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The Pulse Dose Series devices are fundamentally repackaged versions of the OMS 20 and 50, DeVilbiss' current Oxygen Management Systems. The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liguid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.
The provided text describes a 510(k) summary for DeVilbiss Health Care's "Oxygen Management Systems" (Pulse Dose Series). This document focuses on demonstrating substantial equivalence to predicate devices (OMS 20 and 50) rather than presenting a study against specific acceptance criteria for a novel device. As such, the information needed to fill out all the requested sections for a study proving device meets acceptance criteria is largely absent.
Here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the traditional sense for a new medical device study. Instead, it focuses on demonstrating that the performance of the Pulse Dose Series is identical to the predicate devices (OMS 20 and 50).
| Acceptance Criteria (Implied) | Reported Device Performance (Pulse Dose Series) |
|---|---|
| Gas dosage methodology is identical to predicate devices | Dosage methodology is identical to OMS 20 and 50. |
| Oxygen delivery specifications are identical to predicate devices | Oxygen delivery specifications are identical to OMS 20 and 50. |
| Overall performance is identical to predicate devices | Performance of the devices in the Pulse Dose Series are identical to those of the OMS 20 and 50. Non-clinical testing reveals the same dosage delivery. |
| Energy source is the same type as predicate devices | Utilizes batteries as the energy source, same as OMS 20 and 50. |
| Materials are substantially the same as predicate devices | No significant changes in materials compared to OMS 20 and 50. |
| No greater risk to the end user than predicate devices | Tests and analysis indicate no greater risk to the end user than with the predicate devices. |
| Performance for the end user is not altered | Performance for the end user is identical to OMS 20 and 50; performance is not altered despite improvements. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "various comparison matrices and testing reports" and "non-clinical testing" but does not provide details on the number of units tested or the duration/scope of these tests.
- Data Provenance: Not specified. It's likely internal testing by DeVilbiss Health Care, Inc. The nature of a 510(k) submission generally involves in-house testing for substantial equivalence. It does not mention country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The assessment relies on engineering and technical comparisons to the predicate devices, not on expert clinical evaluation for establishing a "ground truth" in the clinical sense.
4. Adjudication method for the test set:
This information is not provided. As implied in point 3, there's no mention of expert consensus or adjudication. The determination of "identical" or "substantially equivalent" would be based on comparison of technical specifications and test results.
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:
This is not applicable. The device is an oxygen management system, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is a hardware medical device with some "technological improvements (microprocessor control)," but it's not an algorithm meant to operate independently in a diagnostic or interpretive capacity.
7. The type of ground truth used:
The "ground truth" in this context is the performance and specifications of the predicate devices (OMS 20 and 50). The Pulse Dose Series is being compared directly against these established devices to demonstrate equivalency. This is a technical comparison rather than a clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set:
This is not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable as there is no training set mentioned.
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DeVilbiss Health Care, Inc.
1200 East Main Street
P.O. Box 635
Somerset, PA 15501-0635
U.S.A.
(814) 443-4881
Fax: (814) 443-7572
CT 21 1996
510 (k) Summary 16.0 Summary of Safety and Effectiveness
| Firms name: | DeVilbiss Health Care, Inc.Pulsair DivisionP.O. Box 26094106 Avenue DFort Pierce, Fla. 34954 |
|---|---|
| Submitter's name: | Gregory W. Good |
| Phone: | (814) 443-7466 |
| Fax: | (814) 443-7571 |
| Date of Preparation: | 9 October 1996 |
| Trade name: | Oxygen Management Systems |
| Common name: | Pulse Dose Series |
| Classification name: | Non-Continuous Ventilators 73BZD (21 CFR 868.5905 |
The Pulse Dose Series devices are fundamentally repackaged versions of the OMS 20 and 50, DeVilbiss' current Oxygen Management Systems. The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liguid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.
The gas dosage methodology, oxygen delivery specifications, and performance of the devices in the Pulse Dose Series are identical to those of the OMS 20 and 50. This is evidenced in the various comparison matrices and testing reports contained in this 510(k). This equivalency is also evidenced in the non-clinical testing which reveals the same dosage delivery when comparing the predicate devices with the devices in the Pulse Dose Series. The device's performance to the end user are identical as compared to the OMS 20 and 50.
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2004
When compared to the predicate devices, the OMS 20 and 50, the devices in the Pulse Dose Series utilize the same type of energy source, and there are no significant changes in the materials or features.
All the devices in the Pulse Dose series utilize batteries as the energy source, as do the OMS 20 and 50. The fundamental operational features are identical; however, the devices in the Pulse Dose Series include some additional features, e.g.,battery level indicator, which make the devices more user friendly.
The differences between the devices in the Pulse Dose Series and the OMS 20 and 50 can be categorized as additional patient features (battery level indicator), technological improvements (microprocessor control), or re-packaging (improved cosmetics and manufacturing /servicing assembly). Tests and analysis indicate that there is no greater risk to the end user than there is with the predicate devices. These device improvements were intended to make the devices in the Pulse Dose Series more user friendly while increasing their reliability, without altering their performance for the end user.
Therefore, based on the above mentioned similarities, especially the dosage methodology, the Pulse Dose Series devices and the OMS 20 are substantially equivalent devices.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).