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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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AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults.

The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

The AFFINITY - Variable Angle Distal Radius System is contains a set of titanium plates and screws that are intended to be end-user sterilized. The AFFINITY - Variable Angle Distal Radius System plates are provided in different configurations and are intended to be used in combination with the variable angle drilling guide and the Styloid hole variable angle drill guide to provide the necessary angulation for optimal screw positioning. The system includes Extra-articular plates (intermediate, wide, and narrow), Distal dorso-ulnar and dorso-radial L-plates, Distal ulnar T-plates, and straight Radius styloid plates.

This is a medical device 510(k) summary, not a study of an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not applicable.

The document describes the AFFINITY - Variable Angle Distal Radius System, which is a set of titanium plates and screws for fixing fractures and osteotomies of the distal radius. This is a traditional medical device, not an AI/ML product.

Instead of clinical performance, the summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the non-clinical testing performed, presented in a table format, though it's important to note this does not align with the AI/ML-specific request for acceptance criteria and device performance:

• Annex 1 Static Bend Testing
• Annex 2 Fatigue Bend Testing | Substantial equivalence to predicate device |
  | Mechanical Testing of Screws:
  ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws)
• Annex 1 Torsional Properties
• Annex 2 Driving Torque
• Annex 3 Axial Pullout | Substantial equivalence to predicate device |
  | Biocompatibility Testing:
• ISO 10993-5: Tests for in-vitro cytotoxicity
• ISO 10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials.
• XPS investigation for film-forming contaminations
• Detection and Quantification of Bacterial Endotoxins | - no cytotoxic effect
• chemical characterization as per the report
• appropriate surface cleanliness
• no risk of bacterial pyrogenicity |
  | Sterilization Testing:
  Validating steam sterilization method according to ISO 11737-2:2009, ISO 17665-1:2006, ISO 14161:2009. | The results of the validating steam sterilization method show that the implants, accessories, and models can be sterilized to a SAL of 10-6 using the recommended steam sterilization instructions |

Regarding the specific points requested for an AI/ML device:

1. A table of acceptance criteria and the reported device performance: Provided above for non-clinical testing, but not for AI/ML performance.
2. Sample size used for the test set and the data provenance: Not applicable as there is no test set for an AI/ML algorithm. The "test set" for this device refers to physical samples used in mechanical and biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
7. The type of ground truth used: Not applicable. The "ground truth" for this device is established by international standards for material properties, mechanical strength, and biocompatibility.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional mechanical medical device, not an AI/ML product. The evaluation criteria are based on established engineering and biological standards for such devices, demonstrating substantial equivalence to a predicate device rather than AI/ML performance metrics.

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