(405 days)
The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.
The Rebellion is a Bone Punch and it is available in two lengths (200 – 250 mm) with tree different tip sizes (2, 3 and 3 mm). The Rebellion can be connected to a rinsing solution (NaCl 0,9%) via integrated Luer Lock connection. The tubes are flushed with the rinsing solution, so a clogging of the tube is prevented. At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.
This document is a 510(k) Premarket Notification for a medical device called "Rebellion, Phantom Multi-Bite Kerrison Rongeur." The FDA has reviewed and determined the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with corresponding device performance values for clinical efficacy. Instead, it describes performance testing related to safety and functionality. Since this is a non-AI based device, the acceptance criteria are focused on demonstrating substantial equivalence to predicate devices in areas like material safety, sterilization, packaging, and basic function. While specific numerical acceptance criteria aren't provided in the same way they would be for an AI device (e.g., sensitivity/specificity thresholds), the document implies acceptance by stating that the device meets the requirements of the standards and passes the tests.
| Type of Test/Criterion | Acceptance Implication | Reported Device Performance |
|---|---|---|
| Clinical Performance | Not applicable; no clinical testing submitted for 510(k). | No clinical performance data provided in this 510(k). |
| Biocompatibility | Device must meet ISO 10993 requirements for external communicating devices with limited contact (≤24 h). | Assessed endpoints: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systematic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility. (Implied successful completion by FDA clearance) |
| Sterilization | Device must be sterilized according to ISO 11135:2014. | Validation conducted in accordance with ISO 11135:2014. (Implied successful completion by FDA clearance) |
| Packaging & Shelf Life | Device packaging and shelf life must be validated according to ISO 11607:2017. | Validation conducted in accordance with ISO 11607:2017. (Implied successful completion by FDA clearance) |
| Functional Performance (Cadaver Test) | Device must demonstrate function and performance under simulated environmental and application conditions by potential users. | A cadaver test was performed in an operating room with two potential users. (Implied successful demonstration of function) |
| Functional Performance (Product Validation) | Device must perform up to the maximum life cycle, cutting simulated bone. | Product validation performed, testing the product up to maximum life cycle by cutting simulated bone. (Implied successful demonstration of function) |
2. Sample Size Used for the Test Set and Data Provenance
- Cadaver Test: The document states that a cadaver test was performed with "two potential users." The sample size for cadavers is not specified, nor is the data provenance (e.g., country of origin, retrospective/prospective).
- Product Validation (Simulated Bone): The document mentions "maximum life cycle by cutting simulated bone." No sample size for the simulated bone tests or data provenance is provided.
- Biocompatibility, Sterilization, Packaging & Shelf Life: These would involve specific test samples as defined by the respective ISO standards, but the document does not detail the sample sizes used in those validations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided.
- For the cadaver test, "two potential users" were involved, implying they were experts in orthopedic, neurosurgery, or spine surgery. However, their specific qualifications (e.g., years of experience, board certification) are not detailed.
- For other tests (biocompatibility, sterilization, etc.), ground truth is established by adherence to recognized international standards and testing methodologies, not typically by expert consensus on specific cases.
4. Adjudication Method for the Test Set
This information is not explicitly provided. For the functional tests (cadaver and simulated bone), it's implied that the "potential users" or test operators observed and evaluated the device's performance, but no formal adjudication method (like 2+1 or 3+1 consensus) is described. Since this is a mechanical device, ground truth for its function would be based on its physical performance metrics rather than interpretation of medical images or diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a manual rongeur, not an AI-assisted diagnostic tool. Therefore, studies comparing AI with and without human assistance are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This is a physical, manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Functional Performance (Cadaver Test & Simulated Bone): The ground truth for functional performance would primarily be the direct observation of the device's ability to cut and remove bone/tissue as intended, without failure or malfunction, under simulated surgical conditions. This is an objective assessment of the device's mechanical integrity and operational effectiveness.
- Biocompatibility, Sterilization, Packaging: Ground truth for these aspects is established by compliance with published international standards (ISO 10993, ISO 11135, ISO 11607, respectively). The tests performed according to these standards provide objective evidence of safety and performance.
8. The Sample Size for the Training Set
This information is not applicable and is not provided. Since this is a physical medical device (a manual rongeur) and not an AI/software device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and is not provided, as there is no training set for this type of device.
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).