(75 days)
The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).
The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the device "Symmetry Sharp Kerrison® Rongeur":
This document describes a medical device called the "Symmetry Sharp Kerrison® Rongeur," which is a manual rongeur used for cutting bony tissue of the spine. The information provided heavily emphasizes comparison to a predicate device (K130541 Kerrison Disposable Tip Rongeur) to establish substantial equivalence for FDA 510(k) clearance. The testing described primarily focuses on validating the safety and performance characteristics for a mechanical surgical instrument, not an AI/ML-driven device. Therefore, many standard questions related to AI/ML device studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) are not applicable or directly addressed in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Cleaning Validation for Reusable Components | Residual proteins, residual hemoglobin, and residual carbohydrates must meet specified acceptance criteria. | "For substantial equivalence the device must be able to be adequately cleaned for reuse. Pass" (Indicates criteria were met) |
| Steam Sterilization Validation for Reusable Components | Must meet requirements in applicable ISO Standard for the overkill method to achieve an SAL (Sterility Assurance Level) of 10-6. | "For substantial equivalence the reusable components must be able to be effectively sterilized with steam sterilization. Pass" (Indicates criteria were met) |
| Gamma Sterilization Validation for Single-Use Components | Must meet requirements in applicable ISO standard for VDMax to achieve an SAL of 10-6. | "For substantial equivalence the single use component must be able to be sterilized using gamma sterilization. Pass" (Indicates criteria were met) |
| Confirmation of Multiple Use for Reusable Components (Durability) | Detachable tips must maintain acceptable cutting performance for up to 100 cuts. Reusable handle must maintain performance for 50 reuse cycles. | "For substantial equivalence the reusable must be sufficiently robust to support reuse. Pass" (Indicates criteria were met for both tips and handle as per the criteria) |
| Resistance to Corrosion for Reusable Components | Must not corrode when exposed to a corrosion challenge. | "For Substantial Equivalence device must be resistant to corrosion. Pass" (Indicates criteria were met) |
| Packaging Validation/Shelf Life for Single-Use Components | Package and product must demonstrate package and product stability over the claimed shelf life period. | "Package and product performance evaluations conducted on the single use component for shelf life confirm a two year shelf life. Pass" (Indicates a 2-year shelf life was confirmed, meeting stability criteria) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of rongeurs tested for cleaning, sterilization, or durability). It refers to standard validation activities but doesn't quantify the number of units or cycles performed for each test.
- Data Provenance: The studies are described as "Design verification and validation testing" which are prospective tests conducted by the manufacturer specifically for this submission. The origin (e.g., country) is not specified beyond the manufacturer's location (Antioch, TN, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" for a mechanical device like a rongeur is based on objective performance metrics (e.g., sterilization efficacy, cutting performance, corrosion resistance) measured against defined standards or engineering specifications, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.
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 mechanical surgical instrument, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a mechanical surgical instrument.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance tests relies on:
- Established Standards: Primarily ISO standards for sterilization (SAL of 10-6), ASTM standards for shelf life.
- Engineering Specifications: Criteria for residual proteins/hemoglobin/carbohydrates, number of cuts/reuse cycles for durability, and absence of corrosion. These are objective, measurable parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this mechanical 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).