(117 days)
Synthes ALPS is a place and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur.
Synthes ALPS is a place and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur. The ALPS urilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the holes in the plate. The screws are available in thread diameters from 3 mm, in a variery of lengths.
The provided text describes a medical device, the Synthes Anatomical Locking Plate System (ALPS), and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a "Summary of Safety and Effectiveness Information" (K961413) from Synthes, dated July 1996, which is typically a premarket notification (510(k)) submission to the FDA. In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device already on the market, rather than proving a device meets specific quantitative performance acceptance criteria through a clinical study with detailed statistical analysis.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
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Acceptance criteria and reported device performance: Not mentioned. The document states "Based on the results of confidential testing, it is our opinion that the ALPS is substantially equivalent to the devices with which it is being compared." It doesn't specify what criteria were used in that testing or the results of those tests in measurable terms.
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Sample size, test set data provenance: No information on any test set, sample size, or data provenance (country, retrospective/prospective). The "confidential testing" is vaguely referenced.
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Number of experts and qualifications for ground truth: Not applicable, as there's no mention of a study involving expert-established ground truth.
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Adjudication method for test set: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for diagnostic imaging AI devices, not typically for orthopedic implants where the primary comparison is usually mechanical and clinical equivalence.
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Standalone (algorithm only) performance: Not applicable, as the device is a physical orthopedic implant, not an algorithm.
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Type of ground truth used: Not applicable.
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Sample size for training set: Not applicable.
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How ground truth for training set was established: Not applicable.
In summary, the provided document focuses on describing the device and asserting its substantial equivalence to predicate devices, a common approach for 510(k) clearances. It does not provide the detailed study design, acceptance criteria, or performance metrics typically requested for a device with explicit performance claims and associated studies.
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AUG - 7 1996
K961413
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700 Contact: Angela Silvestri July 1996
Device: Synthes Anatomical Locking Plate System (ALPS) compared to Synthes PC-Fix, Condylar Plate 95°, Condylar Buttress Plate, 4.5 mm Cortex Screws, and 6.5 mm Cancellous Screws
Synthes ALPS is a place and screw system intended to treat fractures of various long bones, including the radius, ulna, humerus, tibia, fibula and femur. The ALPS urilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation. The plates are available with and without an anatomically contoured head, in a variety of sizes. The head of the screw has a round cross section with a conical underside to fit into the plate. The underside has a tapered thread to match the holes in the plate. The screws are available in thread diameters from 3 mm, in a variery of lengths.
It is anticipated that the ALPS will be used as follows:
- a) The place is percutaneously inserted through a stab incision at either the distal or proximal end of the bone.
- b) The fracture is reduced and temporary fixation may be applied.
- c) The Insertion Guide is first attached to a screw hole at the head of the plate (the last screw hole on either end of the shaft plate) using the Connecting Screw.
- d) The distal end of the plate is then inserted into the incision first. This end is tapered and rounded to gently lift and separate tissue.
- e) The plate is manipulated using the insertion handle.
- f) Once the plate is in position the ALPS screw can be inserted.
- g) The Insertion Sleeve and Trocar are placed through one of the aiming boles. The trocar perforates the skin and facilitates the sleeve positioning to the corresponding screw hole in the plate. The trocar is removed from the sleeve.
- h) The screwdriver, with a screw attached, is then inserted through the sleeve.
- The screw is inserted into the bone securing the plate. 1)
- After tightening the screw to the plate, the function of the implant and fixation will not be ]) jeopardized if the plate is not flush against the bone.
- k) After the screws are in place the Insertion Guide is removed.
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- An additional screw can be placed in the screw hole that secured the Insertion Guide if necessary.
Synthes Anatomical Locking Plate System will be provided both sterile and non-sterile. The sterile device will be sterilized by gamma radiation. Of course, non sterile devices must be sterilized prior to use; moist heat sterilization is recommended.
Based on the results of confidential testing, it is our opinion that the ALPS is substantially equivalent to the devices with which it is being compared.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.