(44 days)
The Flexitron Remotely Controlled Brachytherapy Afterloading System is intended to enable an operator to apply by remote control a radionuclide source (Flexisource) into the body or to the surface of the body for radiation therapy.
Flexitron is intended to be used in combination with applicators which makes it suitable for intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy treatment.
Flexitron is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and authorized medical professional.
Flexitron is a computer controlled medical device for brachytherapy treatment. The Flexitron Remotely Controlled Brachytherapy Afterloading System comprises subjoined listed subsystems: TDU - Treatment Delivery Unit, TCC - Treatment Communications Console, and TCP Treatment Control Panel. The TDU houses the radioactive source in its built-in shielding safe, the microcomputer controlled driving mechanism and channel selector mechanism. The TCC is for treatment program data entry, data storage and data displaying. The TCP comprises the basic operator elements for start and stop treatment and for displaying device status and used and remaining treatment time. The TDU is designed for positioning the source at 401 separate dwell positions in each of the 40 treatment channels and together with dwell time settings for each individual dwell position it enables the creation of isodose shapes targeted to the patients anatomy and geometry in order to irradiate the target patient body site and spare the healthy surrounding tissue. Dwell positions can be programmed at 1 mm intervals. The maximum source outdrive distance is 1400 mm from the channel selector front plate. Dwell times are programmable with increments of 0.1 second. Maximum dwell time is 999.9 seconds per position. Minimum dwell time is 0.1 second per position. A dwell position is skipped if its dwell time is 0 seconds. Before the radioactive source is moved into a treatment channel a check cable is first moved into it. A check cable is of a similar construction of a source cable but without radioactive isotope. It is a measure to check the treatment channel for free passage of the source immediately after the check. The TDU is connected to TCC via a serial data communications link to receive the patient treatment program and to return data of the performed patient treatment. TCC allows for manually entering a patient treatment program or for electronically transferring a patient treatment program from Brachytherapy Treatment Planning Software (Treatment planning software is not subject of this 510(k) PreMarket Notification). During patient treatment TCC displays treatment progress and logs patient treatment data and machine performance data in separate log files. TDU is connected via another serial communications port to TCP. TCP is a touchscreen device which is directly controlled from the TDU embedded microprocessor. TCP allows for starting the patient treatment when all conditions are fulfilled.
The provided document is a 510(k) summary for the Flexitron Remotely Controlled Brachytherapy Afterloading System. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria through a clinical study with detailed performance metrics.
Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present in this type of regulatory submission.
The document primarily discusses the device's technical characteristics and intended use in comparison to predicate devices. It states that "The differences between Flexitron and predicate devices do not concern the basic principle of operation nor does it adversely effect the safety or effectiveness of the device." This implies that the device is considered safe and effective because it is technologically similar to existing approved devices.
Here's what can be extracted and what cannot:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics in the provided document. The overarching "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device, meaning it is as safe and effective.
- Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision) from a study are reported. The document focuses on describing the device's capabilities (e.g., dwell positions at 1 mm intervals, dwell times with 0.1-second increments).
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Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document describes a comparison to predicate devices and the device's technical specifications, not a study with a test set of data or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No ground truth establishment is described for a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or adjudication method is described.
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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. This device is a remote-controlled brachytherapy afterloading system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant or included.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable / Not provided. This is a hardware system for delivering radiation, not an algorithm, so "standalone performance" in the AI sense is not relevant. Its "standalone" performance is inherent in its operational specifications.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No "ground truth" (in the context of clinical AI performance) is mentioned. The ground truth for this device's function would be its ability to accurately deliver radiation as programmed, which is validated through engineering and dosimetry checks, not clinical data labels.
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The sample size for the training set:
- Not applicable / Not provided. This device is not an AI/ML model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable / Not provided. Not an AI/ML model.
Summary of what is provided related to acceptance and evidence:
- Acceptance Criteria (Implied by 510(k) process): Substantial equivalence to legally marketed predicate devices in terms of safety and effectiveness.
- Study Proving Acceptance (Method): Comparison of technological characteristics and intended use to predicate devices.
- Predicate Devices Used:
- Key Similarities (evidence presented):
- All devices have a subsystem comprising a shielding safe, drive mechanism, channel selection, and controlling electronics connected to a personal computer for treatment program data entry.
- All use a radioactive source sealed in a stainless steel capsule connected to a stranded cable.
- Intended use is the same: remote-controlled application of a radionuclide source for radiation therapy (intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative, and surface brachytherapy).
- Conclusion: The Flexitron device is considered substantially equivalent to the predicate devices because its differences do not concern the basic principle of operation nor do they adversely affect the safety or effectiveness of the device.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.