(235 days)
The agp Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aqp's washers may be used with the screws in certain applications.
Minimally invasive fracture / joint reconstructions .
Additive osteosynthesis for complex joint fractures ●
Multiple- fragment joint fractures .
Femoral neck and femoral head fractures .
Femoral supracondylar fractures ●
Tibial plateau fractures ●
Simple metaphyseal fractures
Simple epiphyseal fractures
Fractures of the head of the humerus o
Fractures of the head of the tibia O
Cooper fractures of the tibia o
Fractures of the radius O
Fractures of the wrist, ankle, elbow and shoulder
Scaphoid fractures and other fractures of the hand ●
Metatarsal fractures and other fractures of the foot ●
Ligament fixation of the proximal humerus ●
Fractures of the acetabulum ●
Fractures of the dorsal pelvic rinq ●
. Condylar fractures
Peadiatric epiphyseal and metaphyseal fractures .
Ligament avulsion injuries (Apohysis) .
Fractures of small ioint bones .
o Malleolar fractures
Navicular fractures o
Fractures of the calcaneus and talus
Arthrodesis of the ankle joint .
Avulsion fracture and metatarsl V
Fractures of the tarsal region
The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti Al6 V4 E.L.) and 316 L Stainless Steel. The agp Small and Large Cannulated Screws are available in various length and various thread diameters.
This document is a 510(k) summary for a medical device called the "aap Small and Large Cannulated Screw System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously approved devices. Therefore, it describes the device's characteristics and its proposed intended use, but it does NOT contain a study proving the device meets specific acceptance criteria as would be found in a performance study for a novel device.
Instead, the submission for this type of device (a Class II orthopedic implant) focuses on demonstrating that it is "substantially equivalent" to existing, legally marketed predicate devices. This involves comparing material composition, intended use, and technological characteristics to show that it raises no new questions of safety or effectiveness.
Because this is a 510(k) submission for substantial equivalence rather than a performance study with acceptance criteria, most of the requested information (sample sizes, ground truth, expert adjudication, MRMC studies) is not applicable or present in this type of document.
Here's how to address the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria for performance as would be seen in a clinical trial or a novel device's validation study. Instead, the "performance" here is demonstrating substantial equivalence to predicate devices, primarily through material composition and similarity in intended use.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Material Composition Equivalence: Manufactured from materials identical or equivalent to predicate devices. | The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), and 316L Stainless Steel (ASTM F 138). |
| Comparison: "The aap Small and Large Cannulated Screws are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." | |
| Intended Use Equivalence: Indications for use are the same as or within the scope of predicate devices. | "The aap Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation." (Followed by a long list of specific fracture types). |
| Comparison: This set of indications is implicitly equivalent to the combined indications of the cited predicate devices. | |
| Technological Characteristics Equivalence: Design features are similar or present no new safety/effectiveness concerns compared to predicate devices. | "The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti Al6 V4 E.L.) and 316 L Stainless Steel. The aap Small and Large Cannulated Screws are available in various lengths and various thread diameters." |
| Comparison: "The aap Small and Large Cannulated Screws are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." | |
| Manufacturing/Quality Standards: Compliance with relevant industry and regulatory standards. | "Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001." |
| Sterilization: Clear and acceptable sterilization methods. | "The devices are distributed in non sterile, recommendations for sterilization are contained in package insert. Note: These devices are sterilised by end users utilizing the approved/outlined guidelines found in the AAMI Guideline 'Good Hospital Practice: Steam Sterilisation and Sterility Assurance' and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level (SAL)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a submission for substantial equivalence based on product design, materials, and intended use comparison, not a study involving a test set of data. There are no patient samples or data provenance mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the context of clinical data or AI performance studies is not relevant to this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study assessing reader performance with or without AI. This is a submission for a cannulated screw system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive implant (screw system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" for clinical or AI performance is not relevant to this 510(k) submission for a physical medical device. The "truth" for substantial equivalence is based on the documented characteristics of the predicate devices.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI or data-driven device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.