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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:

• 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.

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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:

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.

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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.

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.

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