(42 days)
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.
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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).
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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.
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Adjudication Method for the Test Set:
- Not specified.
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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.
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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.
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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.
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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.
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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.
§ 892.1630 Electrostatic x-ray imaging system.
(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.