(29 days)
ONC Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
ONC Markers exist as a series of individual gold ring members connected over a gold inner wire. The ring members can be of different diameters and different quantities can be joined together to form longer length markers. The markers will range in nominal diameter from 0.35mm to 1.2mm. The markers will range in overall length from 10mm to 60mm. ONC Markers are packaged in two different formats: A. Markers inside sterile packages for single use only B. Markers inside Preplugged Introducer Needles, inside sterile packages for single use only Sterilization is achieved by a validated EO sterilization method.
This 510(k) submission for the ONC Marker is for a physical medical device (a tissue marker) and does not include information about an AI/ML-based device or a study involving AI performance.
Therefore, most of the requested information (acceptance criteria for AI, training/test set details, expert ground truth, MRMC study, standalone performance, etc.) is not applicable and cannot be extracted from the provided text.
The document primarily focuses on establishing substantial equivalence to predicate devices based on material, size range, and intended use, rather than on performance metrics from a clinical study as would be expected for an AI device.
Here's what can be extracted based on the provided text, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a physical device and not an AI algorithm, the concept of "acceptance criteria" for performance is typically tied to manufacturing specifications and safety standards rather than diagnostic accuracy metrics. The document mentions compliance with general medical device regulations.
| Acceptance Criteria / Performance Aspect | Reported Device Performance (from submission) |
|---|---|
| Material | Pure metallic gold (identical to predicate devices) |
| Diameter Range | 0.35mm to 1.2mm (identical to predicate devices) |
| Overall Length Range | 10mm to 60mm (identical to predicate devices) |
| Intended Use | To radiographically mark soft tissue for future therapeutic procedures (identical to predicate devices) |
| Manufacturing Standards | Manufactured, labeled, and packaged in accordance with current FDA QSR (21 CFR Part 820) |
| Sterilization | Achieved by a validated EO sterilization method |
| Delivery Method | Delivered through preloaded introducer needles or loaded into similar needles at implantation site |
| Fundamental Scientific Technology | Has not changed compared to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This document describes a physical medical device, not an AI/ML system that would typically undergo testing with a "test set" of data. Performance is established through comparison to predicate devices and adherence to manufacturing and sterilization standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No ground truth establishment by experts for a test set is mentioned as this is not an AI/ML device.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical marker and not an AI system. Such a study would not be relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm.
7. The Type of Ground Truth Used:
- Not applicable. For a physical device like this, "ground truth" typically refers to engineering verification and validation (e.g., material composition, dimensions meeting specifications, sterility achieved), not a clinical 'truth' established for diagnostic accuracy. The substantial equivalence argument is based on comparison to legally marketed predicate devices, not on a new clinical ground truth.
8. The Sample Size for the Training Set:
- Not applicable. There is no AI/ML model, hence no training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no AI/ML model, hence no training set ground truth.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (tissue marker) and lacks the specific details requested for an AI/ML-based device performance study.
§ 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.