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The Point-of-Care is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images.

The LLI is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.

Point of care including LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the OREX Computed Radiography Ltd. "Point of care including LLI" device:

The provided 510(k) summary (K073670) is very high-level and does not contain the detailed information required to fully answer all aspects of your request. Specifically, it lacks quantitative acceptance criteria and detailed study parameters.

However, I can extract and infer some information based on typical 510(k) submissions:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Bench and clinical data demonstrate that the device meets the required specifications." However, it does not explicitly list quantitative acceptance criteria (e.g., specific imaging parameters like DQE, spatial resolution, contrast-to-noise ratio, or specific clinical performance metrics). Therefore, a table with specific numbers cannot be generated from this text.

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

The document mentions "Bench and clinical data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information about the number of experts, their qualifications, or how ground truth was established for any clinical evaluations.

4. Adjudication Method

The document does not specify any adjudication method for a test set.

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

The document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study.

6. Standalone (Algorithm Only) Performance Study

The device is a Computer Radiography (CR) acquisition scanner. The "LLI" component is a CR cassette for Long Length Imaging. This is a hardware and software system for image acquisition, not an AI algorithm for image interpretation. Therefore, a "standalone algorithm only" performance study in the context of AI without human-in-the-loop is not applicable to this type of device as described. Its performance would be evaluated on image quality metrics and clinical utility for capturing long-length images.

7. Type of Ground Truth Used

The document mentions "clinical data" but does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). For an image acquisition system, the ground truth would typically relate to the accuracy and quality of the acquired image compared to a reference standard, and the ability of the acquired image to allow for accurate diagnosis by radiologists.

8. Sample Size for the Training Set

The document does not provide any information about a training set size. As this is a CR acquisition scanner and cassette, not an AI diagnostic algorithm, the concept of a "training set" in the machine learning sense is unlikely to apply in the same way.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information about how ground truth for a training set was established, as it does not mention a training set.

Summary of what can be extracted/inferred:

• Acceptance Criteria: Stated as "required specifications" and met by "Bench and clinical data," but no quantitative details are provided.
• Study Type: Bench and clinical data were collected.
• Device Type: CR acquisition scanner with a long-length imaging cassette. Its evaluation would focus on image quality, safety, and functionality, rather than diagnostic accuracy of an AI algorithm.
• Regulatory Pathway: Special 510(k), indicating modifications to an existing predicate device (Orex K003256 and Kodak K021829). This often implies that the modifications are minor and do not significantly alter the fundamental scientific technology or risks, and therefore, extensive new clinical studies with detailed acceptance criteria might not be required if performance is shown to be equivalent to the predicate.

In conclusion, the provided 510(k) summary is insufficient to answer many of your specific questions, particularly those related to quantitative acceptance criteria, clinical study parameters, and AI-specific evaluation metrics. This is common for 510(k) summaries, which aim to provide a high-level overview rather than the full detailed submission. The full 510(k) submission would contain this information, but it is not publicly available in this snippet.

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The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.

The provided 510(k) summary for the PoRT Cassette (K032654) contains very limited information regarding detailed acceptance criteria and the specifics of the study conducted. The summary focuses on establishing substantial equivalence to a predicate device and does not include an in-depth clinical or performance study breakdown typically found in a full submission.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document states: "Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications." However, it does not explicitly define what those specifications or acceptance criteria are, nor does it provide specific numerical results for device performance against those criteria. It only makes a general statement of compliance.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Study Details

The provided text mentions "Bench testing and clinical validation," but offers almost no specifics about these studies.

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

   • Sample Size (Test Set): Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

   • Not specified. The document does not mention the use of experts for ground truth establishment.

3. Adjudication Method for the Test Set:

   • Not specified.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No mention of an MRMC study being performed.
   • No data on the effect size of human readers improving with AI vs. without AI assistance. This device is an accessory to a digital imaging system, not explicitly an "AI" device as typically understood today, so such a study would likely not be relevant in this context.

5. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

   • The document implies performance testing of the device itself ("bench testing"). However, it does not explicitly detail a "standalone" study in the context of an algorithm's performance without human interaction. The PoRT Cassette is a hardware component (reusable phosphor screen) and an associated software upgrade, not a standalone diagnostic algorithm.

6. Type of Ground Truth Used:

   • Not specified. Given the nature of a portal imaging accessory for radiation therapy quality control, ground truth would likely involve comparison to known radiation fields, phantom measurements, or possibly expert assessment of image quality for therapy verification. However, this is speculative as the document is silent on this point.

7. Sample Size for the Training Set:

   • Not specified. The document does not mention a "training set" in the context of machine learning, as this device is not presented as an AI/ML algorithm that would typically require such a set. Its "software upgrade" likely refers to functionality rather than an AI model.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable/Not specified, as no training set (in the ML sense) is mentioned or implied.

Summary of Missing Information:

The provided 510(k) summary is extremely high-level and does not contain the detailed study results, acceptance criteria, or ground truth establishment methods that would typically be expected for a comprehensive clinical study report. It primarily serves to establish substantial equivalence based on intended use, technological characteristics, and operational characteristics, stating that "Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications" without providing those specifications or results.

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