(26 days)
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarc can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
FlexiMarc is an implanted marker used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The FlexiMarc soft tissue marker is fabricated of all biocompatible pure gold. It is available in varying lengths from 2 mm overall to 4 CM overall and ranges in diameter from 0.5 mm to 1.6 mm so that it can be identified in the varying medical imaging formats. FlexiMarc is delivered in sterile preexisting needles ranging from 20 GA to 16 GA.
FlexiMarc is intended for single use and is permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
Here's a breakdown of the acceptance criteria and study information for the FlexiMarc device based on the provided text:
Important Note: The provided 510(k) summary primarily focuses on the substantial equivalence of the FlexiMarc to a predicate device based on technological characteristics and image visibility. It does not detail a formal clinical study with acceptance criteria for device performance as would be expected for a complex AI/software device. Instead, the "study" is a comparison validating visual equivalence in various imaging modalities.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (FlexiMarc) |
|---|---|
| Visibility across imaging modalities: |
- CT
- CBCT
- MR
- kV x-ray
- MV x-ray | Visible in all modalities:
- CT: Visible
- CBCT: Visible
- MR: Visible
- kV x-ray: Visible
- MV x-ray: Visible (larger diameter markers required for both devices) |
| Flexibility: Reduce potential for migration and provide a unique shape. | Fabricated to be flexible, which "serves to reduce the potential for migration of the marker" and "provides a unique shape form which the treatment area can be identified." |
| Deployment method: Equivalent to predicate device. | "Both markers systems are deployed in the same fashion making this portion actually equivalent in its entirety." |
| Material: Biocompatible. | Fabricated of all biocompatible pure gold. |
| Availability (lengths/diameters): Varying sizes for different imaging and use cases. | Available in varying lengths (2 mm to 4 CM) and diameters (0.5 mm to 1.6 mm). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the traditional sense. The "clinical performance comparison (image based)" describes testing both the FlexiMarc and the predicate device across various imaging modalities.
- Data Provenance: Not specified. It appears to be an internal comparison or bench testing rather than using patient data from a specific country or setting.
- Retrospective/Prospective: Not specified, but given the nature of the comparison, it likely involves imaging of the markers themselves rather than a clinical study on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of a 510(k) for a physical marker, the "ground truth" for visibility would likely be established through objective observation by qualified personnel, possibly engineers or imaging specialists, rather than clinical experts.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The comparison focuses on the technological characteristics and imaging visibility of the device itself, not on human reader performance with or without AI assistance. This is a physical medical device, not an AI/software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical implanted marker, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" primarily involved objective observation of marker visibility across different medical imaging modalities (CT, CBCT, MR, kV x-ray, MV x-ray) for both the FlexiMarc and the predicate device. It also included verification of physical characteristics like flexibility and material composition.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device. There is no concept of a "training set" as would apply to a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8 above).
§ 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.