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The Ortho Device is intended to generate tomosynthesis images of human anatomy for diagnostic purposes of the hand, elbow and foot in patients of all ages.

The imaging will provide the physician visualized information about anatomical structures to facilitate assessment in orthopedic cases such as:
• Fractures of bones in finger, metacarpus or wrist
• Fractures of foot, ankle or elbow joint
• Arthritis

The Ortho Device is a 3D tomographic X-ray device intended to be used to produce radiological images of a specific cross-sectional plane of the body. The device is comprised of a Flat Panel X-ray source combined with a digital detector within a mounting frame, a control unit and a workstation. It is intended to offer 3D imaging of orthopedic structures by using a panel of X-ray sources that construct a 3D tomosynthesis image with the associated reconstruction software from individual images; it is also possible to create synthetic 2D images of the desired anatomy.

The Ortho Device is a portable system that can be mounted on a stand for tabletop applications or on a trolley cart for added mobility with motorized vertical positioning. The C-Arm and Control Unit components are both designed to be carriable by a single person. To allow for the ideal positioning of the anatomy (hand and weight-bearing foot images) in the beam path and to achieve the desired plane of view, the Ortho Device C-Arm can be manually rotated by up to 90°. The central beam is aligned perpendicularly to the image receptor.

The "Ortho Device" was created to fill a diagnostic niche in orthopedic medicine for cost effective and portable imaging for patients and is used, amongst other applications, for 3D-radiographic diagnostic imaging of hand, elbow and foot in orthopedic and radiological practices as well as in emergency departments of hospitals. The Ortho Device results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decisionmaking on human anatomy.

The Ortho Device system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.31.

The provided text is a K221949 510(k) summary for the ADAPTIX 3D Orthopedic Imaging System ("Ortho Device"). It does not contain information about acceptance criteria, detailed study designs, or reader study results with explicit performance metrics. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone performance details.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
• Sample size for the training set.
• How ground truth for the training set was established.

However, based on the section "9. Non-Clinical Performance Data," I can extract the following relevant information regarding performance evaluation, albeit without specific quantitative acceptance criteria or detailed study methodologies:

The study that "proves the device meets the acceptance criteria" in this context refers to a series of non-clinical tests summarized in Section 9. While "acceptance criteria" for specific performance metrics are not explicitly stated with quantitative thresholds, the document implies that these criteria were met by stating "Passed" for each test.

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

Since explicit quantitative acceptance criteria are not provided, the table below lists the performance aspects tested and the reported outcome.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "sample clinical images" being evaluated by radiologists but does not specify the sample size, data provenance, or whether the study was retrospective or prospective for these clinical image evaluations. For other non-clinical tests (e.g., toxicity, electrical safety), the "sample size" would refer to the number of device units or components tested, which is not stated.

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):
The document states "Evaluation of sample clinical images by radiologists". It does not specify the number of radiologists, their qualifications, or their experience levels.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method used for the evaluation of clinical images.

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:
The document does not mention an MRMC comparative effectiveness study or any evaluation of human reader performance with or without AI assistance. The device is an imaging system, not explicitly described as having AI for interpretation in this summary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the device as an "imaging system" that "results are detailed multi-slice 3D images of patients that allow radiologist interpretation of clinical image data and by this support medical professionals decision-making." This implies the device provides images for human interpretation, and there is no mention of an algorithm performing standalone diagnoses.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the evaluation of clinical images, "Evaluation of sample clinical images by radiologists to demonstrate that the device is able to image all intended body parts" and "to help clinician for the assessment of bone fracture and arthritis" implies that the ground truth for these evaluations was based on expert assessment/consensus (i.e., the radiologists' judgment). No pathology or outcomes data is mentioned as ground truth.

8. The sample size for the training set:
Not applicable/not provided. This document describes a medical imaging device, not a machine learning algorithm that requires a separate training set. The "software verification and validation testing" mentioned refers to the device's operational software, not an AI training process.

9. How the ground truth for the training set was established:
Not applicable/not provided, as there is no mention of a training set for an AI algorithm.

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