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The InteliFUSE, Inc. Warmsystem with StimuLinks is used as a system for the following indications:

1. hand and foot bone fragment and osteotomy fixation and joint arthrodesis.

2. fixation of proximal tibial metaphysis osteotomy.

3. fixation of soft tissue to bone such as anterior cruciate reconstruction.

4. fixation of maxillofacial and mandibulofacial fractures and osteotomies.

5. fixation of unloaded craniofacial bone fractures and craniostomies. The StimuLinks are contraindicated for craniofacial patients with a skull thickness less than the selected prong length.

6. adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum

The InteliFUSE, Inc. StimuLinks are shape memory alloy staples available in various sizes and guages appropriate for the fixation of bone to bone or soft tissue to bone. The staples have prongs which are parallel during insertion. Application of heat from the Warmsystem Console, or from the portable InteliFUSER warming devices results in compression and retention of the staples. Accessories to the System include instruments for locating drill holes, gauging hole depth, and inserting and tamping the staples in place.

The provided document describes the InteliFUSE, Inc. Warmsystem with StimuLinks, a device intended for bone and soft tissue fixation. The document focuses on its substantial equivalence to a predicate device and details non-clinical performance data.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with numerical targets. Instead, it describes functional performance requirements and then reports on successful bench testing. The primary acceptance criterion for this type of device, as indicated by the submission, is substantial equivalence to an existing predicate device (BioMedical Enterprises, Inc. Memograph System with OSStaples) in terms of intended use and technological characteristics, and demonstrated functional performance through non-clinical testing.

Based on the provided text, here's a summary of the implied acceptance criteria and reported performance:

Study Information:

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

   • The document refers to "bench testing" for functional heating, electrical/mechanical safety, sterilization validation, and biocompatibility. However, it does not specify the sample size for these non-clinical tests.
   • The data provenance is non-clinical bench testing, which means it was conducted in a laboratory setting. The document does not specify the country of origin for the testing itself, but InteliFUSE, Inc. is located in New Orleans, LA, USA. The testing would be considered prospective in the sense that it was conducted specifically to demonstrate the performance and safety of this new device for regulatory submission.

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

   • This question is not applicable in the context of the provided information. The study described is non-clinical bench testing. There is no mention of human experts being used to establish a "ground truth" for the test set, as the testing involves objective measurements of physical performance (heating, deflection, sterilization, biocompatibility).

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., image reading) to resolve discrepancies among experts. Since the testing was non-clinical bench testing, such methods were not used.

4. 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:

   • This is not applicable. The device is a bone fixation system, not an AI-based diagnostic or assistive software. No MRMC study or AI-related comparative effectiveness study was conducted or mentioned.

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

   • This is not applicable. The device is a physical medical device (staples and a warming system), not an algorithm or software. No standalone algorithm performance testing was performed or described.

6. The type of ground truth used:

   • For the non-clinical tests described, the "ground truth" was established by objective physical measurements and adherence to recognized standards.
     • For heating performance: Measurement of temperature (45°C) and visible deflection of prongs.
     • For safety: Compliance with electrical and mechanical safety parameters (unspecified specific metrics, but implied by "properly functioning" and "electrical and mechanical safety").
     • For sterility: Laboratory testing to achieve a sterility assurance level (SAL) of 10^-6, which is a defined microbiological standard.
     • For biocompatibility: Compliance with ISO 10993 standards, which are internationally recognized biological evaluation standards for medical devices.

7. The sample size for the training set:

   • This is not applicable. As a physical medical device that is not based on AI or machine learning, there is no "training set." The device's function is governed by its material properties (shape memory alloy) and electro-mechanical design, not learned from data.

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

   • This is not applicable, as there is no training set for this device.

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The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications:

1. hand and foot bone fragment and osteotomy fixation and joint arthrodesis

2. fixation of proximal tibial metaphysis osteotomy

3. fixation of soft tissue to bone such as anterior cruciate reconstruction.

The system consists of two and four prong staples for use in various fixation techniques. The Nitinol staples have prongs which are parallel during insertion. Application of heat from the Warm System to the staple causes the prongs to deflect inward. This inward deflection results in staple compression and retention. The heat is applied through two electrodes in an autoclavable heating wire. The electrodes are applied to the back of the implanted staple to activate heating.

An accessory pack is provided with the Warm System and includes the resterilizable current source, drill bits of different sizes for creating proper hole diameters, a drill guide for depth gauging, an impactor for tapping the staples in place, forceps, and a locator pin. The accessory pack components are all commercially available finished devices.

The 2 prong StimuLink staples are available in wire thicknesses from 1.2 x 1.2 mm to 2mm x 3 mm, and in lengths and heights from 5 to 30 mm, including uneven prong heights. Four prong plates for multiaxial loads are available in ranges from 15 x 6 x 6 mm to 15 x 6 x 10 mm.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document describes a medical device (InteliFUSE, Inc. Warm System with StimuLinks) and its intended use, but does not include details of any studies or tests conducted to prove its performance against specific criteria.

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