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AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

• · Simple metaphyseal fractures (Classification AO 41-A2)
• · Multifragmentary metaphyseal fractures (Classification AO 41-A3)
• · Simple bicondylar fractures (Classification AO41-C1, 41-C2)
• Multifragmentary bicondylar fractures (Classification AO 41-C3)
• · Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
• · Diaphisary fractures (Classification AO 42A and 42B)

AFFINITY Proximal Tibia System consists of anatomical plates and screws for the placement of the proximal tibial condyles, improving the restoration of the original structure. Similarly, in combination with the variable angle technique, it allows for the placement of screws in different configurations providing appropriate support for the correct healing of fractures.
AFFINITY Proximal Tibia System consists of pre-contoured bone fixation plates and screws. The plates are made from biocompatible commercially pure titanium grade 4 according to ISO 5832-2 and ASTM F67 standard. The screws are made from biocompatible titanium alloy (Ti6Al4V) according to ISO 5832-3 and ASTM F136 standard.
The AFFINITY Proximal Tibia System plates can be fixed with variable angle technique.

The provided text is an FDA 510(k) summary for the AFFINITY Proximal Tibia System. This document describes a medical device (a bone plate and screw system for tibial fractures) and its claim of substantial equivalence to existing predicate devices.

Crucially, the document states that "Clinical testing was not necessary for the substantial equivalence determination." This means that the device's acceptance criteria and the proof it meets them do NOT involve human clinical studies or AI-driven performance metrics such as accuracy, sensitivity, specificity, or human-in-the-loop improvements.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/machine learning performance. The provided text details non-clinical performance testing for a medical implant, focusing on mechanical, biocompatibility, and sterilization aspects.

Here's why I cannot provide the requested information based on the given text:

• No AI or algorithm present: There is no mention of any AI component, algorithm, or software in the device description or its testing.
• No clinical performance data (e.g., accuracy, sensitivity): The document explicitly states "Clinical testing was not necessary." The performance testing described is mechanical (bend, torsion, pullout strength), biocompatibility, and sterilization, which are relevant for physical implants, not AI diagnostic or assistive devices.
• No human reader studies (MRMC): Since no AI is involved, there are no studies assessing how human readers improve with AI assistance.
• No ground truth establishment for diagnostic performance: The "ground truth" mentioned in your prompt (expert consensus, pathology, outcomes data) is typically for validating diagnostic or classification algorithms. For a bone plate, ground truth relates to its mechanical integrity and biological safety, which were assessed through laboratory tests.

In summary, the provided document describes the regulatory approval of a physical medical device (a bone plate and screw system) through established non-clinical testing and comparison to predicates, not the validation of an AI/ML medical device.

If you have a document describing an AI/ML medical device's performance study, I would be happy to analyze it according to your detailed criteria.

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TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.

TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones.

The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit.

Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).

The provided text describes the TECHFIT Patient-Specific Maxillofacial System and its substantial equivalence to predicate devices, focusing on non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions specific non-clinical performance tests and their outcomes.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the numerical sample size for the bending & fatigue testing. It refers to comparing "the subject plates against plates previously cleared in reference device K032442," suggesting a comparative test, but the number of plates tested is not specified.
• Data Provenance: The data provenance is implicitly from laboratory testing ("Mechanical testing was conducted") as part of the regulatory submission by Industrias Medicas Sampedro S.A.S. The geographic origin of this specific testing (e.g., country) is not mentioned. It is non-clinical, ex-vivo data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the document describes non-clinical, mechanical, and biocompatibility testing, not studies requiring expert ground truth for a clinical test set.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical, mechanical, and biocompatibility testing, not studies requiring adjudication for a clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the substantial equivalence determination."

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

This question is not directly applicable in the context of this device. The TECHFIT Patient-Specific Maxillofacial System is a physical implant, not an algorithm. However, the design process involves "virtual planning" with "input from the physician during virtual planning and prior to finalization and production of the device." In this sense, the "device" (the physical implant) is designed with human-in-the-loop involvement, but there isn't an "algorithm only" performance that would typically be evaluated for AI/software devices. The verification involves "virtually fitting the generated implant over a 3D model of the patient's anatomy."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described:

• Bending & Fatigue Testing: The "ground truth" or reference was the performance of plates from the previously cleared reference device K032442, as measured by standard mechanical testing protocols (ASTM F382).
• Biocompatibility: The "ground truth" was compliance with established international standards (ISO 10993-1:2018) and FDA guidance for biological evaluation.
• Sterilization: The "ground truth" was achieving a Sterility Assurance Level (SAL) of 10^-6 according to international standards (ISO 17665-1, ISO 17665-2, and ISO 14937).

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device and its non-clinical testing, not an AI/ML algorithm that would require a "training set" in the conventional sense. The device is manufactured based on patient-specific CT scan data, which informs the design of each individual implant rather than training a general model.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no "training set" in the context of this physical device. The device design relies on patient-specific medical imaging (CT scans) and physician input for virtual planning, not on a generalized training dataset with pre-established ground truth labels.

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