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510(k) Data Aggregation
(112 days)
Smart Check O2 (MA0236)
The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service and repair centers.
The Smart Check O2 is an ultrasonic oxygen analyzer, used to verify the performance of oxygen concentrators. The device is typically used by durable medical equipment technicians while servicing concentrators in their workshops or while visiting patient homes, but it is not left with the patient and is not patient contacting.
The device measures the performance of the oxygen concentrator by making ultrasonic time-of-flight measurements, both upstream and downstream. Gas flow rate and oxygen concentration are determined using the resulting data. Temperature and pressure sensors inside the sample cell allow for accurate flow and oxygen readings over the range of specified operating environment conditions.
Oxygen and flow readings are shown to the user on the display. The Smart Check O2 can be toggled into a mode for testing pulsing (conserving) oxygen concentrators wherein it displays oxygen concentration and pulse volume instead of flow rate. The user may initiate a pressure check mode by stopping the sample exhaust port with their finger during which the Smart Check O2 measures and displays the maximum pressure generated by the concentrator. The user may also enter a calibration check mode and deliver pure oxygen to the Smart Check O2 to verify its performance. However, it does not require regular calibration after manufacturing.
The Smart Check O2 is for prescription use only.
Key Components:
- Handheld analyzer unit
- Removable battery door
- Replaceable sample tube
- Two Alkaline AA cells
The provided FDA 510(k) Clearance Letter for the Smart Check O2 device does not contain the specific details of a study proving the device meets acceptance criteria, nor does it present acceptance criteria in a structured table format with reported performance. The document focuses on demonstrating substantial equivalence to a predicate device, and the "Non-Clinical Performance Data" section primarily lists compliance with consensus standards, rather than presenting test results against performance specifications.
Therefore, for the purpose of answering your request, I will extract relevant performance specifications from the "Substantial Equivalence Comparison Table" and present them as "Acceptance Criteria" and "Reported Device Performance." Please note that these are derived from the comparison table and are not explicitly stated as "acceptance criteria" within the provided text.
Here's an attempt to reconstruct the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
As the document does not explicitly present acceptance criteria or detailed study results in a table, the following table is constructed from the performance specifications listed in the "Substantial Equivalence Comparison Table" where the Subject Device (K250002) performance characteristics are taken as the "Reported Device Performance" and are implicitly assumed to have met an internal "Acceptance Criteria" derived from either design requirements or predicate device performance.
| Performance Metric | Acceptance Criteria (Derived from Subject Device Spec) | Reported Device Performance (Subject Device K250002) |
|---|---|---|
| Oxygen Measurement Range (concentrator) | 20.9 - 96% | 20.9 - 96% |
| Oxygen Measurement Accuracy | +/- 1.5% | +/- 1.5% |
| Oxygen Measurement Resolution | 0.1% | 0.1% |
| Flow Measurement Range | 0-10 LPM | 0-10 LPM |
| Flow Measurement Accuracy | +/- 0.2 LPM | +/- 0.2 LPM |
| Flow Measurement Resolution | 0.1 LPM | 0.1 LPM |
| Pressure Measurement Range | 0 - 40 PSI | 0 - 40 PSI |
| Pressure Measurement Accuracy | +/- 0.5% of reading | +/- 0.5% of reading |
| Pressure Measurement Resolution | 0.1 PSI | 0.1 PSI |
| Pulse Volume Measurement Range | 3 - 200 ml | 3 - 200 ml |
| Pulse Volume Measurement Accuracy | +/- 3 ml | +/- 3 ml |
| Pulse Volume Measurement Resolution | 0.1 ml up to 100 ml, 1 ml above 100 ml | 0.1 ml up to 100 ml, 1 ml above 100 ml |
| Response Time | ≤ 10 seconds (implicitly improved from predicate) | 10 seconds |
| Start-up (Warm-up) Time | ≤ 2.5 seconds (implicitly acceptable despite predicate being faster) | 2.5 seconds |
| Operating Temperature | 5˚C - 40˚C | 5˚C - 40˚C |
| Storage Temperature | -25˚C - 70˚C | -25˚C - 70˚C |
| Atmospheric Pressure | 700 – 1060 hPa (mbar) | 700 – 1060 hPa (mbar) |
| Humidity | 0 - 90% (non-condensing) | 0 - 90% (non-condensing) |
| Battery Life | > 16,000 read cycles | > 16,000 read cycles |
| Electromagnetic Emissions Compliance | Group 1, Class B | Group 1, Class B |
| Ingress Rating | IP22 | IP22 |
The provided document describes a 510(k) submission, which primarily focuses on demonstrating "substantial equivalence" to a predicate device. It does not describe a clinical study involving human subjects or interpretation of medical images. Instead, it details the technical performance of a medical device (an oxygen gas analyzer) used for servicing other medical equipment (oxygen concentrators).
Therefore, many of the requested items related to clinical studies, expert consensus, and human reader performance are not applicable to this type of device submission as described in the provided text.
Based on the information given, here's what can be inferred for the other requested points:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "non-clinical tests" and demonstrates compliance with standards. Testing would involve a number of units of the Smart Check O2 device under various conditions.
- Data Provenance: Not explicitly stated. Given it's a device performance test, the data would likely be generated in a lab setting by the manufacturer, Life Spark Medical. It would be prospective data collected during device testing and verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. This device measures physical parameters (oxygen purity, flow, pressure, pulse volume). The 'ground truth' is established by calibrated reference standards and test equipment, not by human experts interpreting clinical data.
4. Adjudication Method for the Test Set
- Not applicable. Since the ground truth for device performance is based on measurements against calibrated physical standards, there is no human interpretation or adjudication process as would be seen in, for example, a radiology study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI vs. Human Assistance
- Not applicable. This is not an AI-powered diagnostic device that assists human readers. It's a measurement tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The performance metrics (accuracy, range, resolution, response time, etc.) are characteristics of the device itself (its internal sensors and algorithms) without human intervention in the measurement process, beyond initiating the test. The "Substantial Equivalence Comparison Table" lists these standalone performance characteristics.
7. The Type of Ground Truth Used
- The ground truth for the performance metrics (oxygen purity, flow, pressure, pulse volume) would be established by calibrated reference standards and test equipment (e.g., precise gas mixtures for oxygen purity, calibrated flow meters, and pressure gauges).
8. The Sample Size for the Training Set
- Not applicable/Not stated. This document describes a physical measurement device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data for model training. The device's underlying technology is ultrasonic time-of-flight measurements, which is a physics-based method, not a data-driven learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a non-AI/ML device, the concept of a training set and its ground truth is not relevant here. The device's accuracy relies on its design, component quality, and calibration procedures.
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