(85 days)
The SOMATOM Project 10 systems are 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 angels 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 translation of the patient.)
The Siemens SOMATOM Project 10 systems are a whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image . . archive/evaluation.
This submission is a 510(k) premarket notification for the Siemens SOMATOM Project 10 Computed Tomography X-ray Systems. The document declares the device's substantial equivalence to previously marketed devices (Siemens SOMATOM Plus 4 and General Electric Hispeed systems).
Given the nature of a 510(k) for an established radiological imaging device like a CT scanner from 1999, the "acceptance criteria" and "study" are not presented in the same way as they would be for a novel AI/ML-driven diagnostic device undergoing recent FDA clearance.
Here's a breakdown based on the provided text, highlighting the differences in evaluation for this type of device:
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A table of acceptance criteria and the reported device performance
There isn't a table of specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) for the SOMATOM Project 10 system, nor are there reported device performance metrics in that context.
For CT scanners of this era, "acceptance criteria" primarily relate to:
- Compliance with established performance standards: "All components of the SOMATOM Project 10 systems subject to the Federal Diagnostic Equipment Performance Standard and applicable regulations of 21CFR § 1020.30 and § 1020.33 are certified to meet those requirements."
- Safety standards: "The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY."
- Substantial Equivalence: The primary "performance" reported is its substantial equivalence to existing, legally marketed predicate devices (Siemens SOMATOM Plus 4 and General Electric Hispeed (DX/i and LX/i) systems). This means its intended use, technological characteristics, and safety/effectiveness profiles are comparable to those already approved.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
There is no test set, data provenance, or specific clinical study with a sample size mentioned for this 510(k) submission. Approval for a CT scanner in 1999 primarily relied on demonstrating adherence to engineering and safety standards, and demonstrating substantial equivalence to predicate devices, rather than a prospective clinical trial with a defined test set of patients.
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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)
This is not applicable as there was no test set requiring ground truth establishment by experts for this type of device approval.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there was no test set requiring adjudication.
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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 MRMC study was performed. This device is a CT scanner, not an AI-driven image analysis tool. The concept of "human readers improve with AI" is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The SOMATOM Project 10 is an imaging device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
No clinical ground truth in the sense of comparing device output to a definitive medical diagnosis (like pathology) was used for this 510(k). The "ground truth" for this submission revolves around engineering specifications, safety standards, and documented equivalency to predicate devices.
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The sample size for the training set
This is not applicable. The device is a CT scanner, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
This is not applicable as there was no training set.
Summary for Siemens SOMATOM Project 10 Computed Tomography X-ray Systems (K991764):
The provided documentation details a 510(k) premarket notification for a Computed Tomography X-ray System from 1999. In the context of regulatory approval for such a device at that time, "acceptance criteria" and "studies" are fundamentally different from those applied to modern AI/ML-driven diagnostic software.
For K991764, the primary "study" was demonstrating Substantial Equivalence to legally marketed predicate devices, coupled with compliance with established safety and performance standards. There were no specific clinical performance studies (e.g., sensitivity, specificity trials) with defined patient test sets, ground truth, or expert adjudicators explicitly detailed or required for this type of device in a 510(k) notification in 1999.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Criterion / Requirement | Reported Device Performance / Compliance |
|---|---|---|
| Intended Use Equivalence | Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from axial or spiral planes. | "The SOMATOM P10 systems are 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 angels or spiral planes* taken at different angles." (Matches predicate functionality) |
| Technological Characteristics Equivalenc | Continuously rotating tube-detector system, fan beam principle, SOMARIS/4.5 software, whole body scanner. | "The SOMATOM Project 10 systems are whole body X-ray computed tomography scanners, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The systems are based on the existing SOMATOM Plus 4 system... The system will operate with SOMARIS/4.5 software." (Equivalent to predicate) |
| Federal Performance Standard Compliance | Adherence to 21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard (21CFR § 1020.30 and § 1020.33). | "All components...are certified to meet those requirements; and an initial report as per 21 CFR § 1002.10 will be filed..." |
| Electrical & Mechanical Safety Standards | Compliance with IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY. | "The SOMATOM is designed to meet the ELECTRICAL AND MECHANICAL SAFETY STANDARD IEC 601-1 and UL 187 X-RAY EQUIPMENT STANDARD FOR SAFETY." |
| Substantial Equivalence | Demonstrated equivalence in safety and effectiveness to legally marketed predicate devices. | "The SOMATOM Project 10 systems operating with SOMARIS/4.5 software are substantially equivalent to the Siemens SOMATOM Plus 4 and General Electrics Hispeed (DX/i and LX/i) systems in commercial distribution." |
Additional Details:
- Sample Size (Test Set): Not applicable for this type of 510(k) submission.
- Data Provenance: Not applicable.
- Number of Experts/Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not performed.
- Standalone Performance Study (Algorithm Only): Not applicable, as this is an imaging device, not a standalone algorithm.
- Type of Ground Truth: Not directly applicable in the clinical diagnostic sense. "Ground truth" was established by adherence to engineering specifications, safety standards, and comparison to the design and performance of predicate devices.
- Training Set Sample Size: Not applicable.
- Ground Truth for Training Set: Not applicable.
§ 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.