(89 days)
The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus.
The APTUS® Foot 3.5 System consists of titanium locking plates and titanium locking and non-locking screws. Plates are provided in three sizes in designs specifically for the right and left calcaneus. The plates are used with TriLock (locking) screws or cortical (non-locking) screws having self-tapping cortical thread forms and a thread diameter of 3.5 mm. The screws are provided in various overall lengths ranging from 16 mm to 60 mm. APTUS Foot 3.5 System plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67. APTUS TriLock and cortical screws are made of titanium alloy conforming to ASTM F136.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not contain specific acceptance criteria or quantitative performance data for the APTUS® Foot 3.5 System. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The performance data mentioned is to establish this equivalence, not to meet specific, quantifiable acceptance criteria in the way one might see for a diagnostic AI device.
Table of Acceptance Criteria and Reported Device Performance (Based on the provided text):
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Devices | - Same intended use | - "has the same intended use." |
| - Same operating principles | - "uses the same operating principles." | |
| - Same basic designs | - "incorporates the same basic designs." | |
| - Same or very similar materials | - "incorporates the same or very similar materials." (Titanium locking plates, titanium locking/non-locking screws; Commercially pure titanium, Grade 4 for plates; Titanium alloy conforming to ASTM F136 for screws) | |
| - Similar packaging and sterilization methods | - "has similar packaging and is sterilized using the same materials and processes." | |
| - No new issues of safety or efficacy due to technological differences | - "Any differences in the technological characteristics do not raise new issues of safety or efficacy." | |
| Material Conformance | - Plates conform to ASTM F67 | - "APTUS Foot 3.5 System plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67." |
| - Screws conform to ASTM F136 | - "APTUS TriLock and cortical screws are made of titanium alloy conforming to ASTM F136." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a test set in the context of evaluating an AI or diagnostic device. The "performance data" mentioned refers to engineering tests and dimensional analyses used to demonstrate physical and functional equivalence to predicate devices, not clinical data from a "test set" of patients or images.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This information is not relevant to a medical device submission focused on substantial equivalence through material and design comparison, rather than diagnostic performance assessed against a ground truth.
4. Adjudication Method for the Test Set:
Not applicable. There is no described "test set" or diagnostic evaluation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The product is a bone fixation system (plates and screws), not an AI algorithm or a diagnostic tool that would be evaluated in an MRMC study.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
Not applicable in the context of a diagnostic or AI device. The "ground truth" for this device's performance would be its mechanical properties, biocompatibility, and ability to fulfill its intended function (fracture fixation), which are assessed through engineering tests and material standards, not against clinical ground truth data like pathology or outcomes for diagnostic accuracy.
8. Sample Size for the Training Set:
Not applicable. The APTUS® Foot 3.5 System is a manufactured medical implant, not an AI or machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established:
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.