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The iFuse-TORQ™ Implant System is indicated for:
· Fusion of the sacroiliac joint for sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
· Fracture fixation of small and large bones of the pelvis

The iFuse-TORO Implant System consists of the iFuse-TORO Implants and associated Instruments which are included in two Instrument Sets: iFuse-TORQ Instrument Set and iFuse-TORQ Revision Instrument Set. The iFuse-TORQ Implant System is designed to provide a non-impacted, threaded solution for sacroiliac joint fusion, as well as compression across the SI joint, and for fracture fixation of small and large bones of the pelvis.
The iFuse-TORQ Implants are sterile, single use 3D-printed implants that are provided in various lengths and diameters, and feature flutes and multiple fenestrations along the shaft length (Table 1). The iFuse-TORO Implants are provided in two primary configurations – fully threaded and lag implant designs with optional washers. The cannulated implants include a tapered distal tip and dualsingle-dual lead threads that are compatible with off-the-shelf 3.2 mm guidewires. The iFuse-TORQ Implant designs allow for packing of autograft and allograft materials.
The iFuse-TORO Instruments are provided in two sets: iFuse-TORO Instrument Set (with Primary and Navigation Instruments) and the iFuse TORO Revision Instrument Set. The iFuse-TORO Instruments Sets consist of single use, disposable and reusable instruments. The instruments are provided non-sterile and are intended for cleaning and steam sterilization by the user prior to each use. The iFuse-TORQ Instruments consist of both Class II and Class I medical devices which facilitate the introduction, adjustment / positioning, final placement, and removal (if required) of the implants in the target anatomy.

The provided text describes the regulatory clearance of a medical device, the iFuse-TORQ™ Implant System. It details its purpose, technical specifications, and the testing performed to demonstrate its substantial equivalence to previously cleared predicate devices.

However, the document focuses on the mechanical and material-based acceptance criteria and testing for the implant system itself, rather than the performance of an AI/algorithm-based device.

Specifically, the "Study that proves the device meets the acceptance criteria" in this document refers to bench testing of physical properties, sterilization validation, biocompatibility, and packaging, as listed in Table 2. It does not describe a study involving an algorithm's performance, human readers, or image analysis.

Therefore, many of the requested criteria for an AI/algorithm-based device cannot be answered from the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

Cannot be extracted from the provided document (related to AI/Algorithm performance):

• Table of acceptance criteria and reported device performance for an AI/Algorithm: The document lists standards for physical properties, sterilization, etc., not for AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample size used for the test set (for an AI/Algorithm): No test set of medical cases/images for AI evaluation is mentioned.
• Data provenance (e.g., country of origin, retrospective/prospective): Not applicable to the presented physical/material testing.
• Number of experts and their qualifications for ground truth: No expert review of cases/images is described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study involving human readers and AI assistance is mentioned.
• Stand-alone (algorithm only) performance: No algorithm is described.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable to the physical device testing.
• Sample size for the training set (for an AI/Algorithm): Not applicable, as there's no AI/algorithm.
• How ground truth for the training set was established: Not applicable.

What can be extracted, interpreting "device" as the iFuse-TORQ™ Implant System:

1. A table of acceptance criteria and the reported device performance:

   The document lists various standards (acceptance criteria) that the device was tested against. The "reported device performance" is implicitly stated as meeting these standards, leading to the "substantially equivalent" determination. However, the specific quantitative results of each test (e.g., exact fatigue life, specific shear strength values) are not provided in this summary.

   Acceptance Criteria (Standards Met/Evaluated against)	Type of Test/Performance Demonstrated (Reported)
   SS EN ISO 11137-1, 2, 3	Sterilization Validation (Implants)
   ANSI / AAMI / ISO 11737-1, 2	Sterilization Validation (Implants)
   ANSI/AAMI/ISO 17665-1, AAMI TIR12, ANSI/AAMI ST79, ST77	Sterilization Validation (Instruments)
   EN ISO 19227, ISO 10993-5	Cleaning Validation (Implants)
   AAMI TIR30	Cleaning Validation (Instruments)
   AAMI TIR12, TIR17	Repeat Cleaning & Steam Sterilization (Instruments)
   EN ISO 11607-1, ASTM D4332-14, D4169-16, F2096-11, F88-15	Packaging Validation (Implants & Instruments)
   ASTM F1980-16	Shelf Life Rationale (Implants)
   ISO 10993-1	Biocompatibility Assessments (Implants & Instruments)
   ASTM F543-17, F2193-20	Bench Testing (Implants & Instruments), Torsion Testing (Implants)
   ASTM F3001-14	Elemental Analysis (Implants)
   ASTM F2193-20	Fatigue Testing (Implants)
   ASTM F1854-15	Stereological Evaluation of Porous Layer
   ASTM F1044-05	Static Shear Testing
   ASTM F1160-14	Shear Fatigue Testing
   ISO 13179-1, ASTM F1147-05	Static Tensile Testing
   ASTM F1978-18	Abrasion Properties
   ASTM F2052-15, F2119-13, F2182-19e2, F2213-06, F2503-13	MR Compatibility Assessment
   ASTM F2554-2018	Positional Error (Navigational Instruments)
   ANSI/AAMI HE75, EN 62366, IEC 62366-1	Simulated Use Testing (System Validation)

2. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of implants tested for fatigue). It generally states "comprehensive Design Verification and Validation Testing."
   • Data Provenance: Not applicable in the context of human data. The testing was laboratory-based, performed by SI-BONE.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable to the type of testing performed. Ground truth for material and mechanical properties is established through standardized testing methods, not expert consensus on cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable.

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:

   • No. This document does not pertain to an AI-assisted diagnostic device, but rather a physical implant system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For the physical device, the ground truth is established by the specifications defined in the relevant ASTM, ISO, and AAMI standards for materials, manufacturing, sterility, biocompatibility, and mechanical performance.

8. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established:

   • Not applicable, as this is not an AI/ML device.

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