(779 days)
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No
The device description and performance studies focus on mechanical fixation and do not mention any AI/ML components or functions.
Yes
The device is intended to fix fractures in a stable position to allow healing, indicating it is used for treatment and promotes healing.
No
The device is described as a mechanical combination of a bone plate and a bone clamp intended to fix fractures and nonunions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical, mechanical implant (bone plate and bone clamp) with hardware components (screws, spikes). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a mechanical combination of a bone plate and bone clamp intended to fix fractures in the proximal femur and humerus. This is a surgical implant used directly on the patient's bone.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
The device described is a surgical orthopedic implant.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
proximal femur and the humerus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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.