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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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The CAP-35BIII and the CINE 275 are intended to view 35 mm cineangiogram film.

The CAP-35BII cineangiogram projector is a continuous film transport 16-facet rotating prism projectors. The CINE 275 is a simpler version of the CAP-35BIII, with fewer options. The CAP-35BIII consists of a 35 mm film projector with built-in viewing hood, a movable cart, a sheet film duplicator, a 35 mm slide camera, a remote control, and an optional TV camera assembly. The CINE 275 consists of a 35 mm film projector with built-in viewing hood and a movable cart.

This document describes a 510(k) submission for two cineangiogram projectors, the CAP-35BIII and CINE 275. It focuses on demonstrating substantial equivalence to a predicate device, the Vanguard XR-350, rather than proving performance against specific acceptance criteria through a clinical study in the way modern AI/ML devices might.

Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information and indicate where information is not available or not required for this specific device type and regulatory pathway.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (cineangiogram projector), the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This involves comparing technical characteristics and intended use. Performance is typically assessed by ensuring the device can perform its intended function (viewing 35mm cineangiogram film) safely and effectively, demonstrating equivalence in key operational and design parameters.

Note: For a 510(k) for a device like this, "acceptance criteria" are not usually defined as quantitative performance metrics with specific targets (e.g., AUC > 0.9). Instead, the primary criterion is demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through a comparison of technological characteristics and intended use. Differences are acceptable if they do not raise new questions of safety or effectiveness.

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

• Sample Size for Test Set: Not applicable. This submission is for a medical device (cineangiogram projector), not an AI/ML diagnostic algorithm. There is no "test set" of patient data in the context of evaluating a diagnostic algorithm's performance. The "test" is primarily the comparison of technical specifications and features to the predicate device.
• Data Provenance: Not applicable. The "data" here refers to the device's design specifications and performance under engineering tests/benchmarking, not patient-derived data.

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

• Number of Experts: Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No "test set" in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. This type of study is relevant for evaluating the impact of an AI/ML diagnostic tool on human reader performance, which is not applicable to a cineangiogram projector.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: Not applicable. This device is an instrument for viewing film, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on the technical specifications and functional performance of the predicate device (Vanguard XR-350), and engineering verification of the new devices (CAP-35BIII and CINE 275) against their own design specifications and relevant safety standards. It does not involve patient outcomes, pathology, or expert consensus on a diagnostic finding.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of Key Takeaways for this Specific Document:

The provided document is a 510(k) Summary for medical device clearance. The primary focus is on demonstrating substantial equivalence to a predicate device. This is achieved by comparing the new devices' (CAP-35BIII and CINE 275) technical characteristics and intended use with those of the predicate device (Vanguard XR-350). The "acceptance criteria" are implicitly met if the sponsor can convince the FDA that the new devices are as safe and effective as the predicate, despite some technological differences, and do not raise new questions of safety or effectiveness. Clinical trials or extensive performance studies with patient data, as required for AI/ML algorithms, are not typically part of this specific type of 510(k) submission for a non-AI hardware device like a projector.

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The intended use of the Philips EasyDIAGNOST is the same as for the Philips DIAGNOST 76 plus.

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 Medio, Super CP, and OPTIMUS families, with digital spot film cameras from the Philips DSI family, and with a Philips EASY VISION workstation. The system comes with a trimode Image Intensifier, XTV imaging system, Philips glass or metal X-ray tube(s), and TV monitor(s). An optional dedicated ultrasound system (Scanner 200X) can also be added.

The system can also be extended with an overtable tube which operates on a bucky tray 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 provided text is a 510(k) Summary for the Philips EasyDIAGNOST, an R/F (Radiography/Fluoroscopy) system. It focuses on demonstrating substantial equivalence to a predicate device and compliance with established safety and performance standards for X-ray equipment. It does not include information about specific acceptance criteria related to a device's diagnostic performance, nor does it describe a study to prove the device meets such criteria in the context of diagnostic accuracy, which is what your request implies.

Therefore, I cannot populate the table or answer most of your questions based on the provided text. The document is about regulatory clearance of an imaging hardware system, not the diagnostic performance of an AI or image analysis algorithm.

Here's what I can extract and address from your request based on the provided text, and what I cannot:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The document describes a hardware system and its compliance with engineering standards. It does not refer to a test set of data for evaluating diagnostic performance.

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 / Not provided. No test set or ground truth establishment relevant to diagnostic accuracy is mentioned.

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

• Not applicable / Not provided. No test set or adjudication process relevant to diagnostic accuracy is 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 / Not provided. This device is an R/F system, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided. This device is an R/F system, not a standalone algorithm.

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

• Not applicable / Not provided. No ground truth for diagnostic purposes is mentioned. The "ground truth" for the claims made in this document relates to engineering specifications and regulatory compliance.

8. The sample size for the training set

• Not applicable / Not provided. No training set for an algorithm is mentioned.

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

• Not applicable / Not provided. No training set or ground truth establishment for an algorithm is mentioned.

In summary, the provided document is a regulatory submission for a medical imaging hardware system, demonstrating its safety and equivalence to existing technology, not an AI or diagnostic software study. Therefore, the information you're requesting regarding diagnostic performance, test sets, ground truth, and reader studies is not present.

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to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals.

the Electrophysiology 40 Tilt Table (Model 9660) and the Delux Model 9660 are designed for clinical applications such as: to position patients for a dia procedure employing some imaging technique or to position a patient for various treatments in or hospitals. This device is used by a physician or a health care professional; this device is not operated by a patient. This is a Class II device. As such this device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892. 11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004, and is manufactured by Biodex Medical Systems, Inc. of Shirley New York.

The provided text is a Summary of Safety & Effectiveness for a medical device, the Electrophysiology 40 Tilt Table (Model 9660). It is a premarket notification (510(k)) submission from 1997, which focuses on demonstrating substantial equivalence to a predicate device.

Unfortunately, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The summary states:

• "This device has performance characteristics substantially equivalent to its predicate device {which includes differences to facilitate the various clinical applications for which it is intended }."
• "This device is safe and effective for the application for which it is intended and has been tested to confirm its safety and effectiveness."

However, it does not provide any specific data, metrics, or details about these tests, nor does it define any acceptance criteria. It also doesn't involve any AI or algorithm performance.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided text.

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to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.

This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional: this device is not operated by a patient. This is a Class II device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004. and is manufactured by Biodex Medical Systems. Inc. of Shirley New York.

This document is a 510(k) summary for a Class II medical device, specifically fluoroscopic tables and a C-arm stretcher designed for patient positioning during diagnostic imaging or treatment. It aims to demonstrate substantial equivalence to a predicate device.

Based on the provided text, it's explicitly stated that the device's substantial equivalence is based on its mechanical support, conventional design and materials, adherence to Good Manufacturing Procedures, performance characteristics, and safety and effectiveness for its intended application.

However, the provided text does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed metrics typically associated with proving a device meets acceptance criteria through a formal study.

The document primarily focuses on establishing substantial equivalence to a predicate device by asserting:

• The device offers mechanical support and adjustment.
• It uses conventional design, construction, and materials.
• It conforms to Good Manufacturing Procedures.
• It has performance characteristics substantially equivalent to its predicate.
• It is safe and effective for its intended use.

Therefore, I cannot populate the requested table or sections because the necessary detailed information is not present in the provided text. The document describes the basis for regulatory clearance (substantial equivalence), but not a rigorous study proving specific performance metrics against pre-defined acceptance criteria.

Missing Information:

• Specific quantitative acceptance criteria are not mentioned. The document states "performance characteristics substantially equivalent to its predicate device," but doesn't define what those characteristics are or what thresholds must be met.
• No study details are provided. There's no mention of a particular study, its design, endpoints, or results. The statement "This device has been tested to confirm its safety and effectiveness" is a general claim, not a description of a specific study.
• Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set information are entirely absent.

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Ask a specific question about this device

Ask a specific question about this device