(403 days)
The Calypso System is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise, and continuous localization of a treatment isocenter by using two or more Beacon transponders.
Anchored Beacon transponders are indicated for permanent implantation in small airways in the lung to align and/or monitor the internal position of targets that move with respiratory and other patient motion in real time during radiation therapy.
The Anchored Beacon® transponder is a small passive implant, intended for permanent implantation in small airways in the lung. It is provided pre-loaded in a single-use delivery catheter for bronchoscopic implantation in a lung airway.
The Anchored Transponder is comprised of a Permanent Beacon Transponder (glassencapsulated electrical circuit) coupled to a stability feature (self-expanding 5-legged structure in a shell assembly). When implanted in a small diameter airway, the anchor legs of the stability feature expand independently to contact the airway wall.
When used with the Calypso® System, the Anchored Transponder signals enable realtime, objective measurement of the location of the treatment target in four dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to radiation therapy and/or to monitor the position of the treatment target during treatment.
The provided document is a 510(k) summary for the Anchored Beacon® Transponder. It describes the device, its intended use, and a summary of the testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not explicitly detail acceptance criteria in a table format or provide a comprehensive study report with quantitative performance metrics that would directly address all the requested points.
Based on the information available in the document, here's what can be extracted and inferred regarding the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Bench testing was performed and demonstrated: (1) the Anchored transponder satisfied the established performance requirements, including related to use in the lung". However, the specific quantitative acceptance criteria for these performance requirements (e.g., specific thresholds for localization accuracy, stability, or drift) are not provided in the document. Similarly, the exact reported device performance values against these established criteria are not explicitly stated in a quantitative manner.
We can infer the types of performance evaluated, but not the specific metrics or acceptance thresholds.
| Performance Characteristic | Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Localization | Ability to be localized for patient position monitoring. | "the Anchored transponders can be localized to monitor patient position" |
| Positional Stability | Stability of the transponder in the airway for monitoring. | "the Anchored transponder is positionally stable in the airway" and "equivalence of stability over time" when compared to commercially-available fiducial markers. |
| Safety | Safe as a permanent implant in the lung. | "the Anchored transponder is safe as a permanent implant in the lung," "biocompatibility testing ... supports safety," and "presence of the transponders is unassociated with radiographic pulmonary abnormalities attributable to the transponder." Also, "safety profile is consistent with the original study patient data." |
| Biocompatibility | Biocompatible with the human body for permanent implantation. | "biocompatibility testing in conformance with ISO 10993 supports safety of the Anchored transponder materials and the delivery catheter materials." |
| Packaging & Sterility | Provides protection and a sterile barrier. | "the packaging provides protection and a sterile barrier." |
| Functionality | Satisfaction of "established performance requirements" related to lung use. | "the Anchored transponder satisfied the established performance requirements, including related to use in the lung." (Specific quantitative performance not provided, but implies successful operation as intended). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "69-patient cohort"
- Data Provenance: The document states "Clinical study data obtained in lung cancer patients undergoing radiation therapy (69-patient cohort)". It doesn't explicitly state the country of origin, but it implies a prospective clinical study context. It is not explicitly stated if it was retrospective or prospective, but the phrasing "obtained in" and "undergoing" suggests a prospective collection of data for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information about the number of experts used to establish ground truth or their qualifications. The clinical study primarily evaluates the device's ability to be localized, its stability, and its safety, which would likely rely on direct measurement, imaging, and clinical follow-up rather than expert consensus on an independent "ground truth" per se.
4. Adjudication Method for the Test Set
The document does not provide any information about an adjudication method. Given the nature of the device (a physical fiducial marker for real-time tracking), the "ground truth" would likely be derived from direct instrumental measurements or clinical observations rather than subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The clinical study compared the stability of the anchored transponders in a subset of study patients to "a matched cohort of patients with commercially-available fiducial markers implanted in lung (including the predicate, the superlock Cobra)". This is a comparative study, but it's focused on the device's performance (stability) rather than human reader improvement with or without AI assistance. The device itself is a passive marker, not an AI diagnostic tool that assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a physical transponder, not an algorithm or AI. Its performance is evaluated in conjunction with the Calypso System (which includes hardware and software to track the transponders). Therefore, the concept of a "standalone" algorithm performance study without human-in-the-loop is not directly applicable in the way it would be for a diagnostic AI. The "localization" and "stability" assessment can be considered analogous to a standalone performance in that it evaluates the device and system's objective measurement capabilities.
7. Type of Ground Truth Used
The ground truth used in the studies described appears to be based on:
- Real-time localization data: objective measurements from the Calypso System.
- Clinical observation and follow-up: for safety, monitoring of patient position, and positional stability.
- Radiographic assessment: for detecting pulmonary abnormalities attributable to the transponder.
- Biocompatibility testing: in conformance with ISO 10993 standards, involving scientific testing rather than expert consensus on a clinical case.
It is not explicitly stated as pathology or outcomes data in the sense of disease progression or diagnosis, but rather related to the physical behavior and clinical impact of the implanted device.
8. Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This device is a physical fiducial marker, not a machine learning algorithm that requires a separate training set. The descriptions of "bench testing" and "clinical study data" refer to validation and verification, not training data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an algorithm, this question is not applicable based on the provided document.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.