(34 days)
The intended function and use of the Drive Solistice Oxygen Concentrator (models 18050 and 18055) is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
The Drive Solstice Oxygen Concentrator is a PSA (Pressure Swing Adsorption) system Oxygen Concentrator, the output of oxygen is 1 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of the adsorption material -molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed top. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the top of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Drive Solstice Oxygen Concentrator:
The provided document is a 510(k) summary for the Drive Solstice Oxygen Concentrator. It primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against pre-defined acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and sample sizes for testing and training sets is not explicitly present in this type of regulatory submission.
The document argues that the device meets acceptance criteria by demonstrating that it is substantially equivalent to a legally marketed predicate device (Zhongshan A&J Medical Equipment Co., Ltd's A&J-POCA01 Oxygen Concentrator - K071608). The underlying assumption is that if the predicate device met its acceptance criteria and the proposed device is equivalent, then the proposed device also meets those implied criteria.
Let's break down what can be inferred or is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria." Instead, it presents a comparison of specifications between the proposed device and two predicate devices. The acceptance criteria are implicitly the performance characteristics of the predicate device, which the proposed device must meet or be comparable to.
| Parameter | Acceptance Criteria (Implied from Predicate - Zhongshan A&J A&J-POCA01 K071608) | Reported Device Performance (Drive Solstice Oxygen Concentrator) |
|---|---|---|
| Oxygen Concentration | 1-5 LPM: 90% ± 3% | 1-5 LPM: 90% ± 3% |
| Delivery Rate | 1 to 5 LPM | 1 to 5 LPM |
| Outlet Pressure | 8.5 psig | 8.5 psig |
| Alarms | pressure relief / thermal protection on compressor, high / low pressure, power failure, low oxygen purity (optional), current overload shutdown | pressure relief / thermal protection on compressor, high / low pressure, power failure, low oxygen purity (optional), current overload shutdown |
| Electrical Rating | 115V/60Hz | 115V/60Hz |
| Power Consumption | 300W average | 300W average |
| Filters | Cabinet, intake, outlet HEPA filter | Cabinet, intake, outlet HEPA filter |
| Dimensions (in. L x W x H) | 12x14x20 | 12x14x20 |
| Weight (lbs) | 38 | 38 |
| Approvals | Class II equip, double insulated, Type B Applied Part | Class II equip, double insulated, Type B Applied Part |
| Operating System | Timed cycle / pressure swing | Timed cycle / pressure swing |
| Sound Level | 45~48dBA | 45~48dBA |
| Operating Environment | 50 to 95 deg. F, Humidity: 30% to 75% | 50 to 95 deg. F, Humidity: 30% to 75% |
| Valve | The dual solenoid, three-position, five-way valve increases shift efficiency, valve life, and reliability and comes with a lifetime warranty | The dual solenoid, three-position, five-way valve increases shift efficiency, valve life, and reliability and comes with a lifetime warranty |
| Compressor | GSE-280A compressor | GSE-280A compressor |
| Oxygen Sensor | Yes (Optional) | Yes (Optional) |
| HEPA Filter | Yes | Yes |
| ASTM 1464 | Meets Standard | Meets Standard |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/not provided. This document does not describe a performance testing study with a "test set" in the traditional sense of a clinical or image-based AI study. The "test" here is a comparison of specifications to a predicate device.
- Data Provenance: Not applicable/not provided. The document states "Medical Depot claims the proposed device to be substantially equivalent to the device previously cleared by FDA in K071608." This implies the "data" is the set of specifications published or known for the predicate devices. There is no mention of country of origin for any new test data or whether it was retrospective or prospective, as no such new test data is presented for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not provided. There is no mention of experts establishing ground truth for a test set, as no such test set or study is described. The "ground truth," in this context, is the established performance and safety of the predicate device, which the FDA has already cleared based on its own review.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. No test set requiring expert adjudication is described in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is typically associated with AI/medical imaging devices, assessing human reader performance with and without AI assistance. The device in question is an oxygen concentrator, a physical medical device, not a diagnostic AI tool.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: No, a standalone algorithm-only performance study was not done or described. This concept is most relevant for AI algorithms. For a physical device like an oxygen concentrator, performance is measured against its technical specifications (e.g., oxygen purity, flow rate, alarms). While the manufacturer would have performed internal testing to ensure the device met its specifications, this 510(k) summary does not detail those specific test results or methodology; instead, it relies on substantial equivalence.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" implicitly used in this 510(k) submission is the established performance and safety of the legally marketed predicate device(s), specifically the Zhongshan A&J A&J-POCA01 Oxygen Concentrator (K071608). The manufacturer is asserting that their device is essentially identical in form, function, and materials, and therefore shares the same "truth" of being safe and effective.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not provided. This concept applies to machine learning models. The Drive Solstice Oxygen Concentrator is a physical device, not an algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable/not provided. As the device is not an AI algorithm, there is no training set or ground truth associated with it in that context.
§ 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).