(154 days)
The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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 4-7 mm. The fusion rods are implanted using instrumentation similar to that previously described in K080398, K092375, K110838, K122074 and K123850.
The provided text is a 510(k) summary for the iFuse Implant System®, and it primarily discusses substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria and a detailed analysis of device performance. The only "performance data" mentioned is related to MR compatibility.
Therefore, an extensive table of acceptance criteria and reported device performance, information about sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, training set details, or specific types of ground truth cannot be extracted from this document as these types of studies were not included in the submission.
Here's a summary of the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Magnetic Resonance (MR) Imaging Compatibility: Compatibility and safety under typical MR conditions, following aspects of ASTM F2052-06, ASTM F2182-11A, and ASTM F2119-07. | The iFuse Implant is MR conditional and labeled in compliance with ASTM F2503-08. |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is detailed as "Magnetic resonance (MR) imaging testing."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified. The document states "Magnetic resonance (MR) imaging testing was performed" but does not give details about the number of implants or test conditions.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The MR imaging testing does not involve establishing ground truth through expert review in the way a diagnostic imaging study would. The ground truth for MR compatibility testing lies in meeting specific standards through physical testing.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which is not the nature of MR compatibility testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC comparative effectiveness study was not performed. The data presented relates to MR compatibility, not clinical effectiveness studies comparing human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an implant, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The performance refers to the physical properties of the implant under MR conditions.
7. The Type of Ground Truth Used:
The ground truth for the MR compatibility testing is based on the standards themselves (ASTM F2052-06, ASTM F2182-11A, ASTM F2119-07, and ASTM F2503-08). Meeting these objective, predefined standards through physical testing constitutes the "ground truth" for MR safety and compatibility.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set.
§ 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.