(90 days)
The Anatom 2000 is a whole body CT scanning system. It is intended to be used as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
The Anatom 2000 consists of a light weight gantry with built-in computer and power supplies, patient table, and operating console with display. The gantry uses a translatable rotating disk with X-ray generator and tube, pre-collimator, 384-element solid state detector array, control computer, energy storage banks, communications link, data acquisition, and power management and power supply electronics. The gantry is driven by a brushless DC motor. The gantry can be tilted +30/-25 degrees from the vertical and can translate horizontally approximately +7" (+178mm) for a total travel distance of approximately 14 inches (356mm). The high precision, highly stabilized X-ray generator is powered by sealed dry batteries which essentially eliminate dependence on AC line quality. The battery banks are charged in the stand-by mode from the main power source. Even when charging, the total line power is less than 1500 watts. The patient table connected to the gantry is driven by brushless DC motors for horizontal and vertical movement under microprocessor control. In the event of a power failure, the table top can be manually removed from the gantry opening so that the patient can be conveniently removed from the system.
The operator console or work station consists of a Sun Spare 5 computer and keyboard, 17" monitor, audio system, emergency controls, and uninterruptible power supply. The work station is responsible for the control-selection of the gantry, table, image processor, X-ray generator and tube.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:
Based on the provided 510(k) Premarket Notification Number K944131 summary (and internal reference to K964890), there is no specific information provided about acceptance criteria or a study that proves the device meets those criteria in the way you've outlined.
This submission is a traditional 510(k) for substantial equivalence, not a new de novo application or a submission for an AI/ML-driven device with performance metrics like sensitivity, specificity, or clinical improvement.
Here's why and what we can infer:
Key Takeaway: The provided document is focused on demonstrating substantial equivalence to a previously cleared predicate device for a conventional medical imaging system (Computed Tomography X-ray System). It does not contain the detailed performance metrics, expert adjudication, or study designs typically associated with evaluating AI/ML-driven medical devices or devices with novel performance claims that would necessitate the type of acceptance criteria you've asked about.
Here's a breakdown based on your requested information, highlighting what isn't present in this type of 510(k):
1. A table of acceptance criteria and the reported device performance
- Not Applicable: This type of 510(k) does not present acceptance criteria in terms of quantitative performance metrics like sensitivity, specificity, or AUC for a diagnostic task. The acceptance criteria for a substantial equivalence submission are typically alignment with recognized standards (e.g., electrical safety, EMC, radiation dose limits) and demonstrated equivalent performance characteristics to the predicate device in aspects like image quality, scanning capabilities, and safety. These are generally qualitative or based on engineering specifications rather than clinical study results comparing device performance against a medical ground truth.
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: There is no indication of a "test set" in the context of evaluating diagnostic accuracy using patient data. This 510(k) is for a CT scanner itself, not a software algorithm that interprets images. Performance evaluation for such devices often involves phantom studies, image quality assessments, and engineering verification and validation, rather than clinical studies with patient test sets for diagnostic accuracy.
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: As there's no mention of a diagnostic accuracy test set, there's no corresponding mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: For the same reasons as above, an adjudication method for a test set is not mentioned.
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: MRMC studies and the concept of AI assistance for human readers are entirely outside the scope of this 1997 510(k) for a conventional CT scanner. This device does not inherently include AI for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This device is a CT scanner, which requires a human operator and a human reader for image interpretation. It does not provide standalone diagnostic capabilities without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: Ground truth, in the context of diagnostic accuracy, is not directly discussed for this type of device submission. Performance evaluation would focus on physical characteristics like spatial resolution, contrast resolution, noise, dose efficiency, and artifact reduction, often using phantoms.
8. The sample size for the training set
- Not Applicable: The concept of a "training set" is relevant for AI/ML algorithms. This 510(k) is for hardware (a CT scanner), not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable: For the same reason as above, this information is not relevant to a conventional CT scanner submission.
Summary of the document's content relevant to "acceptance criteria" through the lens of a 1997 510(k):
The "acceptance criteria" for K964890 (the device being submitted) are implicitly to demonstrate substantial equivalence to the predicate device K944131 (Analogic Corporation Anatom 2000 (A) model; Philips Medical systems - (Tomoscan M / EG)).
The document asserts this by stating:
(6) In the opinion of Analogic Corporation, the Anatom 2000 Computed Tomographic X-ray System with the 2 additional options (HA+ / A+ model) is of comparable type in design, shape, materials, functionality and technology, and is substantially equivalent to the above indicated predicate device previously cleared through the 510(k) process under K944131.
This means that the "study" proving it meets "acceptance criteria" likely involved:
- Engineering verification and validation: Demonstrating that the new features (MPR and Helical Scanning) on the Anatom 2000 HA+/A+ model function as intended and meet relevant engineering specifications for CT systems.
- Comparison to predicate device specifications: Showing that the core performance characteristics (e.g., image quality, dose, scan speed, safety features) of the new model, even with added options, are equivalent or superior to the predicate device K944131. This would involve bench testing, phantom studies, and possibly limited clinical data for comparison if necessary to address the new features.
- Compliance with recognized standards: Adherence to electrical safety standards (e.g., IEC 60601-1), electromagnetic compatibility (EMC) standards, and possibly radiation safety standards.
The 510(k) summary provided does not detail these specific tests or their results, as it is a high-level summary. Full details would be in the complete 510(k) submission available to the FDA at the time.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.