(31 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 250 mm, 200 mm and 160 mm with tree different tip sizes (2, 3 and 3 mm). 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 FDA 510(k) clearance letter for the Rebellion, Phantom Multi-Bite Kerrison Rongeur (K230256) indicates that it is a manual rongeur, a Class II device. The nature of this device (a surgical tool for cutting and removing bone and tissue) means that the acceptance criteria and study information typically associated with AI/ML-powered diagnostic or predictive devices are not applicable.
This device is not an AI/ML product. The document describes a traditional medical device (a surgical instrument). Therefore, many of the requested categories for acceptance criteria and study details (like expert adjudication, MRMC studies, standalone algorithm performance, training set details) are irrelevant.
Here's an interpretation based on the provided document regarding this specific traditional medical device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Characteristics | Demonstrated substantial equivalence (identical or very similar characteristics) to predicate devices (K200768 and K221818) in terms of: |
- Product Code (HAE)
- Class (II)
- Regulation # (882.4840)
- Classification Name (Manual, Rongeur)
- Indication for Use (Identical)
- Anatomical location (Skull and spine)
- Sterility (Sterile)
- Re-Use (No)
- Material (Stainless Steel: 420, 304 and 302; Polymer: PVC, ABS, PA6 GF60, TPE, Fluoropolymer)
- Patient Contacting Materials (Stainless Steel: 420, 304; Polymer: Fluoropolymer)
- Design features (Manual Rongeur)
- Bone Removal (Suctional function)
- Shaft-length (160, 200 and 250 mm)
- Jaw opening (14 mm)
- Bite size (2 - 4 mm)
- Cutting angulation (90° up-biting)
- Packaging (double packed in a PET/PP composite film)
- Shelf life (packaging) |
| Material Biocompatibility | Patient-contacting materials (Stainless Steel: 420, 304; Polymer: Fluoropolymer) are the same as predicate devices, implying biocompatibility acceptance. |
| Sterilization & Packaging Integrity | Passed shelf-life validation according to ISO 11607-1 for 5 years for the sterile barrier system (SBS). Predicate device had a 2-year shelf-life, and the subject device improved this to 5 years. |
| Device Functionality/Performance | The subject device does not represent a new worst-case compared to predicate devices (K200768 and K221818), implying comparable cutting and bone/tissue removal functionality. |
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical surgical instrument, not a data-driven system. Testing would involve physical devices. The non-clinical performance mentioned refers to evaluating the sterile barrier system and comparing material/design characteristics to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic/AI devices, refers to an agreed-upon clinical truth. For a surgical instrument, the "truth" is its ability to perform its intended mechanical function and safety characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a traditional manual surgical tool, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense of AI/diagnostic devices. For this device, "ground truth" relates to the physical and material properties meeting established standards and being equivalent to predicate devices. This is established through engineering and physical tests (material testing, sterilization validation, dimensional checks) rather than clinical "ground truth" derived from patient data.
8. The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML product that undergoes training.
9. How the ground truth for the training set was established: Not applicable.
§ 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).