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The Televere Podiatry X-Ray System HF is intended for use by qualified clinicians for the x-ray of hands and feet. Not for mammography. Not fluoroscopy.

The Televere Podiatry X-Ray System HF consists of a combination of previously cleared Tigerview digital imaging software (K061035), a high frequency X-Ray generator (X-CEL MODEL HF 718BD, K160857), a PC-based computer and a power supply. Tigerview software provides an exposure control upgrade of the previously cleared HF x-ray generator by replacing the manual touchscreen of the Predicate Device (K160857) with the Tigerview computer software interface. Tigerview software provides basic image adjustment features as well as x-ray exposure control settings. An image adjustment system allows the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. Tigerview software runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card.

The provided text is a 510(k) premarket notification for the Televere Podiatry X-Ray System HF. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for diagnostic performance.

Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance as it would for a new AI/CAD device. Specifically:

• No specific acceptance criteria for diagnostic performance are stated. The submission focuses on regulatory compliance and technical specifications.
• No numerical performance metrics (e.g., sensitivity, specificity, AUC) are reported for diagnostic tasks. The "device performance" mentioned refers to electrical and safety aspects.
• No information on sample size for test sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types (pathology, outcomes data) is provided. These are typical for studies assessing diagnostic accuracy.
• No information on training set sample size or how training ground truth was established is provided. This is because the device is an X-ray system, not a machine learning algorithm requiring a training set for diagnostic tasks.

The document states:

• "The results of clinical image inspection, bench, and laboratory test results demonstrate that the new device is as safe and effective as the predicate device. Clinical images highlight equal or better image quality as compared to the predicate." (Page 4, Section 6)
• "Sample clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence." (Page 5, Section 8)

This indicates that clinical images were reviewed, but a formal study with detailed acceptance criteria and quantitative diagnostic performance metrics was not conducted or deemed necessary for this 510(k) submission, which primarily addresses hardware and software integration.

The "Acceptance Criteria" provided in the document relate to the technical performance of the X-ray system itself (e.g., kVp accuracy, mA accuracy, timer accuracy, reproducibility, leakage radiation) and compliance with various electrical safety and radiation standards. These are listed under "Performance Accuracy" and "X-ray Beam Quality Metrics" in the Substantial Equivalence Chart on Page 5.

Summary of available information related to performance/acceptance criteria:

Missing Information (as per your request, not available in the document):

1. Sample size used for the test set and the data provenance: Not applicable for a diagnostic performance study as described in the prompt. Clinical images were inspected, but details like sample size or origin for that inspection are not provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no formal diagnostic performance study is presented.
3. Adjudication method for the test set: Not applicable.
4. 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: Not applicable, as this is solely an X-ray system, not an AI/CAD diagnostic aid.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For technical performance, the ground truth would be precise measurements and compliance with regulatory standards. For the "clinical image inspection," the ground truth would be expert visual assessment, but details are not provided.
7. The sample size for the training set: Not applicable, as this is an X-ray system, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

In essence, the document serves as a regulatory submission demonstrating technical and safety equivalence, not a publication detailing a diagnostic performance study for a machine learning or CAD device.

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