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Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).

Microware DHS/DCS Plate System is provided non-sterile. Microware DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fracture.

The Bone Plates and Bone Screws system & DHS/DCS Plate System consist of non-sterile bone plate and bone screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. They are principally differentiated by their function. Thus there are five kinds of styles: dynamic compression plate (DCP), tubular, special, mini and dynamic hip screw/dynamic condylar screw (DHS/DCS). The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. Every plate is divided various types as following:

The series in size of Microware bone screws and bone plates except DHS/DCS are divided into mini, small and large. The range of plates in thickness are from 1.0 to 6.0 mm, width from 3.8 to 17 mm, length from 17 to 359 mm, and hole number from 2 to 22 holes.

On the other hand, the screws used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. Thus there are four kinds of style: cortex, cancellous, malleolar, and cannulated. All screws have a hexagonal recess; this feature has proven itself to be of great advantage at the time of the screw removal and insertion. The range of screws in thread is diameter from 1.5 to 7.3 mm, total length from 6 to 150 mm.

The DHS/DCS Plate System consists of DHS/DCS plate, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5mm Cortex Screw (self-tapping). The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95', 135 , 140', 145', and 150'. The self-tapping 4.5mm Cortex Serew can be used to fix the DHS/DCS Plate to the femoral shaft.

The DHS/DCS Screw is available in total length from 50 to 145mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter 12.5 to 14mm. The thread of DHS/DCS screw has a buttress type.

The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26mm and outer diameter 4.0mm.

The provided text describes a 510(k) submission for bone plates and bone screws. A 510(k) submission is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not typically a study that proves a device meets specific performance acceptance criteria in the way a clinical trial or a novel technology validation would.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) are not applicable in the context of this 510(k) submission for bone plates and bone screws.

Here's why and how the document addresses substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. This submission is not about performance against specific acceptance criteria for a new or novel device's function (e.g., diagnostic accuracy, treatment efficacy). Instead, it's about demonstrating that the proposed device is "substantially equivalent" to predicate devices already on the market.
• The document states: "A comparison between the proposed device and the predicate device has shown that three devices are very similar or identical in terms of indication for use, material, followed performance and standard and sterilization, and no significant difference between the proposed and predicate devices has been found." This statement is the "reported device performance" in the context of a 510(k) – it performs similarly to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. No test set or human/animal data is mentioned for performance evaluation. The substantial equivalence is based on comparison of specifications and materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. No ground truth establishment for a test set is part of this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No adjudication method is relevant here.

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:

• Not Applicable. This is a submission for medical implants (bone plates and screws), not an AI/software device. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. Not an algorithm/AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. No ground truth for an evaluation dataset is created. The "truth" in a 510(k) is the established safety and efficacy of the predicate device, to which the new device is compared.

8. The sample size for the training set:

• Not Applicable. No training set for an algorithm is involved.

9. How the ground truth for the training set was established:

• Not Applicable. No training set or ground truth establishment is involved.

Summary of the 510(k) Submission's Approach:

The Microware Bone Plates and Bone Screws & Microware DHS/DCS Plate System received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices:

• Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495)
• Syntec-Taichung Non-sterile DHS/DCS Plate System (K983873)
• INTAI Bone Plate and Bone Screw System & INTAI DHS/DCS Plate System (K063020)

The key findings for substantial equivalence were:

• Indication for use: "very similar or identical"
• Material: "very similar or identical" (316L stainless steel meeting ASTM F138 and ASTM F139, and titanium alloy (Ti-6Al-4V) meeting ASTM F136).
• Performance and standard: "followed performance and standard" – implying compliance with relevant engineering standards applicable to such implants.
• Sterilization: "very similar or identical" (provided non-sterile).

The essence of a 510(k) is not to prove that a device meets independently defined acceptance criteria through a specific study, but rather to show that it is as safe and effective as a legally marketed device and does not raise new questions of safety and effectiveness. This is done through direct comparison of indications for use, technological characteristics (materials, design, function), and any relevant performance testing (often mechanical, biocompatibility, etc.) that demonstrates equivalence to the predicate. The document implies such testing was done ("followed performance and standard") but does not detail it with acceptance criteria tables or study specifics in this summary.

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