(295 days)
The Spiro-Master PC-10 Spirometry System is intended to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate pulmonary function These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases The spirometer should only be used with pattents able to understand the instructions for performing the test
The Spiro-Master PC-10 Spirometry System is indicated for use with people of all ages, of either gender, excluding infants and neonates, to acquire, view, store and print measures and waveforms of the exhaled breath of a person and evaluate, access, describe, measure, or monitor
- Symptoms, signs, or abnormal laboratory tests 1
- Effects of disease on pulmonary function 2
- 3 Individuals at risk for pulmonary disease
- 4 Preoperative risk
- 5 Post-surgical prognosis
- ર્ભ Pre-treatment health status
- 7 Therapeutic interventions
- 8 The course of disease affecting lung function
- 9 Persons exposed to pollutants
- Adverse reactions to drugs with known pulmonary toxicity 10
- Rehabilitation programs 11
- Risks as part of an insurance evaluation 12
- Individuals for legal reasons 13
- 14 Epidemiological surveys
- Derivation of reference equations । રે
The "Spiro-Master PC-10 Spirometry System" is a handheld spirometer that connects to a Personal Computer (PC) via a Universal Serial Bus (USB 11 and 20) cable Windows 10-based software on the PC runs the diagnostic spirometer application
The device consists of a plastic handle which houses the amplified pressure transducer, analog to digital converter. USB microcontroller and connection via a USB cable The electronics in the handle are powered by the 5 volts DC of the PC USB port The top of the handle has a connection for the flow sensor, which connects to the mouthpiece
A Pneumotach sensor is incorporated into the Spiro-Master PC-10 Spirometry System to detect arrilow The flow sensor consists of two flow tubes that connect to each other around a sensor mesh ring which provides flow resistance A differential pressure across the mesh is generated depending on the inhalation/exhalation strength of the person being tested Inside the flow tube, the front and back of the mesh is connected to a pressure sensor through pressure outlet ports and tubes This differential pressure transducer measures the pressure difference across the flow sensor (mesh ring) as the air-stream passes through it The resulting pressure change is converted to a signal proportional to the airflow rate
The patient places their mouth on the mouthpiece, which is connected to a bacterial filter (KoKo Moe White Filter) between the mouthpiece and the sensor The mouthpiece is a single-use, disposable component.
The patient breathes as instructed through the mouthpiece The pressure transducer in the handle continuously transmits the differential pressure in the flow tube to the analog to digital converter The digitized 12 bit data is sent to the PC via the USB cable at 12 bit samples per second The Spiro-Master PC-10 Spirometry System application software (which requires Windows 98 or later), calculates the flow and integrates the flow to calculate volume The flows are calculated from the 12 bit data stream by applying a calıbration polynomial algorithm All flow and volume data are calculated in real tıme for the flow-volume measurements which includes Peak Flow, Forced Vital Capacity, Forced Expiratory Flows Forced Inspiratory Vital Capacity as well as FEF and FIVC
The spirometer technician/operator uses the software on the PC to perform the tests The software includes a number of screens and 'buttons' that assust to logically perform the tests in the correct order The tests can be saved to the PC hard drive, printed (report format) and recalled for later review There are various parameters that are displayed to assust the technician in the quality control of the test procedure per the ATS 1994 update and the ATS 2005 standards The system calıbration procedure requires sıx (6) varyıng strokes from a three (3) liter syringe
The provided document is a 510(k) summary for the Spiro-Master PC-10 Spirometry System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a standalone study proving the device meets those criteria.
Therefore, the requested information, specifically acceptance criteria and a study to prove they are met, sample sizes for test and training sets, details on ground truth establishment, expert qualifications, and MRMC study details, is not explicitly provided in this 510(k) summary.
Instead, the document states:
- "As with the predicate devices, the Spiro-Master PC-10 Spirometry System has been tested for compliance to the ATS1994 (Update), IEC60601-1 and IEC60601-2 standards. In addition the Spiro-Master PC-10 Spirometry System also complies with the ATS2005 standard."
- "Therefore CHEST MI, INC believes that the Spiro-Master PC-10 Spirometry System is substantially equivalent to the predicate devices and does not raise any new questions regarding safety or effectiveness."
This indicates that the device's performance is assessed against the requirements of the ATS (American Thoracic Society) standards (1994 Update and 2005) and IEC (International Electrotechnical Commission) standards (IEC60601-1 and IEC60601-2) for medical electrical equipment safety. These standards would contain the acceptance criteria for spirometry measurements. However, the summary does not detail the specific performance metrics or the study results that demonstrate compliance. It relies on the assertion of compliance with these established standards.
Without the actual study report or further supporting documentation, the specific numerical acceptance criteria and reported device performance directly from a study, the sample sizes, data provenance, ground truth establishment, and MRMC study details cannot be extracted.
Based on the available information, here's what can be inferred and what is missing:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document refers to compliance with ATS 1994 (Update), ATS 2005, IEC60601-1, and IEC60601-2 standards. These standards define performance requirements for diagnostic spirometers (e.g., accuracy for FVC, FEV1, PEF measurements across specified flow/volume ranges).
- Reported Device Performance: The summary states compliance but does not report specific performance values (e.g., "FVC accuracy ±3% or 50mL, whichever is greater" and then "Device achieved FVC accuracy of ±2%"). These details are typically found in the full test report, not usually in a 510(k) summary focused on substantial equivalence.
Conclusion for Table: Cannot be fully populated from the provided text as specific numerical performance results or explicit acceptance criteria specific to this device's testing are not detailed. It only states compliance with general standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The testing is implied to be against engineering/laboratory standards rather than clinical data from patients. The device calculates flow and volume from digitized pressure data, based on a calibration polynomial algorithm. Calibration involves "six (6) varying strokes from a three (3) liter syringe," which is a laboratory calibration process, not a patient test set.
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 question is not applicable in the context of this device. A diagnostic spirometer's "ground truth" for performance testing (i.e., whether it accurately measures flow and volume) is established through highly precise laboratory instruments and calibrated artificial lungs/syringes, not through human expert consensus in the way an AI diagnostic imaging device would. The calibration procedure mentions a "three (3) liter syringe," which is a standard method for establishing the known "ground truth" volume.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical evaluations, which is not described for the technical performance testing of a spirometer. The accuracy is assessed by comparing device measurements to known values from calibrated equipment.
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 device is a diagnostic spirometer, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting images or complex patterns with or without AI assistance. Therefore, an MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The device's core function is to acquire, calculate, and display spirometry parameters. The compliance testing against ATS and IEC standards is essentially a standalone performance evaluation of the device's accuracy and safety, without considering human clinical interpretation improvements. The "algorithm only" performance refers to the device's ability to accurately measure and calculate flow and volume from the pressure transducer's data stream. The claim of compliance with ATS and IEC standards signifies that this standalone performance has been verified.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for performance testing is established by calibrated reference equipment, specifically a known fixed volume (e.g., from a calibrated 3-liter syringe) for volume measurements, and precise flow generators for flow accuracy. This is a laboratory-based, objective ground truth.
8. The sample size for the training set
- Not applicable / Not specified. Spirometers like the Spiro-Master PC-10 typically rely on physics-based algorithms and calibration, not machine learning or AI models that require "training sets" in the conventional sense. The "calibration polynomial algorithm" is derived from physical principles and calibration procedures, not from vast datasets in anticipation of "machine learning" training.
9. How the ground truth for the training set was established
- Not applicable. As explained in point 8, there isn't a "training set" in the context of AI/ML. The calibration of the device (which ensures its accuracy) is done by injecting known fixed volumes from a calibrated syringe and establishing the relationship between differential pressure and airflow/volume. This process sets the "ground truth" for the device's internal algorithms and transducers.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).