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SPS-1TM is intended for the flushing and cold 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.

SPS-1 TM is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolality of 320 mOsm, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.

The provided document (K091656) does not contain information about a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for a "Static Preservation Solution" that establishes substantial equivalence to predicate devices based on shared manufacturing processes, chemical composition, and intended use.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of what can be extracted and what is missing:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "functional and safety testing" mentions verifying device design met its requirements through biocompatibility, sterility, chemical identification, and particle enumeration in accordance with standards. However, the specific acceptance criteria (e.g., maximum allowable particle count, sterility pass/fail definition) and the results against these are not detailed.
   • Reported Device Performance: Not provided in terms of outcome statistics from a study (e.g., organ viability rates, post-transplant function). The document states the primary evidence for equivalence is that the device and predicate devices "are manufactured by the same process, with exactly the same chemical composition and have the same intended use." This implies performance is assumed to be equivalent due to these factors, rather than directly measured in a comparative study.

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

   • Sample Size: Not applicable. No clinical or comparative study data is presented. The "testing" mentioned refers to laboratory tests (biocompatibility, sterility, etc.), not a test set of patient or organ data.
   • Data Provenance: Not applicable.

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. No ground truth establishment for a test set is described.

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

   • Not applicable. No test set requiring adjudication 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. This device is a static preservation solution, not an AI-assisted diagnostic tool or system that involves human readers.

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

   • Not applicable. This device is a medical solution, not a software algorithm.

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

   • Not applicable in the context of a performance study. For the laboratory testing (biocompatibility, sterility, chemical ID, particle enumeration), the "ground truth" would be the established industry standards and validated test methods for these specific properties.

8. The sample size for the training set:

   • Not applicable. This device is a medical solution, not a machine learning model requiring a training set.

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

   • Not applicable.

Summary of Device Acceptance Rationale from the Document:

The acceptance of the SPS-1™ Static Preservation Solution (K091656) by the FDA is based on demonstrating substantial equivalence to existing legally marketed predicate devices (CoStorSol® K083453, K073693, and ViaSpan® K944866).

The key arguments for substantial equivalence are:

• The SPS-1™ is manufactured by the same process as the predicate devices.
• It has exactly the same chemical composition as the predicate devices.
• It has the same intended use (flushing and cold storage of kidney, liver, and pancreas organs for transplantation).

Functional and safety testing mentioned includes biocompatibility, sterility, chemical identification, and particle enumeration, all performed "in accordance with applicable industry standards and/or FDA guidance documents." However, specific results or acceptance criteria for these tests are not detailed in this summary. The primary evidence presented for equivalence relies on the identical nature of the product to already approved devices.

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LifePort™, Kidney Perfusion Transporter (KTR) is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

Not Found

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) clearance letter from the FDA for the 'LifePort™ Kidney Perfusion Transporter (KTR)', indicating that the device is substantially equivalent to legally marketed predicate devices.

The letter and the 'Indications for Use Statement' do not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific information using the provided text.

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KPS-1™, The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

KPS-1™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.

KPS-1™ should be cooled to about 5°C (4°C to 8°C) prior to use and should be used in a perfusion machine that is capable of maintaining temperature within the above specified range.

It is recommended that the KPS-1™ be stored between 2 °C and 8 °C. The solution should not be frozen or exposed to excessive heat.

KPS-1™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/~ 8 hours.

KPS-1™ The Kidney Perfusion Solution shelf-life is 6 months from data of aseptic fill. The stability of the perfusion solution was verified by accelerated aging for 6 months equivalency.

The provided text is a compilation of sections from a 510(k) summary and an FDA clearance letter for a medical device called KPS-1, Kidney Perfusion Solution. This document primarily focuses on demonstrating substantial equivalence to a predicate device (KPS-17M), rather than presenting a detailed study proving the device meets specific acceptance criteria through a formal statistically powered performance study.

Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample size, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance), and training set details are not explicitly described in the provided text.

However, based on the information available, here's a breakdown of what can be inferred:

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

The document does not explicitly present acceptance criteria in a quantitative table format as one might expect for a performance study. Instead, the "performance" discussed relates to the compositional characteristics and intended use of the solution, which are aligned with the predicate device.

2. Sample size used for the test set and the data provenance

The document does not describe a specific "test set" or clinical study with a defined sample size in the context of proving performance against acceptance criteria. The submission is a 510(k) for device modifications, demonstrating "substantial equivalence" to a predicate, KPS-17M. The "data presented in this submission" refers to information validating that the modified KPS-1 maintains the same technological characteristics and performance as the predicate.

• Sample Size: Not applicable/not provided for a clinical performance study.
• Data Provenance: The data primarily relates to the chemical and physical properties of the solution, as well as stability testing (accelerated aging). The geographical origin of this data or if it involved human or animal subjects is not specified, but it would typically be laboratory-based testing. It's retrospective in the sense that it evaluates the modified device against established characteristics of the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/not provided as there's no mention of a clinical study involving human or animal subjects that required expert ground truth establishment for a test set. The validation is chemical/physical.

4. Adjudication method for the test set

This information is not applicable/not provided as there's no mention of a clinical study or expert review process requiring adjudication.

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 provided. The device is a kidney perfusion solution, not an imaging or diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable/not provided. The device is a chemical solution, not an algorithm.

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

The "ground truth" in this context would be the established chemical and physical properties of the predicate device (KPS-17M, University of Wisconsin Machine Perfusion Solution Formulation) and standard analytical methods to verify that the modified KPS-1 solution matches these characteristics. For instance:

• Chemical Analysis: To verify osmolarity, sodium, potassium concentrations, and pH.
• Sterility/Pyrogenicity Testing: To ensure the solution is free from contaminants.
• Stability Testing: Accelerated aging studies to determine shelf-life.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided as there is no training set.

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KPS-I™, The Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.

KPS-I™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a votassium concentration of 25mEg/1, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.

The provided text is a 510(k) summary for KPS-ITM, The Kidney Perfusion Solution, seeking substantial equivalence to a predicate device, Belzer MPS™. It does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance evaluation. Instead, it argues for substantial equivalence based on identical indications for use, technological characteristics, and formulation.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or cannot be extracted from this document as the submission is not for a new medical device that requires clinical performance data in the same way a diagnostic algorithm or a surgical tool would.

Here's the information that can be extracted, along with explanations for categories that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is Not Applicable (N/A) in the context of this 510(k) submission. The submission relies on establishing substantial equivalence to a legally marketed predicate device based on identical indications for use, similar technological characteristics, and identical formulation and packaging, rather than a clinical study with a "test set" of patient data. Performance data provided (e.g., mean perfusion time) would typically come from internal testing or literature, but the specific "sample size" and "provenance" for a test set as described are not detailed because it's not a performance study in the classic sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is Not Applicable (N/A). Ground truth established by experts is typically for evaluating diagnostic or algorithmic performance against a gold standard. This 510(k) is for a medical solution, and its equivalence is based on its composition and functional characteristics relative to a predicate, not on expert interpretations of medical data.

4. Adjudication Method for the Test Set

This is Not Applicable (N/A) for the same reasons as #3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is Not Applicable (N/A). An MRMC study is relevant for evaluating the impact of an AI or diagnostic device on human reader performance. KPS-I™ is a perfusion solution, not a diagnostic or AI device.

6. Standalone (Algorithm Only) Performance Study

This is Not Applicable (N/A). KPS-I™ is a medical solution, not a standalone algorithm.

7. Type of Ground Truth Used

This is Not Applicable (N/A) in the sense of expert consensus, pathology, or outcomes data used to validate an algorithm or diagnostic tool. The "ground truth" here is the established characteristics and performance of the predicate device (Belzer MPS™), to which KPS-I™ is being compared for substantial equivalence. The claim is that KPS-I™'s characteristics are identical or sufficiently similar to those of the predicate.

8. Sample Size for the Training Set

This is Not Applicable (N/A). There is no machine learning model or algorithm being trained here.

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

This is Not Applicable (N/A) for the same reason as #8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) submission process itself, which aims to demonstrate substantial equivalence to a previously cleared predicate device, Belzer MPS™ (UW Kidney Preservation Solution, K972066). The core of the evidence presented is a comparison table and descriptive text highlighting the identical indications for use, identical solution formulation, similar technological characteristics (e.g., clarity, sterility, pH, osmolarity, presence of key components), and identical packaging system between KPS-I™ and Belzer MPS™.

The argument for meeting "acceptance criteria" (which in this case are defined by the predicate device's characteristics and intended use) is that KPS-I™ is fundamentally the same product as the predicate device. The submission states directly: "Data contained in the 510(k) demonstrates that KPS-I™, The Kidney Perfusion Solution is substantially equivalent to Belzer MPS." The FDA's clearance letter confirms this finding of substantial equivalence based on the provided information.

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