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The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for up to six hours. The Safeline coating is used to reduce the surface tension on blood contact surfaces.

The Jostra HLM Tubing Sets with Safeline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the Jostra HLM Tubing Sets with Safeline Coating are used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the Jostra HLM Tubing Sets with Safeline Coating is to connect the patient to the heartlung machine and it's components. The Jostra HLM Tubing Sets with Safeline Coating are therefore a component in the extracorporeal perfusion circulation system, for the oxygenation of blood and the removal of carbon dioxide. The utilization period of the use of the tubing sets is restricted to six hours.

The provided document does not contain any data, tables, or studies that prove the device meets acceptance criteria.

The document is a 510(k) premarket notification for the Jostra HLM Tubing Sets with Safeline Coating. It describes the device, its intended use, and states that its performance data are comparable to the uncoated version. It also outlines a risk analysis (FMEA) performed to assess the impact of the Safeline coating. The conclusion is that the device is safe and effective for its intended use and substantially equivalent to predicate devices.

However, it does not provide quantitative acceptance criteria or detailed study results to demonstrate this. The key statement regarding performance is: "The performance data of the Jostra HLM Tubing Sets with Safeline Coating are comparable with the performance data of the Jostra HLM Tubing Sets without the Safeline Coating."

Here's a breakdown of why I cannot answer your request based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document states comparability but doesn't list criteria or specific performance metrics.
• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method for the test set: Not mentioned.
• 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, as this is a medical device (tubing sets) and not an AI-assisted diagnostic tool involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not explicitly stated, as there are no detailed studies presented. The "ground truth" here would likely be the established performance and safety profiles of the predicate, uncoated device.
• 8. The sample size for the training set: Not applicable and not mentioned, as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable and not mentioned.

The document focuses on substantiating that the addition of the "Safeline Coating" does not negatively impact the established safety and performance of the existing Jostra HLM Tubing Sets. The evidence provided is primarily through:

• Statement of Technical Comparison: The device has the same intended use, design, principles of operation, and performance as the predicate, with the only difference being the coating.
• Non-clinical Testing: All tests from the predicate 510(k) (K0503025) are deemed applicable. This implies that the new device would pass those same tests, but the results are not detailed here.
• Risk Analysis (FMEA): This identified potential hazards related to the coating (biological, functional, interaction with other coatings), and states that "Design verification tests were performed as a result of this risk analysis assessment" and that "The evaluation and test results do not show any kind of risk potential." Again, the specific tests and their quantitative results are not provided in this summary.

In summary, the document asserts comparability and safety through risk analysis and reliance on previous clearances, rather than presenting new, detailed performance study data against explicit acceptance criteria.

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The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
The Jostra HLM Tubing Set is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, fifters, and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support up to six hours.
Tubing with a 3/32 inch wall thickness may also be used in a roller type displacement blood pump to propel the blood/fluid through the circuit.
The Maquet tubing is made of polyvinyl chloride (PVC) and ranges in size from 1/8" diameter to 1/2" diameter.
The following generic types of barbed connectors will be used: straight with or without luer locks, reducer with or without luer port, Y with or without luer port, male or female luer locks. Connectors may range in size from 1/8 to 1/2 inch.

The Maquet Cardiopulmonary AG Jostra HLM Tubing Set is a sterile, non-pyrogenic device intended for single use in extracorporeal circulation during cardiopulmonary bypass procedures lasting up to six hours. This summary outlines the acceptance criteria and the study that demonstrates the device meets these criteria.

The acceptance criteria for the Jostra HLM Tubing Set revolved around demonstrating that its components (tubing and connectors) are safe and effective for their intended use and are substantially equivalent to currently marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

1. Bond strength: Performed on the tubing and connectors.
2. Burst pressure: Performed on the tubing and connectors.
3. Effects upon cellular components (hemolysis): Performed on the tubing and connectors, indicating a measure of blood compatibility.
4. Spallation: Performed on the tubing and connectors, assessing resistance to shedding particles.
   The non-clinical tests' overall conclusion was that the materials "are safe and effective for their intended use." Additionally, the data supported that "Maquet tubing and connectors are substantially equivalent to the tubing and connectors that currently hold market clearance." This also extended to the complete "Jostra HLM Tubing Sets," which were deemed "substantially equivalent to the Custom Tubing Packs that currently hold market clearance." |
   | Intended Use | The device is suitable for extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less. The "Indications for Use" explicitly state: "The Jostra HLM Tubing Sets are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less." |
   | Sterility | The device is provided sterile. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
   | Non-pyrogenicity | The device is non-pyrogenic. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only." |
   | Single Use Only | The device is designed for single use and not to be re-sterilized. The device description states, "The Jostra HLM Tubing Set is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user." |

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

The provided document does not specify the exact sample size for each performance or biocompatibility test performed (e.g., number of tubing segments for burst pressure, number of samples for hemolysis). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based and conducted in a controlled environment, likely by the manufacturer or a contract testing lab.

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

This information is not applicable to the type of device and study described. The ground truth for this device is established through objective, standardized engineering and biological tests (e.g., measuring bond strength, burst pressure, hemolysis rates) against predefined criteria or comparison to predicate devices, rather than expert interpretation of data.

4. Adjudication Method

Not applicable. The "adjudication method" usually refers to a process of resolving discrepancies in expert interpretations, which is not relevant for objective laboratory and physical performance tests of a device.

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

Not applicable. This device is not an AI-powered diagnostic tool or a device that involves human interpretation of output. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical medical device (tubing set) and does not involve an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily objective, quantifiable laboratory measurements and performance metrics according to standardized protocols. This includes:

• Engineering specifications (e.g., bond strength and burst pressure measurements).
• Biological responses (e.g., hemolysis and spallation tests).
• Comparison to established performance characteristics of predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a 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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