(106 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 the length 160 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.
The provided text is a 510(k) premarket notification for a medical device called the "Rebellion; Phantom Multi-Bite Kerrison Rongeur." This document focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a study.
Therefore, the document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance from a study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone algorithm performance study.
- Type of ground truth used in a study.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document states:
Acceptance Criteria and Study that Proves the Device Meets Acceptance Criteria:
The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission. The "study" in this context is the comparison presented in the 510(k) itself.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of acceptance criteria in the typical sense of numerical thresholds for performance metrics. Instead, it compares the technological characteristics of the subject device (Rebellion; Phantom Multi-Bite Kerrison Rongeur) to its predicate device (Rebellion, K200768) and a reference device (Fehling-punches, K153243) to demonstrate substantial equivalence. The "performance" is implicitly demonstrated through this comparison and non-clinical testing.
The table below summarizes the comparison of characteristics, which are implicitly the "criteria" for substantial equivalence:
| Characteristic | Subject Device (Rebellion) | Predicate Device (Morpheus AG Rebellion, K200768) | Reference Device (Fehling Instruments GmbH & Co. KG Fehling-punches, K153243) |
|---|---|---|---|
| 510(k) | -- | K200768 | K153243 |
| Product Code | HAE | HAE | HAE |
| Class | II | II | II |
| Regulation # | 882.4840 | 882.4840 | 882.4840 |
| Classification Name | Manual, Rongeur | Manual, Rongeur | Manual, Rongeur |
| Indication for Use | 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 indicated to cut and remove bone, vertebral body and tissue in the orthopedic, neuro and spine surgery involving the skull or spinal column. | Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column. |
| Anatomical location | Skull and spine | Skull and spine | Skull and spine |
| Sterility | Sterile | Sterile | Non-Sterile |
| Re-Use | No | No | Yes |
| Material | Stainless Steel: 420, 304 and 302; Polymer: PVC, ABS, PA6 GF60 (Grivory GV-6H); TPE (TM5MED) and Fluoropolymer (Altera MT1000A) | Stainless Steel: 420, 304 and 302; Polymer: PVC, ABS, PA6 GF60 (Grivory GV-6H); TPE (TM5MED) and Fluoropolymer (Altera MT1000A) | 420 and 304 Stainless Steels; Coating: CERAMO® (TiAIN); Polymer: Silicone |
| Patient Contacting | Stainless Steel: 420, 304; Polymer: Fluoropolymer (Altera MT1000A) | Stainless Steel: 420, 304; Polymer: Fluoropolymer (Altera MT1000A) | 420 and 304 Stainless Steels; CERAMO® (TiAIN) |
| Design features | Manual Rongeur | Manual Rongeur | Manual Rongeur |
| Bone Removal | Suctional function | Suctional function | Manual |
| Shaft-length | 160 mm | 200 - 250 mm | 110 - 400 mm |
| Jaw opening | 14 mm | 14 mm | 9 - 19 mm |
| Bite size | 2 - 4 mm | 2 - 4 mm | 0.8 - 8 mm |
| Cutting angulation | 90° up-biting | 90° up-biting | 40° and 90° up/down biting |
The document concludes that the "Different characteristics do not raise different questions of safety and effectiveness, and scientific methods were applied to evaluate different characteristics' effects on safety and effectiveness."
Non-Clinical Performance Testing:
The document states: "The subject device does not represent a new worst-case when compared to the previously cleared Morpheus Rebellion Rongeur (K200768)." This implies that previous non-clinical testing for the predicate device is considered sufficient, and the new device performs at least as well or does not introduce new risks.
7.1 Clinical performance testing:
"Clinical performance testing was not submitted in this 510(k)."
Disclaimer: This response is based solely on the provided text. The document is for a 510(k) submission, which often relies on substantial equivalence rather than extensive clinical efficacy studies to demonstrate safety and effectiveness for Class II devices.
§ 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).