(106 days)
The RIALTO™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.
The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO™ implant are made using Titanium Alloy and are 40mm-60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.
The subject Medtronic Reusable Taps, Drivers and Drills are spine preparation instruments made of high grade stainless steel and are designed specifically for subject RIALTO™ SI Fusion System. The subject Taps, Drivers and Drills are compatible with Medtronic's IPC® POWEREASE® System may be connected to the IPC® POWEREASE® handpiece. The subject Taps, Drivers and Drills can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.
The subject Medtronic Navigated Reusable Taps, Drivers and Drills are spine preparation instruments made of high grade stainless steel. These instruments were specifically designed for use with subject RIALTO™ SI Fusion System in procedures where the use of stereotactic surgery may be appropriate. The subject Taps, Drivers and Drills are also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.
The provided text describes the RIALTO™ SI Fusion System, Medtronic Reusable Instruments for Use with the IPC™ Powerease™ System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation™ and IPC™ Powerease™ Systems. Within the summary of the 510(k) submission, the "Performance Data" section details the testing conducted.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Met pre-determined acceptance criteria | Met the pre-determined acceptance criteria for all tests. |
| Push-Out Testing | Not explicitly stated, implied to be based on predicate performance. | Passed |
| Torque-to-Fail Testing | Not explicitly stated, implied to be based on predicate performance. | Passed |
| Four Point Bend Testing | Not explicitly stated, implied to be based on predicate performance. | Passed |
| Shear Testing | Not explicitly stated, implied to be based on predicate performance. | Passed |
| Navigation accuracy (Navigated Instruments) | Not explicitly stated, implied to be based on predicate performance. | Passed |
| Biocompatibility | Safe and effective use in similar commercially available medical devices. | Not required, based on material history (titanium alloy, stainless steel). |
| Non-Pyrogenicity Endotoxin Testing | 20 endotoxin units (EU)/device pyrogen limit specification. | Confirmed that the subject implants meet the 20 EU/device testing limit. |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes used for any of the mechanical tests (Push-Out, Torque-to-Fail, Four Point Bend, Shear, Navigation Accuracy). It also does not specify the number of implants used for the Non-Pyrogenicity Endotoxin Testing beyond "worst case subject RIALTO™ SI Fusion implants."
The data provenance is from Medtronic Sofamor Danek USA, Inc. and is for the purpose of a 510(k) premarket notification, which typically involves laboratory testing rather than patient data. Therefore, it is not retrospective or prospective in terms of human clinical data. The materials used (Titanium alloy and stainless steel) have a "long clinical history of safe and effective use," implying a historical, general provenance but not a specific study for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the types of studies described. The performance data consists of mechanical and biocompatibility testing, which do not involve expert assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to the types of studies described, as no expert review or adjudication process for a test set is mentioned.
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
There is no mention of an MRMC comparative effectiveness study or any study involving human readers or AI assistance. The device is a physical medical implant system, not a diagnostic or AI-driven system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical implant system, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" is established by engineering standards and specifications (ASTM F543-13, ASTM F2193-02 (2007)) and comparison to the performance of predicate devices. For biocompatibility, the "ground truth" is based on the established clinical history of materials. For non-pyrogenicity, the "ground truth" is a regulatory standard (20 EU/device pyrogen limit, ANSI/AAMI ST72, USP ).
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" for an algorithm or AI.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a "training set" for an algorithm or AI.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.