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The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE.

The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges).

The 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 fractures.

Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

The KENS INTERNAL FIXATION SYSTEM consists of NON-STERILE plate, screw, pins, wires and DHS/DCS plate systems. The plates are devices, which are fastened by screws to bone for the purpose of providing fixation. According functional differences, plates are gathered in four kinds: Dynamic Compression Plate (DCP), tubular, special and DHS/DCS. The shape of the plate is designed to an adaptation of the local bone anatomy and doesn't denote any particular function. KENS plates are divided as the following:

KENS screws & plates are grouped in 3 subsystems: mini fragment, small fragment and basic (also known as large fragment). The size range of plates are in thickness from 1.0 to 6.0mm, width from 3.8 to 17mm, length 17 to 370mm. and hole number from 2 to 22 holes. The size ranges of screw are in thread diameter from 1.5 to 7.0 mm. total length from 6 to 180mm. In which the screws are differentiated in 5 main kinds of: cortex, cancellous, malleolar, shaft and cannulated screws.

The DHS/ DCS plate system consists of DHS/DCS Plate, Lag Screw, DHS/DCS Compression Screw and 4.5mm Cortex Screw. 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 Screw can also be used to fix the DHS/DCS Plate to the femoral shaft. The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter from 12.5 to 14mm.

The DHS/DCS Compression Screw with buttress thread, length 26mm and outer diameter 4.0mm, can be used to achieve fracture compression.

Pins and wires are divided into groups of:

• . Kirschner wires are in length from 100 to 300mm and range in diameter is under 3.0mm and are available with trocar or diamond tip.
• Steinmann pin are in diameter 2.0~5.0mm and range in length from 125 to 300mm and are available with trocar or diamond tip.
• . Schanz pins are supplied in diameter 1.25 ~6.0 and range in length from 80mm to 300mm.
• Knowles pins are with square and hexagonal drive, a break off length ranges from 63.5 to 152.4mm, and a thread diameter 4.0 & 4.8mm.

The provided text describes a medical device called the "KENS INTERNAL FIXATION SYSTEM" and its 510(k) submission. However, it does not contain any information about acceptance criteria, specific performance studies, or clinical trial data that would typically be used to demonstrate a device meets acceptance criteria.

The document primarily focuses on:

• Device Description: What the device is made of, its components (plates, screws, pins, wires, DHS/DCS system), and their dimensions.
• Intended Use: The types of fractures and bones the device is designed to fix.
• Substantial Equivalence: A statement that the device is substantially equivalent to a predicate device (INTAI bone plates and bone screw system & INTAI DHS/DCS plate system - K063020) based on similar intended use, performance characteristics, materials, design, and manufacturing processes.
• Regulatory Information: Classification, product codes, and the FDA's clearance letter.

The "Performance Data" section explicitly states: "Instruction for Use and Labeling were given to understand the safety purposed all these instruction for use prior to clinical use and the results of laboratory (nonclinical) performance testing demonstrate that the devices are safe and effective."

This statement indicates that nonclinical (i.e., bench or in-vitro) performance testing was conducted, but it does not provide any specific criteria, results, sample sizes, or details about these tests. In the context of a 510(k) submission for a Class II device like this, the primary demonstration of safety and effectiveness often relies on substantial equivalence to a predicate device, supported by non-clinical testing to ensure the device meets established engineering and material standards for such implants. Clinical studies with human subjects are typically not required for 510(k) clearance if substantial equivalence can be demonstrated through other means.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information is absent from the provided 510(k) summary. For devices of this nature, performance is typically confirmed by adherence to recognized ASTM or ISO standards for mechanical properties (e.g., fatigue strength, torsional strength, bending strength), biocompatibility testing, and sterility validation, rather than through clinical studies where "ground truth" or "expert consensus" on imaging or diagnostic performance would be relevant.

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