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The CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of xray transmission data taken at different angles and planes. The CTXXX85 CT scanner systems are indicated for head and whole-body X-ray Computed Tomography applications for both pediatric and adult patients. The images delivered by the system can be used by a trained physician and trained healthcare professionals as an aid in diagnosis, treatment preparation and radiation therapy planning.

The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration). The CTXX85 system is designed for routine radiological imaging procedures as well as advanced techniques such as coronary CT angiography, brain / organ perfusion, cardiac imaging with gated ECG, and CT-guided procedures. The CTXX85 system is designed with LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution and Iterative Bone Correction (IBC) in scan protocols associated with Head patient anatomy. The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box). Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder, QA phantom and mount, CIVCO table overlay and cardiac trigger module (CTM).

The provided text describes a 510(k) premarket notification for a CT scanner (CTXX85 with software version 1.3). The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for a novel AI/ML-based device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI/ML performance.

The submission confirms that:

• No clinical studies were required or conducted to support the substantial equivalence claim.
• The device's enhancements are primarily related to software-based algorithms (Metal Artifact Reduction, Extended Field of View), and new accessories/functionalities, rather than a completely new AI/ML diagnostic algorithm requiring extensive clinical validation.
• Performance data was collected through non-clinical test/performance testing (bench testing, phantom tests), adhering to various international and FDA consensus standards related to CT image quality, electrical safety, EMC, and software life-cycle processes.

Without a clinical study, details like sample size for a test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set specifics are not available in this document.

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The Analogic CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 CT Scanner systems are indicated for pediatric and adult patients.

The CTXX85 CT Scanner is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are three (3) models of the CTXX85 CT Scanner: CT1685 (16 slice configuration), CT6485 (64 slice configuration) and CT12885 (128 slice configuration).

The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.

The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).

Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.

The provided text describes specific performance data for the Analogic CTXX85 CT Scanner, particularly focusing on the CT1685 model and its iterative reconstruction algorithm (LISA). However, the document does not present a formal table of acceptance criteria with corresponding reported device performance, nor does it detail a clinical study with specific metrics like sensitivity, specificity, or reader performance improvement (MRMC).

Based on the information provided, here's a breakdown of the requested elements:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of acceptance criteria with precise numerical targets. Instead, it indicates that the device's performance was evaluated against a set of standards and for image quality. The general acceptance criterion seems to be that the device "performs as intended" and its image quality is "diagnostic."

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The Analogic CTXX85 systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 systems are indicated for pediatric and adult patients.

The CTXX85 is a whole-body, multi-slice CT scanner platform that enables multiple configurations for diagnostic imaging. The systems produce images and calculations that are intended for use by competent medical personnel as part of a clinical diagnosis. There are two models of the CTXX85 scanner: CT6485 (64 slice configuration) and CT12885 (128 slice configuration).

The CTXX85 CT Scanners includes LISA (Low-dose Iterative noise reduction Solution by Analogic), an advanced algorithm which reduces image noise while maintaining (or improving) spatial resolution.

The following main subsystems make up the scanner platforms: tilting gantry (X-ray tube, X-ray generator, X-ray beam collimator), data management system (detector array, electronics), patient table with accessories, power distribution unit, and operator console (touchscreen user interface computer, gantry control box).

Accessories for the CT scanners include: patient table CT slicker cushion, head holder, foot extension board, wedge knee pad, patient restraints, IV pole and holder and QA phantom and mount.

The provided text describes a 510(k) premarket notification for the Analogic CT6485 and CT12885 Computed Tomography (CT) systems. It details the device, its intended use, comparison to predicate devices, and performance data to support substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not specify explicit "acceptance criteria" in a numerical or target performance metric for image quality. Instead, it refers to fulfilling requirements of various consensus standards and demonstrating performance comparable to predicate devices. The reported device performance is described qualitatively as meeting these standards and the images being of diagnostic quality.

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

• Sample Size for Test Set: The document mentions "sample clinical images of the brain, chest, abdomen and extremity," but does not specify the exact number of images or cases used in the clinical evaluation.
• Data Provenance: Not specified. It's unclear if the clinical images were retrospective or prospective, or their country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: "a board-certified radiologist" (singular).
• Qualifications of Experts: "board-certified radiologist." No further details on years of experience or subspecialty.

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

• Adjudication Method: None specified. The text only states that a single board-certified radiologist evaluated the images.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not performed. The study description focuses on confirming diagnostic quality by a single reader and benchmarking against physical phantom measurements.
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• Standalone Performance: The non-clinical performance testing on phantom models directly assesses the algorithm's performance without human interpretation (e.g., MTF, low contrast detectability, noise, CT number accuracy). This can be considered a form of standalone performance evaluation for image quality metrics.
  • "Image Quality performance testing for the CTXX85 was conducted on standard phantom models to assess modulation transfer function (MTF), low contrast detectability, noise, CT number accuracy, CT uniformity, axial slice thickness, helical slice sensitivity profile, axial and helical image quality for head and body."
  • "Testing was conducted to evaluate image quality performance of the iterative reconstruction algorithm."

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

• Non-clinical (Image Quality): The ground truth for image quality metrics (MTF, noise, etc.) is established by the physical properties of the phantom models and expected system performance based on established engineering principles and physics.
• Clinical (Diagnostic Quality): For the clinical images, the ground truth was expert opinion/assessment by "a board-certified radiologist" confirming "diagnostic quality." This is a subjective assessment rather than a definitive ground truth like pathology.

8. The sample size for the training set

• Training Set Sample Size: Not specified. The document does not mention the training of the LISA algorithm or any other components, nor does it provide a sample size for a training set. The focus is on the performance of the device as a whole.

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

• Training Set Ground Truth: Not specified. Since the training set sample size and details of the training itself are not provided, how its ground truth was established is also not mentioned.

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The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.

Intended Use: Diagnostic ultrasound imaging and visualization of vessels for vascular access guidance of needles and catheters as follows: Peripheral vascular

The Sonic Window with the addition of software to perform and display ultrasound fluid flow analysis is a fully integrated handheld ultrasound imaging system that displays real-time ultrasound images on a coronal plane at a constant depth from the transducer. The depth is controllable by the operator. The Sonic Window system consists of the Sonic Window handheld device, the Docking Station/Charger and the AC Adapter. The Sonic Window uses an imaging mode, C-Mode, which provides the visualization in the coronal plane of peripheral vessels and assessment of vessels width and depth for needle/catheter placement.

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria or detail a specific performance study with measured results for the "Sonic Window" device. It generally states that "predetermined acceptance criteria was met" without specifying what those criteria were or the achieved performance values.

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

The document does not provide any information regarding the sample size used for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective). The studies mentioned are "Performance, verification and validation testing" without specific details about patient data.

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

The document does not provide any information about the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not provide any information about the adjudication method used for the test set.

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

The document does not indicate that an MRMC comparative effectiveness study was done, nor does it provide any effect size for human readers improving with AI vs. without AI assistance. The device description mentions a "C-Mode" for visualization and assessment but doesn't describe AI assistance for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

The document focuses on the device as an imaging system for "visualization of vessels and vascular access guidance." It does not describe a standalone algorithm performance without human-in-the-loop. The system displays images for an operator to use.

7. The Type of Ground Truth Used:

The document does not specify the type of ground truth used. It mentions design validation testing and performance testing but not the method for establishing ground truth for evaluating the device's accuracy in visualizing vessels or guiding access.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. The device is described as an ultrasound imaging system, and the submission is a "Special 510(k) Device Modification" which implies changes to an existing device rather than the development of a de novo AI algorithm with specific training data.

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

As no training set is described, the document does not provide any information on how ground truth for a training set was established.

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The Sonic Window is intended for the visualization of vasular access guidance of needles and catheters (Insertion of Peripheral Intravenous (PIV) Catheters as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only.

The Sonic Window is a fully integrated handheld ultrasound imaging system that combines electronics, transducer, display and battery into the same device. The device is designed and optimized to visualize real-time ultrasound images on a Coronal (Constant Imaging Depth) plane positioned at a distance (depth) from the transducer that is controllable by the user.

The Sonic Window device is an integrated handheld ultrasound imaging system designed for the visualization of peripheral vessels and assessment of vessel width and depth for needle/catheter placement. It is intended for use by medical professionals via prescription.

There is no study described that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or accuracy for its intended clinical use. The document primarily focuses on non-clinical testing for safety and technical equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical engineering and safety tests, not a clinical test set with patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance was not established as part of the described non-clinical testing.
3. Adjudication method for the test set: Not applicable. No clinical test set.
4. 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 an ultrasound system, not an AI-assisted diagnostic tool as described in this document.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
6. The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering and safety standards (e.g., maximum permissible acoustic output, compliance with IEC standards for electrical safety and EMC, mechanical and environmental endurance specifications).
7. The sample size for the training set: Not applicable. This document does not describe machine learning or AI components requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

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The SynePix 4600 is Thallium-doped Cesium Iodide and amorphous Silicon (a-Si) Digital Radiography (DR) detector intended for use by a qualified/trained doctor or technician and is designed to generate radiographic images of human anatomy. If is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

The detector will be used with Analogic AN6255 and AN6265 (SyneRad Omni and SyneRad Omni RT) Systems. The AN6255 has a single tall stand and single detector, the AN6265 is a dual detector system with a tall stand and short stand.

The detector is not for use for mammography.

The SynePix 4600 is a 17 inch by 17 inch digital detector. It is intended to convert Xrays into electrical signals to create usable images for diagnostic use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Analogic Corporation SynePix 4600 Detector:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the SynePix 4600 Detector. Instead, it relies on a comparison to a predicate device.

Acceptance Criteria (Implied): Substantial equivalence to the legally marketed predicate device (Kodak DirectView DR System Detector, K051483) in terms of technological characteristics and performance.

2. Sample Size for the Test Set and Data Provenance

The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The claim of substantial equivalence is made based on "testing," but details of this testing are absent.

3. Number of Experts and Qualifications for Ground Truth Establishment

The provided text does not mention the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a 510(k) submission primarily focused on substantial equivalence based on technological characteristics and non-clinical testing, explicit details about clinical expert reviews for ground truth are often not included unless a specific clinical study with human review is part of the submission.

4. Adjudication Method for the Test Set

The provided text does not specify an adjudication method for any test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance. This device is a digital radiography detector, not an AI-powered diagnostic tool, so such a study would not typically be part of its clearance.

6. Standalone (Algorithm Only) Performance Study

The provided text does not describe a standalone (algorithm only) performance study. This device is hardware (a detector) that produces images, not an algorithm that performs interpretations.

7. Type of Ground Truth Used

The provided text does not explicitly state the type of ground truth used. Given that the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, it's highly probable that the "ground truth" would be based on technical performance metrics derived from phantom studies, physics measurements, and comparisons of image quality against the predicate device, rather than clinical outcomes or pathology.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. As a digital detector (hardware), rather than an AI/ML algorithm requiring training, the concept of a "training set" in the context of machine learning does not apply here.

9. How Ground Truth for the Training Set Was Established

Since the device is a digital detector and not an AI/ML algorithm, the concept of a "training set" with established ground truth is not applicable to this submission.

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The FETALGARD Lite-NIBP is a Perinatal Monitoring System for non-invasively measuring and showing graphically abdominal contractions, fetal heart rate, maternal non-invasive blood pressure, and maternal heart rate by means of display on a non-permanent graphical display and optionally on a printer. This data is to aid in assessing the well-being of the fetus and mother during the final trimester of pregnancy (non-stress test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices, and patient's home.

The FETALGARD Lite-NIBP is a compact, lightweight device for measuring, processing, displaying, and printing information derived from four physiological measurements:

• Fetal Heart Rate. Two types of ultrasound transducers can be used to monitor single or twins fetal heart rate and display real-time on the LCD screen or permanently recorded on the optional printer.
• Uterine Activity. Uterine pressure changes via a tocotonometer are used to monitor uterine contractions. The waveforms are displayed real-time on the LCD screen or permanently recorded on the optional printer.
• Maternal non-invasive blood pressure. Blood pressure is measured non-invasively (NIBP) by the oscillometric method.
• Maternal heart rate. The algorithm used to derive maternal heart rate is identical to the derived heart rate parameter used in the C3 Patient Monitor when the NIBP module is the measurement source.
  A printer records fetal heart rate and tocotonometer waveforms, maternal non-invasive blood pressure value, and maternal heart rate value.
  The FETALGARD Lite-NIBP is powered by internal sealed lead-acid batteries or from the mains supply via an external battery eliminator. A fully charged battery will power the monitor for two hours minimum.

The provided document is a 510(k) Summary for the Analogic Corporation's FETALGARD Lite-NIBP. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance: The document cites various IEC and ANSI/AAMI standards that the device will be tested against, but it does not provide specific acceptance criteria or the numerical results of these tests in a table form.
• Sample size used for the test set and data provenance: No test set is described in terms of sample size or origin.
• Number of experts and their qualifications for ground truth: Ground truth establishment by experts is not mentioned for non-clinical testing.
• Adjudication method for the test set: No adjudication method is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The document focuses on non-clinical testing.
• Standalone (algorithm only) performance: As this is a medical device, the focus is on the integrated system rather than a standalone algorithm.
• Type of ground truth used: For the non-clinical tests mentioned, the "ground truth" would be compliance with the standards, not clinical outcomes or pathology.
• Sample size for the training set: There is no mention of a "training set" as the device is not an AI/ML algorithm that requires training data in the typical sense.
• How ground truth for the training set was established: Not applicable, as there's no mention of a training set.

What the document does describe in terms of testing and "acceptance" (equivalence):

The document outlines a series of non-clinical tests to demonstrate compliance, performance, and reliability, thereby supporting its substantial equivalence to predicate devices. These tests are primarily focused on safety, electromagnetic compatibility, alarm systems, and specific performance for non-invasive blood pressure monitoring.

Key statements regarding "acceptance criteria" (though not explicitly stated in a quantitative table):

• Compliance with Standards: The device must comply with a range of international and national standards, which serve as its de facto acceptance criteria for various aspects (safety, performance). These include:
  • IEC 60601-1 (and Amendments 1 & 2): Medical Electrical Equipment - General Requirements for Safety
  • IEC 60601-1-2: 2001: Medical electrical equipment - Electromagnetic compatibility emission limits meet Group 1 Class B
  • IEC 60601-1-4: Medical electrical equipment – Programmable electrical medical systems
  • IEC 60601-1-8: General requirements, tests and guidance for alarm systems in medical electrical equipment
  • IEC 60601-2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
  • IEC 60601-2-49: Particular requirements for the safety of multifunction patient monitoring equipment
  • ANSI/AAMI SP10: Manual, Electronic, or Automated Sphygmomanometers
  • IEC 60068 series of standards: Mechanical shock and vibration tests
  • ISTA; Project 2A: Shipping container transportation tests (packaging)
• Other Tests:
  • Altitude tests (to ensure operation at higher altitudes does not adversely affect electrical safety or performance).
  • Tests to verify enclosure material robustness and resistance to cleaning materials.

Study Proving Acceptance (Substantial Equivalence):

The document refers to a "test schedule" of non-clinical tests that will be performed. The conclusion drawn is that "The test schedule of the FETALGARD Lite-NIBP combined with 'Information for Manufacturers,' September 1997, Track 1 tests already performed demonstrate that the FETALGARD Lite-NIBP and its associated safety and effectiveness is substantially equivalent to the performance of the FETALGARD Lite and the C3 Patient Monitor predicate devices cited in Section 5 of this summary."

In summary, for a 510(k) submission like this, "acceptance criteria" are generally understood as compliance with recognized standards and the demonstration of equivalent performance and safety to a predicate device through non-clinical bench testing. Specific quantitative performance metrics or clinical study results are typically not required unless a significant difference in technological characteristics or a new indication for use is introduced that cannot be assured through non-clinical data.

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