is not intended for intra-cardial use.

A qualified physician has to reasurements. An interpretation by CardioSphere is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the CardioSphere represent partial qualitative and quantitative information on the patient's cardition and no therapy or drugs can be administered based solely on the interpretation statements. The CardioSphere is not intended for use in an EMS environment (Emergency Medical Services Environment).

The minimum age for ECG application is 4 years.

It can be used by physicians in the office or hospital.

SpiroSphere is a compact spirometry device. Its Sensor Unit is batterypowered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time.

SpiroSphere ECG is a compact spirometry device. Its Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere / SpiroSphere ECG is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved to the device and can be read out at any time.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

The Main Unit can be powered by battery or power supply. The Main Unit is wirelessly connected to an ECG amplifier via Bluetooth.

With the ECG option (subject of this 510(k)), 12-channel surface electrocardiogram can be measured and recorded.

A printer can be connected and data (e.g. reports, screenshots) can be printed. Moreover, it is possible to transfer data by USB. Wifi. 3G. and Ethernet connections.

Pulmonary function assessments

• Slow Spirometry .
• Forced Spirometry .
• Flow-Volume loop and Volume-Time tracing, pre/post tests ●
• Trending capabilities ●

Cardiovascular assessments

• 12 Lead Electrocardiogram ●

The provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA, along with a device description and comparison tables to predicate devices. It discusses general information about the device, its intended use, technological characteristics, and a summary of device testing (e.g., software verification, risk analysis, electrical safety, EMC, human factors, cybersecurity, reprocessing validation). However, it does not specify quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) for its interpretation software, nor does it detail a specific study proving these criteria were met.

Therefore, I cannot provide the requested information based on the given text.

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The SpiroSphere is a compact device to measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older.

It can be used by physicians in the office or hospital.

The SpiroSphere is a compact spirometry device. It's Sensor Unit is battery-powered. The Main Unit can be powered by battery or power supply. The SpiroSphere is used to measure inspiratory and expiratory lung function parameters in adults and children 4 years and older. The measured data is saved into the device and can be read out at any time.

A printer can be connected with the SpiroSphere and all needed data (e.g. reports, Screenshots) can be printed. Moreover it is possible to transfer data by USB, Wifi, 3G, and Ethernet.

Pulmonary functions

• Slow Spirometry
• Forced Spirometry
• Flow-Volume loop and Volume-Time tracing, pre/post tests
• Trending capabilities

The provided text describes the SpiroSphere, a device for measuring lung function, and its substantial equivalence to a predicate device (SpiroPro). However, it does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving the device meets them.

The document is a 510(k) summary for premarket notification to the FDA. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing the detailed clinical or performance study results you're asking for.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria and Reported Device Performance (Table): The document states adherence to ATS/ERS standards (2005) for spirometry accuracy and precision and lists various parameters measured (FEV1, FVC, PEF, etc.). However, it does not provide a specific table of acceptance criteria (e.g., +/- x% accuracy) or numerical reported device performance against those criteria. It only generally states that "Tests were performed to confirm that the SpiroSphere meets the recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005."
• Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Performance, Training Set Sample Size/Ground Truth: These details are typically found in a dedicated clinical or performance study report, which is not included in this summary. The 510(k) summary only mentions general verification and validation activities and conformance to standards.

In summary, based only on the provided text, I cannot complete the table or answer the specific questions about the study details because that level of detail is not present in this FDA 510(k) summary.

The document discusses:

• Device Name: SpiroSphere
• Predicate Device: SpiroPro (K000648) and SpiroPro with BT (K092324)
• Intended Use/Indications for Use: To measure inspiratory and expiratory lung function parameters in adults and children aged 4 years and older, usable by physicians in office or hospital.
• Technological Characteristics: Uses a pneumotachograph (Lilly Type) for pressure to flow conversion, measures various parameters (FEV1, FVC, PEF, FEF25-75, VC, IC, ERV) conforming to ATS/ERS Spirometry Standards (2005).
• Testing Mentioned: Software verification and validation (IEC 62304), Risk analysis (ISO 14971), electrical safety (IEC 60601-1:2012), EMC (IEC 60601-1-2:2014), wireless technology (FDA Guidance 2013), Human Factors/Usability (IEC 62366), Biocompatibility (ISO 10993-1:2009, ISO 18562:2017), Cybersecurity (FDA Guidance 2014), Reprocessing (FDA Guidance 2015).

To answer your questions thoroughly, a complete performance study report would be required, which typically contains the specific data and methodologies.

Ask a specific question about this device