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To provide hemodialysis treatment to patients with acute or chronic renal failure.

A hemodialysis delivery system which will provide dialysate at the prescribed temperature and ionic concentration to be used for hemodialysis treatment. It has the ability to monitor machine, dialysate, and blood circuit functions during dialysis. The machine treatment parameters are displayed on a Liquid Crystal Display monitor screen. The operator controls is done through a interactive touch screen.

This 510(k) summary does not contain the level of detail required to fulfill all aspects of your request. It's a summary for clearance, not a comprehensive study report. Based on the provided text, here's what can be extracted and what cannot:

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

This information is not available in the provided text. The document states that the AltraTouch™ 1000 is a modification of a predicate device and that "Althin Medical, Inc. believes that the design and testing of this modified System1000® machine demonstrates that it is safe and effective." However, it does not specify any quantitative acceptance criteria or present performance data against them.

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

This information is not available in the provided text. No details about specific testing or data are mentioned.

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)

This information is not available in the provided text. No mention of experts or ground truth establishment is made.

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

This information is not available in the provided text. No mention of adjudication or test methods is made.

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

This information is not applicable/not available in the provided text. The device described is a hemodialysis delivery system, not an AI diagnostic tool that would involve human readers or MRMC studies.

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

This information is not applicable/not available in the provided text. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant.

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

This information is not available in the provided text. No ground truth is mentioned.

8. The sample size for the training set

This information is not available in the provided text. No mention of a training set is made.

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

This information is not available in the provided text. No mention of a training set or its ground truth establishment is made.

Summary of available information regarding the device and its compliance:

The document describes the AltraTouch™ 1000 Single Patient Hemodialysis Delivery System as a modification of the Drake Willock® System 1000. The key modifications are:

• Replacing a 12-inch CRT with a 9.5-inch LCD, reducing height and weight.
• Reducing maximum dialysate flow rate by 20%.
• Increasing the minimum temperature requirement for incoming water.
• Making some standard features from the predicate optional.

The document emphasizes that "Except for the parts associated with the change to the LCD screen, the AltraTouch™1000 machine is built from the same parts as the predicate device. The only software changes are those that control the display color pallet. All machine/patient safety systems are identical to the predicate device."

This reliance on the predicate device's established safety and effectiveness, along with the assertion that "All machine/patient safety systems are identical to the predicate device," is the primary argument for the device meeting safety and effectiveness criteria in this 510(k) summary. It suggests that the "study" proving the device meets criteria is largely a comparison to and demonstration of equivalence with the previously cleared predicate device, rather than a de novo clinical trial or extensive independent performance study reported here.

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