(90 days)
The InteliFUSE, Inc. Warmsystem with StimuLinks is used as a system for the following indications:
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hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
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fixation of proximal tibial metaphysis osteotomy.
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fixation of soft tissue to bone such as anterior cruciate reconstruction.
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fixation of maxillofacial and mandibulofacial fractures and osteotomies.
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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.
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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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Heating Capacity: Ability of Warmsystem console and hand-held units to properly heat StimuLinks staples to transition temperature (45°C) and cause prongs to deflect. | "Bench testing demonstrated that both the Warmsystem console and hand held units properly heat the StimuLinks until the staple is transformed and the prongs deflect." "The non-clinical test results demonstrate that both the Warmsystem console and the hand held heating units supply the required degree of heat to transform the StimuLink staples." |
| Electrical and Mechanical Safety (Warmsystem console): Safe operation for its intended purpose. | "The Warmsystem console testing included electrical and mechanical safety when used for its intended purpose." |
| Sterility (Portable units - InteliFUSER I & II): Achievement of specified sterility assurance level (SAL). | "The portable units are provided sterile using a validated ethylene oxide sterilization cycle, and a sterility assurance level (SAL) of 10^-6 has been demonstrated." |
| Sterility (StimuLinks): Achievement of specified sterility assurance level (SAL). | "StimuLinks are radiation sterilized at a minimum dose validated to attain a sterility assurance level (SAL) of 10^-6." |
| Biocompatibility (StimuLinks): Compliance with relevant biocompatibility standards. | "StimuLinks meet the ISO 10993 standards for biocompatibility." |
| Identical Indications for Use: Indications are identical to the predicate device. | "The indications are identical to those of the predicate device, the BioMedical Enterprises, Inc. Memograph System with OSStaples." The listed indications for use for the Warmsystem with StimuLinks cover: hand and foot bone fragment and osteotomy fixation and joint arthrodesis; fixation of proximal tibial metaphysis osteotomy; fixation of soft tissue to bone (e.g., anterior cruciate reconstruction); fixation of maxillofacial and mandibulofacial fractures and osteotomies; fixation of unloaded craniofacial bone fractures and craniostomies; adjunctive fixation of small bone fragments in various bones. |
Study Information:
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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.
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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).
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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.
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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.
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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.
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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.
- For the non-clinical tests described, the "ground truth" was established by objective physical measurements and adherence to recognized standards.
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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.
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set for this device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.