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The NL3000 CereTom is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck.

The NL3000 CereTom is a high resolution, 8 row, 32 cm bore, 25cm field of view, Computed Tomography System. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, 3264-element solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, touch screen LCD display, power system, brushless DC servo drive system (disk rotation), and stepper drive system (translation). The power system consists of dry sealed batteries which provide system power while unplugged from the charging outlet. When plugged into an outlet the system charges the batteries with a line power drain of less than 1300 watts. The work station consists of a Sony Vaio laptop computer. The workstation software consists primarily of a certified off-the-shelf CT viewing system from a third party vendor. In addition the system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. It requires very little x-ray power in comparison to large bore systems to obtain equivalent CT image quality. The gantry has retractable 100mm diameter rotating caster wheels so the system can be moved easily to different locations.

The provided text is a 510(k) summary for the NeuroLogica NL3000 CereTom Computed Tomography System. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics. Therefore, much of the requested information regarding acceptance criteria, study details, and performance statistics is not available in the provided text.

Specifically, the document primarily addresses:

• Device description and intended use.
• Comparison of technological characteristics with predicate devices (Philips Tomoscan M/EG, GE LightSpeed Ultra CT, Siemens SOMATOM Plus 4).
• General safety and effectiveness concerns, stating adherence to regulations and standards (e.g., 21 CFR Part 1020, UL60601-1, IEC 60601-1, EN 60601-1).
• A conclusion of substantial equivalence to the predicate devices based on design, material, functionality, and technology.

There is no information about a specific study with clearly defined acceptance criteria, reported device performance metrics against those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on training set size and ground truth establishment in the provided text.

The document is a submission for regulatory clearance based on substantial equivalence, which often means demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical study results with detailed performance metrics.

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The CT device with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*Spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous movement of the Sliding Gantry).

The Sliding Gantry option is designed to allow whole body x-ray computed tomography scanning on a single patient that can be performed on different types of patient tables in different environments. The Sliding Gantry Option integrates the function of precise scan control driven horizontal movement, which is usually a function of the dedicated CT-table, into the CT gantry itself. The original CT gantry is mounted on a rail system and a scan control system moves the gantry relative to the table, instead of moving the table relative to the gantry.

This 510(k) summary focuses on establishing substantial equivalence for the "Sliding Gantry Option for CT Devices" by comparing it to predicate devices. It does not contain information regarding specific acceptance criteria, performance studies, or details on ground truth establishment for a new device's performance claims. Therefore, I cannot provide the requested information based solely on the provided text.

The document states that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The FDA's clearance is based on this substantial equivalence, not on independent performance studies for novel acceptance criteria.

However, I can extract the following relevant information based on the provided text:

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

The document does not explicitly define acceptance criteria or report specific device performance metrics in the way a clinical study would. The basis for clearance is "substantial equivalence" to predicate 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. The document does not describe a performance study with a test set.

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. The document does not describe a performance study with a test set or ground truth establishment.

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

Not applicable. The document does not describe a performance study with a test set.

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 an optional hardware component for CT scanners, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This device is a hardware component, not an algorithm, and no standalone performance study is mentioned.

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

Not applicable. The document does not describe a performance study with an explicit ground truth. The substantial equivalence relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary of what is present in the document:

• Identified Device: Siemens Sliding Gantry Option for CT Devices
• Intended Use: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
• Basis for Clearance: Substantial Equivalence to previously cleared predicate devices (Siemens Angio-CT MIYABI K990491 and Siemens Plus 4 with Sliding Gantry Option K991600).
• Device Description: The Sliding Gantry option integrates the function of precise scan control driven horizontal movement into the CT gantry itself, moving the gantry relative to the table instead of the table relative to the gantry.

To answer your full request, a different type of submission (e.g., a PMA or a more detailed 510(k) for a novel device with new performance claims) would be needed. This document primarily focuses on demonstrating that the Sliding Gantry Option is a modification to an existing CT system that maintains the safety and effectiveness of the predicate devices.

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