(157 days)
The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue of the spine.
The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device. The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Symmetry Kerrison Disposable Tip Rongeurs":
The provided document is a 510(k) Summary for a medical device that introduces disposable tips to an existing rongeur design. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy or a specific performance metric against a defined acceptance criterion the way AI/ML devices typically would.
Therefore, many of the requested fields are not applicable to this type of submission. I will fill in what can be inferred and explicitly state when information is not available or not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a mechanical surgical instrument, the "acceptance criteria" are not reported as numerical thresholds for sensitivity, specificity, etc., but rather as functional performance. The performance data section vaguely states that the devices perform according to their description and intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to cut bony tissue (as intended use) | Demonstrated through "cut testing" |
| Structural integrity and function under intended use | Demonstrated through "foot load plate testing" and "cycle testing" |
| Resistance to degradation (e.g., rust) | Demonstrated through "corrosion resistance" |
| Conformance to design specifications | Conforms to design specifications. |
| Substantial equivalence to predicate devices in function | "Substantial equivalence is based on intended use, performance characteristics, materials, and principle of operation." |
| Safety and effectiveness (overall) | "Demonstrates the proposed devices perform according to its description and intended use and supports the safety and effectiveness of the device." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Performance testing consisting of cut testing, foot load plate testing, cycle testing and corrosion resistance." The number of devices or components tested in these non-clinical tests is not provided.
- Data Provenance: Not applicable in the context of clinical data for diagnostic or AI/ML devices. The testing is internal non-clinical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. This is not a study requiring expert interpretation or ground truth establishment in the traditional sense of a clinical or image-based diagnostic study. The "ground truth" here is the physical performance of the device against engineering specifications.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a study requiring subjective interpretation or adjudication. The performance tests are objective mechanical or material tests.
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
- MRMC Study: No. This is a surgical instrument, not a diagnostic imaging device, and does not involve AI assistance or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a manual surgical instrument, not an algorithm or AI device.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context would be the engineering specifications and performance benchmarks derived from the predicate devices or industry standards for similar instruments. The tests performed ("cut testing, foot load plate testing, cycle testing and corrosion resistance") are designed to verify that the device meets these physical and functional requirements.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no machine learning or AI component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. There is no machine learning or AI component requiring a training set.
§ 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).