(378 days)
The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BEL-GEN® Cold Storage Solution:
Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device (BEL-GEN® Cold Storage Solution). This type of regulatory document primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria as one might find for a novel diagnostic AI algorithm. Therefore, many of the requested fields related to AI model performance, expert ground truth, and comprehensive clinical study design are not applicable or not present in this document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Identical intended use as predicate device (SPS-1 Static Preservation Solution) | The BEL-GEN Solution has an identical intended use to the SPS-1 predicate. |
| Chemical Composition Equivalence | Identical chemical composition as predicate device (SPS-1 Static Preservation Solution) | The BEL-GEN Solution has an identical chemical composition to the SPS-1 predicate. |
| Principle of Operation Equivalence | Identical principle of operation as predicate device (SPS-1 Static Preservation Solution) | The BEL-GEN Solution has an identical principle of operation to the SPS-1 predicate. |
| Sterility | Must be sterile | The BEL-GEN Solution is sterile. |
| Pyrogenicity | Must be pyrogen-free | The BEL-GEN Solution is pyrogen-free. |
| Clarity | Clear to light yellow solution | The BEL-GEN Solution is clear to light yellow. |
| Osmolality | Approximate osmolality of 320 mOsm/kg | The BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg. |
| Sodium Concentration | Sodium concentration of 29 mmol/L | The BEL-GEN Solution has a sodium concentration of 29 mmol/L. |
| Potassium Concentration | Potassium concentration of 125 mmol/L | The BEL-GEN Solution has a potassium concentration of 125 mmol/L. |
| pH | pH of 7.4 at 20°C | The BEL-GEN Solution has a pH of 7.4 at 20°C. |
| Biocompatibility | No new questions of safety or effectiveness compared to predicate | Evaluated through biocompatibility testing; results did not raise new questions of safety or effectiveness. |
| Stability | No new questions of safety or effectiveness compared to predicate | Evaluated through stability testing; results did not raise new questions of safety or effectiveness. |
| Chemical Identity | No new questions of safety or effectiveness compared to predicate | Evaluated through chemical identity testing; results did not raise new questions of safety or effectiveness. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- The document does not describe a "test set" in the context of an AI algorithm or a clinical trial with a defined patient sample size. The substantial equivalence determination is based on the chemical and physical properties of the solution and container, as well as its intended use.
- Data provenance for specific tests (biocompatibility, stability, chemical identity) is not specified, but these are typically conducted in-house by the manufacturer or by contract labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI diagnostic device and does not involve expert-established ground truth for a test set in that sense. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the adherence of the new device to its specified chemical and physical properties.
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Adjudication method for the test set:
- Not applicable. No "test set" or adjudication method in the context of AI algorithm evaluation is described.
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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 cold storage solution for organs, not an AI diagnostic device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical solution, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the substantial equivalence claim relies on:
- The established safety and effectiveness of the predicate device (SPS-1 Static Preservation Solution).
- Laboratory test results demonstrating the physico-chemical properties (osmolality, pH, concentrations) of the BEL-GEN Solution.
- Validation of device characteristics such as sterility, pyrogenicity, and biocompatibility, stability, and chemical identity of the dispensing bag.
- The "ground truth" for the substantial equivalence claim relies on:
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The sample size for the training set:
- Not applicable. This is a medical solution, not an AI model, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).