(81 days)
8080 System is a piece of durable equipment The Drager DVE intended to provide ceiling mounted overhead physical support anaesthesia machines, medical/surgical monitoring and for and ceiling mounted related equipment, storage space, dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.
8080 will be used in the same indications as the DVE The DVE 4000 System and the DVE 8000/1/2 System and the Drager 8032E which provide physical support, storage space, and overhead, ceiling mounted dispensing of medical gases and electrical The DVE 4000 has previously been reviewed by FDA power. (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). The new DVE 8080 Series will be used in indications which are the same as indications for the DVE 4000, DVE 8000, for other pendant systems currently offered for DVE 8032E and commercial distribution in the United States.
The DVE 8080 Series System is a ceiling mounted overhead supply system of modular design. The individual components of any modular system are divided into four categories: ceiling fixture, support systems, pendant head or column, and equipment carrier. The pendant column contains four terminal plates that can be outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc. Add-on terminal boxes are available. The support system consists of either a fixed vertical support tube (DVE 8080 basic version of the series) or a single (DVE 8081) support arm or two (DVE 8082) support arms. The support arms are equipped with pneumatic brakes and are available in three combinable lengths. The DVE 8080 Series System rotates laterally and is powered for up and down adjustment. The motor used in the DVE 8080 is an induction motor manufactured by Gefeg GmbH & Co KG. An equipment shelf provides for better positioning of the medical devices required and can be installed at time of purchase or added-on afterwards. Shelves are available in one standard size: 620 mm (width) by 400 mm.
This document (K961742) is a 510(k) premarket notification for a medical device called the Drager DVE 8080 System. It describes a ceiling-mounted overhead support system for medical equipment in clinical settings. The purpose of this type of submission is to demonstrate substantial equivalence to a predicate device, not to present a detailed study on performance against acceptance criteria in the way a clinical trial for a diagnostic algorithm would.
Therefore, the provided text does not contain the specific information requested about acceptance criteria, device performance studies, sample sizes, expert involvement, or statistical methods typically associated with evaluating AI/software performance.
Instead, the submission focuses on comparing the features and technical specifications of the Drager DVE 8080 Series System to existing predicate devices (DVE 8032E and ORBITER system) to demonstrate that it is substantially equivalent in terms of materials, design, and function.
Here's an analysis based on the provided text, addressing your points where possible and noting where information is absent:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria with a performance study. The tables provided (Table I and Table II) compare features and technical specifications of the DVE 8080 with its predicate devices, rather than showing performance against pre-defined acceptance criteria.
For example, the load-bearing capacity is mentioned: "Maximum load-bearing capacities have been established for all possible numbers and lengths of carrying arm combinations. These numbers have been derived from both UL testing and in-house testing." However, the specific numerical acceptance criteria (e.g., "must support X kg") and the exact reported performance against those criteria are not provided in a table format.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/not present. The submission is for a physical medical device (a support system), not a diagnostic algorithm or a device that processes data in a "test set" in the computational sense. The "test set" would typically refer to data used to evaluate an algorithm's performance.
The text mentions "UL testing and in-house testing" for load-bearing capacities and electrical safety (in accordance with National Electrical Code, ANSI/NFPA), which implies physical product testing. However, details about the sample sizes for these physical tests, their origin country, or whether they were retrospective/prospective, are not provided.
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 information is not applicable/not present. "Ground truth" and "experts" in this context typically refer to establishing definitive diagnoses or classifications for an algorithm's evaluation data. For a physical support system, the "ground truth" would be engineering specifications and safety standards. The testing mentioned (UL, in-house) would be conducted by qualified engineers and technicians, not medical experts establishing ground truth for diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not present. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., interpreting medical images) where multiple readers' opinions need to be reconciled to establish a ground truth. This is not relevant for the physical device described.
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 information is not applicable/not present. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for performance evaluation of AI-driven diagnostic or assistive technologies. The Drager DVE 8080 System is a physical support system; it does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not present. "Standalone" performance refers to an algorithm's performance without human intervention. As this is a physical medical device, not a software algorithm, this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the typical sense for an AI device. For this device, the "ground truth" for safety and performance would be engineering specifications, safety standards (e.g., UL, National Electrical Code), and established functional requirements (e.g., load-bearing capacity, electrical parameters, rotational capabilities). The product's compliance with these standards and specifications is demonstrated through specific tests by organizations like UL and internal company testing.
8. The sample size for the training set
This information is not applicable/not present. "Training set" refers to data used to train a machine learning model. This device is a physical product and does not involve machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable/not present. As there is no training set for an AI model, there is no ground truth established for one.
Summary regarding K961742:
The provided document describes a physical medical device (a ceiling-mounted support system for medical equipment). The information is presented as a 510(k) premarket notification, which aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
The type of "study" detailed is a comparison of features and technical specifications between the new device and its predicates, along with a general statement about meeting safety standards (UL testing, National Electrical Code compliance) and in-house testing for load capacity. This is distinctly different from the type of performance study (e.g., clinical trials, AI algorithm evaluation) that would generate the specific data points requested in your prompt regarding acceptance criteria, sample sizes for data, ground truth establishment, or human-in-the-loop performance.
§ 878.4960 Operating tables and accessories and operating chairs and accessories.
(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.