(168 days)
The OsteoMed Neuro Rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.
The OsteoMed Neuro Rongeur is a low profile instrument designed to cut bone 180° off the straight axis of the ronguer. It has a rectangular scoopshaped tip which compresses and cuts cranial or spinal bone. The ronguer is a manually operated instrument used for cutting and biting soft tissue and bone during surgery involving the skull or spinal column. The OsteoMed Neuro Rongeur is made from Medical Grade Stainless Steel per ASTM F-899.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to make effective cuts in media | Both the OsteoMed Neuro Rongeur and the Instrumed Micro Kerrison Rongeur made effective cuts in the same media. |
| Equivalent force comparison during cutting | The data demonstrated that both instruments performed equally in terms of force required to make cuts. |
| Equivalent overall cutting mechanics | The change in design (180° off-axis cut versus 90° for predicates) does not affect the overall cutting mechanics of the device. |
| Biocompatibility of materials | The OsteoMed Neuro Rongeur is made from medical grade stainless steel, which is biocompatible, similar to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of a typical AI/software study. Instead, the performance evaluation was a direct comparison between the OsteoMed Neuro Rongeur and a predicate device (Instrumed Micro Kerrison Rongeur) using "the same media."
- Sample size: Not explicitly stated as a number of "samples" or "cases." The testing involved a comparison of "force comparison" while "making cuts" in "the same media." This implies a series of cuts or measurements were taken, but the quantity of these measurements is not provided.
- Data provenance: Not specified. It's likely an in-house laboratory study.
- Retrospective/Prospective: Prospective, as it was a direct comparison experiment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert-established ground truth for a test set. The performance assessment was based on objective mechanical measurements (force comparison and effective cuts) rather than subjective expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method was used as there was no expert-derived ground truth.
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
No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manually operated surgical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to objective mechanical performance:
- Ability to make effective cuts: Visually assessing if the rongeur successfully cut the media.
- Force comparison: Quantifiable measurement of force required to make cuts.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There was no training set for this 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).