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510(k) Data Aggregation
(139 days)
The NL4000 BodyTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
BodyTom Elite CT system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.
The BodyTom Elite is an improved version of BodyTom computed tomography (CT) system providing enhanced functionality. It still has the same high resolution, multi row, 85cm bore and 60cm field of view. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and stepper drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and their corresponding performance values in a direct numerical table for the entire device. However, it does list several image quality parameters that are important for Low Dose CT Lung Cancer Screening (LDCT LCS) and the general use of CT, along with reasons for their inclusion. The performance is stated as meeting all image quality criteria used for testing the predicate device.
Image Quality Parameters Relevant to LDCT LCS and General CT Use (Implicit Acceptance Criteria)
| Imaging Parameter | Reason for Inclusion / Implicit Criterion | Reported Device Performance |
|---|---|---|
| Modulation Transfer Function (MTF) | Describes the size of the smallest object that can be seen with large difference in CT value. Needs at least 2mm sampling rate or resolution of at least 5 lp/cm; 8 lp/cm recommended for detecting 4mm objects. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." (Implies it meets the 5-8 lp/cm recommendation). Explicitly, the Spatial Resolution MTF at 0% is given as 17.5 lp/cm (matches predicate). |
| Slice Thickness | Determines the smallest size that can be seen in scan direction. Needs to be thin enough to allow identification of objects of at least 4.0 mm in diameter. ACR recommends under 2.5 mm. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." (Implies it meets the <2.5mm ACR recommendation). |
| CT Number (accuracy and uniformity) | Helps determine the nature of the nodule; not affected by dose since filter on tube does not change. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." |
| CT Number Linearity | The quality of the X-ray beam is the same at high and low dose, so CT linearity should not be affected by low dose scanning. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." |
| Image Noise | Background noise increases with LDCT LCS which affects detectability of lung nodules. Low contrast analysis should show good detectability. | "Our low contrast analysis show good detectability as the lung nodules are surrounded by air. CNR results are included in Performance Testing (section 18)." (This implies acceptable noise levels enabling good detectability). |
| Noise Power Spectrum (NPS) | Changes in noise texture may impact lung nodule detection capabilities. Will increase with low dose scanning, but NPS is minimally affected. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." (Implies NPS is minimally affected as expected). |
| Contrast to Noise (CNR) | Important when background noise is close to density of lung nodules. Typically high for lung nodules surrounded by air, even for low dose scanning. | "CNR results are included in Performance Testing (section 18)." (Explicitly mentions results are provided, implying acceptable performance). |
| Scanner Speed | ACR recommends a maximum of 15 seconds scan and pitches that vary from 0.7 to 1.5. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." (Implies it meets the ACR speed recommendations). |
| Safety Standards | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-44, NEMA XR 25, NEMA XR 29, ISO 14971, 21 CFR §1020.30/§1020.33, and FDA Quality System Regulations and ISO 13485. | The device "is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485 requirements" and "is in conformance with all applicable parts of the following FDA Recognized Consensus Standards: [listed standards]". EMC, Electrical, and Mechanical Safety were ETL Tested. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing primarily using phantoms. No human subject data (patients or test sets for diagnostic accuracy) is mentioned for the BodyTom Elite device's specific performance evaluation in this 510(k) summary.
- Sample Size: Not applicable as no human test sets are used. Phantom studies do not typically operate on "sample size" in the same way clinical studies do; they involve specific measurements on physical phantoms.
- Data Provenance: Not applicable. The testing was internal to NeuroLogica Corporation ("tested internally", "validated internally").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the evaluation primarily relies on phantom studies and comparison to a predicate device's established performance, rather than a diagnostic accuracy study requiring expert ground truth for interpretation.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
- This information is not provided and is not applicable to the non-clinical, phantom-based testing described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported for the BodyTom Elite device within this 510(k) summary.
- The document states that "Published literature, clinical trials including the NLST (N Engl J Med 2011; 365:395-409) and governmental review reflect understanding by the medical community that the specific use of LDCT LCS is a subset of the general use of CT rather than a new intended use." This refers to the evidence base for LDCT LCS in general, not a comparative effectiveness study involving the BodyTom Elite device itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, the evaluation conducted was a form of standalone performance assessment, focused on the technical imaging parameters of the CT system itself. It assessed the "algorithm only" in the sense that the CT system's reconstruction algorithms and hardware capabilities were measured directly using phantoms, without human interpretation for diagnostic accuracy.
- The document states: "Specific image quality metrics were compared between the subject device (BodyTom Elite) and the previously cleared reference device of Philips Multislice CT System... The imaging parameters for the subject device were measured using standard IQ phantom and compared to the IQ results from the reference device."
7. Type of Ground Truth Used
- The ground truth for the image quality measurements was based on physical phantoms with known properties. These phantoms are designed to have quantifiable features (e.g., specific object sizes, densities, spatial frequencies) that allow for objective measurement of CT system performance against established standards and expected values.
8. Sample Size for the Training Set
- This information is not applicable as the BodyTom Elite is a CT imaging system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The "LDCT LCS and MAR protocols have been tested internally and can be used with the filtered back projection reconstruction algorithms for BodyTom Elite," suggesting these are pre-defined protocols and features, not learned from a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as the BodyTom Elite is not an AI/ML algorithm requiring a training set with associated ground truth as typically understood in that context.
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