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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.

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The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.

The SpiroScout is an electronic measurement device intended to be used for measurement of lung function (determination of the respiratory flows and volume) parameters. It enables the determination of the following parameters.
Spirometry
Inspiratory and expiratory vital capacity (VC) Inspiratory and expiratory subdivisions
Flow/Volume
The measurement of the flow/volume curve enables the determination of the dynamic lung volumes. FEV1 value (forced expiratory volume within the first second of exhalation).
Maximum Voluntary Ventilation MVV
The respiratory limit value indicates the respired volume per minute during maximally forced respiration. The respiratory limit value is also referred to as "Maximum Voluntary Ventilation".
The SpiroScout sensor operates using two diagonally opposing ultrasound transducers that alternately send and receive ultrasonic waves. The ultrasound technology simultaneously measures the flow, temperature and humidity.
The SpiroScout is a PC-based system running the Ganshorn LFX software program. The system comprises:

• the hand-held ScoutSensor
• Base station where the sensor is stored.
• Spirette, a single use, disposable mouthpiece and flow tube

The provided text lacks a detailed study description with acceptance criteria and reported device performance. It primarily focuses on the device's substantial equivalence to a predicate device for regulatory approval. However, certain performance specifications and adherence to standards are mentioned, which can be interpreted as acceptance criteria.

Here's an attempt to extract and present the information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the technical specifications provided for the proposed device (Ganshorn SpiroScout) and are implicitly considered acceptable due to its substantial equivalence claim to the predicate device.

Notes on the Table:

• Acceptance Criteria Derivation: The "Acceptance Criteria" column is largely inferred from the predicate device's specifications, as the submission claims "substantial equivalence" to the predicate. The text states: "Performance and Specifications -As above the performance and specifications are substantially equivalent to the predicate." For standards compliance, the acceptance criterion is simply compliance with the named standard.
• "Reported Device Performance": This refers to the specifications listed for the proposed device, the "Ganshorn SpiroScout."

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

The document explicitly states "No clinical testing was performed" and "No animal testing was performed." Therefore, there is no test set of patient or animal data used in a clinical study for performance evaluation that can be described. The performance data presented (e.g., flow and volume accuracy) appears to be from non-clinical, likely bench or engineering, testing.

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

Not applicable, as no clinical testing was performed, and therefore, no expert ground truth was established for a clinical test set. The accuracy and performance metrics are based on non-clinical engineering testing against established standards and specifications, not expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable, as no clinical testing was performed requiring adjudication of results from a test set.

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 applicable. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in interpretation.

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

Yes, the performance listed in the table (flow accuracy, volume accuracy, etc.) represents the standalone performance of the device (SpiroScout) based on non-clinical testing. The text describes it as an "electronic measurement device intended to be used for measurement of lung function." The approval is based on its direct measurement capabilities, not an algorithm's interpretation of findings that would require human-in-the-loop consideration.

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

For the non-clinical performance evaluation, the "ground truth" would have been established by reference standards or calibrated instruments used to measure flow, volume, and other parameters according to the requirements of the ATS (2005) standards and the device's technical specifications. These are laboratory-based, objective measurements, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is a measurement device, not a machine learning or AI model that requires a training set.

9. 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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The Spiros, a CML, is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to an Intravascular Administration Set. The Spiros provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).

The Spiros is a closed connector which is compatible with and used to access, standard female luers and known needlefree connectors. The Spiros is a normally closed design which will prevent the leakage of fluid or ingress of air when in the inactivated state. When activated the luer is an open two-way conduit for fluid flow. The Spiros will be an accessory to an IV administration device including tubing sets and syringes, such that an integral female luer is used to connect to such devices.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested.

The document is a Special 510(k) Summary for the Spiros™ Closed Male Luer, and it focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria as typically found in medical device approvals based on clinical trials or extensive engineering verification.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

Acceptance Criteria and Device Performance:

The document states: "The Spiros™ closed male luer device has been tested post sterilization and passed all acceptance criteria." However, it does not list what those specific acceptance criteria are, nor does it report specific device performance metrics against those criteria. It only makes a general statement of compliance.

Missing Information (Not found in the provided text):

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size of human reader improvement with AI vs. without AI assistance.
• If a standalone (algorithm only) performance study was done.
• Type of ground truth used (pathology, outcomes data, expert consensus, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

Information Extracted from the Text:

Since the detailed information for the requested table and study details is not present, I will summarize the general statements made in the document regarding testing and equivalence.

Summary of Device Evaluation (Based on provided text)

Device Name: Spiros™ Closed Male Luer

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document makes general statements about passing acceptance criteria and meeting claims but does not provide specific quantitative or qualitative criteria or corresponding performance data.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. (The document mentions testing "post sterilization," implying laboratory or engineering testing, not clinical data.)

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

• Number of Experts: Not applicable/Not specified.
• Qualifications of Experts: Not applicable/Not specified.
  This type of evaluation is not relevant as this is a device for fluid administration, not one requiring expert human interpretation of data (like medical images).

4. Adjudication method for the test set:

• Not applicable/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:

• No. This type of study is not relevant for this device. The Spiros™ is a physical medical device (closed male luer) for intravenous fluid administration, not an AI-powered diagnostic or assistive technology that would involve human readers or AI algorithms for interpretation.

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

• No. Not applicable as this is a physical device, not an algorithm.

7. The type of ground truth used:

• The concept of "ground truth" as typically applied to diagnostic or AI devices is not explicitly detailed here. The evaluation of this device would involve engineering and performance testing against established physical and functional standards (e.g., fluid leakage tests, pressure resistance, sterility, biocompatibility), rather than a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set:

• Not applicable/Not specified. (This device does not involve a "training set" in the context of machine learning or AI.)

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

• Not applicable/Not specified.

Study that Proves the Device Meets the Acceptance Criteria:

The document states: "The Spiros™ closed male luer device has been tested post sterilization and passed all acceptance criteria."

• Nature of the Study: Based on the context of a 510(k) for a physical medical device (intravascular administration set accessory), the "study" referred to would be a series of verification and validation (V&V) tests, including:

  • Performance testing: To ensure the device functions as intended (e.g., preventing leakage, allowing fluid flow when activated, resistance to pressure).
  • Biocompatibility testing: To ensure materials are safe for patient contact.
  • Sterilization validation: To confirm the device can be consistently sterilized.
  • Shelf-life testing: To ensure stability over time.
  • Material compatibility testing: Especially given the change in polycarbonate vendor and the addition of an O-ring.

• Evidence of Meeting Criteria: The document asserts that the device "passed all acceptance criteria" and "meets the functional claims and intended use." The basis for this claim is the "testing post sterilization." This aligns with the requirements for demonstrating substantial equivalence for a Class II device.

• Specifics Missing: The document does not provide details of which specific tests were conducted, what the passing thresholds were, or what the actual results recorded were for each test. This level of detail is typically contained in the full 510(k) submission, not necessarily in the summary provided for the public. The focus of the provided summary is to highlight substantial equivalence to an existing predicate device, primarily through comparing features and stating that performance testing confirmed safety and effectiveness.

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The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.

The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.

This document is a 510(k) premarket notification decision letter from the FDA for the SpiroSoft device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the text provided. Questions 1 through 9 cannot be answered.

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To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing

A disposable bacterial/viral filter used in pulmonary function testing

The provided text describes the SpiroSafe Filter, a disposable bacterial/viral filter for pulmonary function testing. The study demonstrates the device's substantial equivalence to a predicate device (PDSI KoKo Filter - K914272) based on performance criteria.

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

1. Acceptance Criteria and Reported Device Performance

Note: While the text doesn't explicitly state "acceptance criteria", the comparison table to the predicate device implies that the performance characteristics of the predicate serve as the benchmark for substantial equivalence. The SpiroSafe Filter meets or exceeds the critical performance aspects (bacterial/viral efficiency) of the predicate. The resistance to airflow value for the predicate is 0.9, and the intended device is ">1.5", which seems to indicate the SpiroSafe filter exceeds the predicate in this metric; however, for resistance, lower is generally better. This could be a typo in the document or interpreted differently. Assuming the acceptance criteria aligns with being "comparable or better" than the predicate, the device broadly meets this.

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

The document does not specify the sample size used for the performance testing shown. It is simply presenting performance data.

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be a direct presentation of product specifications rather than a clinical study.

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

This information is not applicable. The device's performance is measured against technical specifications, not subject to expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-in-the-loop assessment or expert review for adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical filter, and the evaluation is based on its physical and filtering properties, not on diagnostic accuracy requiring human reader interpretation.

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

Yes, in a sense, a "standalone" performance assessment was done. The performance metrics (bacterial efficiency, viral efficiency, resistance to airflow) are inherent to the device itself and do not involve human interaction beyond conducting the tests. The results presented are solely based on the device's intrinsic characteristics.

7. The Type of Ground Truth Used

The ground truth used is based on measured physical and performance characteristics (e.g., bacterial efficiency percentage, viral efficiency percentage, resistance to airflow in cmH2O/L/Sec.). This is analogous to laboratory testing/engineering specifications.

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" in the context of this device. The evaluation is focused on the manufactured product's specifications rather than a machine learning model.

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

This information is not applicable as there is no mention of a "training set" or a machine learning context.

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