(64 days)
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the kidneys.
Here's an analysis of the provided text regarding the RM3 Renal Preservation System, broken down by your requested categories.
Important Note: The provided text is a 510(k) Summary and FDA Clearance Letter. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria and performance metrics for a new device. Therefore, much of the information you requested regarding study design, acceptance criteria, and quantitative performance will likely be absent or only indirectly inferable, as the primary justification for clearance is the similarity to an already approved device.
Acceptance Criteria and Study Details for RM3 Renal Preservation System
1. Table of acceptance criteria and the reported device performance
The provided 510(k) summary and FDA letter do not specify quantitative acceptance criteria or detailed reported device performance metrics for the RM3 Renal Preservation System in the way one might see for a diagnostic AI or imaging device. The core of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device (also the "RM3 Renal Preservation System").
Therefore, the "acceptance criteria" here are implicitly tied to maintaining the same safety and effectiveness as the predicate. The "reported device performance" is essentially that it functions equivalently to the predicate.
| Criteria Category | Specific Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance (Inferred from 510(k)) |
|---|---|---|
| Intended Use | Maintain kidneys for transplant. | Identical to predicate device. |
| Methodology | Perfusion and monitoring of kidneys. | Identical to predicate device. |
| Safety | No new safety concerns. | Material change evaluated through risk analysis and biomaterial safety assessment; no new questions of safety raised. |
| Effectiveness | Function as a renal preservation system. | Substantially similar to predicate in design, configuration, and materials; control unit identical. |
| Material Change | Improve manufacturability without impacting safety or effectiveness. | Successfully improved manufacturability without raising new safety/effectiveness questions. |
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 510(k) summary describes a comparison to a predicate device (also named "RM3 Renal Preservation System") and mentions a "risk analysis and a biomaterial safety assessment" for a material change. This is typically a technical/engineering assessment, not a clinical study involving a "test set" of patient data or clinical outcomes. No details on sample size, data provenance, or study type (retrospective/prospective) are present because a clinical study of this nature was likely not required for this type of 510(k) clearance based on substantial equivalence to an identical predicate.
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. There is no mention of a "test set" or "ground truth" establishment by experts in the context of clinical performance, as this was not a clinical effectiveness study. The evaluation focused on engineering and material equivalence to the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set or adjudication method is 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 a renal preservation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant to its function and was not performed or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a physical system that performs renal perfusion and monitoring, not an algorithm. Its operation is inherently "standalone" in mechanical function, but "human-in-the-loop" is always present for medical device use (e.g., technicians operating it, surgeons using the preserved organ). This question is framed for AI/software, which isn't the primary nature of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. For the material change, the "ground truth" was likely established through engineering specifications, material testing standards, risk assessments (e.g., ISO standards), and biomaterial safety assessments, rather than clinical outcome data or expert consensus on clinical cases. For the device as a whole, the "ground truth" for its function and safety is its predicate device.
8. The sample size for the training set
Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no training set mentioned, this question is not applicable.
§ 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).