(174 days)
Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.
DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric). DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used.
The provided document is a 510(k) premarket notification for the DORO® Sterile Disposable Skull Pins. This document asserts the substantial equivalence of the new device to legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I describe an MRMC comparative effectiveness study or details about the training set.
The document focuses on demonstrating substantial equivalence for a physical medical device (skull pins) by comparing its technological characteristics and performance testing results to those of predicate devices. It does not involve AI/ML components or studies of human reader performance.
However, I can extract information related to the performance data provided for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance (as listed in the document for the physical device):
| Test | Acceptance Criteria (Implied by action 'Confirms ability to withstand' or 'Confirms acceptance', and 'Pass' result) | Reported Device Performance |
|---|---|---|
| DORO® Sterile Disposable Skull Pins (Stainless Steel & Titanium) | ||
| Axial Load, and Creep Test | Ability to withstand typical loads with additional safety factor without plastic deformation and with an accepted distension. | Pass: The Pins are able to withstand typical static loads w/ additional safety factor w/o plastic deformation and an accepted distension. |
| Shear Test | Ability of the skull pins and its interface with the cranial bone to withstand typical shear force with additional safety factor without spatial locomotion. | Pass: The Pins are able to withstand typical shear force w/ additional safety factor w/o spatial locomotion. |
| Transport Validation | Capability of the transport packaging as well as the product packaging to protect the skull pins against hazards, which may occur during handling, storage, and transport by air or ground. | Pass: The utilized packing system for the skull pins is capable to protect those against visible damage. |
| Packing Integrity Test | Capability of the sterile barrier system of the blister pack as well as the blister pack itself utilized for the skull pins whether it is effective, efficient and safe to use. | Pass: The utilized sterile barrier system as well as the blister pack was proven to perform efficiently, safely, and effectively. |
| System Handling Test | Safe and effective utilization of the skull pins with skull clamps without negative impact on utilized single-use gloves. | Pass: Skull Pins performed safely and effectively. |
| Input Materials | Acceptance of utilized materials of the skull pins for medical use prior biocompatibility test. | Pass: All utilized materials are accepted for medical use. |
| Biocompatibility Test | Biocompatibility of the skull pins by cytotoxicity test and chemical analysis of utilized materials (no cell growth inhibiting character, no chemical substance above harmful threshold). | Pass: The skull pins obtain no cell growth inhibiting character. No chemical substance above harmful threshold was detected. |
| Color Coding | Coloring of the plastic pin collets that enables the user to differentiate between MR conditional and MR unsafe skull pins as well as between skull pins for the adult population and pediatric population. | Pass: Differentiation between designated patient populations as well as different applications is possible due to different colors utilized for the plastic pin collets. |
| Sterility Test | Sterility of the skull pins as well as the maintained sterility of the skull pins at the end of the product's shelf life. | Pass: VDmax validation as well as dye penetration test have proven the sterility of the product at delivery status as well as at the end of shelf life. |
| DORO® Sterile Disposable Skull Pins (Titanium) | ||
| MR-Compatibility | MR-Compatibility of the skull pins dedicated for the utilization in conjunction with MRT scanner utilizing the worst-case product. | Pass: The skull pins are MR conditional. |
2. Sample size used for the test set and the data provenance:
The document describes performance testing of physical properties of the skull pins (e.g., axial load, shear, sterility, biocompatibility) and packaging, not a study involving a "test set" of medical images or patient data in the typical sense of AI/ML evaluation. The specific sample sizes for these engineering and material tests are not detailed in this 510(k) summary, beyond indicating that "worst-case product" was utilized for some tests. The data provenance is from the manufacturer's internal testing (Pro Med Instruments GmbH, Germany). The tests are not clinical studies, so terms like "retrospective or prospective" do not apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to the type of device and testing described. Ground truth for a physical device's performance tests would typically involve established engineering standards, material specifications, and validated laboratory procedures, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or adjudication of medical data.
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 document is for a physical medical device (skull pins), not an AI/ML diagnostic or assistive device. Thus, there is no mention of MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the physical device, the "ground truth" for the performance tests would be defined by engineering specifications, material standards (e.g., ISO, ASTM), and validated test methodologies. For example, for the "Axial Load and Creep Test," the ground truth is the specified load and deformation limits that the device must withstand. For "Biocompatibility," the ground truth is the absence of cytotoxicity or harmful chemical substances as per established biocompatibility standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML model.
In summary, the provided document is a regulatory submission for a physical medical device focusing on substantial equivalence based on material properties, design, and mechanical performance testing, rather than an AI/ML device requiring clinical validation or human reader studies.
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).