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The Albacomp Personal Monitor is intended to display video images while mounted on the user's head.

In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques of videoendoscopy, relates to the disconnection between instrument movements on the video monitor and the doctor's hand movements. With the displacement and axial rotation of the monitor, the doctor must re-learn the image to tissue relationship at each procedure, and witheach manipulation of the camera. With this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South to North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend.

The Albacomp Personal Monitor projects a high resolution color video image that appears in the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area where the image appears; otherwise users are free to view the surrounding environment. The Albacomp Monitor provides an added convenience to surgeons compared to conventional monitors. The device enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The Albacomp Personal Monitor can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD displays require.

The Albacomp Personal Monitor is a monoscopic binocular displays with a relatively narrow field of vision. The Albacomp Personal Monitor takes standard video signals and displays them on a small TFT-LCD display that can be connected to any standard video source. The Albacomp Personal Monitor consists of a monitor block, eyeglasses, cable and controller box. The monitor block contains the display for Albacomp Personal Monitor, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD display. The LCD direct display control signals are sent through a flexible shielded cable to the displays.

The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V AC-DC adaptor with low EMI.

All components and accessories of the device are marketed as non-sterile.

Here's the analysis of the provided text regarding the Albacomp Personal Monitor:

Based on the provided "510(k) Summary" document, the Albacomp Personal Monitor is a Head Mounted Display/Virtual Display Device intended to display video images while mounted on the user's head, primarily for use in endoscopic procedures.

Important Note: This document describes a 510(k) submission, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. This process typically relies on comparing technical specifications and intended use rather than extensive clinical studies with specified acceptance criteria and performance metrics against ground truth. Therefore, many of the requested points regarding acceptance criteria, study details, and comparative effectiveness will not be explicitly present or directly derivable from this type of regulatory submission. The information below reflects what can be extracted from the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goal (Implied by Substantial Equivalence to Predicate)

Summary of Device Performance: The Albacomp Personal Monitor is stated to be substantially equivalent to the predicate device in terms of intended use and technological characteristics, thus implying it meets the performance characteristics of the predicate. The document doesn't provide specific numerical performance metrics (e.g., contrast ratio, luminance, refresh rate) that would typically be associated with explicit "acceptance criteria" for a novel device. Instead, the demonstration of equivalence relies on shared fundamental design and functional principles.

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

The provided document does not describe a specific test set or a study conducted to generate performance data for the Albacomp Personal Monitor against acceptance criteria in the traditional sense of a clinical trial or performance study.

The "study" cited is the 510(k) premarket notification process, which is a regulatory pathway. The "data provenance" is largely the comparison to already cleared predicate devices (MedVision Personal Monitor Models A & B, K961343, and Vista Medical Technologies' Head Mounted Display, K961800). The submission focuses on demonstrating that the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

Therefore, there is no explicit test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for this specific device's performance testing reported in this summary.

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

As no specific performance test set (clinical or analytical) for the Albacomp Personal Monitor is described in this document, there were no experts used to establish ground truth in the context of device performance metrics for a study.

The "experts" involved would be the FDA reviewers who assessed the substantial equivalence claim, comparing the device to the predicate information and relevant regulatory standards. Their qualifications are not specified in this document.

4. Adjudication Method for the Test Set

Since no specific test set or performance study is described, there was no adjudication method reported for a test set in this document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document does not describe any studies involving human readers or comparative effectiveness with or without AI assistance.

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

The Albacomp Personal Monitor is a hardware device (a head-mounted display), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device.

7. The Type of Ground Truth Used

Given the nature of this 510(k) submission, the "ground truth" implicitly refers to:

• The established safety and effectiveness profile of the predicate devices (MedVision Personal Monitor Models A & B, and Vista Medical Technologies' Head Mounted Display).
• Compliance with recognized electrical and medical device safety standards (IEC-601-1, IEC-601-2, IEC 10004-3).
• Technical specifications that are comparable to those of the predicate devices.

There is no "expert consensus, pathology, or outcomes data" ground truth established for this device's performance in this document.

8. The Sample Size for the Training Set

This question is not applicable as the Albacomp Personal Monitor is a physical display device, not an AI/ML algorithm or system that requires a "training set."

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

This question is not applicable as the Albacomp Personal Monitor is a physical display device, not an AI/ML algorithm or system that requires a "training set" with established ground truth.

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