(267 days)
The Portable Oxygen Concentrator, model: Spirit-3, is intended to provide supplemental oxygen in a home, institutional, or travel environment. And the device is used with adult only, not used with pediatrics, infant, or neonate patients, etc.
Portable Oxygen Concentrator, model: Spirit-3, is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to deliver oxygen from the concentrator to the patient. The Portable Oxygen Concentrator is small, portable and may be used in home, institutional, or travel environment. Portable Oxygen Concentrator, model: Spirit-3, is capable of continuous use in a home, institutional, or travel environment. Power options include 100 – 240 V (50/ 60Hz) AC power supply, DC power supply and rechargeable lithium-ion battery. The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories.
The FDA 510(k) clearance letter and supporting documentation for the Portable Oxygen Concentrator (Spirit-3) do not describe a study involving an AI/ML component or human readers. Therefore, there is no information available regarding acceptance criteria related to AI/ML performance, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
The provided document focuses on demonstrating the substantial equivalence of the Spirit-3 Portable Oxygen Concentrator to predicate devices through technical specifications, non-clinical performance testing (bench testing), and compliance with various international standards. The "performance" being discussed in the document refers to the physical and functional performance of the oxygen concentrator itself (e.g., oxygen concentration, flow control, electrical safety, biocompatibility), not the performance of an AI/ML algorithm in an image or data interpretation task.
Therefore, many of the requested categories are "Not Applicable" (N/A) in the context of this specific regulatory submission.
However, I can extract the acceptance criteria and reported device performance for the Spirit-3 Portable Oxygen Concentrator based on the non-clinical tests described.
Here's the information derived from the provided text, adapted to the requested format where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature / Test | Acceptance Criteria (from Standards/Predicate Device Comparison) | Reported Device Performance (Spirit-3) |
|---|---|---|
| Oxygen Concentration | 90%-3%/+6% at all settings (Same as predicate) | 90%-3%/+6% at all settings |
| Startup time | 2 minutes (Same as predicate) | 2 minutes |
| Acoustic Noise | Similar to 55.3 dBA at 0.84 LPM (predicate) | 55 dBA at 0.75 LPM (Similar) |
| Electrical Safety | Compliance with IEC 60601-1 | Complied with ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69, ISO 80601-2-67, IEC TS 60601-4-2:2024, CISPR 25: 2021 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Biocompatibility - Cytotoxicity | Compliance with ISO 10993-5:2009 | Tested and complied (explicitly stated in "Discussion of difference" for patient contact materials) |
| Biocompatibility - Sensitization | Compliance with ISO 10993-10:2021 | Tested and complied (explicitly stated in "Discussion of difference" for patient contact materials) |
| Biocompatibility - Irritation | Compliance with ISO 10993-23:2021 | Tested and complied (explicitly stated in "Discussion of difference" for patient contact materials) |
| Biocompatibility - Particulate Matter (Breathing Gas Pathway) | Compliance with ISO 18562-2:2017 | Tested and complied |
| Biocompatibility - Volatile Organic Compounds (Breathing Gas Pathway) | Compliance with ISO 18562-3:2017 | Tested and complied |
| Software Verification & Validation | Performs as intended according to FDA Guidance | Performed and demonstrated as intended |
| Battery Safety | Compliance with IEC 62133-2 | Tested and verified via IEC 62133-2 |
| Operating Condition (Temperature) | Within acceptable range (Predicate: 5 to 40˚C) | 10˚C to 35˚C (Narrower, but compliant with ISO 80601-2-69) |
| Operating Condition (Humidity) | Within acceptable range (Predicate: 10% to 90%) | 15% to 75%, noncondensing (Narrower, but compliant with ISO 80601-2-69) |
| Operating Condition (Altitude) | Within acceptable range (Predicate: 0 to 3048 meters) | 0 to 3000 meters (Narrower, but compliant with ISO 80601-2-69) |
| Pulse mode bolus size | Similar to 42 mL per breath at setting 4 with 20 BPM (predicate) | 37.5mL per breath at setting 4 with 20BPM (Smaller, but covered by subject device and does not raise new questions of safety and effectiveness) |
| Rated breath rate | Similar to 10 - 40 Breath per minute (predicate) | 15 - 40 Breath per minute (Narrower, but meets ISO 80601-2-67:2020 requirement for disclosure and covered by predicate range) |
| Maximum oxygen discharge pressure | Close to 151.68kPa (22psi) (reference device) | 150kPa (21.8psi) (Higher than predicate, close to reference device, no new questions of safety/effectiveness) |
Study Proving Device Meets Acceptance Criteria
The study conducted to prove the Spirit-3 Portable Oxygen Concentrator meets its acceptance criteria was a series of non-clinical bench tests and evaluations demonstrating compliance with recognized consensus standards and comparison to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm being evaluated. For the performance testing of the physical device, it implicitly refers to the specific unit(s) of the Spirit-3 device undergoing testing. The document does not specify the number of devices tested but implies standard product testing.
- Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturing and submission process for Jiangsu Yuyue Medical Equipment & Supply Co., LTD. (China). This is prospective testing of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical oxygen concentrator, not an AI/ML diagnostic or interpretative device that requires expert ground truth for output validation.
4. Adjudication method for the test set:
- Not Applicable. As no expert interpretation was required. Device performance was objectively measured against predefined standard requirements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is relevant for AI/ML systems that assist human readers in tasks like image interpretation. The Spirit-3 is a portable oxygen concentrator and does not involve human reading or AI assistance in that capacity.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device does not involve a standalone algorithm for diagnostic or interpretative purposes. "Standalone" performance in this context refers to the device's inherent mechanical, electrical, and oxygen delivery performance.
7. The type of ground truth used:
- The "ground truth" for the performance of the portable oxygen concentrator is defined by the international consensus standards mentioned (e.g., ISO 80601-2-69, ISO 80601-2-67, IEC 60601-1, ISO 10993 series) and the specifications of the predicate devices. These standards provide benchmarks and methodologies for evaluating physical and electrical safety, essential performance, and biocompatibility.
8. The sample size for the training set:
- Not Applicable. This device does not use an AI/ML training set.
9. How the ground truth for the training set was established:
- Not Applicable. No AI/ML training set was employed for this device.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).