(100 days)
The indications for the Emerge Medical Bone Plate System are as follows for the four subsystems:
The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomics, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.
The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations of small bones and bone fragments including tarsals, metatarsals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone.
The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomics, non-unions, deformations, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones.
The Emerge Medical Modular Foot System is intended for fixation of fractures, ostcotomics, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.
The Emerge Medical Bone Plate System consists of stainless steel and titanium components including locking plates, cortex screws, cancellous screws, and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.
The provided document is a 510(k) summary for a medical device called the "Emerge Medical Bone Plate System." This type of summary describes the device and its intended use, but does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found for software or AI-driven medical devices.
Instead, for implantable hardware like bone plates, the "study" referred to here is a series of non-clinical mechanical performance tests. The acceptance criteria for such devices are generally established by demonstrating "substantial equivalence" to predicate devices through these mechanical tests, rather than clinical performance metrics like sensitivity or specificity.
Therefore, many of the requested points are not applicable or cannot be answered from the provided text.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | Dynamic four-point bending (per ASTM F382-99) | Demonstrated strength sufficient for intended use and substantial equivalence to predicate devices. | Strength sufficient for its intended use and substantially equivalent to legally marketed predicate devices. |
| Mechanical Strength | Static torsion testing (per ASTM F543-13) | Demonstrated strength sufficient for intended use and substantial equivalence to predicate devices. | Strength sufficient for its intended use and substantially equivalent to legally marketed predicate devices. |
| Mechanical Strength | Static axial pullout (per ASTM F543-13) | Demonstrated strength sufficient for intended use and substantial equivalence to predicate devices. | Strength sufficient for its intended use and substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided text. Mechanical tests typically use a certain number of samples, but the exact count is not disclosed here.
- Data provenance: Not applicable in the context of device performance in a clinical setting. The tests are non-clinical, likely performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For mechanical testing of orthopaedic implants, "ground truth" is established by the engineering standards themselves (e.g., ASTM F382, ASTM F543) and the measured physical properties of the device, not by expert interpretation.
4. Adjudication method for the test set
- Not Applicable. No adjudication method is described as the "test set" refers to mechanical test results against engineering standards.
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
- No. This type of study is not relevant for a mechanical bone plate system. MRMC studies are typically for diagnostic or screening devices evaluated by human readers (e.g., radiologists) with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm or AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this device's performance is based on established engineering standards and physical measurements of mechanical properties. The "acceptance" is that these measurements demonstrate the device's strength is sufficient for its intended use and substantially equivalent to predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth for this mechanical 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.