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The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greater than 12 through 21 years of age) where all growth plates within the acetabulum are fused.

The DePuy Synthes 3.5 mm Intrapelvic Acetabular System can be used to treat fractures of the acetabulum involving the anterior column, with or without involvement of the posterior column, including the quadrilateral surface (QS). The subject system is comprised of four plate types per anatomic side, left and right, (Large Extended, Small Extended, Large Standard and Small Standard) which are designed to accept the following existing cortex screws: 3.5 mm Cortex Screws, 3.5 mm Pelvic Cortex Screws, 3.5 mm Cortex Screws with low-profile head, 3.5 mm Stardrive Cortex Screws, and 4.5 mm Cortex Screws. The implants are available in a sterile configuration and are offered in Stainless Steel (SSt). In total the system is comprised of eight different plate designs. Each plate configuration consists of a long, slender suprapectineal portion that is intended to be placed along the anterior column, superior to the pelvic brim and a trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect of the posterior column, overlapping at least a portion of the quadrilateral surface. The suprapectineal portion is divided into anterior and posterior segments that are configured to mimic existing 3.5 mm reconstruction plates and a central segment, to which the quadrilateral surface portion is connected by two connecting bars.

This document is a 510(k) summary for the DePuy Synthes 3.5 mm Intrapelvic Acetabular System, a medical device for bone fixation. It describes the device, its intended use, comparison to predicate devices, and performance data.

Based on the provided document, here's an analysis of the acceptance criteria and study that proves the device meets the criteria:

The provided text describes a medical device (bone fixation appliance) and its regulatory clearance process, not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically have acceptance criteria related to algorithmic performance (e.g., sensitivity, specificity, AUC).

Therefore, I cannot extract the information required for questions 1, 2, 3, 4, 5, 6, 7, 8, and 9 in the context of an AI/SaMD study. The document focuses on the physical and mechanical properties of a metallic implant and its substantial equivalence to previously cleared implants.

Let's break down why the requested information isn't present in this specific document:

• Acceptance Criteria for AI/SaMD: The document does not specify acceptance criteria like sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), or Area Under the Curve (AUC), which are common for AI/SaMD devices. Instead, the acceptance criteria for this structural implant are related to mechanical performance (e.g., strength, durability), biocompatibility, and sterilization.
• Study Proving Device Meets Acceptance Criteria: The "studies" mentioned are non-clinical performance data for a physical implant, not studies involving algorithms, human readers, or ground truth derived from expert consensus on images.

However, I can extract the information that is present in the document related to its non-clinical performance and its comparison to predicate devices, which serve as its "proof" of meeting safety and effectiveness for a traditional device clearance.

Information Extractable from the Provided Document:

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

Since this is a physical medical device (implant) and not a diagnostic AI/SaMD, the "acceptance criteria" are related to mechanical and biocompatibility standards rather than typical AI performance metrics.

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

• Sample Size for Test Set: Not applicable in the context of a "test set" for an AI algorithm. The mechanical and endotoxin tests would have involved a specific number of device samples, but this quantity is not disclosed in the summary.
• Data Provenance: Not applicable in the context of human data or geographical origin for a physical device's mechanical testing. The testing was conducted internally or by a contracted lab to industry standards.

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 is not an AI/diagnostic device where expert 'ground truth' is established for a test set of medical images. The "ground truth" for this device's performance is derived from standardized mechanical and biological testing.

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

• Not applicable. This concept applies to human reader consensus in image interpretation, not to the testing of a physical implant.

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 device is a surgical implant, not an AI-powered diagnostic or assistance tool. No MRMC study was conducted.

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

• Not applicable. This is not an algorithm.

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

• For the non-clinical performance data, the "ground truth" is established by adherence to pre-defined engineering standards, mechanical testing protocols (e.g., ASTM standards), and biological safety limits (e.g., endotoxin limits). It's essentially "physical ground truth" based on material science and biomechanics.

8. The sample size for the training set:

• Not applicable. There is no AI model or "training set" for this physical device.

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

• Not applicable. There is no AI model or "training set" for this physical device.

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