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The aap Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications.

• minimally invasive reconstruction of fractures and joints
• adjuvant for osteosynthesis in complex joint fractures
• multifragment joint fractures
• fractures of the femoral head and neck
• supracondylar femoral fractures
• tibial plateau fractures
• simple metaphyseal fractures
• simple epiphyseal fractures such as:
• fractures of the humeral head
• fractures of the tibial plateau
• pilon fractures
• fractures of the radius
• fractures of the wrist, ankle, elbow, and shoulder
• scaphoid fracture and other fractures of the hand
• metatarsal fractures and other fractures of the foot
• ligament fixation at the proximal humerus
• acetabular fractures
• fractures of the posterior pelvic ring
• condylar fractures
• epiphyseal and metaphyseal fractures in children
• ligament avulsion injuries
• fractures of small joints, such as:
• ankle fractures
• navicular fractures
• calcaneal and talar fractures
• arthrodesis of the ankle
• avulsion fractures and fractures of metatarsal V
• tarsal fractures

The app Cannulated Screws are manufactured from Titanium Alloy conforming to ASTM F136 or ISO 5832-3 and Stainless Steel conforming to ASTM F138 or ISO 5832-1. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.

This 510(k) premarket notification for the aap Cannulated Screws 2.7-7.5 is for a line extension of previously cleared devices (K021233 and K080101). As such, it does not involve the type of clinical study typically associated with an AI/ML medical device. Instead, the "study" for this device is a demonstration of substantial equivalence through mechanical testing and comparison to predicate devices.

Here's the breakdown based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this traditional medical device submission revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices in terms of material, design, mechanical performance, and indications for use.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of an AI/ML device. For this submission, "test set" refers to the specific new screw sizes and materials that underwent mechanical testing. The document does not specify the exact number of new screws or configurations tested, but it refers to "those screws for which no test reports have been provided with the predicate device submissions."
• Data Provenance: The mechanical testing data would have been generated in a laboratory setting, likely in Germany (based on the applicant's location). This would be prospective testing conducted specifically for this submission. The "data" also includes the specifications and performance of the predicate devices.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. For this type of device, ground truth is established through material standards (ASTM, ISO), established design principles for orthopaedic implants, and mechanical testing protocols. There isn't a need for expert consensus on a 'ground truth' in the same way as evaluating diagnostic image interpretation.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The "adjudication" is achieved through compliance with established mechanical testing standards (ASTM F543) and comparison to the performance of predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is not an AI/ML device, so an MRMC comparative effectiveness study is not relevant or performed.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of AI is not applicable. The equivalent here would be the physical device's mechanical performance, which was evaluated through testing.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device is based on engineering standards, material specifications, and the established safety and effectiveness of predicate devices. Specifically:
  • Material Standards: ASTM F136, ISO 5832-3 (Titanium Alloy), ASTM F138, ISO 5832-1 (Stainless Steel).
  • Mechanical Testing Standards: ASTM F543.
  • Predicate Device Performance: The previously cleared aap Small and Large Cannulated Screw System (K021233) and aap Cannulated Screws (K080101) serve as the established benchmark for safety and effectiveness.

8. Sample Size for Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device, so there is no "training set."

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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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.

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.

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