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This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms that contain the tube and solid state detector (either one or two), x-ray generator and a patient table.

The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. INFX-8000V. This document is a pre-market notification for a medical device and does not contain the specific detailed information typically found in a study report regarding acceptance criteria and performance data for a device under evaluation.

Here's a breakdown of why the requested information cannot be extracted from the provided text and what the document does indicate:

What the document is:

• 510(k) Summary: This is a concise overview of the device and its substantial equivalence claim, submitted to the FDA for pre-market notification.
• Substantial Equivalence Claim: The core of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.

Why the requested information is not present:

For a 510(k) submission that relies on substantial equivalence to a predicate device, a full-blown clinical study with defined acceptance criteria and performance metrics like accuracy, sensitivity, or specificity is often not required. Instead, the focus is on demonstrating that the new device performs similarly or no worse than the predicate.

Therefore, the document does not include:

• A table of acceptance criteria and reported device performance (in terms of clinical outcomes, diagnostic accuracy, etc.).
• Details about sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training/test sets. These are typical components of a study proving a device meets specific performance criteria.

Information that can be inferred or directly stated from the document, relevant to the spirit of your request:

The acceptance criteria in this context are primarily related to safety, effectiveness, and substantial equivalence to the predicate devices, rather than specific clinical performance metrics.

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

   Acceptance Criteria (Implied)	Reported Device Performance (Summary)
   Compliance with Quality System Regulations (21 CFR § 820)	"This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820."
   Compliance with Federal Diagnostic Equipment Standard (21 CFR § 1020)	"All requirements... will be met and reported via an initial report."
   Conformance with IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28	"Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards."
   Substantial Equivalence to Predicate Devices (GE Innova 3130, Toshiba DFP-8000D/FPD)	"The INFX-8000V is of comparable type and substantially equivalent to: GE Innova 3130... Toshiba DFP-8000D/FPD... Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device."
   Manufacturing processes and materials similar to predicate device	"This device employs similar materials and processes as found in the predicate device."
   Same intended use as predicate devices	"This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities." (Matches the general use of predicate angiography systems).

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

   • Not Applicable / Not Provided: The document does not describe a clinical study with a specific test set. The substantial equivalence claim is based on technological characteristics and comparison to predicate devices, not on a new clinical performance study.

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):

   • Not Applicable / Not Provided: No such information is present as no specific test set requiring expert ground truth is detailed.

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

   • Not Applicable / Not Provided: No test set described.

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:

   • Not Applicable / Not Provided: This device is an X-ray system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • Not Applicable / Not Provided: The device is a medical imaging system, not an AI algorithm.

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

   • Not Applicable / Not Provided: No specific ground truth is referenced for performance evaluation in this type of submission. The "ground truth" for substantial equivalence is primarily the established safety and effectiveness of the predicate devices and compliance with regulatory standards.

8. The sample size for the training set:

   • Not Applicable / Not Provided: This device is an X-ray system; there's no mention of a "training set" in the context of an AI algorithm.

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

   • Not Applicable / Not Provided: As above.

In summary, the provided 510(k) document is for an imaging system demonstrating substantial equivalence to existing devices. It does not detail specific performance studies with clinical endpoints or AI evaluations, which are common for different types of medical devices, especially AI/ML-driven ones. The "proof" that it meets acceptance criteria comes from its demonstrated similarity to already-approved predicate devices and its adherence to general safety and quality standards.

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