(137 days)
The Speed Shift™ is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
The Speed Shift™ is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is then transformed by ambient and body heat after insertion, and contracts to a "closed" austenitic state. The implants do not require any external heating; they are completely transformed by body heat. This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.
The provided documentation describes the Speed Shift™ device, a nitinol implant for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The submission focuses on demonstrating substantial equivalence to predicate devices (BME OSStaple™ and OSStaple™ Chill) through comparison of technological characteristics and performance bench testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the traditional sense of specific numerical thresholds for performance. Instead, the performance studies aim to demonstrate that the Speed Shift™ is equivalent or superior to the predicate devices in key mechanical properties. The acceptance is implicitly based on achieving this equivalence or superiority.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Speed Shift™) |
|---|---|---|
| Pull-out Strength | Higher than or equivalent to predicate OSStaple™ | Higher pull-out resistance than the predicate OSStaple™ |
| Bending Strength | Greater than or equivalent to predicate OSStaple™ | Greater bending strength when compared to the predicate OSStaple™ |
| Corrosion Resistance | Equivalent to predicate OSStaple Chill™ | Equivalent corrosion resistance to the predicate OSStaple Chill™ |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states that "Specimens of the largest and smallest sizes of the Speed Shift™ were used and compared to a comparably sized predicate OSStaple™" for pull-out and bending strength tests. For corrosion resistance, "representative samples of the new Speed Shift™" were compared to the predicate. The exact number of samples (n-value) for each test is not specified.
- Data Provenance: The studies are described as "Performance Bench Testing." This indicates the data was generated in a laboratory setting, likely in the US, by the manufacturer (BioMedical Enterprises, Inc.). It is retrospective in the sense that the device had already been designed and manufactured, and then tested for comparison. It is not clinical data from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable to the provided information. The "ground truth" here refers to the actual mechanical properties, which are measured using well-established ASTM standards, not subjective expert assessment. No experts were used to establish ground truth for this type of bench testing.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation to resolve discrepancies between human readers or between human readers and an AI. In mechanical bench testing, the results are quantitative measurements, not subject to human adjudication in the same way.
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:
This question is not applicable. The Speed Shift™ is a physical medical implant (a bone staple), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable. As explained above, the Speed Shift™ is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
The ground truth used for these performance studies is physical measurement against established industry standards.
- For pull-out strength and bending strength: ASTM F564-10 (2010)
- For corrosion resistance: ASTM F2129-08
These standards define methods for objectively measuring the mechanical properties of bone fixation devices.
8. The Sample Size for the Training Set:
This question is not applicable. The Speed Shift™ is a manufactured device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The device undergoes design, manufacturing, and then testing.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable, as there is no "training set" for a physical medical 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.