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The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.

The SPIRO PD spirometer is indicated for the following age groups:

2-12 years Child
13-21 years Adolescent
22 and over- Adult

Device Description

The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information provided by the signal related to the pulmonary function. For processing purposes, mechanical signals must be changed to electrical signals. The devices responsible for this change are called transducers. The SPIRO PD has a Turbine-type transducer. The turbine transducer performs transduction in two stages: The volume to be measured crosses the turbine vane and records its rotation that is proportional to that Volume, this rotation is detected by the interrupting of a beam of infrared light, the sensor of which converts the light received into a digital-type electrical signal.

The SPIRO PD performs the following tests:

FVC,
FEV1 .
FEV1/FVC ●
PEF
FEF 25-75%
Estimated Lung Age and Flow/Volume Curve .

The Spiro PD performs the following calculations:

% Predicted of FVC ●
Severity of FVC .
% Predicted of FEV1
Severity of FEV1 .
% Predicted of FEV1/FVC .
Severity of FEV1/FVC .
% Predicted of FEF 25-75% .
Severity of FEF 25-75%
% Predicted of PEF, Severity of PEF .

The physical configuration of the Spiro PD:

Display Color, Touch screen LCD 320 x 240 resolution .
Keyboard - Touch screen
Power supply 3.7V Lithium-ion battery 650 mAh .
Dimensions 200 x 96 x 40mm .
Weight 256g with battery .

AI/ML Overview

Acceptance Criteria and Device Performance Study for SPIRO PD Spirometer

The SPIRO PD Spirometer's acceptance criteria and performance are primarily based on demonstrating substantial equivalence to predicate devices and adherence to relevant industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

This device is a spirometer, and its performance is judged on several technical specifications, adherence to guidelines, and safety. There isn't a single "acceptance criteria" table with corresponding "reported device performance" in the submission that details a pass/fail against specific clinical accuracy thresholds. Instead, the acceptance is demonstrated through a combination of comparative analysis with predicate devices and successful completion of non-clinical tests.

Below is a summary of the key performance and safety characteristics, showing how the device performance aligns with generally accepted standards for spirometers and its predicate devices.

Acceptance Criteria (Inferred from Predicate Comparison & Standards)	Reported Device Performance
Functional Parameters:
Maximum Volume (Comparable to predicates)	0 - 10 L (Identical to SDI Diagnostics' Spirotel, greater than Vitalograph's 0.99 L BTPS, which has a more limited test scope)
Flow Range (Comparable to predicates)	0 - 16 L/s (Comparable to SDI Diagnostics' Spirotel which is +16 L/s. Vitalograph has a different metric of 0.15 kPa/L/s at 14 L/s)
Flow Accuracy (Comparable to predicates and ATS/ERS guidelines)	±5% or 200 mL/s (Identical to SDI Diagnostics' Spirotel. Vitalograph reports ±3%)
Volume Accuracy (Comparable to predicates and ATS/ERS guidelines)	±3% or 50 mL, whichever is greater (Identical to SDI Diagnostics' Spirotel. Vitalograph reports ±3%)
Adherence to ATS Spirometry Performance Recommendations	Yes
Test Duration (Compliance with ATS guidelines)	Minimum of three tests at 15 sec per test (Consistent with ATS guidelines and Vitalograph. Spirotel has a maximum of 60 seconds)
Biocompatibility (ISO 10993 Series)	Elution Test (ISO 10993-5): Test article's extracts meet requirements.
Guinea Pig Closed Patch Sensitization Test (ISO 10993-10) Cottonseed Oil Extract: Elicited a minimal sensitization reaction.
Guinea Pig Closed Patch Sensitization Test (ISO 10993-10) Saline Extract: Did not elicit a sensitization reaction.
Primary Dermal Irritation in Rabbits (ISO 10993-10) Cottonseed Oil Extract: Elicited a negligible dermal response.
Primary Dermal Irritation in Rabbits (ISO 10993-10) Saline Extract: Elicited a negligible dermal response. (Patient contacting materials passed biocompatibility testing in accordance with ISO-10993)
Electrical Safety & EMC (IEC 60601 Series)	IEC 60601-1: Pass
IEC 60601-1-4: Pass
IEC 60601-1-6: Pass
IEC 60601-1-2: Pass (All electrical safety and EMC tests required for medical devices passed)
Human Factors/Usability	Ease of Use Scores: Averaged greater than 92.5% across all age groups.
Label Comprehension Scores: Averaged 97% across all age groups. (Data provided confidence that all age groups could use the device effectively and achieve expected results)
Operation Environment (Temperature, Humidity, Pressure)	Temperature range: 15 °C - 50 °C
Humidity Range: Relative humidity below 95% (without condensation)
Atmospheric Pressure Range: 430mmHg to 800 mmHg (Within the same range as the predicate Spirotel, and comparable to Vitalograph's specified temperature/humidity ranges.)

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

Sample Size: The document does not explicitly define a "test set" in the context of clinical performance data, as no clinical data was collected or assessed for this 510(k) submission.
- For the Human Factors Study, a sample size of 45 participants was used.
  - 15 participants aged 2-12 years
  - 15 participants aged 13-21 years
  - 15 participants aged 22+ years
Data Provenance: The human factors study data was generated by PMD Healthcare, implying it was conducted specifically for this device submission. The country of origin of the participants is not specified. The study was prospective for its specific purpose.

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

N/A. Since no clinical performance data was collected or assessed, there was no "ground truth" to be established by experts for a test set in a clinical evaluation context. The human factors study involved participants using the device, but "ground truth" for clinical performance metrics was not applicable.

4. Adjudication Method for the Test Set

N/A. As no clinical data was collected for performance evaluation, no adjudication method for a test set was applied.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data was not required to determine the safety and effectiveness of the Spiro PD or to show substantial equivalence to the predicate devices. Therefore, no clinical data was collected or assessed as part of this 510(k) premarket notification." Therefore, there is no effect size reported for human readers improving with or without AI (which this is not an AI device).

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

While the device includes algorithms for calculations, its standalone performance was demonstrated through non-clinical (engineering) testing against established standards (e.g., accuracy for flow and volume measurements as per ATS guidelines) and comparison with predicate devices' technical specifications. It is a diagnostic device used by a human, and its core function involves direct interaction. The "standalone" performance here refers to the device's technical measurement accuracy, not an AI algorithm performing a diagnostic task.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the technical performance aspects (flow, volume accuracy), the ground truth can be considered the reference standards used in factory calibration and the ATS (American Thoracic Society) guidelines for spirometry performance recommendations.

For the human factors study, the ground truth for "ease of use" and "label comprehension" would be the observed user interactions and responses collected during the study, quantified by the scores (e.g., >92.5% for ease of use, 97% for label comprehension).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device in the context of requiring a "training set" for model development. The algorithms are based on established physiological calculations and predictive models like NHANES III.

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

N/A. Not applicable as this device does not utilize a "training set" in the context of machine learning model development. The predictive models (e.g., NHANES III) are pre-established and widely accepted in pulmonary medicine. The device incorporates these existing models.

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