(779 days)
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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Image /page/0/Picture/0 description: The image shows a document titled "510(k) SUMMARY" with the text "HSS PLAMP" underneath. The number "K942032" is circled, and the text "(prepared 4/3/96)" is below the circled number. The document appears to be a summary related to a medical device or product.
JUN 1 3 1996
Submitter:
Bruce H. Robie, Ph.D. Assistant Scientist Department of Biomechanics & Biomaterials Hospital for Special Surgery 535 East 70 Street New York, NY 10021 212.606.1067 (phone) 212.794.4020 (fax)
Plamp, plamp plate, plamp with hook Trade Name(s): Common Name: Bone plate with clamps Classification Name: Plate, Fixation, Bone (per 21 CFR 888.3030)
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. It is substantially equivalent to components of the Dall-Miles Trochanteric Cable Grip System (Howmedica) and the Dall-Miles Broad Bone Plate (Howmedica).
The use of spikes and clamps to hold fractured bones was examined in an animal model comparing the strength of bones fixed using standard bone plates, intramedullary rods and a clamp-like device. This experiment showed that the in vivo performance of the clamp portion of the plamp was superior to the use of plates alone as measured by torsional strength at failure and energy to failure.
§ 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.