(83 days)
The Stryker Hummer II MicroDebrider system, is to be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the Head and Neck.
When using the Stryker Hummer II MicroDebrider system, the surgeon has the ability to choose either open or endoscopic viewing and the option to utilize irrigation or vacuum as the surgeon deems necessary. The precise cutting action of the Hummer II Shaver blades allow the surgeon to achieve desired tissue removal, thus minimizing unwanted contour lines, skin discoloration and patient trauma.
The Stryker Hummer II MicroDebrider System, consisting of instrumentation which power disposable irrigated cutters and burs, is used in Endoscopic or open plastic, reconstructive and aesthetic surgery of the Head and Neck.
The disposable cutters, burs and tubing sets employed as accessories with the Stryker Hummer II MicroDebrider system, are provided sterile, for single use only, and are validated to an SAL of 10-6. The materials of construction, cutting action, speed of rotation, availability of suction/irrigation and tip configuration are equivalent to Linvatec blades and or the Xomed shaver system, and patient contact materials are demonstrated to be biocompatible per ISO standard 10993. The accessory devices offer no new safety or effectiveness concerns.
The powered instrumentation technology utilized in the device is equivalent to existing marketed devices and is currently cleared for use in Functional Endoscopic Sinus Surgery under K# 952681. This instrumentation is designed to meet TEC 601-1 electrical standards, as well as UL and CSA requirements.
The provided text describes a 510(k) submission for the Stryker Hummer II MicroDebrider System. This submission focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a new or novel performance against specific acceptance criteria in the way a clinical study for a high-risk device might.
Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria are met is not directly applicable here. The device is a surgical instrument and its "performance" is implicitly evaluated through its substantial equivalence to other legally marketed devices with similar functions.
However, I can extract the relevant information regarding what constitutes "acceptance" for this type of submission and how it was achieved based on the provided text.
Here's how to interpret the available information:
Acceptance Criteria (for a 510(k) Substantial Equivalence Determination):
For a 510(k) submission like this, the "acceptance criteria" are not quantitative performance metrics in the traditional sense. Instead, they are met by demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This involves showing that the device:
- Has the same intended use as the predicate device.
- Has the same technological characteristics as the predicate device, OR
- Has different technological characteristics from the predicate device but data are provided that demonstrate that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.
The "Study" Proving Acceptance Criteria (Substantial Equivalence):
The "study" in this context is the detailed comparison and justification provided in the 510(k) premarket notification. The text provided is a summary of the FDA's decision, relying on the manufacturer's submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for 510(k) Substantial Equivalence) | Reported Device Performance (as summarized in the 510(k) submission and FDA letter) |
|---|---|
| Identical Intended Use: Device's use must be the same as the predicate device. | Met: "used in Endoscopic or open plastic, reconstructive and aesthetic surgery of the Head and Neck." This is implied to be equivalent to the predicate devices. |
| Equivalent Technological Characteristics: Device's components, materials, operating principles, etc., are similar to the predicate device. | Met: |
- Disposable cutters, burs, tubing sets are "validated to an SAL of 10-6" (Sterility Assurance Level).
- Materials of construction, cutting action, speed of rotation, suction/irrigation availability, and tip configuration are "equivalent to Linvatec blades and or the Xomed shaver system."
- Patient contact materials are "demonstrated to be biocompatible per ISO standard 10993."
- Powered instrumentation technology is "equivalent to existing marketed devices and is currently cleared for use in Functional Endoscopic Sinus Surgery under K# 952681." |
| No New Safety/Effectiveness Concerns: The device does not introduce new risks or raise different questions of safety/effectiveness compared to the predicate. | Met: "The accessory devices offer no new safety or effectiveness concerns." and "The Stryker Hummer II MicroDebrider system does not raise any new safety or effectiveness concerns when compared to, and is therefore equivalent to, the Linvatec and Xomed shaver systems." |
| Compliance with Standards: Device meets relevant electrical, manufacturing, and other standards. | Met: "This instrumentation is designed to meet IEC 601-1 electrical standards, as well as UL and CSA requirements." Implied compliance with QSR (GMP) as noted in the FDA letter. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a clinical test set. The "test set" here refers to the components and characteristics of the device itself and its comparison to predicate devices, not patient data from a clinical trial.
- Data Provenance: The data comes from the manufacturer's internal design, testing, and comparison documentation. This is not a "study" with patients or a retrospective/prospective design as would be applied to a diagnostic AI algorithm.
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 this context generally refers to objective measurements of the device's characteristics (e.g., material properties, sterilization efficacy, electrical safety) and a comparison of these to predicate devices, as well as regulatory and engineering standards. This is done by the manufacturer's engineers and quality assurance personnel. The FDA's review personnel (e.g., Lillian Yin, Ph.D., Director, Division of Reproductive, Abdominal, ENT, and Radiological Devices) serve as regulatory experts who evaluate the completeness and adequacy of the submission.
4. Adjudication method for the test set:
- Not applicable. No "adjudication" in the clinical sense is described. The FDA review process involves comparing the submitted data against regulatory requirements and historical predicate device information.
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 surgical instrument, not a diagnostic AI device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this 510(k) submission relies on:
- Engineering Specifications and Bench Testing: For material properties, cutting action, speed, electrical safety (IEC 601-1, UL, CSA), sterility (SAL of 10-6), and biocompatibility (ISO 10993).
- Comparison to Predicate Devices: The "truth" that the device is safe and effective is established by demonstrating its equivalence to the Linvatec and Xomed shaver systems, which are already legally marketed and presumed safe and effective.
- Regulatory Standards: Compliance with 21 CFR Part 820 (Quality System Regulation) and general controls.
8. The sample size for the training set:
- Not applicable. There is no training set as this is a physical medical device, not an AI/machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable. See #8.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.