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The DeVilbiss PD1000 Compact Conserver is intended as a delivery device for medial-grade oxygen from high-pressure oxygen cylinders. This is an ambulatory device, which allows patients to ambulate Joneer than they would with a continuous flow regulator on the same cylinder.

The DeVilbiss PD1000 compact conserving device is designed to extend the use time of oxygen cylinders. The device uses PulseDose technology to accomplish the oxygen savings. PulseDose senses the start of inhalation and instantly releases a short "pulsed" dose at the very beginning of the inhalation cycle. Since all of the "pulsed" oxygen finds its way deep into the lungs, less oxygen is required to accomplish the same effect than with traditional continuous flow oxygen systems.

The PD1000 compact conserving device contains an integral pressure regulator with CGA 870 style yoke. The pressure regulator reduces the cylinder pressure to 19 - 25 psig. The PD1000 then delivers oxygen to the patient by sensing inhalation via a pressure switch and opening a two-way valve for a specified period of time controlled by a microprocessor. The unit is designed to deliver 16.5 cc/lpm of oxygen to the patient at 1.0. 1.5. 2.0, 2.5, 3.0, 4.0, 5.0 and 6.0 flow settings. The unit is powered by two "AA" alkaline or nickel metal hydride batteries. The PD1000 has a continuous flow back-up mode that will deliver 2 ipm continuous to the patient in the event of a device failure or dead batteries.

The device has two LED's that indicate battery status and valve activation. When the unit is first turned on, either a red or green LED will flash to indicate the unit is turned on and the battery status. Each time the valve is activated during an inhalation, the red or green LED will flash to indicate the valve was activated and the battery status. The device will operate approximately 4 -- 8 hours when the red LED first begins to flash. When the battery voltage drops below approximately 1.9 vdc the red LED will remain on continuously and the valve will no longer operate. The continuous flow back-up mode can still be used to provide oxygen therapy to the patient when the batteries are no longer able to operate the unit.

The ability of the PD1000 to detect patient inspirations is based on the sensitivity of the pressure switch which is set within a range of .1 to .25 cm H2O. The device is capable of delivering a bolus of oxygen at the beginning of each inhalation up to 40 breaths per minute (every 1.5 second minimum delay between breaths will cause the device to "skip" breaths at rates greater than 40 breaths per minute.

Here's an analysis of the provided text regarding the DeVilbiss PD1000 Oxygen Conserver and its acceptance criteria, focusing on the requested information:

Acceptance Criteria and Device Performance for DeVilbiss PD1000 Oxygen Conserver (K020329)

The submission for the DeVilbiss PD1000 primarily focuses on demonstrating substantial equivalence to its predicate device, the DeVilbiss EX2000 PulseDose Conserver, through technological characteristic comparisons and performance data. The core acceptance criteria revolve around matching the pulse volumes of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "The pulse volumes of the PD1000 were compared to the pulse volumes of the EX2000 predicate device. The pulse volume in cubic centimeters, valve "ON" time and waveform of the pulse volume or "bolus" was recorded for each setting of the PD1000. This data was also obtained for the same settings on the EX2000."

• Sample Size for Test Set: Not explicitly stated in terms of the number of unique device units tested or the number of measurements taken per unit. It refers to "each setting" and "same settings." However, given the nature of the device (mechanical/electronic), the sample size would likely refer to a representative number of manufactured units. Specific numbers are not provided.
• Data Provenance: The study appears to be an internal, prospective laboratory study conducted by the manufacturer, Sunrise Medical HHG, Inc., Respiratory Products Division, located in Somerset, PA, USA. There is no indication of external data sources or retrospective analysis of clinical patient data.

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

• Number of Experts: Not applicable. The "ground truth" for the performance data (pulse volumes, breath detection sensitivity, etc.) was established through direct measurement and comparison to the predicate device's performance, not through expert consensus on qualitative data.
• Qualifications of Experts: Not applicable. The performance data is quantitative and measured instrumentally.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "test set" involves direct technical measurements of physical characteristics (e.g., pulse volume, valve "ON" time, sensitivity). These are objective measurements and do not require human adjudication in the way that, for example, classifying medical images would.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study is a non-clinical, technical comparison of the new device's performance against a predicate device's measured performance in a laboratory setting.
• Effect Size: Not applicable, as no MRMC study was conducted. The study is focused on demonstrating technical equivalence rather than a clinical improvement over a human-in-the-loop process.

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

• Standalone Performance: Yes, the performance evaluation described is entirely standalone. The device (DeVilbiss PD1000) was tested intrinsically for its ability to produce specific pulse volumes and detect breath events, independent of a human operator influencing its core function during the test. There is no "human-in-the-loop" aspect to the technical performance measurements described.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is primarily objective, quantitative measurements of physical characteristics and performance parameters, directly observed and compared to the established performance of the legally marketed predicate device (DeVilbiss EX2000 PulseDose Conserver). In essence, the predicate device's performance served as the "ground truth" for the new device's expected performance. There is no mention of pathology, expert consensus, or outcomes data for this specific validation.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical/electronic oxygen conserver, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "programming" of the device involves fixed valve times programmed during assembly, not learned parameters from a data set.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set." The device's operational parameters (e.g., fixed valve times) are pre-programmed based on engineering design and prior knowledge from the predicate device, not established through an iterative training process with a ground truth dataset.

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