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The Siemens Koordinat Angiographic X-ray Table family is intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required.

The Koordinat Table family is a modification to an existing floor mounted X-ray table for angiographic examinations and interventions, and surgery. The modified Koordinat table is based on knowledge and experience gained with the predecessor model, the Koordinat M Table. The Koordinat M was described in the 510(k) Submitted on 4/30/95 with the number K951176.

The provided text is a 510(k) summary for the Siemens Koordinat Angiographic and Operating Room Model X-Ray Table Family. It details the device's intended use and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or specific studies demonstrating device performance against such criteria.

Here's why and what information is missing based on your request:

• Type of Device: The device is an X-ray table, which is a physical piece of equipment for patient positioning, not a medical device that produces diagnostic results (like an AI algorithm for image analysis). Therefore, the provided text focuses on hardware specifications and substantial equivalence, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI or diagnostic device.
• Focus of 510(k) Summary: A 510(k) summary primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and safety/effectiveness profiles, rather than presenting detailed clinical trial data with acceptance criteria for quantitative performance metrics.

Therefore, for your specific numbered points, the information is largely absent from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The text describes the device's function and technical characteristics, but no quantitative performance metrics or acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. This is a hardware device; there isn't a "test set" of data in the sense you're referring to for AI or diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method for the test set: Not applicable/not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable/not present. This device is not an AI for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/not present.
7. The type of ground truth used: Not applicable/not present.
8. The sample size for the training set: Not applicable/not present.
9. How the ground truth for the training set was established: Not applicable/not present.

Summary of available information related to performance/equivalence:

• Device Description: The Koordinat Table family is a modification of an existing floor-mounted X-ray table.
• Technological Characteristics Comparison: The new Koordinat Table has "the same technological characteristics" as the predicate Koordinat M table. The primary difference highlighted is a change from analog to CAN bus interface for reporting and controlling table movements in the higher-end models.
• Predicate Devices: The new models are deemed substantially equivalent to the Koordinat M Table (K951176), OP/PTCA-System 1520 (K883613), Synchra Tilt (K940696), and 90/50 Mobile Imaging Table (K884531). This substantial equivalence implies that the new device meets the same safety and effectiveness standards as these previously cleared devices.
• Intended Use: "intended to support and position patients for Angiographic examinations, Angiographic interventional techniques where an X-ray translucent tabletop is required, and for use during surgery where an X-ray translucent tabletop is required."

In essence, the "study" demonstrating the device meets "acceptance criteria" in this context is the 510(k) submission itself, which argues and validates substantial equivalence to existing, legally marketed predicate devices. The "acceptance criteria" are implicitly met if the device fundamentally performs its intended function (patient support and positioning) in a manner that is as safe and effective as the predicate devices, despite minor technological updates.

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