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Celsior™ is intended for flushing and cold storage of a heart at the time of its removal from a donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Celsior (SangStat Medical Corporation, Fremont, CA) is a clear to slightly yellow, sterile, non-pyrogenic, extracellular solution for hypothermic flushing and storage of hearts. The solution is slightly acidic (pH 7.3 + 0.10), slightly hypertonic (osmolarity 320-360 mOsmol) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). The composition of Celsior is thus consistent with that of an extracellular solution.

Celsior is filled into 1 liter ethylene-vinyl acetate copolymer (EVA) bags. The EVA bags are sterilized (ethylene oxide) and aseptically filled up to 1,000 mL in a sterile area. After filling, each EVA bag is enveloped by an aluminum protected bag containing an oxygen absorbent sachet. This product must be stored under refrigerated conditions at 2° to 8°C (36° to 46°F) until it is used.

Here's a breakdown of the acceptance criteria and study information for the Celsior™ Cold Storage Solution, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the overall clinical trial. The document mentions "subjects receiving Celsior-treated hearts" but does not give a total N.
• Data Provenance:
  • Country of Origin: The primary clinical study was conducted in the U.S. (IDE file number G970052), described as a "multicenter" trial.
  • Type: Clinical studies are inherently prospective.

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

• This information is not provided in the given text. Clinical endpoints like patient survival and adverse events are typically recorded by clinical staff (doctors, nurses) as part of standard medical practice and trial protocols, rather than being "established" by a specific number of experts in a ground truth panel. The safety and efficacy data would be gathered by the clinical trial investigators.

4. Adjudication Method for the Test Set

• This information is not provided in the given text. While clinical trials often have data monitoring committees or adjudication processes for serious adverse events, the specific method is not detailed here.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Celsior is a medical solution used for organ preservation, not a diagnostic tool requiring reader interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• No, a standalone algorithm performance study was not done. Celsior is a medical solution, not an algorithm. The "performance" refers to its biological effect on organs and patient outcomes.

7. Type of Ground Truth Used

• For the clinical studies, the "ground truth" was based on patient outcomes data, specifically:
  • 7-day patient survival
  • 30-day patient survival
  • 30-day graft survival
  • Cardiac-related serious adverse events
  • Overall adverse event profiles
• For preclinical studies, the "ground truth" was based on physiological performance metrics in isolated animal hearts and live animal models (e.g., "Celsior-treated hearts performed better than ViaSpan-treated hearts").
• For biocompatibility, sterility, and stability studies, the "ground truth" was based on laboratory test results (e.g., cytotoxicity assays, sterility cultures, chemical stability analysis).

8. Sample Size for the Training Set

• This concept of a "training set" is not applicable here as Celsior is not an AI/ML device. The clinical trials would involve a patient cohort, but it's not a "training set" in the machine learning sense. The text does not provide an overall sample size for the clinical trial, just that it was a "multicenter" trial conducted in the U.S.

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

• As in point 8, this question is not applicable as there is no "training set" in the context of an AI/ML device. The clinical trial data for Celsior versus controls would be used for direct comparison to demonstrate substantial equivalence, not for training a model.

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ThymoStat™ is a qualitative plate ELISA for the detection of human anti-rabbit antibodies in human serum. The presence of human anti-rabbit antibodies has been associated with patients receiving injections of rabbit antibodies for therapeutic purposes.

Not Found

This document is primarily a letter from the FDA regarding 510(k) clearance for the ThymoStat™ ELISA device. It confirms FDA approval but does not contain detailed information about acceptance criteria or specific study methodologies, performance data, or ground truth establishment.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about the experts for ground truth.
• Adjudication methods.
• Whether MRMC studies were done or effect sizes.
• Stand-alone performance.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

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The CycloTech™ Cyclosporine Oral Solution Dispenser (Dispenser) is intended to dispense SangCya™ cyclosporine oral solution USP (for microdispersion) as well as display and store dose size, time to next dose, remaining available doses, and doses dispensed.

CycloTech™ is designed for use with a standard fifty (50) mL bottle. A disposable fluid path, fully enclosed by the outer plastic shell, has a 0.1 to 5.0 mL dose range with 0.1 mL per step resolution and an accuracy of plus or minus five percent (+ 5%) for dispensed volumes. This device has two (2) user buttons, a custom LCD display, one (1) year memory at two (2) doses per day (uploadable to a PC), six (6) months battery life using common AA-type alkaline batteries, and pump technology for a specified volume range.

Use of a pump mechanism and microcomputer allows control of fluid delivery. The primary system upon which this product is based is the gravimetric principle of fluid delivery. The pump mechanism is used to assist the microcomputer in measuring amounts of liquid cyclosporine as well as dispensing the medication. The microcomputer, taking into account fluid viscosity, is able to provide an accurate, reproducible amount of liquid medication.

CycloTech™ is comprised of a molded plastic case assembly with an interchangeable disposable fluid path assembly. The fluid path assembly will only accept the original container of cyclosporine oral solution obtained from the drug manufacturer (reservoir or medication supply bottle). The case assembly provides for setting or adjusting the amount of liquid delivered, for measuring time, and for storing data. This apparatus also provides visual and audio output to the user, a control processor for monitoring and recording the time and number of dispensed doses of medication, a method for alerting a user of the time for taking their dose(s) of medicine, and monitoring the amount of medication remaining in the fluid path and reservoir. Audio alarms for alerting a user are also included in the Dispenser. The control processor, via interface, may be linked with an external computer. A liquid dispensing valve assembly and pump are used for dispensing liquid medicines from the reservoir through the fluid path assembly.

The provided text describes the CycloTech™ Cyclosporine Oral Solution Dispenser and its regulatory submission. It mentions performance testing but does not provide detailed acceptance criteria or the specifics of a study proving those criteria were met in the format requested.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical acceptance criteria for accuracy and precision beyond the +/- 5% for dispensed volumes.
• The exact numerical performance results achieved in the tests (e.g., the measured accuracy, precision values). The document only states that "accuracy and precision data met specified internal standards."

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

This information is not provided in the document.

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

This information is not applicable as the device is a drug dispenser, and the performance criteria relate to physical dispensing characteristics, not interpretation of data by experts. The "ground truth" would be the actual dispensed volume compared to the target volume, or the actual time recorded compared to real-time.

4. Adjudication Method for the Test Set:

This information is not provided and is likely not applicable for this type of device where quantitative measurements are the primary outcome.

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

This information is not provided and is not applicable to this type of device. An MRMC study typically involves human readers interpreting diagnostic images or data, often with and without AI assistance. This device is a drug dispenser, not a diagnostic tool.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, a standalone performance study was done. The document states: "Non-clinical performance testing results for CycloTech™ indicate accuracy and precision data met specified internal standards and are available for review." This refers to the device's inherent mechanical and computational ability to dispense accurately and precisely, without human intervention or interpretation as part of the primary performance metric.

7. Type of Ground Truth Used:

The ground truth used for this device would be physical measurements of dispensed volume, timing, and other mechanical/electrical parameters, as compared to the device's intended output. This is inferred from the mention of "accuracy and precision data" and the nature of the device (a liquid dispenser).

8. Sample Size for the Training Set:

This information is not provided. The device uses a microcomputer and pump mechanism, implying an algorithm to control fluid delivery, potentially developed using a "training set" of data to calibrate for fluid viscosity, but this is not explicitly detailed.

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

This information is not provided. If a training set was used for calibration (e.g., for fluid viscosity compensation), the ground truth would likely have been established through highly accurate physical measurements of dispensed volumes under various conditions.

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