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The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

The HOLOSCOPE-i is a software-controlled optical system that displays 3D holographic medical images. The system generates color 3D holograms from 3D volumetric imaging datasets acquired from standard imaging modalities such as CT and 3D ultrasound. The HOLOSCOPE-i is comprised of an Optical Unit that creates the optical path for the generation of the holographic image; a system computer and electronics supporting the Human Machine Interactions (HMI) and a graphical user interface (GUI) display; a cart and boom mechanical fixture that mechanically connects the Optical Unit and the system computer; and a 3D Control Device for interfacing with the hologram.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: HOLOSCOPE-i (Medical display workstation for 3D image visualization and interaction)

Intended Use: The HOLOSCOPE-i is a medical display workstation intended for 3D image visualization and image interaction. The holograms are generated from 3D volumetric data acquired from CT and Ultrasound sources. The device is intended to provide visual information to be used by the healthcare professional for analysis of surgical options, and the intraoperative display of the images. The HOLOSCOPE-i is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. The HOLOSCOPE-i is intended to be used as a reference display for consultation to assist the clinician who is responsible for making all final patient management decisions.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two main clinical studies: an "Expert Evaluation study" primarily focusing on visualization and ease of identification, and a "comparative clinical study" establishing substantial equivalence through measurement agreement. While explicit "acceptance criteria" values are not presented in a table format with pass/fail thresholds, the outcomes of these studies serve as the "reported device performance" against implied clinical acceptance.

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

• Expert Evaluation Study:
  • Sample Size: 10 adult 3DTEE images and 10 adult CT images.
  • Data Provenance: Not explicitly stated, but clinical studies are generally conducted with patient data. No indication of specific country or retrospective/prospective nature is provided.
• Comparative Clinical Study:
  • Sample Size: 41 adult Mitral Valve images (19 normal, 22 pathological).
  • Data Provenance: Not explicitly stated. Assumed to be retrospective clinical images for such a comparative measurement study. Nothing about country of origin is mentioned.

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

The document refers to "expert evaluators" in the "Expert Evaluation study" but does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience"). For the comparative study, it refers to a "validated reference device" for ground truth comparison, implying an established, accurate measurement method rather than a panel of human experts directly establishing ground truth for the measurements themselves.

4. Adjudication Method for the Test Set

• Expert Evaluation Study: The document states that "All landmarks were identified for all images and ease of identification, as expected, was scored at least 3, with 99% of identifications scoring 5 (very easily)." This phrasing suggests consensus or high agreement, but an explicit adjudication method (e.g., 2+1, 3+1, majority vote) is not described.
• Comparative Clinical Study: For the measurement comparison, the "validated reference device" serves as the standard, so human adjudication of measurements is not the primary method for ground truth establishment. Agreement was measured against this reference.

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

• An MRMC study per se comparing human readers with and without AI assistance was not explicitly described.
• The "Expert Evaluation study" involved expert evaluators assessing the device's visualization capabilities, which is a form of human interaction with the device.
• The "Comparative clinical study" focused on the device's measurement agreement with a reference device, rather than human reader performance improvement.

Effect Size: Not applicable, as a direct MRMC comparative effectiveness study for human reader improvement with AI assistance was not detailed.

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

The device, HOLOSCOPE-i, is a display workstation for human users. Its intended use inherently involves human interaction ("visual information to be used by the health care professional," "assist the clinician"). Therefore, standalone algorithm-only performance metrics separate from human interaction are not directly relevant to its function and were not a focus of the described clinical evaluations. Performance tests cover resolution, sharpness, luminance, contrast, color, 3D fidelity, orientation, and measurement accuracy, which are technical standalone performance aspects, but these are assessed for the purpose of supporting the human user's visual perception and interaction.

7. The Type of Ground Truth Used

• Expert Evaluation Study: The ground truth for this study was the pre-identified anatomical landmarks. The experts' role was to identify these landmarks using the device and assess the ease of identification and spatial perception. The existence and location of these landmarks implicitly serve as the ground truth. This combines aspects of expert consensus (likely used to pre-identify the landmarks) and defined anatomical structures.
• Comparative Clinical Study: The ground truth for the measurements was established by a "validated reference device" (K132165 - Philips QLAB Quantification (MVN) Software). This is a previously cleared or established measurement tool, implying its measurements are considered accurate and reliable.

8. The Sample Size for the Training Set

The document focuses solely on the validation/test sets for demonstrating performance and substantial equivalence. It does not provide any information regarding the training set size for the algorithms that generate the holographic display or process the 3D data.

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

As no information is provided about the training set, there is no information on how its ground truth was established.

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QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems.

Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. It can be used for the off-line review and quantification of ultrasound studies.

QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. QLAB software functions through Q-App modules, each of which provides specific capabilities.

QLAB builds upon a simple and thoroughly modular design to provide smaller and more easily leveraged products.

Philips Ultrasound is submitting this 510(k) to address QLAB 11.0 modifications which include:

• Dynamic Heart Model (DHM) an enhancement to the Heart Model Quantification ● application that provides tracking of the entire cardiac cycle
• QLAB functionality upgraded to the HSDP Platform 2 from the HSDP Platform 1 ●
• O-Store Shared central database supporting multiple clients. .

The document provided is a 510(k) premarket notification for the Philips QLAB Advanced Quantification Software. It states that the submission is for modifications to an existing device (QLAB 10.8 K171314) and does not introduce new indications, modes, features, or technologies that require clinical testing. Therefore, there is no detailed study described that definitively calculates specific acceptance criteria and device performance metrics in the traditional sense of a clinical trial for a novel device.

However, based on the information provided, we can infer the approach to acceptance criteria and "performance" from the perspective of software verification and validation for modifications to an already cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for modifications to an existing cleared device, the "acceptance criteria" revolve around ensuring the modified software functions as intended and does not negatively impact the safety and effectiveness of the previously cleared predicate device. Performance is demonstrated through software verification and validation against internal requirements.

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

The document does not specify a "test set" in the context of patient data or clinical images for evaluating the diagnostic performance of the algorithms. Instead, the testing described is focused on software verification and validation. This typically involves:

• Test Cases: Software testing would involve a suite of test cases designed to cover all functionalities, new and existing, and boundary conditions. The number of these test cases is not specified.
• Data Provenance: The document does not mention the use of patient data for performance evaluation in terms of diagnostic accuracy. The testing is focused on the software's functional and technical aspects. Since this is an upgrade to an existing quantification software, it is likely that existing image data (possibly de-identified, potentially from various sources including internal datasets or public datasets for software testing purposes) would have been used to validate the functions of the application, but this is not explicitly stated. The document strongly emphasizes that no new indications or technologies requiring clinical testing are introduced.

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

Given that no clinical testing requiring a "ground truth" established by external experts is detailed, this information is not provided. The "ground truth" for software verification and validation is defined by the product's functional and technical requirements.

4. Adjudication Method for the Test Set

Not applicable, as no external expert adjudication for a "test set" (in the clinical sense) is described.

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

No. The document explicitly states: "QLAB 11.0 introduces no new indications for use, modes, features, or technologies relative to the predicate device (QLAB 10.8 K171314) that require clinical testing." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

The QLAB Advanced Quantification Software is described as a "software application package" designed to "view and quantify image data." It functions as an "off-line review and quantification" tool. While its primary function is quantification, the context implies it's a tool used by a human to assist in diagnosis or assessment. The mention of "tracking of the entire cardiac cycle" and "expanding the measurements" for the Dynamic Heart Model suggests algorithmic quantification, but it is not presented as a standalone diagnostic AI system that operates without human review or interaction. The performance data focuses on the software fulfilling its functional requirements within the existing framework of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for the software verification and validation activities is based on the defined software requirements and specifications. This is a functional "ground truth" rather than a clinical ground truth (like pathology, expert consensus on patient outcomes). The goal was to demonstrate that the software modifications (Dynamic Heart Model, HSDP Platform 2, Q-Store) work as designed.

8. The Sample Size for the Training Set

No training set is mentioned. This submission is for modifications to quantification software, not a de novo AI model that requires training on a dataset. The "Dynamic Heart Model" is described as an "enhancement" to an existing application providing "tracking" and "expanding measurements," suggesting algorithmic improvements rather than a new discriminative AI model requiring a separate training set.

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

Not applicable, as no training set for a de novo AI model is mentioned.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetabl/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal.

The clinical environments where the EPIQ 5, EPIQ 7, Affiniti 50 Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The proposed EPIO and Affiniti Diagnostic Ultrasound Systems, which includes EPIO 5. EPIQ 7, Affiniti 50 and Affiniti 70 systems, are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation.

The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel, the user interface consists of a touch screen with soft key controls. EPIO also has a QWERTY keyboard.

The removable transducers are connected to the system using a standard technology, multipin connectors. The proposed EPIQ and Affiniti systems use standard transducer technology, and supports phased, linear, curved linear array, TEE, motorized 3D curved linear arrays as well as non-imaging (pencil) probes.

Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG. AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA.

The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow.

The proposed EPIQ and Affiniti systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis. The proposed EPIQ and Affiniti systems enable image guided navigation and image fusion via the optional PercuNav feature (K121498).

The document describes the Philips EPIQ 5 and EPIQ 7 Diagnostic Ultrasound Systems, and Affiniti 50 and Affiniti 70 Diagnostic Ultrasound Systems. It primarily details their indications for use and compares their technological characteristics to a previously cleared predicate device (Philips EPIQ Diagnostic Ultrasound System K132304).

Based on the provided text, a "study that proves the device meets the acceptance criteria" in terms of clinical performance or specific statistical metrics is not explicitly described. The document explicitly states: "Clinical data was not required to demonstrate safety and effectiveness of the proposed EPIQ and Affiniti Diagnostic Ultrasound Systems since the proposed EPIQ or Affiniti system introduces no new indications for use, modes or features that have not been previously cleared with the predicate device EPIQ system (K132304). The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Therefore, the acceptance criteria are demonstrated through substantial equivalence to a predicate device, and compliance with recognized safety and performance standards, rather than a de novo clinical study for this specific submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance (Compliance Statement)

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

• Test Set Sample Size: Not applicable. No new clinical test set data from human subjects was used for this submission to demonstrate safety and effectiveness.
• Data Provenance: Not applicable for a new clinical test set. The submission relies on the established safety and effectiveness of the predicate device and compliance with recognized standards.

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

• Not applicable. As no new clinical study was required, there was no independent ground truth labeling process with experts described for a test set. The predicate device's clinical safety and effectiveness are considered "well accepted."

4. Adjudication Method for the Test Set:

• Not applicable. There was no new clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, ... and its effect size:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this submission states "Clinical data was not required". The device is considered substantially equivalent to a predicate.

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

• Not applicable in the context of device performance claims. The devices are general-purpose diagnostic ultrasound systems used by human operators. The document mentions "Integration of OLAB Heart Model software" and "PercuNav feature" as integrated software components, but their standalone performance is not detailed in this summary.

7. The Type of Ground Truth Used:

• Established Equivalence to Predicate Device: The primary "ground truth" or basis for acceptance is the substantial equivalence to the Philips EPIQ Diagnostic Ultrasound System (K132304), whose safety and effectiveness are considered "well accepted."
• Compliance with Recognized Standards: Compliance with various IEC and ISO standards for acoustic output, electrical safety, EMC, usability, and biological evaluation also serves as a "ground truth" for non-clinical performance aspects.

8. The Sample Size for the Training Set:

• Not applicable. This submission describes hardware and integrated software for an ultrasound system, not a machine learning algorithm requiring a separate training set. The software components mentioned (OLAB Heart Model, PercuNav) were previously cleared, implying their training and validation were addressed in prior submissions.

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

• Not applicable for this submission directly, as it does not detail the training of a new algorithm. For historical or integrated software components, the ground truth would have been established during their respective development and clearance processes, but this is not specified here.

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Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provides integrated tools that allow users to manually assess and score cardiac wall motion and export images and/or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT, and X-Ray modalities for reference viewing. It supports connectivity to ultrasound systems, PACS and other DICOM storage repositories.

Q-Station is designed to manage post-acquisition ultrasound images and other data, for the purposes of diagnosing the patient's condition. This includes using Q-Station on a PC to review images and measurements sent from an ultrasound acquisition device, analyze 3D and other data with QLAB. Q-Station is used to review various ultrasound exam types, including Adult echo, General Imaging, Stress echo, Vascular, and TEE. In addition, Q-Station can be used for reference viewing of non-ultrasound DICOM images. Q-Station can be used to add interpretive findings, key images, measurements and calculations and other comments that create reports that can be shared with other clinicians. During this review, users may also use Q-Station to import and export exams, print reports, and anonymize images for export. Q-Station supports QLAB Q-Apps for advanced analysis (K132165).

Here's a breakdown of the acceptance criteria and the study information for the Philips Q-Station (K140808) based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a traditional efficacy study. As such, the information you requested regarding numerical performance metrics, sample sizes for test sets, expert involvement for ground truth, and comparative effectiveness studies (MRMC) is not present in this type of regulatory submission. The submission explicitly states "The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence."

Therefore, many of the requested fields will state "Not Applicable" or "Not Provided" in the table below, as the submission relies on verification and validation activities rather than formal clinical studies with statistical acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided. The submission states that "The subject of this premarket submission, Q-Station 3.0 software did not require clinical studies to support substantial equivalence." Testing involved "system level tests, performance tests, and safety testing from risk analysis," implying internal validation rather than a formal test set of patient data.
• Data Provenance: Not provided (not applicable as clinical studies were not performed).

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

• Not applicable/Not provided. Clinical studies with expert-established ground truth were not conducted.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Clinical studies with adjudication were not conducted.

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

• No. An MRMC comparative effectiveness study was not done. The device is a Picture Archiving and Communications Systems Workstation, and this type of study is not relevant to demonstrating its substantial equivalence for its stated functions of viewing, analysis, and reporting.

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

• Not explicitly described as a standalone algorithm performance study. The device itself is software for managing, viewing, and analyzing images, implicitly involving human interaction. The validation focused on the software's functionality, reliability, and safety when used with a human.

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

• Not applicable/Not provided. For the internal verification and validation, ground truth would likely refer to expected software behavior based on product specifications and design requirements, rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable/Not provided. This device is described as software for managing, viewing, and analyzing existing image data, rather than an AI/ML algorithm that requires a "training set" in the conventional sense. Its "analysis packages" are "essentially the same as those included with the EPIQ ultrasound system," suggesting pre-existing modules rather than newly trained AI.

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

• Not applicable/Not provided, as there is no mention of a training set for an AI/ML algorithm.

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