(56 days)
The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.
It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond & S8 Series CPAP Systems, positive airway pressure flow generators.
The performance and functional characteristics of the ResTraxx Data Center System includes all the performance and functional characteristics of the predicate device, SomnoTraxx System (K030797).
The ResTraxx Data Center System is designed to function with ResMed's S7™ Elite, AutoSet™ Respond and AutoSet Spirit™ CPAP Systems and S8 Series CPAP Systems for the transfer, storage, retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and display of stored information from the flow generators to the clinician. There is no patient access to the system.
The ResTraxx Data Center System comprises two distinct components, ResTraxx or S8 ResTraxx and the Server System. Data taken from the flow generator is transmitted via a wireless network, stored in the Server System and displayed on the Clinical reviewer's PC.
ResTraxx™ and S8 ResTraxx™ are optional wireless modules designed to attach to ResMed S7™ Elite, AutoSet Respond and AutoSet® Spirit or S8 Series flow generators respectively using a docking mechanism. This mechanism allows the device to be electrically connected with the existing expansion port located at the rear of the flow generator. When attached, the ResTraxx can automatically collect patient and machine information stored within the flow generator's memory.
The ResTraxx and S8 ResTraxx sends information utilizing existing messaging networks providing wireless coverage to large portions of the US population.
Server System – The Server System consists of several functional software modules that are designed to retrieve information from ResMed flow generators through the ResTraxx or S8 ResTraxx and a secure into the wireless messaging network, store the information in a database and provide a secure into the wireless messaging network, store the information in a database and provide of the information.
This document (K051314) is a 510(k) premarket notification for the ResTraxx Data Center System, which is a device intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than to prove safety and effectiveness through extensive clinical trials. Therefore, the information provided relates to design verification and validation rather than a typical clinical study with acceptance criteria for device performance.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of detailed acceptance criteria for particular performance metrics and their corresponding reported device performance values. Instead, it states:
| Criterion Type | Details |
|---|---|
| Design & Verification | "Design and Verification activities were performed on the ResTraxx Data Center System as a result of the Design and product requirements. All tests confirmed the product met the acceptance criteria." |
| Risk & Product Req. | "All tests confirmed the product to the product risk and product requirements." (This appears to be a slight typo in the original document, likely meaning "product met the product risk and product requirements.") |
| Substantial Equiv. | "ResMed has determined that the new device is Substantially Equivalent to the predicate device... The new device complies with the FDA guidance documents: FDA Draft Reviewer Guidance for Ventilators (July 1995) and FDA reviewer's and industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information about a specific "test set" in the context of clinical data for performance evaluation. The "tests" mentioned are related to design verification and validation, as typically performed during medical device development. There is no information regarding sample size, country of origin, or retrospective/prospective nature of data for a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the provided document. The submission focuses on demonstrating substantial equivalence through design and functional testing, not through a study involving expert-established ground truth for a clinical "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The document does not describe a clinical study requiring an adjudication method for ground truth.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. The ResTraxx Data Center system is a data transmission and display system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm-only diagnostic tool. It's a system for collecting and displaying existing data from CPAP devices to clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of clinical data (like expert consensus or pathology) is not described in this document. The "truth" for the device's functionality is its ability to accurately transmit and display data as intended, which would be verified through engineering and functional testing.
8. The sample size for the training set
This is not applicable. The device is not a machine learning or AI model that requires a training set of data.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI model.
Summary of what the document indicates for "proving device meets acceptance criteria":
The document states that "Design and Verification activities were performed on the ResTraxx Data Center System as a result of the Design and product requirements. All tests confirmed the product met the acceptance criteria" and "All tests confirmed the product to the product risk and product requirements." This indicates a standard medical device development process where the device's design and functionality were verified against predefined engineering and product requirements. The "acceptance criteria" here refer to internal design specifications, performance standards, and risk mitigation requirements rather than the performance against a clinical ground truth dataset. The primary "proof" of meeting requirements for this 510(k) submission is the demonstration of substantial equivalence to the predicate device (SomnoTraxx System K030797) based on similar intended use, operating principle, technologies, and manufacturing process, and compliance with relevant FDA guidance documents.
§ 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).