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Pangea Platform:
The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures
  The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures

Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures

Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:

• Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• Non-unions, malunions, and deformities
• Periprosthetic fractures

This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System, and Pangea Tibia Plating System. This line extension consists of Class II instruments intended to assist in targeting.

The provided text describes a 510(k) premarket notification for the Stryker Pangea Platform and related plating systems. This document outlines the regulatory review and clearance of a medical device based on substantial equivalence to a predicate device, rather than a study demonstrating the device meets acceptance criteria through its own performance evaluation.

Specifically, the text states for "Performance Data":

• Non-Clinical Performance: "The new subject devices... are reusable and provided non-sterile. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. Testing was performed on the subject devices to verify that the T20 and T15 targeting construct can withstand typical physical loads during its use using functional aging. A biocompatibility safety evaluation was performed per ISO 10993-1 to support the verification of biological safety."
• Clinical Performance: "Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices."

The conclusion is that "The subject devices have identical intended use and indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using same materials and processes as the predicate devices. The performance analyses demonstrate that: Any differences do not raise new questions of safety and effectiveness; and The subject devices are at least as safe and effective as the legally marketed predicate devices."

Therefore, the document does not present a study with acceptance criteria and reported device performance in the way typically expected for a new AI/software device or a device requiring new clinical efficacy data. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

Given this, I cannot extract most of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets, as this type of information is not present in the provided 510(k) summary for this particular device submission.

I will, however, attempt to fill in what information can be inferred or directly stated from the text in relation to the non-clinical performance and the basis for clearance.

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

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

• Test Set Sample Size: Not specified in the provided text. The non-clinical testing mentioned "functional aging" but did not specify the number of units or cycles.
• Data Provenance: Not specified. The testing was non-clinical.

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 as no clinical or human-expert-based ground truth was established for this submission. The evaluation was primarily based on engineering and biocompatibility testing, and comparison to predicate devices.

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

• Not applicable for this type of submission.

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. The device described is a metallic bone fixation appliance and accessories, not an AI or imaging diagnostic device that would typically undergo an MRMC study.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this 510(k) clearance is primarily based on compliance with established engineering standards (e.g., for mechanical load and biocompatibility) and the demonstrated "substantial equivalence" to legally marketed predicate devices, which are assumed to be safe and effective.

8. The sample size for the training set

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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The Pangea Utility Plating System is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures
  The Pangea Utility Plating System is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

The Pangea Platform is indicated for the internal fixation of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:

• · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
• · Non-unions, malunions, and deformities
• · Periprosthetic fractures
  The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis and metaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the Pangea Utility Plating System and the Pangea Platform. This submission encompasses multiple systems (Pangea Utility Plating System and Pangea Platform) that have similar intended use and/or will be used together during the surgical procedure. The Pangea Utility Plating System consists of mini-, small-, and large-fragment plates manufactured from Ti6Al4V-ELI per ASTM F136. The plates range in length from 26 mm to 486 mm. The Pangea Platform consists of screws and cable plugs. The screws are offered as locking or non-locking variants. The locking screws are manufactured from CoCr and are available as Ø2.7 mm (L8 mm – 80 mm), Ø3.5 mm (L10 mm – 120mm), Ø4.0 mm (L14 mm – 95 mm), Ø5.0 mm (flat tip) (L10 mm – 20 mm), and Ø5.0 mm (L14 mm – 120 mm). The non-locking screw is manufactured from Titanium alloy (Ti6Al4V-ELI per ASTM F136) and is available in Ø2.7 mm (L6 mm – 80 mm). The cable plugs are made of Titanium alloy (Ti6Al4V-ELI per ASTM F136), and the T15 and T20 cable plugs are available for the 3.5mm locking mechanism. The Cancellous screws are available as Ø4.0 mm fully and partially threaded (L10-100 mm) and Ø6 mm 16mm thread (L30 -150 mm), Ø6 mm 32mm thread (L45 -150 mm) and fully threaded (L20-150 mm).

The provided document is a 510(k) summary for the Stryker GmbH Pangea Utility Plating System and Pangea Platform. It is a regulatory submission for medical devices (bone fixation systems) and does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot extract the information required to describe the acceptance criteria and the study proving an AI/ML device meets them, as the document pertains to physical orthopedic implants, not software or AI.

The bulleted list in your request (acceptance criteria, sample size, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training ground truth establishment) is highly relevant for evaluating AI/ML medical devices, but this document does not contain such details. It focuses on the mechanical and material equivalence of the Pangea systems to previously cleared predicate devices.

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