(128 days)
Used as an accessory to aid in the auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgical procedures.
X12's Sterile Reflective Marker Spheres consist of two hemispheres, coated with a retroreflective foil, bonded together on a central pin to form a sphere. The central pin can be threaded with an M3 female thread or have a snap hole to mate with a mounting pin. The retro-reflective foil is applied in such a way as to provide reflectivity from all angles that is equivalent to the predicate devices. The spheres are individually packaged in a special sterile package and are gamma sterilized.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the X12 Sterile Reflective Marker Sphere:
This submission (K111443) is for a Class II medical device, specifically a "Neurological Stereotaxic Instrument" and "Orthopedic Stereotaxic Instrument" in the form of a "Disposable Reflective Marker Sphere." The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.
The information provided does not describe a study involving human subjects or AI assistance, nor does it present specific quantitative acceptance criteria in the format of a performance table with reported device performance metrics. Instead, it relies on comparative performance testing against predicate devices to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text, with explicit notes on what is not available or applicable:
1. A table of acceptance criteria and the reported device performance
No specific quantitative acceptance criteria or a direct performance table are provided in the document. The device's performance is described as "equivalent" or "substantially equivalent" to predicate devices for the tested characteristics.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Retro-reflectivity equivalent to predicate devices | Both polar and equatorial views showed retroreflectivity that was equivalent to the predicate devices. |
| Maintain mechanical properties after water soak | Maintained mechanical properties after being soaked in water. |
| Surface durability substantially equivalent to predicate devices | Surface durability was substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The text mentions "X12's Sterile Reflective Marker Spheres were tested" and implies testing of multiple units for water soak and surface abrasion ("the markers," "which showed the surface durability"). For retro-reflectivity, it refers to "Both the polar and equatorial views."
- Data Provenance: Not specified (e.g., country of origin). The testing seems to have been conducted by the manufacturer, X12 Co., Ltd. (Bulgaria), or on their behalf. The testing is for premarket notification, indicating it's prospective for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical marker sphere. Its performance characteristics (retro-reflectivity, mechanical properties, surface durability) are assessed through physical and optical tests, not by expert interpretation of clinical data to establish a "ground truth" in the diagnostic sense.
4. Adjudication method for the test set
Not applicable. As noted above, this device relies on physical and optical tests, not human interpretation requiring an adjudication process.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive reflective marker sphere, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of 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 physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by physical and optical measurements of its properties (retro-reflectivity, mechanical integrity after water soak, surface durability) compared against predicate devices that are already legally marketed. There is no biological or diagnostic "ground truth" like pathology or outcomes data associated with the markers themselves, other than their intended function in surgical navigation.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an algorithm or machine learning for this physical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).