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510(k) Data Aggregation
(91 days)
The NL3000 [CereTom Elite] CT system 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 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.
The CereTom Elite is an improved version of CereTom computed tomography system providing enhanced functionality. It still has the same high resolution, 8 row, 32 cm bore and 25cm field of view. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, Gd2O2S detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system and brushless DC servo drive system (disk rotation). 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, xray indicators, interlocks, patient alignment laser and 110% x-ray timer. CereTom Elite also has a scanner drive system (SDS), so that the system can be moved easily to different locations.
The provided text describes the CereTom Elite Computed Tomography system and compares it to a predicate device (CereTom K051765) and a reference device (Philips Brilliance CT 16-slice Configuration K012009). The document focuses on demonstrating substantial equivalence rather than presenting a standalone study with specific acceptance criteria and performance metrics for a novel AI/algorithm.
Based on the information provided, here's an analysis of the requested points, with the understanding that this is a CT system, not an AI algorithm in the typical sense for which these questions are usually posed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with reported numerical performance values in the context of an AI-driven diagnostic accuracy study. Instead, it discusses the device's conformance to safety, performance, and image quality standards, and its equivalence to a predicate device.
The "acceptance criteria" here are implied by the compliance with recognized consensus standards and the demonstration of comparable image quality to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Electrical Standards: | |
| Compliance with IEC 60601-1 (General Safety) | ETL Testing (Compliant) |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | ETL Testing (Compliant) |
| Compliance with IEC 60601-1-3 (Radiation Protection) | ETL Testing (Compliant) |
| Compliance with IEC 60601-2-44 (CT Specific Safety) | ETL Testing (Compliant), AEC feature verified |
| Compliance with FDA Diagnostic Equipment Performance Standard | Certified to meet requirements |
| Dose Management Standards: | |
| Compliance with NEMA XR-25 (CT Dose Check) | Compliant (CereTom Elite is XR-29 compliant, which includes NEMA XR-25 features) |
| Compliance with NEMA XR-29 (Dose Optimization & Management) | Compliant |
| Software Standards: | |
| Compliance with IEC 62304 (Software Life Cycle Processes) | Developed & tested in accordance |
| Compliance with FDA guidance for Software in Medical Devices | Developed & tested in accordance |
| Image Quality (Comparable to Predicate Device K051765): | |
| Spatial Resolution (Soft tissue kernel) | 7.0 lp/cm @ 0 % MTF (Matches predicate) |
| Spatial Resolution (High resolution kernel) | 15.0 lp/cm @ 0 % MTF (Matches predicate) |
| Noise, Slice thickness, Low/High contrast resolution, Radiation metrics, MTF | Measured utilizing phantom tests, successfully demonstrated comparable image quality to predicate and met all criteria for testing predicate. |
| Metal Artifact Reduction (MAR) performance | MAR algorithm performs as indicated by successfully mitigating streak artifacts without new safety/effectiveness concerns. |
| Contrast imaging capability | Additional performance testing data provided for expanded indications. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes phantom image quality tests for the CereTom Elite system. It does not mention a test set based on patient data, nor does it specify a sample size for these phantom tests (e.g., how many phantom scans were performed).
- Sample Size: Not specified for image quality tests, but they were conducted using an "anatomical phantom."
- Data Provenance: The tests are internal verification and validation activities, and external testing, implying controlled laboratory or manufacturing settings using phantoms. No patient data provenance (country, retrospective/prospective) is provided as it's not a clinical study on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable in the context of the provided document. The CereTom Elite is a CT imaging device, and its performance evaluation primarily involves physical measurements using phantoms and comparing those measurements to established engineering and medical device standards. There is no mention of human experts establishing "ground truth" for diagnostic accuracy in a clinical dataset.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human expert diagnostic reading study or any adjudication process for a test set of clinical images. The evaluation is based on technical performance metrics from phantom scans.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This typically involves human readers interpreting cases with and without an AI's assistance to measure the AI's impact on diagnostic performance. The document describes the technical performance and equivalence of a CT scanner.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study in the context of an "algorithm only without human-in-the-loop performance" is not explicitly performed or detailed in the way typically expected for an AI algorithm. The document assesses the standalone technical performance of the CT scanner hardware and its integrated software features (like AEC, MAR, reconstruction algorithms) through phantom testing. The performance metrics cited (spatial resolution, noise, etc.) are inherent to the device's image generation capabilities.
7. Type of Ground Truth Used
The "ground truth" for the technical and image quality tests primarily relies on:
- Phantom measurements: Physical properties and known configurations of the phantoms.
- Engineering specifications and regulatory standards: Conformance to established benchmarks for CT system performance (e.g., spatial resolution targets, dose limits, safety standards).
- Comparison to predicate device: The performance of the predicate device (CereTom K051765) serves as a benchmark for equivalence.
8. Sample Size for the Training Set
This information is not applicable. The CereTom Elite is a CT imaging system. While it has embedded software with algorithms for image reconstruction, artifact reduction, and dose control, it is not described as a deep learning or machine learning system that requires a distinct "training set" of patient data in the typical AI sense. The algorithms are likely based on traditional signal processing and image reconstruction techniques, which are validated against known inputs and expected outputs, not "trained" on large datasets.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8. No explicit training set or ground truth establishment method for it is mentioned. Development and validation would involve engineering principles and testing against known physical properties and simulated scenarios.
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(133 days)
The Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment supports, components and accessories. The scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.
The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society.
*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.
Philips Low Dose CT Lung Cancer Screening option can be used with Philips whole body multi-slice CT X-Ray Systems installed in a healthcare facility (clinic / hospital). These systems provide a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. Reconstruction algorithms available are standard reconstruction (filtered back projection), iDose 4 and IMR iterative reconstruction. These systems also include signal analysis and display equipment, patient and equipment supports, components and accessories.
There are no functional, performance, feature, or design changes required for the qualified CT systems onto which the LDCT LCS Option is applied. Because none of the CTs will require hardware or software modifications, the Philips Low Dose CT Lung Cancer Screening option and the currently marketed and predicate Philips Multislice CT System for qualified CT systems in the installed base consists of:
- A set of up to three reference LDCT LCS protocols: standard reconstruction, standard reconstruction with iDose 4, and with IMR iterative reconstruction (where applicable), for each qualified CT System on a per CT platform basis;
- Detailed instructions on how to create the protocols on the corresponding CT System; and
- A dedicated Instructions for Use for LDCT LCS that covers all qualified systems.
This document is a 510(k) premarket notification for the Philips Multislice CT System with Low Dose CT Lung Cancer Screening. It primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a standalone study proving the device meats specific acceptance criteria in a clinical setting with human readers.
However, based on the provided text, I can infer the acceptance criteria relate to maintaining image quality parameters for Low Dose CT Lung Cancer Screening (LDCT LCS) that are equivalent to or better than standard CT performance, especially given the reduced radiation dose. The "study" proving this largely relies on non-clinical bench testing and references to external clinical literature and trials.
Here's a breakdown of the information you requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study with patients. Instead, it focuses on demonstrating that the LDCT LCS option does not degrade image quality compared to existing CT systems and that existing clinical evidence supports the efficacy of LDCT LCS itself.
Here's a table based on the image quality parameters evaluated in non-clinical testing and the reported outcome of that testing:
| Acceptance Criteria (Inferred from Image Quality Parameters Evaluated) | Reported Device Performance (Non-Clinical Bench Testing Outcomes) |
|---|---|
| Spatial Resolution (MTF): Ability to visualize fine anatomical details, preserved at lower dose. | "MTF is a measure of the high contrast spatial resolution performance of the system. Nodules in the lung are high contrast objects and therefore, MTF should be preserved at lower dose conditions." "Demontrates that the image quality metrics including MTF... are substantially equivalent among different family of scanners (Brilliance 16, Brilliance Big Bore, Brilliance 64/Ingenuity, Brilliance iCT and IQon)." |
| Contrast Resolution (CNR): Ability to differentiate tissues with subtle differences in attenuation, sufficient for nodule detection. | "Sufficient Contrast-to-Noise is needed to detect solid and non-solid nodules in the lung. This parameter accounts for the contrast between an object and the background. This could also be a parameter that could influence nodule detectability." "The CNR scans were completed using the LDCT LCS scan protocols for all scanners in the comparison." "The results of non-clinical bench testing demonstrate that the image quality metrics including... Contrast to Noise Ratio are substantially equivalent among different family of scanners." "The contrast of the lung nodules it high relative to this increased noise, demonstrated by the CNR results (section 18) and NLST study." |
| Image Noise (Standard Deviation): Acceptable background noise levels at reduced dose, not compromising nodule detectability/sizing. | "As dose is reduced, background noise in the image increases. If this noise becomes too large, nodule detectability and sizing measurement may be compromised." "The results of non-clinical bench testing demonstrate that the image quality metrics including... Image noise... are substantially equivalent among different family of scanners." "Noise goes up by the square root of the mAs. The contrast of the lung nodules it high relative to this increased noise, demonstrated by the CNR results (section 18) and NLST study." |
| Noise Power Spectrum (NPS): Acceptable noise texture, not influencing nodule detection capabilities. | "Similar to the noise, changes in texture of the noise may have an influence on the nodule detection capabilities." "The NPS scans were completed using the LDCT LCS scan protocol." "The results of non-clinical bench testing also demonstrate the image quality parameters for iDose4 and IMR reconstructions are equivalent to, or better than standard FBP reconstruction." |
| Slice Thickness: Accurate slice thickness for clear edges and boundaries of nodules. | "The ability to produce slice thicknesses (FWHM of the slice sensitivity profile) that are close to the nominal slice thickness is important in defining clear edges and boundaries of the nodule." "The results of non-clinical bench testing demonstrate that the image quality metrics including... Slice Thickness... are substantially equivalent among different family of scanners." |
| CT Number Uniformity: Sufficient uniformity in the lung for robust nodule detectability. | "In a low dose scanning protocols such as with lung cancer screening, maintaining sufficient CT number uniformity throughout the lung and its various structures is important for more robust detectability of the nodules." "The results of non-clinical bench testing demonstrate that the image quality metrics including... CT number linearity, CT number accuracy... are substantially equivalent among different family of scanners." |
| CT Number Linearity: Measured CT number in a nodule not significantly affected by low dose scanning. | "In a low dose scanning protocols such as with lung cancer screening, the CT number measured in a nodule may be affected and therefore measuring CT number linearity is important." "The results of non-clinical bench testing demonstrate that the image quality metrics including... CT number linearity... are substantially equivalent among different family of scanners." |
| Image Artifacts: No new or increased artifacts obscuring anatomical details or mimicking pathology. | (Implicit in overall image quality assessment, not explicitly detailed as a separate quantified metric but mentioned as an important image quality parameter). "Image artifacts can obscure anatomical details and mimic pathology." |
| Geometric Distortion: Accuracy of measurements and image correlation with other modalities. | (Implicit in overall image quality assessment, not explicitly detailed as a separate quantified metric but mentioned as an important image quality parameter). "Geometric distortion can affect the accuracy of measurements and the ability to correlate images with other modalities." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the context of a clinical patient test set for this specific submission. The "test set" for demonstrating substantial equivalence related to image quality was composed of various CT scanner models and reconstruction algorithms.
- Data Provenance: The primary data used to support the efficacy of LDCT LCS itself comes from externally referenced clinical literature, specifically the National Lung Screening Trial (NLST) (N Engl J Med 2011; 365:395-409) and the International Early Lung Cancer Action Program (I-ELCAP), along with "subsequent literature." These were large-scale prospective clinical trials, likely conducted across multiple centers, including within the US (NLST).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable for this specific submission's non-clinical testing. The non-clinical image quality phantom measurements do not involve expert interpretation for ground truth.
- Qualifications of Experts: For the external clinical trials (NLST, I-ELCAP) referenced, radiologists and other medical professionals were involved in establishing diagnoses and outcomes, but their specific numbers and qualifications are not detailed in this 510(k) document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable for this specific submission's non-clinical testing. No human adjudication was performed for the image quality metrics tested.
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 Comparative Effectiveness Study: No, a multi-reader, multi-case comparative effectiveness study with human readers (with vs. without AI assistance) was not conducted or presented in this 510(k) submission. This submission is for the CT system itself with a low-dose protocol option, not for an AI-powered CAD (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) device. The device does not incorporate AI for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, a standalone algorithm-only performance study was not conducted or presented in this 510(k) submission. The device is a CT scanner, not an independent algorithm for diagnosis or detection.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth:
- For the image quality bench testing: Ground truth was established by the physical phantoms used for measurements (e.g., wire phantom for MTF, ramp/disk phantom for slice thickness, water/density phantoms for CT numbers).
- For the clinical efficacy of LDCT LCS (referenced externally): The ground truth for the NLST and I-ELCAP studies would have included pathology reports (for confirmed cancers), clinical follow-up/outcomes data (for stable or resolving nodules), and potentially expert consensus reviews of indeterminate findings.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This submission describes a CT scanner with a new protocol, not a machine learning algorithm that requires a training set. The reconstruction algorithms (iDose4, IMR) themselves would have been developed using various data, but details are not provided here.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as this is not an AI/ML device requiring a training set with ground truth established through labeled data in the context of this submission.
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(14 days)
Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Griffin may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Griffin Imaging System should only be used by trained healthcare professionals.
The Griffin SPECT/CT Imaging System (Griffin) is a hybrid SPECT/CT system for performing CT studies, general nuclear medicine studies, or SPECT/CT scquentially (dual-modality studies) wherein the SPECT and CT studies may be automatically co-registered and displayed in fused form. Because the natures of the imaging modalities, they provide different information; the SPECT study yields functional information about metabolic processes and the CT study yields structural or anatomical information. As radionuctides become more tissue specific, diagnoses from nuclear images alone will be more difficult without the general anatomical detail less specific agents provide. Thus fused SPECT and CT images will provide the information required for accurate and comprehensive diagnoses. Griffin is constructed from two existing systems, the Skylight Imaging System (K031705) and the Brilliance CT (K012009). The Griffin has two acquisition consoles. One console is placed in the acquisition room itself, consistent with the SPECT convention, and the other console is placed in the shielded scanner control room, as required for CT. The acquisition stations provide a single user interface for both SPECT and CT patient acquisition set-up. The SK Ylight and Brilliance system gantries remain intact as major subsystem components located within a common integrated housing. The combined Griffin SPECT-CT Imaging System is designed so that the system can operate in three modes: CT only, SPECT only, and combined SPECT/CT performed sequentially. No modifications have been made to either system, which would affect system performance. Griffin is intended for use primarily as an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. The same clinical protocols and procedures are available on the Griffin Imaging System as in the predicate SPECT or CT systems. Acquired SPECT and CT images on the Griffin may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data to provide anatomical localization of the nuclear medicine image.
The provided document is a 510(k) Premarket Notification for the Griffin SPECT/CT Imaging System. It describes the device, its intended use, and comparison to predicate devices, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
The document states that the system performance was tested in accordance with the NEMA-NU-1 standard and compliance with radiation safety standards (21 CFR 1020.30 and 21 CFR 1020.33). However, it does not provide the specific acceptance criteria derived from these standards or the quantitative results of these tests. Instead, it concludes that the device is "substantially equivalent" to predicate devices based on intended use, technological comparison, and system performance.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the detailed information about sample sizes, experts, ground truth, or MRMC studies, as this information is not present in the provided text.
Based on the information available, here's what can be extracted regarding System Performance and Compliance:
System Performance and Compliance (as described in the document)
The document states compliance with general safety and performance standards, rather than presenting a performance study with specific acceptance criteria as you've requested.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Radiation safety (21 CFR 1020.30 & 1020.33) | Compliance and certification to the performance standards for ionizing radiation emitting product was ensured. A radiation safety product report was to be filed. |
| Electrical & mechanical safety (IEC 60601-1 series) | Assured as the system is designed to applicable voluntary standards. |
| Image quality/performance (NEMA NU-1) | Device performance was measured in accordance with the NEMA-NU-1 standard. (Specific results not detailed) |
Regarding the other requested information, the document does NOT provide the following:
- Sample sizes used for the test set and the data provenance: No information on test sets, patient data, or data provenance is provided.
- Number of experts used to establish the ground truth for the test set and qualifications: No information on expert review for ground truth is available.
- Adjudication method for the test set: Not applicable as no specific test set or adjudication process is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document focuses on substantial equivalence to predicate devices, not improvement over human readers with AI assistance.
- Standalone (algorithm only without human-in-the-loop performance) study: This device is an imaging system, not an AI algorithm. Its performance is inherent in its hardware and software for image acquisition and display, not a standalone AI algorithm.
- Type of ground truth used: Not applicable as no specific performance study with a defined ground truth is described.
- Sample size for the training set: Not applicable, as this is a hardware imaging system, not a machine learning algorithm requiring a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
Conclusion:
The K041218 submission for the Griffin SPECT/CT Imaging System demonstrates substantial equivalence primarily by comparing its intended use, technology, and compliance with general performance and safety standards to predicate devices (Skylight Imaging System and MX8000 IDT CT System). It does not present a detailed study with quantitative acceptance criteria and results as typically found for novel diagnostic algorithms or AI-driven devices.
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(88 days)
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.
The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.
The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as composite images.
Based on the provided text, the submission does not contain a detailed study with specific acceptance criteria and performance metrics. Instead, the focus is on establishing substantial equivalence to previously marketed predicate devices (Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009, and the Mx8000IDT).
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The provided text does not include a table of acceptance criteria or reported device performance metrics for the Brain Perfusion Option. The submission relies on demonstrating substantial equivalence to predicate devices rather than presenting a performance study against predefined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. No specific test set or data provenance is mentioned as there isn't a stand-alone performance study described.
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)
This information is not provided in the document. Since there is no described test set or ground truth establishment process, details about experts are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned as there is no described 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
There is no mention of an MRMC comparative effectiveness study in the provided text. The document focuses on the device's functional capabilities and substantial equivalence, not on human reader improvement with AI assistance. The device is referred to as "intended to assist the user," but no study is presented to quantify this assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm is not explicitly described in the document. The submission emphasizes the device's functional specifications and how it "assists the user," suggesting a human-in-the-loop context, but no specific performance metrics are offered for the algorithm itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. As no performance study with a test set is outlined, the type of ground truth used is not specified.
8. The sample size for the training set
This information is not provided in the document. Details about algorithm training are not included.
9. How the ground truth for the training set was established
This information is not provided in the document. The process of establishing ground truth for any potential training set is not detailed.
Summary of the Study (as inferred from the document):
The "study" described in the provided text is primarily a substantial equivalence review rather than a performance study. Philips Medical Systems (Cleveland), Inc. asserts that the Brain Perfusion Option is "of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009 and the Mx8000IDT."
The basis for this claim is that the devices "comply with the same or equivalent standards and have the same or equivalent intended uses." The document highlights the functional specifications and operator's instructions (Appendices "B" and "C", which are not provided) to support this comparison. It also states that the device adheres to FDA GMPs, 21 CFR 1020.30-33, and voluntary standards for safety/effectiveness (UL 2601) to minimize hazards.
Therefore, the "study" that proves the device meets the acceptance criteria is an argument for substantial equivalence based on comparable intended use, technology, and adherence to regulatory and safety standards, rather than a clinical performance trial with predefined acceptance criteria and measured outcomes against a ground truth.
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(13 days)
The "Philips Plus" is a Whole Body Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
The "Philips Plus" is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
The "Philips Plus" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 40 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
The provided text is a 510(k) summary for the "Philips Plus" CT Scanner. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study outlining specific acceptance criteria and performance metrics for the device itself against a defined ground truth.
Therefore, the information requested as per your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training, and training set size/ground truth establishment) is not available in the provided text.
The document states:
- "The safety of the device is assured by adherence to GMP practices and to International Standards."
- "Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met."
- "Electrical and Mechanical safety is assured by adherence to IEC 60601-1 standards."
- "Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards."
These statements indicate adherence to general regulatory and industry standards for safety and manufacturing, but they do not detail specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or the results of a study designed to demonstrate those.
In summary, the provided text does not contain the information required to answer your specific questions about acceptance criteria and a performance study. It's a regulatory submission for substantial equivalence, not a clinical validation report.
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(10 days)
The device is an imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). The device produces attenuation and nonattenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. The device can provide CT data suitable for use in attenuation correction.
The device is a combination Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanner that can be utilized in both conventional, fixed installations or mobile environments. The system integrates the two system operator consoles into a single workstation to allow straightforward planning and system operation. The individual PET and the CT gantries remain intact as major subsystem located within a common integrated housing. It can be used in clinical protocols and procedures, which have been clinically conducted in a separate CT system and/or a PET system. The system is intended for use primarily as a clinical whole body oncology scanner with high-end multislice CT capability and high-end GSO based PET performance. It mechanically separates to allow for the greater flexibility for above three operation modes.
Here's an analysis of the provided text regarding the Gemini 16 device's acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the Gemini 16 does not specify quantitative acceptance criteria for its performance. Instead, it refers to compliance with established standards. The reported "device performance" is primarily articulated as meeting these technical and safety standards, and being "substantially equivalent" to predicate devices.
| Acceptance Criteria (Reference to Standard) | Reported Device Performance |
|---|---|
| Radiation Safety: | |
| 21 CFR 1020.30 (Performance standards for ionizing radiation emitting products) | Compliance and certification achieved. Radiation safety product report to be filed. |
| 21 CFR 1020.33 (Computed Tomography Equipment) | Compliance and certification achieved. Radiation safety product report to be filed. |
| Electrical and Mechanical Safety: | |
| IEC 60601-1 series (Applicable standards) | Adherence and certification achieved. |
| Imaging Performance: | |
| NEMA NU-2 standard | Device performance measured in accordance with this standard. |
| Clinical Efficacy (Implied): | |
| Substantial equivalence to predicate devices: Gemini (K013521) and Mx8000 IDT (K012009) | Achieved through similar intended use, technological comparison, and system performance. Performance improvements noted for decreasing patient scan time and improving attenuation correction speed compared to the predicate Gemini system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific sample size for a test set or the provenance of any data. The evaluation relies on compliance with technical standards and a comparison to predicate devices, rather than a clinical study with a distinct test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no reported clinical study with a test set requiring expert-established ground truth. The evaluation focuses on technical performance and safety standards.
4. Adjudication Method for the Test Set
This information is not applicable as there is no reported clinical study with a test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on technical safety and performance, and substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
This information is not applicable in the context of this device. The Gemini 16 is a medical imaging system (a PET/CT scanner), not an AI algorithm. Its performance is inherent to its hardware and software functioning, which is evaluated against established physical and safety standards (NEMA NU-2, IEC, CFR). The "algorithm only" concept typically applies to software-based diagnostic aids.
7. The Type of Ground Truth Used
The "ground truth" for the Gemini 16's evaluation is primarily based on:
- Compliance with published technical standards: NEMA NU-2 for imaging performance, 21 CFR 1020.30 & 1020.33 for radiation safety, and IEC 60601-1 series for electrical and mechanical safety.
- Comparison to predicate devices: Establishing "substantial equivalence" based on intended use, technological comparison, and system performance as defined by the aforementioned standards.
8. The Sample Size for the Training Set
This information is not applicable. The Gemini 16 is a physical imaging device, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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