(57 days)
The intended use of Instrumed Rongeurs is to access, cut and bite soft tissue and bone during surgery involving the spinal column.
A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue.
IVD (Intervertebral Disc) Rongeurs are used on cartilage that separates adjacent vertebrae of the spine A rongeur can be used to open a window in a bone. It is used in neurosurgery to expose areas for operation or to reduce pressure by segregating exposed areas.
To ensure the multi-purpose use of this devices, many different models are available.
Common names used for this kind of Rongeurs are: Kerrison, Sella Punch, IVD (Decker, MIS, Spence, Peapod, Selverstone, Williams, Cushing, Love-Gruenwald, Spurling, Cloward, Sypert, Ferris-Smith, Wilde, Hoen, Oldberg, Jackson, Schlesinger)
A manual rongeur is a manually operated instrument used for cutting or biting surgery involving the skull or spinal column.
All Rongeurs are offered in a non-sterile condition.
The provided 510(k) summary for the Instrumed Rongeur does not contain the kind of detailed performance study and acceptance criteria information typically found in submissions for diagnostic AI devices, or even for many other types of medical devices that require quantitative performance data. This Rongeur is a manual surgical instrument, and its 510(k) submission primarily relies on a comparison to predicate devices, rather than robust quantitative performance metrics.
Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilization method, mechanical safety characteristics, and sizes and configurations. | The Instrumed Rongeur is similar to the predicate devices in the listed characteristics. The submission states, "Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the P.D. cited and raise no new issues of safety and effectiveness." |
| Safety and effectiveness for intended use. | "The presented data that was conducted on the Instrumed Rongeurs shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness." |
| Materials are well researched and do not raise new questions regarding safety and effectiveness. | "The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission focuses on design analysis and comparison to predicate devices, not on a clinical "test set" in the context of diagnostic performance. There is no mention of a specific sample size of patients or a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. No "ground truth" establishment by experts, in the sense of reviewing diagnostic images or clinical outcomes, is mentioned. The assessment of substantial equivalence appears to be an internal engineering and regulatory comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is mentioned as there is no "test set" and associated expert review.
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 / Not done. This refers to studies for diagnostic AI devices. The Instrumed Rongeur is a manual surgical instrument and does not involve AI assistance or human readers in an MRMC study context.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable / Not done. This refers to performance of a standalone AI algorithm. The device is a manual surgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not explicitly defined in terms of quantitative data. The "ground truth" for this type of submission is implicitly the established safety, effectiveness, and functional characteristics of the predicate devices based on their historical use and regulatory clearances. The new device is evaluated against these benchmarks.
8. The sample size for the training set
- Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this information is not relevant.
Summary of the Study / Basis for Clearance:
The "study" in this context is a design analysis and comparison of the Instrumed Rongeur against several legally marketed predicate rongeurs (K062711, K023868, K943635, and others). The manufacturer claims that the new device is substantially equivalent to these predicates.
The core of the argument for safety and effectiveness is that:
- The Instrumed Rongeur shares similar technical characteristics, design, indications for use, target population, performance expectations, biocompatibility, sterilization methods, mechanical safety characteristics, and available sizes and configurations with the predicate devices.
- The materials used are "well researched" and do not introduce new safety or effectiveness concerns.
Essentially, the clearance is based on the premise that because the new rongeur is sufficiently similar to devices already proven safe and effective for their intended use, it too can be considered safe and effective without requiring extensive new clinical performance data.
§ 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).