(266 days)
The IntraLock Lapidus System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints in the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.
The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of two diameters and lengths ranging from 22mm to 50mm, as well as a mating washer component consisting of one diameter and lengths ranging from 16mm to 35mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are made of surgical grade stainless steel (ASTM F899).
The provided document is a 510(k) premarket notification for a medical device called the "IntraLock Lapidus System." It is a submission to the FDA seeking to demonstrate substantial equivalence to previously cleared devices.
Based on the content of the document, the device described is a bone fixation fastener (IntraLock Lapidus System), not an AI/ML-based diagnostic device. Therefore, the questions about acceptance criteria (in terms of AI performance metrics like sensitivity, specificity, AUC), sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance do not apply to this type of medical device submission.
This document describes a traditional medical device, and its acceptance criteria and the study to prove it meets them are related to mechanical properties, biocompatibility, and intended use equivalence to predicate devices, rather than AI performance.
Here's an analysis of the provided information relevant to this type of device:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
The "acceptance criteria" for a traditional Class II device like this are primarily demonstrated through non-clinical testing to show that the device performs as intended and is substantially equivalent to predicate devices in terms of safety and effectiveness.
| Acceptance Criteria (Demonstrated via Non-Clinical Testing) | Reported Device Performance / Evaluation |
|---|---|
| Mechanical Performance and Safety: | |
| Static torsion analysis meets criteria | Conducted. Results: Indicate equivalence to predicate devices. |
| Insertion torque analysis meets criteria | Conducted. Results: Indicate equivalence to predicate devices. |
| Pull-out analysis meets criteria | Conducted. Results: Indicate equivalence to predicate devices. |
| Static 4-point bending test meets criteria | Conducted. Results: Indicate equivalence to predicate devices. |
| Dynamic 4-point bending test meets criteria | Conducted. Results: Indicate equivalence to predicate devices. |
| Material Biocompatibility: | |
| Pyrogenicity (endotoxin levels) meets criteria | Evaluated using Limulus amebocyte lysate (LAL) assay. Demonstrated to meet recommended maximum endotoxin level of 20 EU per device. |
| Design and Material Equivalence: | |
| Comparable design principles | The device is described as a two-part construct (lag screw and mating washer) made of titanium alloy (TI6Al4V), which is similar in concept and materials to existing bone fixation fasteners. |
| Comparable materials used (Ti-6Al-4V allele, Stainless steel) | Confirmed. |
| Intended Use Equivalence: | |
| Indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of small bones and joints in the foot. Specifically for Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis. | This aligns with the indications for existing predicate devices. |
Study Proving Device Meets Acceptance Criteria:
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Sample sizes used for the test set and the data provenance:
- For mechanical testing, the "sample size" refers to the number of test specimens (e.g., screws, washers) subjected to the specified tests. The document does not specify the exact number of samples for each mechanical test (e.g., how many screws were pulled out, how many were bent). The provenance is laboratory testing conducted by the manufacturer, Fusion Orthopedics, LLC.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device classification does not involve medical image interpretation or clinical ground truth establishment in the way AI/ML devices do. The "ground truth" for this device's performance is established by standardized engineering and biocompatibility testing methods against predefined specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human adjudication is involved in the mechanical or biocompatibility testing of a bone fixation device for a 510(k) submission.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. MRMC studies are specific to diagnostic devices (especially imaging-based ones) where human reader performance is a critical outcome. This is a surgical implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on engineering standards and specifications (e.g., acceptable loads, torques, displacement) and biocompatibility standards (e.g., endotoxin limits). It's not based on clinical "ground truth" like pathology or expert consensus on a diagnosis.
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The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not applicable. There is no training set.
In summary, the provided document describes a traditional orthopedic implant device undergoing a 510(k) premarket notification. The "acceptance criteria" and "proof" are based on non-clinical laboratory testing to demonstrate mechanical integrity, material compatibility, and substantial equivalence to existing predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.
§ 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.