(411 days)
The Karl Storz Scalp Dura Retractor is intended for use to elevate dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies.
The Karl Storz Scalp Dura Retractor is a non-powered, manual, adjustable, self-retaining retractor for neurosurgery. The assembly comprises a retractor handle, a stationary blade, a telescope sheath/cannula, and an adjustable/movable blade. One knob controls the telescoping of the stationary blade and a second knob controls the angular opening of the adjustable blade. The telescope cannula allows for the introduction of an endoscope for direct visualization of the surgical site.
The Karl Storz Scalp Dura Retractor is a medical device for neurosurgery. The provided document is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with performance metrics.
However, based on the information provided, we can infer the "acceptance criteria" relate to mechanical equivalence and
reprocessing validation, and the "study" is the mechanical testing and reprocessing validation.
Here is an analysis based on the provided text:
1. Table of "Acceptance Criteria" and the Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Mechanical Equivalence | Device's load deflection properties should be substantially equivalent to predicate devices. | "The Karl Storz Scalp Dura Retractor demonstrated mechanical equivalence by a load deflection test, in which the device was loaded and the lateral deflection was measured. The deflection displacements were found to be substantially equivalent to the predicate Tew Cranial Spinal Retractor Model A as well as the Budde-Halo Retractor." |
| Reprocessing Validation | Device must have validated cleaning instructions and sterilization methods for reprocessing in healthcare facilities, adhering to FDA and AAMI guidelines. | "The labeling for the Karl Storz Scalp Dura Retractor includes validated cleaning instructions and device sterilization by steam (pre-vacuum) for reprocessing in health care facilities in accordance with 'Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance' and AAMI TIR 12:2004." |
| Intended Use | The device should be validated for its specific intended use of elevating dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies. | "In addition, the Karl Storz Scalp Dura Retractor has been tested to validate its use for the specific intended use of elevating dura and scalp layers away from cranial bone during endoscopic-assisted strip craniectomies." (Details of this testing are not provided in the summary). |
| Safety and Effectiveness | The device should not raise new issues of safety and effectiveness compared to predicate devices. | "The Karl Storz Scalp Dura Retractor is substantially equivalent to the identified predicate devices and does not raise any new issues of safety and efficacy." |
2. Sample Size Used for the Test Set and the Data Provenance:
-
Mechanical Testing (Load Deflection Test):
- Sample Size: Not explicitly stated in the summary how many units of the Karl Storz Scalp Dura Retractor were tested or how many units of the predicate devices were used for comparison.
- Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer. It is prospective testing of new device models.
-
Reprocessing Validation:
- Sample Size: Not explicitly stated, however, reprocessing validation typically involves multiple cycles of cleaning and sterilization
on a representative number of devices to demonstrate efficacy and device integrity. - Data Provenance: Not specified, but validation studies are generally conducted in a controlled laboratory environment by the manufacturer or a contracted third-party lab. It is prospective testing.
- Sample Size: Not explicitly stated, however, reprocessing validation typically involves multiple cycles of cleaning and sterilization
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This information is not provided in the 510(k) summary. Given the nature of the "studies" (mechanical testing and reprocessing validation), expert consensus in the traditional sense of clinical evaluation with human readers for ground truth would not be applicable. Mechanical and reprocessing tests rely on objective measurements against established standards.
4. Adjudication Method for the Test Set:
- This information is not applicable as the "studies" described are not human reader-based evaluations requiring adjudication. Mechanical testing and reprocessing validation follow predefined protocols and measurement criteria.
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 document describes a medical device (a surgical retractor), not an AI-assisted diagnostic tool or system that would involve human readers and AI assistance for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- Mechanical Testing: The "ground truth" for mechanical equivalence was based on objective physical measurements (load deflection) and comparison to the performance characteristics of predicate devices, adhering to engineering principles and potentially relevant industry standards not detailed in this summary.
- Reprocessing Validation: The "ground truth" was based on successful demonstration of cleaning efficacy (e.g., removal of biological soil to predefined levels) and sterility assurance (e.g., sterilization leading to a sterility assurance level of 10^-6), according to established regulatory guidance (FDA) and industry standards (AAMI TIR 12:2004).
8. The Sample Size for the Training Set:
- Not applicable. This device is a manual surgical instrument, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, there is no "training set" for this type of device.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. The "studies" focus on engineering and reprocessing validation rather than clinical performance that would involve human readers, AI, or traditional clinical endpoints for establishing ground truth from patient data.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).