(112 days)
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049 and K150714.
This document is a 510(k) summary for the SI-BONE iFuse Implant System. It primarily addresses a clarification of existing labeling and explicitly states that no performance testing was required to support this clarification. Therefore, many of the requested details regarding acceptance criteria and study design are not present in this document.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
Not available. The document states: "No performance testing was required to support the clarification of existing labeling that is the subject of this 510(k)." This 510(k) is for a "clarification of existing labeling," not for demonstrating initial device performance or a new device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no performance testing was conducted for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no performance testing was conducted for this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance testing was conducted for this 510(k).
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. The iFuse Implant System is a medical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The iFuse Implant System is a medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no performance testing was conducted for this 510(k).
8. The sample size for the training set
Not applicable, as no performance testing was conducted for this 510(k), and the device is an implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as no performance testing was conducted for this 510(k), and the device is an implant, not an AI model requiring a training set.
Summary based on the provided document:
This 510(k) (K150875) for the SI-BONE iFuse Implant System is a "clarification of existing labeling." It explicitly states that no performance testing was required to support this particular submission. Therefore, it does not contain the information requested regarding acceptance criteria or performance study results. The device itself is an orthopedic implant, not an AI/software device, which explains why questions related to AI models and diagnostic performance are not relevant here.
§ 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.