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The DePuy ACE A.I.M.® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique fractures, spiral fractures, comminuted fractures, fractures, fractures with bone loss, bone transport, open fractive osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions, metaphyseal fractures and epiphyseal fractures.

The DePuy ACE A.I.M.® Titanium Tibial Nail is an intramedullary fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 11mm, 12mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE A.I.M.º Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5cm. The proximal end of the 10mm, 11mm, 12mm , and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nadiameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws and one 5mm long dynamization slot in the M-L plane. The distal end of the nail contains two 5.0mm holes in the M-L plane which accept 4.5mm solid cortical bone screws and one 5.0mm hole in the A-P plane positioned between the two transverse holes. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.

The DePuy ACE A.I.M. Titanium Tibial Nail is manufactured from Titanium 6A1-4V ELI (ASTM standard F-136).

The new DePuy ACE A.I.M.® Titanium Tibial Nail is the same basic design as the current DePuy ACE A.I.M. Titanium Tibial Nail, with the exceptions of adding a proximal dynamization slot in the M-L plane, which allows 5mm of length to dynamize across fracture site and that the two oblique proximal screw holes are moved more proximal to vield a longer working length for the nail. Also, there is an additional hole in the nail in the A-P plane. This is positioned between the current two distal transverse holes, allowing for oblique locking distally, which is more stable and allows the lagging of anterior fragments of the distal tibia. The additional holes and changes in placement are very similar to that of the Synthes Titanium Cannulated Tibial Nail and the Synthes Titanium Unreamed Tibial Nail.

The provided text describes a medical device, the DePuy ACE A.I.M.® Titanium Tibial Nail, which is an intramedullary rod for fixing tibial fractures. However, this document is a 510(k) summary and not a study report. Therefore, it does not explicitly define acceptance criteria or detail a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is the primary regulatory pathway for this type of device. The "study" mentioned is a biomechanical testing study to compare the new device's strength to a predicate device.

Here's an analysis of the provided information in relation to your request, with the understanding that the nature of the document limits the direct answers to your specific questions about "acceptance criteria" for a cognitive task or "AI performance":

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail metrics in the way one would define for a diagnostic or AI device (e.g., "sensitivity must be >X%", "AUC must be >Y%").
  • Implied Acceptance Criteria (for substantial equivalence): The new device must be "at least as strong or stronger" than the predicate device in biomechanical tests.
• Reported Device Performance:
  • "On all tests, the DePuy Tibial Nail was either at least as strong or stronger than the Synthes Tibial Nail."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document only mentions "Biomechanical testing was done." The number of different tests performed or the number of nails tested is not detailed.
• Data Provenance: Not specified. It's a biomechanical test, likely conducted in a lab environment rather than patient data.

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. This document describes a biomechanical test of physical strength, not a diagnostic or interpretive task that requires expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This relates to expert consensus for ground truth, which is not relevant for a biomechanical strength test.

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

• No. This is a biomechanical study, not a study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. There is no algorithm or AI involved. The "device" is a physical implant. The "standalone performance" metaphorically refers to the intrinsic mechanical properties of the nail itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated in these terms. For biomechanical testing, the "ground truth" would be the objective measurement of mechanical properties (e.g., yield strength, ultimate tensile strength, fatigue life) compared against established engineering standards or the performance of a predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a biomechanical test for substantial equivalence.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set. The "ground truth" for biomechanical properties is derived from established material science and engineering principles and testing methodologies.

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The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.

The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.

Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.

The ACE Humerus Plates and Radius Plates are anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws. The humerus plates will offered in two configurations for both the left side and the right side. The plates are offered in three hole and five hole configurations.

The ACE Radius plates are also offered in a right and left configuration both for volar fixation and dorsal fixation. The plates are offered in a large and a small size.

Here's an analysis of the provided information, focusing on acceptance criteria, study details, and ground truth establishment:

Disclaimer: Based on the provided text, the device is a medical implant (bone plates) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories related to AI performance, ground truth establishment for AI, and MRMC studies are not applicable. I will provide information relevant to the provided text for a physical medical device.

Acceptance Criteria and Device Performance (Based on Physical Device Testing)

Study Details (Applicable to Physical Device Testing)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify the exact number of plates tested. It mentions "Three types of plates (proximal humerus, volar distal radius and dorsal distal radius) were tested," implying at least one sample of each type. It's likely more than one per type were tested for statistical validity, but this is not explicitly stated.
   • Data Provenance: Not explicitly stated. This was a laboratory study conducted by Ace Medical Company or a contracted lab. There is no mention of "clinical data" or "patient data," indicating it was a benchtop mechanistic test.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a physical device's mechanical testing, "ground truth" is typically established by engineering standards and measurement accuracy, not expert consensus.

3. Adjudication method for the test set: Not applicable. This refers to consensus among experts, which is not relevant for benchtop mechanical testing. Results are typically determined by measurement and adherence to predefined engineering specifications or comparison thresholds.

4. 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 study refers to an AI/Software as a Medical Device (SaMD), not a physical orthopedic implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI/Software as a Medical Device (SaMD).

6. The type of ground truth used: For mechanical testing, the "ground truth" is defined by established engineering principles and the performance of predicate devices. The study compared the static bending strength of ACE plates to predicate devices (Synthes and DePuy plates). Therefore, the "ground truth" for performance was the established mechanical properties of these legally marketed, equivalent devices.

7. The sample size for the training set: Not applicable. This refers to an AI/Software as a Medical Device (SaMD). The design and development of physical implants do not typically involve "training sets" in the AI sense.

8. How the ground truth for the training set was established: Not applicable. This refers to an AI/Software as a Medical Device (SaMD).

Summary of Non-Applicable Sections for a Physical Device:

The provided text describes a submission for physical bone plates, not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested items related to AI device performance evaluation, such as:

• Sample size for the training set
• How ground truth for the training set was established
• Number of experts for ground truth
• Adjudication method for experts
• MRMC comparative effectiveness study
• Standalone algorithm performance

...are not applicable to this 510(k) summary. The study described focuses on benchtop mechanical testing to demonstrate substantial equivalence to predicate devices, a standard practice for physical orthopedic implants.

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Ask a specific question about this device