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Agfa's Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.

Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.

Agfa's Computed Radiography (CR) Systems with CR 10-X Digitizer is a solid state x-ray imaging device. Principles of operation and technological characteristics of the new and predicate devices are largely the same as other computed radiography systems:

• Phosphor coated imaging plates and cassettes for image capture.
• Laser digitizer for generating the electronic image. .
• NX workstation for image previewing, processing and routing .

Given the provided text, the Agfa Computed Radiography (CR) Systems with CR 10-X Digitizer is a medical imaging device. The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Agfa's CR 30-X digitizer, K062223) rather than proving performance against specific acceptance criteria in a quantitative study with detailed metrics.

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

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

The document does not explicitly state quantitative acceptance criteria in terms of numerical performance thresholds. Instead, the approach is based on demonstrating that the new device (CR 10-X Digitizer) is "substantially equivalent" to the predicate device (CR 30-X Digitizer). The "performance" is generally described as "similar" or "same as predicate" in terms of technological characteristics and image quality.

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

The document states: "Tests included image quality tests with internal and experts comparing the device to its predicate." However, it does not specify the sample size for any test set (e.g., number of images, number of patients).

The data provenance (country of origin, retrospective/prospective) is not mentioned.

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)

The document mentions "experts comparing the device to its predicate" for image quality tests. However, it does not specify the number of experts or their qualifications (e.g., specialty, years of experience).

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

The document does not describe any adjudication method for establishing ground truth or comparing device performance. It simply states "internal and experts comparing the device to its predicate."

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not mentioned in the provided text. The device is a CR digitizer, not an AI-powered diagnostic tool, so the concept of human readers improving "with AI vs without AI assistance" is not applicable here. The study described is a comparison of the new hardware device to a predicate hardware device.

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

This refers to the performance of the device itself. The document states that "The device has completed verification and validation testing to confirm it meets specifications and operates as planned." This includes image quality tests. While it's not an "algorithm only" in the sense of AI, it represents the standalone performance of the imaging system. However, specific performance metrics for this standalone performance (beyond technological characteristics) are not detailed other than being compared by experts to the predicate.

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

For image quality tests, the "ground truth" or reference for comparison appears to be the predicate device's image quality, as assessed by "internal and experts." This suggests a form of expert opinion or visual comparison, rather than an objective "ground truth" like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set as this is a hardware device (CR digitizer) and not an AI/machine learning algorithm that typically requires a training set.

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

Since there is no mention of a training set, this information is not applicable.

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The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

The DIGITAL RETINAL CAMERA CR-1 Mark II is used for taking digital images of a human retina without a mydriatic. Canon EOS Digital Camera is mounted to the CR-1 Mark II. Images can be viewed immediately, making procedures more efficient with many different applications, such as telemedicine and electronic filing.

The provided text is a 510(k) summary for the DIGITAL RETINAL CAMERA CR-1 Mark II. This document focuses on establishing substantial equivalence to a predicate device (Canon CR-1) and does not contain detailed information about a study proving device acceptance criteria in the way a clinical trial report would.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study proving the device meets acceptance criteria from the provided text.

The document primarily describes:

• Device Identification: Manufacturer, trade name, model name, classification, and 510(k) number of the proposed device (CR-1 Mark II) and its predicate (CR-1).
• Description of Device: The CR-1 Mark II is an ophthalmic camera used for taking digital images of the human retina without mydriatics. It uses a Canon EOS Digital Camera.
• Differences from Predicate: The primary difference highlighted is the flash intensity settings, with the CR-1 Mark II offering an additional "Low flash intensity mode (LOW2)" at 1/8 flash intensity compared to the CR-1.
• Intended Use/Indications for Use: To take digital images of the retina of the human eye without a mydriatic.
• FDA Determination: The FDA found the device substantially equivalent to the predicate device.

Key Missing Information for your Request:

The 510(k) summary is a regulatory document to demonstrate substantial equivalence, not a detailed scientific study report. It does not typically include:

• Specific, quantified acceptance criteria for performance (e.g., minimum resolution, image quality metrics).
• Results from a formal study that tests against these acceptance criteria.
• Clinical data with sample sizes, expert ground truth, or MRMC analyses.

Without a detailed clinical or performance study report, which is not part of this 510(k) summary, I cannot fulfill your request for specific study details.

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The device is intended to be used for taking digital images of retina of human eye without a mydriatic.

CR-1 is an improved model of CR-DGi. Canon EOS Digital Camera is mounted with CR-1, can be viewed immediately, making procedures more efficient and many different applications, such as telemedicine and electronic filing. CR-1's intended use is the same as that of CR-DGiand the CF-1 is only being used as a predicate device in regard to the chin rest motion. The differences between CR-1 and CR-DGi are as follows; · The Chin Rest of CR-1 is moved automatically the same like CF-1. but for CR-DGi it is moved manually. · CR-1 has digital magnification function to change angular field of view (24° (H) x 36° (W), diagonal angle of view: 43° ), while CR-DGi does not have such function. · The Working distance (WD) of CR-1 is shorter than CR-DGi (CR-1: 35 mm, CR-DGi: 45 mm). · CR-1 is visually more compact and lighter than CR-DGi. CR-1 is equivalent to CR-DGi in the following respect:. · The optical components and alignment and the mechanical structures of the CR-1 are almost same as the CR-DGi .

The provided text describes a 510(k) summary for the Canon CR-1 Digital Retinal Camera. However, it does not contain specific acceptance criteria or the details of a study demonstrating the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Canon CR-DGi and CF-1) by highlighting an improved model with minor design changes. The key information is about the device's technical specifications and its intended use, not its performance against predefined clinical or analytical benchmarks.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text.

Here's why and what's missing:

• No Acceptance Criteria: The document does not define any quantitative or qualitative performance metrics (e.g., sensitivity, specificity, image resolution, accuracy in detecting specific retinal conditions) that the CR-1 must meet.
• No Performance Study Details: There is no mention of a clinical trial or a validation study conducted to measure the device's performance against any established criteria. The comparison is mainly a technical one, describing how the CR-1 is "equivalent to CR-DGi" in optical and mechanical aspects and "improved" in features like automatic chin rest, digital magnification, and working distance.
• No Ground Truth, Sample Sizes, or Expert Adjudication: Because no performance study is described, there's no information about sample sizes (test or training), data provenance, the number and qualifications of experts, or adjudication methods used to establish ground truth.
• No MRMC or Standalone Performance: The document does not discuss any multi-reader multi-case studies or standalone algorithm performance, as the device is an imaging camera and not an AI-powered diagnostic tool.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence through technical comparison, not a performance study against acceptance criteria.

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the identification, capture, digitization and processing of diagnostic x-ray images from x-ray film and from phosphor imaging plates.

The Cobrascan CR-1 Filmless is a computed radiography dual technology scanner. It is an enhanced modification of the Cobrascan CX-312T (FDA #K953942) CCD x-ray film digitizer.

The provided text is a 510(k) premarket notification letter from the FDA regarding the Cobrascan CR-1 Filmless device, a computed radiography dual-technology scanner. It states that the device is substantially equivalent to a legally marketed predicate device.

However, the document DOES NOT contain information about specific acceptance criteria, study details (like sample sizes, ground truth establishment, expert qualifications, adjudication methods), or performance metrics (like sensitivity, specificity, or reader study results). The letter focuses on regulatory approval based on substantial equivalence rather than detailed clinical or technical performance studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets those criteria, as this information is not present in the provided text.

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