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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 sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life.

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, K141049, K150714, K150875, K151718, and K152681.

This document is a 510(k) summary for the iFuse Implant System®, a medical device intended for sacroiliac fusion. It is a submission to the FDA for market clearance, rather than a study designed to establish acceptance criteria and prove a device meets them in the context of an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies for AI performance is not present in the provided text.

The document primarily focuses on establishing "substantial equivalence" of the iFuse Implant System® to previously cleared predicate devices, an FDA regulatory pathway for non-AI/ML devices.

However, I can extract information related to the clinical evidence supporting the indications for use for this non-AI/ML device.

Clinical Evidence Related to Indications for Use (Not Acceptance Criteria for AI/ML):

The document states:
"Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life."

Study Information Pertaining to Clinical Efficacy (Not AI Performance):

• Study Name: SIFI (Sacroiliac Joint Fusion with iFuse Implant System)
• Study Type: Prospective, multicenter, single-arm clinical trial.
• Sample Size (Patients): 172 patients enrolled, with 149 patients followed for 24 months.
• Data Provenance: Not explicitly stated, but "multicenter" implies data from multiple sites, likely within one country or multiple, but the specific countries are not mentioned. It is a "prospective" study.
• Outcomes Measured: Clinically important and statistically significant improvements in:
  • SI joint pain
  • Disability due to SI joint pain
  • Quality of life (by two measures)
  • Patient satisfaction rates were high.
• Ground Truth: For this type of clinical trial, the "ground truth" would be the patient-reported outcomes (pain scores, disability indices, quality of life questionnaires) and clinician assessments, rather than a consensus of experts on a diagnostic image.
• Training Set/Ground Truth for Training Set: These concepts are not applicable as this is not an AI/ML device study.
• Experts / Adjudication / MRMC Study / Standalone Performance: These are not relevant for this type of non-AI/ML device submission.

In summary, the provided text does not contain the specific details requested for an AI/ML device's acceptance criteria and the study proving it meets them. The document is for a traditional medical device (implant system) seeking 510(k) clearance based on substantial equivalence and clinical effectiveness data.

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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. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

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 diameters of 4mm-7.0mm, 7.5mm, and 10.75mm. The iFuse Implants are implanted using instrumentation described in this submission as well as in K110838, K122074 K123850 K131405, K141049, K150714, K150875 and K151718.

The provided text is related to a 510(k) premarket notification for the iFuse Implant System, a medical device. This type of document is an FDA submission for a device that is substantially equivalent to a predicate device already on the market.

It is crucial to understand that this document explicitly states "No performance testing was required to support this premarket notification."

Therefore, based solely on the provided text, I cannot answer questions 1-9 regarding acceptance criteria and a study proving the device meets those criteria, as such information is not present. The document focuses on the regulatory aspects of substantial equivalence, not a detailed performance study proving compliance with specific acceptance criteria that would typically be found in a clinical trial report or a more extensive validation study.

The closest relevant information is the "Indications for Use," which mentions:
"Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation."

However, this is a summary statement about prior clinical studies (presumably for previous iterations or approvals of the iFuse system, given the numerous predicate devices listed) and does not constitute a "study that proves the device meets the acceptance criteria" within this specific 510(k) submission. It does not provide the detailed methodology, results, or acceptance criteria requested in your prompt.

Therefore, for questions 1-9, the answer is that the information is not available in the provided document, as no performance testing was required or reported for this specific 510(k) submission.

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