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The OrganProtex™ HTK Solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.

OrganProtex™ HTK Solution is a clear, colorless to pale yellow colored solution, sterile, nonpyrogenic electrolyte and amino acid aqueous solution for organ perfusion and preservation. OrganProtex™ HTK Solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. OrganProtex™ HTK Solution is not indicated for continuous machine perfusion of donor organs.

Histidine-tryptophan-ketoglutarate or HTK solution is a high-flow, low-potassium preservation solution used for organ transplantation. The solution was initially developed by Hans-Jurgen Bretschneider.

HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine hydrochloride, so as to prolong the period during which the organs will tolerate interruption of oxygenated blood. The composition of HTK is similar to that of extracellular fluid. All of the components of HTK, with the exception of mannitol, occur naturally in the body. The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.

The document describes the OrganProtex™ HTK Solution, which is an organ preservation solution. This device is applying for 510(k) clearance based on substantial equivalence to a predicate device, Custodiol® HTK Solution (K192408).

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a medical solution, the "acceptance criteria" and "reported device performance" are primarily focused on demonstrating equivalence in composition, function, and safety to a legally marketed predicate device, rather than a quantifiable performance metric against a specific clinical outcome.

The main acceptance criterion for a 510(k) is demonstrating substantial equivalence to an existing predicate device. This is achieved by showing that the new device has the same intended use, and either the same technological characteristics or, if different, that these differences do not raise new questions of safety and effectiveness.

The document provides a detailed comparison table (Table 6.0 in the original document, reproduced below as "Comparison of Technological Characteristics") that serves as the reported device performance against the predicate.

Comparison of Technological Characteristics

2. Sample Size Used for the Test Set and Data Provenance

This is a submission for a medical solution, not typically a device that undergoes "test set" evaluation in the same way an AI/software device would. The "test set" here refers to the data and testing used to demonstrate the solution's properties (sterility, pH, osmolality, shelf life, biocompatibility).

• Sample Size for Test Set: The document doesn't specify a numerical "sample size" in terms of how many units of OrganProtex™ HTK Solution were tested for each non-clinical performance category (biocompatibility, sterilization, shelf-life). These are standard laboratory tests typically performed on a statistically relevant batch size for manufacturing quality control and regulatory submission.
• Data Provenance: The manufacturing entity is Rusoma Laboratories Pvt. Ltd. in India. The studies performed (biocompatibility, sterilization, shelf-life) were conducted to demonstrate the properties necessary for substantial equivalence. The document doesn't specify if the underlying data/tests were conducted retrospectively or prospectively, but typically, these are prospectively planned tests to support the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (number of experts, qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation, such as image analysis for diagnosis. For a medical solution like OrganProtex™ HTK Solution, there isn't a "ground truth" established by human experts in the same way. The ground truth for its properties (like sterility, pH, composition) is established through analytical chemistry, microbiology, and physical property testing performed by qualified laboratory personnel following validated methods.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods (e.g., 2+1, 3+1) are common in clinical trials or human performance studies where multiple experts evaluate cases and discrepancies are reconciled. The non-clinical performance data for OrganProtex™ HTK Solution relies on objective laboratory measurements.

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. This is a medical solution (a liquid for organ preservation), not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and the concept of "human readers" or "AI assistance" are not relevant here.

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

Not applicable. This is a medical solution and does not involve any algorithms or software for standalone performance.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance data is based on:

• Analytical Chemistry: For composition, pH, osmolality.
• Microbiology Testing: For sterility and pyrogenicity.
• Biocompatibility Testing: In accordance with ISO 10993 standards.
• Stability Studies: To determine shelf life.

8. The Sample Size for the Training Set

Not applicable. This product is a medical solution, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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