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ALM Prismalix (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadows, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. Use.is by surgeons and other medical care givers.

The ALM PRX Surgical Lights will be used in indications which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

The new product known as "Prismalix™" is of similar technology to surgical lights covered under D.C. Number K882613 issued on June 29, 1988. The differences between the new Prismalix™ models and models previously sold are cosmetic along with the addition of a tilting mechanism (in selected models) which allows variations in pattern size.

The surgical light consists of single or multiple lightheads attached to suspension arms supported from hospital installed mounting plates. Light heads can be positioned for optimal illumination of the surgical site by grasping sterilizable handles or non-sterile handles on the lighthead.

Low voltage power is supplied to the light bulb by way of a remote mounted transformer similar to those used by other surgical lighting manufacturers. Light intensity is controlled by a dimmer system, mounted remotely at a wall location.

Illumination is measured in footcandles or lux (1 footcandle equals 10.764 lux). Reference publication RP-29-95 Lighting for Hospitals and Health Care Facilities chapter 4, section 11, page 18. Illuminating Engineering Society of North America. New York, NY 1995. IES recommends a minimum illumination level at the surgical site of 2,500 footcandles when the light is positioned one meter above the site. The Prismalix™ series meets and exceeds this recommendation.

The previous range of lighting covered under K882613 is referenced by the three sizes of light heads; 500 mm or 5000 series, 700mm or 7000 series, and 900mm or 9000 series. The Prismalix™ series will be referenced by three sizes of light heads; 400mm or 4000 series, 600mm or 6000 series, and 800mm or 8000 series.

It is possible to provide a fixed focus video camera in selected 4000 series light heads. This Prismavision camera is similar in overall design and construction to the current ALM fixed focus camera, and other surgical/endoscopic video cameras offered for commercial distribution in the United States.

The provided document describes the ALM Prismalix™ Surgical Light and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance in the context of an AI/ML device. Therefore, many of the requested categories for AI/ML device evaluation (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, or standalone performance) are not applicable to this submission.

However, I can extract information related to the device's technical specifications and how its performance is compared to established standards and predicate devices.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance (for a Traditional Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

For this traditional medical device (surgical light), "acceptance criteria" are implied by industry standards and performance metrics of predicate devices. The primary acceptance criterion identified is illumination level.

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

Not applicable. This is a submission for a traditional medical device (surgical light), not an AI/ML device that uses test sets or training sets from patient data. The "test" in this context refers to engineering and safety testing of the physical product.

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

Not applicable. Ground truth for AI/ML models is not relevant here. Device performance is measured against established engineering standards and specifications.

4. Adjudication Method for the Test Set

Not applicable for a traditional medical device submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not an AI/ML device and human reader performance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is based on:

• Engineering Specifications and Standards: Such as IES RP-29-95 for illumination levels and IEC 601-2-41 for safety.
• Performance of Legally Marketed Predicate Devices: The device's features and performance are directly compared to existing, cleared surgical lights to demonstrate substantial equivalence.
• Safety Testing Certifications: UL and C-UL marks from Underwriters Laboratories confirm adherence to safety standards.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML system requiring a training set of data.

9. How the ground truth for the training set was established

Not applicable.

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Drager Gemina System is a nonpowered piece of durable The equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms.

The Gemina System will be used in the same indications as other systems which provide overhead or wall mounted physical support and storage of equipment for dispensing of medical gases and electrical power.

The Gemina System is a wall mounted supply system of modular design. The individual components of this modular system are wall fixture, horizontal element, column, support tube, and equipment carrier (shelf).

column contains two large terminal plates that can be The outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.

The provided text is a summary of safety and effectiveness for the Drager Gemina Wall-Mounted Workplace System, a non-powered device intended to provide physical support for medical equipment, storage, and dispensing of medical gases and electrical power. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical device that generates diagnostic or prognostic outputs, or measures a physiological parameter.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a clinical study. Substantial equivalence is a regulatory pathway for class II devices in the US, where a new device is shown to be as safe and effective as a legally marketed predicate device.

Therefore, many of the requested categories (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to what constitutes "performance" and "safety" in the context of this device's intended use and the provided comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission as a substantial equivalence claim for a physical support system, the "acceptance criteria" are implicitly met by demonstrating equivalence to predicate devices in design, materials, function, and safety features. Performance is described in terms of its features and comparability to other marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study involving a test set with patient data or performance metrics that would require a sample size. The "test" here is a comparison against predicate devices' specifications and functional descriptions. The data provenance is a regulatory filing for a device manufactured in the Federal Republic of Germany, distributed in the United States.

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)

Not applicable. "Ground truth" in the context of evaluating a physical support apparatus's equivalence to existing products does not involve clinical experts establishing a diagnosis or outcome. The "truth" is established by comparing the device's design, materials, and functional specifications to those of legally marketed predicate devices, which is part of the regulatory review process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the conventional sense of a clinical or performance study that would require an adjudication method.

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

Not applicable. This device is a physical support system and does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have an "algorithm" or standalone performance in the context of diagnostic or therapeutic functions. Its "performance" is its ability to physically support equipment, deliver gases/electricity, and its safety features.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this regulatory submission is the specifications, features, and safety profiles of legally marketed predicate devices (DVE 4000 and Horizon Headwall System). The Gemina System's "truth" is established by demonstrating that its characteristics are substantially equivalent to these predicates.

8. The sample size for the training set

Not applicable. This is not a machine learning or data-driven device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device submission.

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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.

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