(71 days)
The agp Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. app'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
- Fractures of the head of the tibia
- Cooper fractures of the tibia
- Fractures of the radius
- 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 ring
- Condylar fractures
- Peadiatric epiphyseal and metaphyseal fractures
- Ligament avulsion injuries (Apohysis)
- Fractures of small joint bones
- Malleolar fractures
- Navicular fractures
- Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint
- Avulsion fracture and metatarsl V
- Fractures of the tarsal region
The aup Cannulated Screws and Washers are manufactured from Titanium Alloy conforming to ASTM F136 or ISO 5832-3. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.
This document is a 510(k) summary for a medical device called "aap Cannulated Screws." It does not contain information about acceptance criteria or a study proving device performance in the way typically found in AI/machine learning medical device submissions.
Instead, this is a premarket notification for a traditional medical device (cannulated screws for bone fixation) seeking substantial equivalence to existing predicate devices.
Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance, effect size) are not applicable to this type of submission.
Here's a breakdown of what can be extracted or inferred from the provided text, in relation to your questions:
Acceptance Criteria and Study for aap Cannulated Screws
This submission is a 510(k) premarket notification for a Class II medical device (cannulated screws for bone fixation). The primary method used to demonstrate safety and effectiveness for such devices is Substantial Equivalence (SE) to a legally marketed predicate device, rather than a clinical study with detailed performance metrics and acceptance criteria as seen in AI/ML device submissions.
The "study" in this context refers to the comparison made against predicate devices, materials testing, and design feature analysis to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Implicit for SE) | Reported Device Performance |
|---|---|
| Material Composition | Conforms to ASTM F136 or ISO 5832-3 (Titanium Alloy) |
| Indications for Use (IFU) | Substantially equivalent to previously cleared aap Small and Large Cannulated Screw System ([K021233](https://510k.innolitics.com/search/K021233)) and aap Cannulated Screws and Washers (990776). (See full list in "Indications for Use" section). |
| Design Features | Substantially equivalent to previously cleared predicate devices. Offered in varying overall lengths and thread lengths. |
| Safety | Adequately supported by substantial equivalence information, materials information, and analysis data provided within the Premarket Notification. |
| Effectiveness | Adequately supported by substantial equivalence information, materials information, and analysis data provided within the Premarket Notification. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a study involving a "test set" from a patient population for performance evaluation in the context of AI/ML or comparative clinical trials. The "test" for substantial equivalence involves comparing the device's design, materials, and IFU to predicate devices. The data provenance would be engineering specifications, material standards, and regulatory filings of the predicate devices.
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. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices as determined by FDA clearance, and industry standards for materials and design. No new panel of experts was convened to establish "ground truth" for a novel performance assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication was used.
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 a physical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. It does not contain an algorithm in the sense of AI/ML software.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the documented safety and effectiveness of the legally marketed predicate devices, as determined by previous FDA clearances. This implicitly includes adherence to material standards (ASTM F136, ISO 5832-3) and established biomechanical principles for bone fixation devices.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of device submission.
9. How the ground truth for the training set was established
- Not Applicable. As per #8, no training set was used.
§ 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.