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The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.

EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously. The diagnostic images are stored in a database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.

The provided text for Biospace Med's EOS (K071546) does not contain detailed information about specific acceptance criteria, a dedicated clinical study proving the device meets those criteria, or most of the requested performance data points. The submission relies primarily on a claim of substantial equivalence to predicate devices, stating that its "Performance data demonstrate that EOS is as safe and effective as common radiography systems."

Therefore, I cannot populate most of the requested fields definitively with information from the provided text. However, I can extract what is available and highlight what is missing.

Here's a breakdown based on the provided text, indicating where information is present and where it is lacking:

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

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

• The text does not provide information on the sample size used for any test set or the data provenance. It generally refers to "performance data" and "additional testing" without specifics.

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 text does not provide information on the number or qualifications of experts used for establishing ground truth.

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

• The text does not provide information on any adjudication method.

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 provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a "Digital Radiography System," not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for human readers to review.

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

• The text describes the EOS as a "Digital Radiography System" that generates images for diagnostic purposes to be "displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed." This implies human interpretation. The text does not indicate that any standalone algorithmic performance (without human-in-the-loop) was evaluated, nor does it present the device as having such a standalone diagnostic function.

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

• The text does not specify the type of ground truth used for any performance evaluation. It broadly mentions "performance data" that demonstrated equivalence.

8. The sample size for the training set

• The text does not provide information on any training set sample size. The submission focuses on the system's design and equivalence to predicate devices, rather than a machine learning model's training.

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

• The text does not provide information on how ground truth was established for any training set.

Summary of what's provided related to "study" and "acceptance":

The submission for K071546 does not detail a specific clinical study with explicit acceptance criteria and corresponding numerical performance metrics for the EOS device. Instead, it relies on a substantial equivalence claim. The core argument is that:

• The EOS has the "same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices."
• "The minor technological differences between EOS and its predicate devices raise no new issues of safety or effectiveness."
• "Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices."
• "Performance data demonstrate that EOS is as safe and effective as common radiography systems."
• "EOS is designed to comply with IEC 60601-1 and collateral standards."

This regulatory strategy indicates that the acceptance criteria are implicitly tied to demonstrating that the EOS performs equivalently to already legally marketed and established radiography systems, thereby being "as safe and effective." The "study" in this context is likely a series of technical and comparative evaluations (referred to as "additional testing" and "performance data") rather than a formal, prospective clinical trial designed to prove specific numerical efficacy metrics against a pre-defined ground truth in a clinical population. The absence of details on patient numbers, expert reads, ground truth, or statistical methods suggests a non-clinical performance evaluation focused on demonstrating technological equivalence to predicates.

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