(117 days)
The Emerge Medical Solid Bone Screws are intended to provide bone fixation in the management of osteotomies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers.
The Emerge Medical Bone Fixation screws consist of cancellous, cortical and shaft screws with washers, as needed, in a variety of sizes to accommodate differing anatomic requirements. The screws are provided non-sterile.
This 510(k) submission (K122489) is for Emerge Medical Solid Bone Screws, which are bone fixation devices. The information provided heavily emphasizes the substantial equivalence of the device to its predicates rather than detailed performance metrics that would typically be associated with software or AI-driven devices. Therefore, the questions related to AI/software performance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and stand-alone performance are not applicable in this context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Device performs as well as or better than the predicate devices in static tests. | "Static tests performed according to ASTM 543 demonstrated that the device performs as well as or better than the predicate devices. Testing included screw variations in material, diameters, lengths, partial versus full threads, and drive types." |
| Material composition meets specified standards. | Titanium alloy (ASTM F136) and Stainless steel (ASTM F138). (This is an inherent characteristic that also serves as an acceptance criterion for material compliance). |
| Intended use, materials, general design, and sizes are equivalent to predicate devices. | "The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are the equivalent the predicate devices." (This is a statement of equivalence, which implies meeting the acceptance criteria for similarity to established devices). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of samples in the traditional sense for algorithm testing. The testing was physical, involving "screw variations in material, diameters, lengths, partial versus full threads, and drive types." The number of individual screws tested for each variation is not provided.
- Data Provenance: Not applicable in the context of clinical data for this device. The testing was conducted in vitro (static tests) and not on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This submission pertains to a physical bone fixation screw, not a device requiring expert interpretation of medical images or data to establish ground truth for a test set. The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM 543).
4. Adjudication Method for the Test Set
- Not Applicable. As the “ground truth” is based on objective mechanical testing against a standard (ASTM 543), there is no need for expert adjudication in the classic sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance
- Not Applicable. This is a physical medical device (bone screw), not an AI/software device. No human readers or AI assistance are involved in its primary function or testing as described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- Mechanical Testing Standards: The ground truth for performance relied on established engineering and material standards, specifically ASTM F543 ("Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications" or similar, applied to the performance of bone screws). The "ground truth" is that the device must meet or exceed the mechanical performance characteristics (e.g., torsion, bending, fatigue strength) demonstrated by the predicate devices or specified by the ASTM standard.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/software device. There is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable.
Summary of the Study Proving Acceptance Criteria:
The study involved static mechanical tests performed according to ASTM F543. These tests were conducted on various configurations of the Emerge Medical Solid Bone Screws, including variations in material (Titanium alloy ASTM F136; Stainless steel ASTM F138), diameters, lengths, partial versus full threads, and drive types. The results of these tests demonstrated that the device "performs as well as or better than the predicate devices" (Synthes K112583 and K061621) against the established mechanical performance standards.
The acceptance criteria centered on demonstrating substantial equivalence to predicate devices in:
- Technological characteristics (intended use, material, general design, sizes).
- Mechanical performance as measured by static tests.
The submission explicitly states, "Clinical data were not needed to demonstrate substantial equivalence for these devices," which is typical for Class II devices like bone screws when robust mechanical equivalence to established predicates can be shown through in vitro testing.
§ 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.