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The device is intended to fix periprosthetic fractures of the proximal femur and the humerus in a stable position to allow healing. The plamp plate with trochanteric hook is intended to fix nonunions of the trochanter in a stable position to allow healing.

The plamp is a mechanical combination of a bone plate and a bone clamp. The clamps connect to the plate via the screws and the bone is held between the plate and the clamps. Both the plate and the clamps have small spikes to fix the components to the bone. For periprosthetic fractures, additional fixation is achieved through the use of cortical bone screws that pass through the plamp plate.

The provided document, a 510(k) Summary for the "HSS PLAMP" (K942032), describes a medical device, its intended use, and a comparison to predicate devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the way that a modern AI/ML device submission would.

Instead, the document focuses on:

• Device identification: Trade names, common name, classification name.
• Intended Use: Fixing periprosthetic fractures of the proximal femur and humerus, and nonunions of the trochanter.
• Device Description: A mechanical combination of a bone plate and bone clamp with spikes, affixed by screws.
• Substantial Equivalence Claim: Compared to the Dall-Miles Trochanteric Cable Grip System and Broad Bone Plate (Howmedica).
• Performance Data (limited): A pre-clinical animal model study comparing a "clamp-like device" to standard bone plates and intramedullary rods, showing superior torsional strength and energy to failure.

Given the document, I cannot fulfill the request for information tailored to AI/ML device studies because the provided text describes a mechanical orthopedic device submission from 1996 and does not contain the specific types of performance data, acceptance criteria, or study methodologies requested.

Therefore, I cannot populate the table or provide details on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. This information is simply not present in the provided 510(k) summary for the HSS PLAMP device.

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