(197 days)
RadioMed™ Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The RadioMed™ Marker is a non-sterile, disposable device in the form of a rhodium coil that is 0.35mm in diameter.
The provided text is a 510(k) summary for the RadioMed™ Marker, a medical device. This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on device description, intended use, and comparison to predicates, along with a summary of performance testing and adherence to standards.
However, the provided text does not contain the detailed information required to fill out all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
Specifically, the document mentions "Visibility Testing (see section V)" and refers to various standards (FDA QSR, ISO 10993-1, AAMI Standard 11134-1994) but does not detail the specific performance acceptance criteria for visibility, a quantitative measure of performance, or the results of the visibility study. It also lacks information on the sample sizes, data provenance, ground truth establishment, or specific details of a comparative effectiveness study.
Therefore, I can only populate the table and answer the questions based on the limited information available in the provided text. Many fields will be marked as "Not provided in the text."
Here's the breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visibility | Visible under fluoroscopy, ultrasound, CT, and x-ray. (No quantitative criteria or specific performance metrics provided in this document excerpt) |
| Biocompatibility | Passes biocompatibility testing per ISO 10993-1 |
| Material (Chemical Composition) | Rhodium (Stated to be identical to a predicate device's material) |
| Manufacturing Standards | Complies with FDA QSR 21 CFR Part 820 Good Manufacturing Practices, AAMI Standard 11134-1994 Recommended Practice for Steam Autoclave |
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 provided in the text. The document refers to "Visibility Testing" and "animal and bench studies" but no sample sizes are mentioned.
- Data Provenance: Not provided in the text.
- Retrospective/Prospective: Not provided in the text.
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 provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the text.
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 described for this device, nor is it an AI-based device. The device is a physical marker.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "Visibility Testing," the ground truth likely involved direct visual confirmation on imaging modalities, possibly by a human observer or sensor, but the specific method (e.g., expert consensus on image quality, quantitative measurement) is not detailed.
- For "Biocompatibility," the ground truth would be established by the results of standardized biological tests as per ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is a physical marker, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical marker, not a machine learning model.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.