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The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use.

The DRF 4343 is Intended to capture digital images from a radiographic/fluoroscopic system through a dynamic digital flat panel, to digitalize, archive and review images and to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices which uses a device.

This 510(k) submission for the DRF 4343, an Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems, does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on shared indications for use and technological characteristics.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or reported device performance metrics are provided in the document. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it functions similarly to already approved devices, its performance is acceptable.

2. Sample size used for the test set and the data provenance:

• Not applicable. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set or ground truth establishment is described.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study is mentioned. The submission focuses on device characteristics and substantial equivalence, not comparative effectiveness with human readers.

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

• Not applicable. This device is an operator console and imaging workstation for X-ray systems, not an AI algorithm performing diagnostic tasks. Its function is to capture, digitalize, archive, and review images, which implicitly involves human interaction.

7. The type of ground truth used:

• Not applicable. As there is no performance study or ground truth establishment described.

8. The sample size for the training set:

• Not applicable. This submission does not describe an AI model or a training set.

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

• Not applicable. As there is no AI model or training set described.

Summary of available information related to the device and its approval:

• Device Name: DRF 4343
• Common Name: Operator Console and Imaging Workstation for Stationary Digital X-Ray Systems
• Indication for Use: "The DRF 4343 is a digital image acquisition system to be used in conjunction with a solid-state detector during radiography or fluoroscopy x-ray examination to capture, digitalize, review images and format images according to DICOM protocol to be sent through network connection. This device is not intended for mammography use."
• Predicate Devices: Nical NDR+/DIVA-D (K053029), Siemens AXIOM Luminos dRF (K062623), Shimadzu DAR7000 RADspeed SAFIRE (K050925).
• Rationale for Substantial Equivalence: The DRF 4343 has the same indication for use and similar technological characteristics as the predicate devices, with minor differences not raising new questions regarding safety or effectiveness.

In conclusion, this 510(k) submission establishes substantial equivalence through comparison to existing predicate devices rather than through a dedicated performance study with acceptance criteria and a test set. Therefore, the specific details requested regarding acceptance criteria and study data are not present in the provided document.

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The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The 0170 Intuition is not intended for mammography.

The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder. The ceiling stand and the table has automatic movements for up and downs, other movements are manual. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.

This document is a 510(k) summary for the Arcoma Intuition Model 0170, a stationary x-ray system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Identification and Classification: Trade name, classification, review panel, product code, regulation number, and device classification.
• Predicate Devices: A list of previously cleared devices to which the Intuition Model 0170 is substantially equivalent.
• Device Description: A brief overview of the physical components and functionalities of the x-ray system.
• Intended Use: The specified clinical application (radiographic imaging of various portions of the human body, excluding mammography).
• FDA Clearance: The letter from the FDA confirming the substantial equivalence determination and allowing the device to be marketed.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used (for test set)
8. Sample size for the training set
9. How ground truth for the training set was established

This type of detailed performance testing and clinical study information is typically found in accompanying technical documentation or clinical study reports, which are not part of this 510(k) summary. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which often relies on technical comparisons and non-clinical bench testing, rather than extensive clinical efficacy studies with predefined acceptance criteria for performance metrics like sensitivity and specificity.

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