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The TDM Plate and Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device.

Mini and Mid Locking Plate and Screw System:
The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:
The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Screws (1.5mm and larger, Solid and Cannulated) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Plate and Screw system consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with locking and non-locking screws and non-locking low profile Screws. The Screw are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 1.5mm to 4.0 in diameter and range from 6mm to 100 in length.

The provided text is a 510(k) premarket notification for a medical device (TDM Plate and Screw System). It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does NOT include acceptance criteria for a quantitative performance metric, nor does it describe a study that uses a test set against ground truth with experts and specific adjudication methods.

Instead, the performance data section mentions nonclinical tests and engineering analysis conducted in accordance with ASTM standards (F543-17 and F1264-16) to establish substantial equivalence. These standards are typically for mechanical properties and material compatibility, not for diagnostic or clinical performance against ground truth as would be evaluated for AI/ML-driven devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance with the specific details requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth establishment for training set). This type of information is generally found in submissions for devices that rely on algorithmic performance, often involving image analysis or diagnostic support, which is not the case for this bone fixation system.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot provide. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance in a clinical or diagnostic context. The "Performance Data" section refers to mechanical tests.

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

• Cannot provide. The document describes mechanical tests, not a study involving a test set of data (e.g., images, patient records).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "ground truth" in the clinical or diagnostic sense for this type of mechanical device evaluation. The "ground truth" for mechanical testing would be the physical properties measured in a lab.

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

• Not applicable. No such adjudication method is described as there isn't a test set with expert interpretation.

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, an MRMC study was NOT done. This type of study is relevant for AI/ML diagnostic tools, not for a bone plate and screw system.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable. The "ground truth" for mechanical testing would be direct measurements of physical properties (e.g., ultimate tensile strength, fatigue life), not expert consensus or pathology in a clinical context.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" for this device, as it is not an AI/ML-driven product.

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

• Not applicable. As there is no training set, this question is not relevant.

Summary of available "Performance Data" from the document:

The "Performance Data" section states:
"The following testing was performed in accordance with the ASTM F543-17 and ASTM F1264-16:

• Static 4-Point Bending
• Axial Pullout
• Torsional
  The nonclinical tests and engineering analysis demonstrate that the TDM Plate and Screw Systems is as safe, as effective, and is substantially equivalent to the legally marketed predicate device."

This indicates that mechanical and material performance was evaluated, likely against the thresholds or expectations set by the referenced ASTM standards, which are considered the "acceptance criteria" for this type of device in terms of its physical integrity and performance. The study demonstrating this is the suite of nonclinical tests and engineering analysis performed according to those standards.

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Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.

The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, from 1.5mm to 4.0mm in diameter and range from 6mm to 100mm in lenath.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies related to its AI performance. The document is a 510(k) premarket notification for a medical device called "TDM Plate and Screw Systems," which are metallic bone fixation appliances.

The document discusses:

• The device's trade name, regulation, and product codes.
• Its intended use (internal bone fixation for fractures, fusions, osteotomies, and non-unions in various parts of the body).
• The materials it is constructed from (Titanium alloy or pure Titanium).
• A comparison to predicate devices for substantial equivalence.
• Performance testing according to ASTM standards for metallic bone plates and screws.

However, it explicitly states: "Clinical data was not needed for this device." This indicates that no clinical studies, and therefore no studies evaluating AI performance or human reader improvement with AI, were conducted or presented in this 510(k) submission.

Therefore, I cannot provide answers to your specific questions regarding acceptance criteria, reported device performance (in the context of AI), sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

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Mini and Mid Locking Plate and Screw System:
The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot.

Small Locking Plate and Screw System:
The small locking plate and screw system is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula and other small bones.

The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.

The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical, or cancellous from 1.5mm to 4.0mm in diameter and range from 6mm to 70mm in length.

This document is a 510(k) summary for the TDM Plate and Screw System. It does not describe a study involving an AI/CADeX device or human readers. The acceptance criteria and the study to prove the device meets those criteria are entirely focused on mechanical and material properties of the bone plates and screws.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the mechanical tests (e.g., how many plates or screws were tested). The provenance of this test data would be the testing facility that performed the ASTM standards and LAL testing, likely a laboratory associated with TDM Co. Ltd. or a contracted testing service. This testing is inherently prospective in nature, as it's performed specifically to demonstrate compliance for regulatory submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a mechanical implant, not an AI/CADeX device requiring expert interpretation of images to establish ground truth. The "ground truth" for this device is based on established engineering standards for strength, durability, and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements against defined standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The TDM Plate and Screw System is a physical implant for bone fixation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical bone plate and screw system, not an algorithm or AI product.

7. Type of Ground Truth Used

The ground truth used for this device's acceptance is based on adherence to established engineering standards (ASTM F382-14 and ASTM F543-13) and biocompatibility testing (LAL bacterial endotoxin testing). These standards define the acceptable mechanical properties and safety profiles for such medical devices.

8. Sample Size for the Training Set

This is not applicable. The TDM Plate and Screw System is a manufactured medical device, not a machine learning model that requires a training set.

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

This is not applicable as there is no training set for this device.

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