(97 days)
The Speed XLTM is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
The Speed XLTM is for use in fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The implant is designed so that it is delivered to the operating room in an "open" martensitic state. The implant is then transformed by room temperature after insertion, and contracts to a "closed" austenitic state. The implant does not require any external heating; it is completely transformed by room temperature. This configuration change for the Speed XL™ consists of a change in device shape, including flattened bridge with wider dimension to be used in hand and foot procedures.
This document describes the Speed XLTM bone staple and its substantial equivalence to a predicate device, the Speed ShiftTM.
Here's an analysis of the provided text based on your request:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the approach taken for the Speed XLTM is based on demonstrating "substantial equivalence" to a legally marketed predicate device (Speed ShiftTM) through performance bench testing. The reported device performance is measured against this predicate.
| Test Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ASTM F564-10 (Pull-out) | Substantially equivalent pull-out resistance to predicate (Speed Shift™) | "The results for the Speed XLTM yielded substantially equivalent pull-out resistance than the comparable predicate Speed Shift™ for similar sizes." (TR-02-129-1316) |
| ASTM F564-10 (Bending) | Substantially equivalent bending stiffness to predicate (Speed Shift™) | "The Speed XLTM devices yielded substantially equivalent bending stiffness when compared to the Speed Shift™ predicates." (TR-01-129-1315) |
| ASTM F2129-08 (Corrosion) | Equivalent corrosion resistance to predicate (Speed Shift™) | "Test results demonstrate the corrosion resistance is equivalent to the predicate Speed Shift™." (FWM # 13-08-30946, FWM # 13-08-31279, & FWM # 13-10-31866) |
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- For the pull-out strength test (ASTM F564-10), "Two lots with three samples each (n=3)" were compared for the Speed XLTM to the predicate. This refers to 3 samples for each of the two different lots of Speed XLTM, compared against similarly sized Speed ShiftTM predicates.
- For the bending strength test (ASTM F564-10), "The largest and smallest Speed XL™ sizes were tested" and compared to similar Speed Shift™ predicates. The exact number of samples for each size isn't specified, but it's likely a small number similar to the pull-out test based on the context of bench testing for substantial equivalence.
- For corrosion resistance (ASTM F2129-08), "representative samples of the new Speed XLIM" were compared to the predicate. The exact number of samples isn't specified.
- Data Provenance: The data is from "Performance Bench Testing" conducted by the manufacturer (BioMedical Enterprises, Inc.). This is prospective testing specifically for the 510(k) submission. The country of origin is implicitly the USA, where the submitting company is based and where the FDA approval process occurred.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission is for a medical device (bone staple) and relies on objective, repeatable physical and mechanical bench testing according to established ASTM standards, not on expert interpretation of data or images to establish ground truth.
4. Adjudication Method for Test Set
Not applicable. As this is bench testing of a physical device, there is no expert adjudication of results in the traditional sense. The results are obtained from standardized laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human readers interpret medical images or data. The Speed XLTM is a bone staple, a physical implant.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is not an algorithm or AI device.
7. Type of Ground Truth Used
The ground truth for the performance tests (pull-out strength, bending stiffness, corrosion resistance) is based on objective, quantifiable measurements obtained through standardized ASTM (American Society for Testing and Materials) test protocols. These standards define the methods for measuring these properties.
8. Sample Size for Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are likely informed by engineering principles and previous device designs, but not in a "training set" manner.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set mentioned or implied for this physical 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.