(175 days)
The Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization.
The BioZorb Marker GOLD / LP Marker GOLD is an implantable radiopaque marker comprised of a bioabsorbable component and a permanent component. The BioZorb Marker GOLD / LP Marker GOLD is provided sterile for single use and is implantable.
The provided text does not contain information about the acceptance criteria or a detailed study proving the device meets specific performance metrics. It primarily focuses on the FDA's regulatory approval process for the BioZorb Marker GOLD / LP Marker GOLD, establishing its substantial equivalence to predicate devices. Therefore, I cannot fulfill most of the requested table and answer many of the specific questions about studies and ground truth.
However, I can extract the general types of performance data that were reviewed and a very high-level statement about meeting criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional / Device Integrity | Met all specified criteria. |
| Imaging Compatibility (Radiographic Visibility) | Met all specified criteria. |
| MR Compatibility | Met all specified criteria. |
| Simulated Use | Met all specified criteria. |
| Safety (No new safety questions) | Did not raise new safety or performance questions. |
Missing Information for the table: Specific quantitative or qualitative acceptance criteria for "Simulated Use", "Device Integrity", "Imaging Assessment", and "MR Compatibility" are not provided. The document only states that the device "met all specified criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Simulated Use," suggesting some lab-based or non-clinical testing, but no details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document does not describe the use of experts for establishing ground truth in a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. 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 MRMC comparative effectiveness study is mentioned. This device is an implantable marker, not an AI-powered diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (an implantable marker), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document does not describe the establishment of "ground truth" as would be relevant for an AI or diagnostic device evaluation. Instead, it refers to performance testing of a physical marker.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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.