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CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.

The CombiDiagnost R90 is a multi-functional remote controlled fluoroscopy system in combination with a high-end digital radiography system consisting of a floor-mounted tilt- and heightadjustable patient support and a scan unit consisting of a tube and a flat panel detector, Pixium FE 4343F. The tabletop can be moved by a motor in the lateral direction and can be tilted +/- 90 degrees. The scan unit tilts with the table and can be moved in the longitudinal direction, relative to the table and to the patient. The fully integrated system is provided with a touch screen console, glass or metal x-ray tube(s) with collimator and high resolution displays. As a fully integrated system, the proposed CombiDiagnost R90 can be configured with a Philips generator, the flat panel detector Pixium FE 4343F, and the Philips Dynamic Eleva Image Chain acquisitionstation also provided with the currently marketed and reference device, Eleva Workspot with SkyFlow (Eleva Workspot). The proposed CombiDiagnost R90 uses the same workflow from the currently marketed and reference device, Eleva Workspot with SkyFlow. The only modification to the Eleva Workspot is integration with the Pixium FE 4343F detector.

The provided text is a 510(k) summary for the Philips CombiDiagnost R90, an X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic AI algorithm.

Therefore, much of the requested information regarding acceptance criteria for a diagnostic performance study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance of an AI algorithm is not applicable to this type of submission. This document describes a medical device, not a diagnostic AI.

However, I can extract the information related to the device's technical specifications and the non-clinical testing performed to show its safety and effectiveness.

Here's the breakdown of the available information:

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

The document does not provide a specific table of quantitative acceptance criteria for diagnostic performance and corresponding reported performance values for the CombiDiagnost R90's imaging capabilities (e.g., sensitivity, specificity for a particular pathology). Instead, it presents a comparison of technological characteristics between the proposed device and its predicate, along with a statement that non-clinical tests met acceptance criteria.

Technological Characteristics Comparison (Proposed Device vs. Predicate Device)

The study (non-clinical verification and validation tests as well as image quality testing) "demonstrate[d] that the proposed CombiDiagnost R90 meets the acceptance criteria and is adequate for its intended use." The acceptance criteria for these non-clinical tests are defined by the referenced international and FDA-recognized consensus standards.

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 as it is a 510(k) submission for an X-ray system, not a diagnostic AI algorithm. The "test set" here refers to the physical device undergoing non-clinical technical testing, not a dataset of patient images.

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 applicable as the document describes non-clinical technical testing of an X-ray system, not a diagnostic study requiring expert ground truth for image interpretation.

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

This information is not applicable for the same reasons as #3.

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

An MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the purpose of this 510(k) submission for an X-ray system.

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

A standalone performance study of a diagnostic algorithm was not done. This document concerns an X-ray imaging system.

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

For the non-clinical testing of the CombiDiagnost R90, the "ground truth" would be established by engineering specifications and validated measurement equipment according to the referenced standards (e.g., IEC 62220-1 for detective quantum efficiency, IEC 60601 series for safety and performance). This is a technical ground truth, not a clinical one based on patient outcomes or expert reads.

8. The sample size for the training set

This information is not applicable as the device is an X-ray system, not an AI algorithm requiring a training set of images.

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

This information is not applicable for the same reasons as #8.

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The X3C 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, lying in the prone or supine positions.

The X3C 1100 (510k submission device) is not intended for mammography.

The X3C 1100 is a modification to Xplorer 1100 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1100 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1100 system is manufactured by Imaging Dynamics.

This submission (K071408) is for a X3C 1100 motorized patient table with digital radiographic detector. This device is a modification of an existing device, where the digital radiographic detector component has been updated.

The key takeaway is that no clinical studies were conducted for this 510(k) submission. The manufacturer relied on non-clinical tests and demonstrating substantial equivalence to a predicate device (Xplorer 1100, K062417) to meet acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No clinical test set was used for this submission. The evaluation was based on non-clinical tests and comparison to a predicate device.
• Data Provenance: Not applicable for clinical data. Non-clinical test data provenance is not specified beyond being generated by Imaging Dynamics Company Ltd.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. No clinical test set requiring expert ground truth establishment was conducted for this submission.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was conducted for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical tests: No clinical tests conducted."

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a digital radiographic detector integrated into an X-ray system, not a standalone algorithm. Also, no clinical studies were performed.

7. Type of Ground Truth Used

• Not applicable for clinical studies. For the non-clinical tests, the "ground truth" would be established by engineering specifications, regulatory standards, and performance against the predicate device through direct comparison testing.

8. Sample Size for the Training Set

• Not applicable. This device does not appear to involve AI/ML requiring a training set in the context of this submission. The evaluation was primarily engineering-based and comparison to a predicate device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set was used.

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The Xplorer 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediation patients and other, performed with patient sitting, standing or lying in the prone or supine positions.

The Xplorer 2200 (510k submission device) is not intended for mammography.

The Xplorer 2200 is a combination of two Xplorer 1000 CCD imagers, a previously marketed device covered by 510k K992955. One imager is in the Xplorer 1100 radiographic table, a previously marketed device covered by 510k K062417 and the other imager is on a vertical stand, a previously marketed device covered by 510k K062405. The system is operated in conjunction with a celling mounted X-ray tube/collimator assembly. The Xplorer 2200 system is manufactured by Imaging Dynamics. The CCD Imagers are unchanged from that which is marketed under K992955.

The provided text does not contain acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) summary for the Imaging Dynamics Xplorer 2200 Digital Radiographic System. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the predicate device) rather than presenting new performance data against acceptance criteria.

The key points from the provided text are:

• Device Description: The Xplorer 2200 is a combination of existing components (two Xplorer 1000 CCD imagers, an Xplorer 1100 radiographic table, and a vertical stand) with a ceiling-mounted X-ray tube/collimator assembly. The core imager technology is unchanged from a previously cleared device (K992955).
• Predicate Device: The Xplorer 1600 Digital Radiographic System (K042041).
• Comparison with Predicate Device: The manufacturer states that "The Xplorer 2200 is substantially equivalent to the currently marketed Xplorer 1600. Xplorer 2200 device does not alter the fundamental scientific technology from Xplorer 1600 predicate device." The only modification is the integration of existing components.
• Non-clinical tests: Evaluated for performance, biocompatibility, thermal, electrical, and mechanical safety, and found substantially equivalent to the predicate device.
• Clinical tests: "No clinical tests conducted."
• Conclusion: The device was evaluated against the predicate device for all performance, safety & effectiveness requirements and found to be substantially equivalent.

Therefore, I cannot provide the requested information because the provided text explicitly states that no clinical tests were conducted to establish new performance data against specific acceptance criteria for the Xplorer 2200. The regulatory approval was based on the substantial equivalence to a predicate device, leveraging the performance data and established safety/effectiveness of its constituent components.

To answer your specific points:

1. A table of acceptance criteria and the reported device performance: Not available. The submission relies on the substantial equivalence to the predicate device's performance, not new performance data for this specific combined system.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.
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 a digital radiographic system, not an AI-powered diagnostic tool, and no clinical study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical study was performed.
8. The sample size for the training set: Not applicable. The device is not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a Special 510(k) submission based on substantial equivalence and the integration of previously cleared components. It explicitly states that no new clinical tests were conducted for this specific permutation of the device.

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The UroVantage is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to Urologic and endoscopic procedures. The device may be used for other imaging applications at physician's discretion.

The UroVantage is an Image-Intensified Fluoroscopic X-Ray System and radiological table. The device consists of: a tilting patient support table; x-ray generator; control panel; remote control panel, x-ray tube assembly, collimator, image intensifier, television ("TV") system with monitor; tableside control. The Isocentric C-arm of the UroVantage ensures easy control and issues intensifier and x-ray tube around the patient. The device s movement of x-ray stand with a tilting table also provides support for both the thou modition is as a m. Standard and optional accessories also are supplied.

The UroVantage is a modification to PCK's UROlogic device that has already been The Orovide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures (K011311). The during diagnootic, barger intended use and fundamental scientific technology as the Orovantage nas the battle interations are: (1) replacement of the fixed imaging arm ("U" arm) with an Isocentric C-Arm; (2) the fixation of the Isocentric C-arm to the support table; (3) minor changes in the dimensions of the support table; and (4) changes in the software to accommodate the use of the Isocentric C-arm.

This 510(k) summary for the UroVantage Urological Table does not contain information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (UROlogic, K011311) based on:

1. Same intended use and indications for use.
2. Similar technological characteristics and principles of operation.
3. Minor differences that do not raise new questions of safety or efficacy.

Therefore, I cannot provide the requested information. The submission describes a device modification, relying on the predicate's established safety and effectiveness rather than presenting new performance data for the UroVantage itself.

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The Bionix Thigh and Foot Positioner patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio) is intended to be used for the positioning and re-positioning of patients for receiving external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

The SuProne Plus from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy.

Thigh Bolster and Foot Positioner: The Thigh Bolster and Foot Positioner consist of two parts, a thigh support and a footrest. The thigh support portion has a generally tent-like shape, with formed contours to support the thighs and calves. The thigh support portion is designed to interface with the Bionix Secure-Bar, allowing it to be secured to the radiation therapy treatment couch in an index-able fashion. The thigh support portion also has attachment points for interlocks that allow the use of low-melt thermoplastic during the patient immobilization procedure. The Thigh Bolster and Foot Positioner are constructed of a thermoformed thermoplastic ABS shell with an air core. The Thigh Bolster and Foot Positioner also have simple mechanical interlocks that allows the individual parts to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the Thigh Bolster and Foot Positioner during the patient positioning process.

SuProne Plus: The SuProne Plus consists of a flat "headboard" comprised of a material with a carbon fiber/epoxy skin and a foam core that rests on a base-plate comprised of similar carbon fiber/epoxy composite material without the foam core. The headboard is designed to hold a patient's head in either the supine or prone position during treatment. An open area in the center of the headboard allows for prone positioning of the patient; during treatment, the patient's forehead and cheekbones rests on a foam cushion for support and comfort. For supine positioning, the patient's head rests on a thin plastic headrest for comfort. With both prone and supine positioning, low-melt thermoplastic may be used to further constrain patient movement. The headboard has clamps or other locking mechanisms that allow the low-melt thermoplastic to attach firmly to the device. The headboard rests on a base-plate made from a carbon fiber/epoxy resin composite material. This base-plate has three main elements: a base, side supports, and an upper frame that mates with the headboard. The base-plate base has simple mechanical interlocking systems that allow the device to be securely attached to the treatment couch tabletop using an attachment bar or similar device. The side supports of the base-plate provide rigidity and have semi-circular slots milled into the side support of the bas a rigid, open box-like design, and has locating pins that mate with the underside of the headboard. The sides of the upper frame have threaded pins that mate with the semi-circular slots in the side supports. These threaded pins allow the upper frame to move in an arcing fashion, following the semi-circular slots in the side supports. Tightening the threaded pins locks the upper frame at desired angle.

The provided document is a 510(k) Premarket Notification for two medical devices: the Thigh Bolster and Foot Positioner, and the SuProne Plus. This submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through a study with detailed quantitative outcomes.

Therefore, the document does not contain the information requested in sections 1-9 of your query, as it describes a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria, sample sizes, expert adjudication, or MRMC studies.

Here's why the requested information is absent:

• No Acceptance Criteria or Reported Performance (Section 1): The document claims "similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam." However, these are qualitative statements of expected similarity to predicates, not specific measurable acceptance criteria with reported performance values as would be found in a performance study.
• No Test Set Sample Size or Provenance (Section 2): Since no performance study is detailed, there is no test set, sample size, or data provenance mentioned.
• No Experts for Ground Truth (Section 3): The submission relies on a comparison to existing devices, not on the generation of new ground truth for a test set.
• No Adjudication Method (Section 4): Not applicable as there's no diagnostic study requiring adjudication.
• No MRMC Study (Section 5): The document focuses on the physical characteristics and intended use of the devices, not on effects on human reader performance.
• No Standalone Performance Study (Section 6): The devices are patient positioning systems, not algorithms. Their performance is described in terms of their intended function (positioning and re-positioning patients for radiation therapy) and comparison to predicate devices, not as standalone diagnostic performance.
• No Ground Truth Type (Section 7): The "ground truth" here is the established safety and effectiveness of the predicate devices based on their long-term clinical use and FDA clearance. No new clinical ground truth is established for these devices in this submission.
• No Training Set Sample Size (Section 8): These are physical devices, not AI/ML algorithms that require training sets.
• No Ground Truth Establishment for Training Set (Section 9): Not applicable for the same reason as above.

The core of this 510(k) submission is the argument that the new devices are "substantially equivalent" to legally marketed predicate devices. This is achieved by comparing their design, materials, function, and intended use. The document repeatedly states:

• "This product is similar in design and function to existing patient positioning devices currently in use..."
• "The Bionix Thigh Bolster and Foot Positioner is substantially equivalent to the Med-Tec Dual Leg Positioner and Knee-and-Foot Lok in design, form, and function."
• "Based on the almost identical design and similar features...it is reasonable to expect that the two devices will have similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam, and should function in a substantially equivalent fashion..."

In summary, this document does not contain the information you requested because it's a regulatory submission demonstrating substantial equivalence through comparison, not a clinical trial or performance study with detailed acceptance criteria and quantitative results.

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The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.

Remote controlled radiology table, collimator and spot film device

I'm sorry, but the provided text does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance as requested.

The document is a 510(k) summary for the APOLLO remote-controlled radiology table. It focuses on establishing substantial equivalence to a predicate device by comparing technical specifications and intended use.

Specifically, the document does NOT contain information on:

• Acceptance Criteria for performance: It lists specifications of the device but not criteria against which its performance was measured to demonstrate safety and effectiveness.
• A "study that proves the device meets the acceptance criteria": There is no description of a clinical trial, performance testing study, or any other formal study conducted to "prove" the device's performance against specific metrics.
• Sample size or data provenance for a test set.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

The document is primarily a comparison table of features between the APOLLO and its predicate device (Philips Omnidiagnost Eleva) to demonstrate substantial equivalence, a regulatory pathway that doesn't typically require extensive performance studies as might be seen for novel devices or AI solutions.

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The Philips EasyDiagnost Eleva intended use is for the following applications: as a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with pediatric examinations and some more specialized interventional applications. This includes the following examples:

Routine Examinations Colon examinations Examinations of the digestive tract Lung fluoroscopy Examinations of the gall bladder Thorax examinations Skeleton imaging Pediatric examinations Special Applications (might require special accessories and technique) Angiography Myelography Phlebography Arthrography Bronchography Tomography Sialography Hysterosalpingography

The Philips EasyDIAGNOST is a multi-functional R/F system consisting of a floormounted tilting patient support table and a spotfilm device holding an image intensifier and the TV camera. The tabletop can be moved by motor in longitudinal and lateral directions. The spot film device tilts with the table, and can be moved in three directions, relative to the table and to the patient. As a fully integrated system, it can be configured with generators from the Philips Velara familiy, with digital spot film cameras from the Philips DI family, and with a Philips ViewForum workstation. The system comes with a 4-mode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Ultramark 400C) can also be added. inside the table and/or on a bucky wallstand (so-called second plane). This second plane option is identical to a Philips bucky DIAGNOST system, except for the table itself.

Philips Grid Controlled Fluoroscopy (GCF) can be provided using an SRM (metal) gridswitched X-ray tube. GCF improves overall image quality and provides dose reduction through precise control of fluoroscopic pulse shapes, eliminating excess radiation associated with pulse ramping and trailing effects of conventional pulsed fluoroscopy. The system supports system-wide application-oriented presets and can be equipped with options for better integration into the hospital IT environment (bidirectional RIS coupling), advanced X-ray control techniques (in-pulse control), dose awareness (dose calculation or measurement, automatic prefilter setting), image handling (automatic iamge transfer to integrated viewing workstation), and postprocessing (overview image reconstruction).

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) summary for the Philips EasyDiagnost Eleva, which primarily focuses on demonstrating substantial equivalence to a predicate device, system description, safety information, and indications for use. It does not include details on specific performance metrics, testing methodologies, or clinical study results for novel performance claims.

Therefore, I cannot provide the requested information based on the input text.

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To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Combi Elevator-2 & Combi Elevator-2 Microtom." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter focuses solely on the regulatory approval and indications for use. Therefore, I cannot provide the requested information based on the provided text.

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The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.

MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC. The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch.

This document is a 510(k) premarket notification for a "Carbon Fiber Conformal Couch Top." It is a regulatory approval letter from the FDA, and as such, it does not contain the detailed technical study information requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

Therefore, most of the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

Here's what can be inferred from the document:

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

• Acceptance Criteria: Not explicitly stated as this is a regulatory approval letter rather than a technical report. However, the FDA's acceptance of substantial equivalence implies that the device met certain safety and effectiveness benchmarks comparable to predicate devices.
• Reported Device Performance: Not explicitly stated with specific metrics. The letter implies that the device operates "in the same manner as an ordinary couch" and is intended "to support and aid in positioning a patient during radiologic and other medical procedures."

Remaining information (2-9) is not available within the provided FDA letter. The letter is a formal notification of approval based on a submission, not the submission itself or a summary of its technical data.

To provide the requested details, a different type of document, such as the actual 510(k) submission summary or a scientific study report, would be necessary.

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This table is intended for use in a diagnostic x-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions.

The Legacy/Legacy-D table is a patient support providing angulation to +/- 90 degrees and tabletop motion in the longitudinal and lateral directions. It includes an integrated table bucky and a spot film/fluoroscopic tower. The new bucky has the same function as the older version.

This submission, K973039, describes the GE Legacy/Legacy-D Radiologic Table. This is a device for patient support during diagnostic x-ray procedures and as such, does not require a study with acceptance criteria.

Here's a breakdown based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is a 510(k) submission for a non-AI/diagnostic device, and no specific test set or clinical study data is presented to prove performance based on a sample size. The equivalence is asserted based on design and intended use compared to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth was established for a test set in the context of a performance study for this device.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI-powered diagnostic device, and therefore, no MRMC study was conducted.

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

Not applicable. This device does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

Not applicable. Performance for this device is based on its mechanical and functional specifications, compared to predicate devices, not on diagnostic accuracy against a ground truth.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of the Study (or basis for clearance):

The GE Legacy/Legacy-D Radiologic Table obtained 510(k) clearance by demonstrating substantial equivalence to existing, legally marketed diagnostic x-ray tables. The "study" in this context is the comparison of the new device's design, materials, and intended use against predicate devices. The manufacturer's conclusion is that the device "is as safe, and performs as well as other diagnostic x-ray tables of similar design having the same intended uses" and that its design "raises no new questions of safety or effectiveness." The FDA's review agreed with this assessment, confirming substantial equivalence and allowing the device to proceed to market. There was no clinical trial or performance study with acceptance criteria in the traditional sense for this type of medical device clearance.

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