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Merit's Rotating Adapters are indicated for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Merit's Rotating Adapters are marketed in two configurations: Male-Male Adapter (MMA) and Male-Female Adapter (MFA). The adapters are comprised of a stand-alone rotator assembly bonded to a polycarbonate male or female luer lock, using a UV cured adhesive. The stand-alone rotator assembly is comprised of individually molded polycarbonate parts (housing connector, retaining collar, hub) and an

The provided text describes a 510(k) premarket notification for a medical device, the Merit Rotating Adapter. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative testing against standards and the predicate device's characteristics, not on AI model performance or deep learning studies.

Given this context, I cannot fulfill all the requested points (especially those related to AI algorithm performance, human reader improvement with AI, ground truth establishment for AI, or training set details) because the document describes a traditional medical device submission, not an AI/ML medical device submission.

However, I can extract information related to the device's functional and safety testing as described.

Acceptance Criteria and Device Performance for Merit Rotating Adapter (K140475)

The device, Merit Rotating Adapter, is a Class II medical device (Product Code DTL) and is intended for use in interventional, diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Merit Rotator, K932251). The performance testing was conducted based on risk analysis and
requirements of international standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list distinct "acceptance criteria values" for each test. Instead, it states that "The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." The tests conducted are listed, implying that passing these tests according to the relevant standards constitutes meeting the acceptance criteria.

• Merit Hydrostatic Pressure Test
• Merit Vacuum Leak Test
• ISO 8536-10 Particulate
• ISO 8536-10 Leakage | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device." (No specific values or thresholds reported). |
  | Chemical | - ISO 8536-4 Chemical Requirements | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device." |
  | Biocompatibility | - Cytotoxicity (based on ISO 10993-5:2009)
• Sensitization (based on ISO 10993-10:2010)
• Irritation (based on ISO 10993-10:2010)
• Systemic Toxicity (based on ISO 10993-11:2006)
• Systemic Injection (based on ISO 10993-11:2006)
• Pyrogenicity (based on USP 36, NF 31, 2013 )
• Hemocompatibility (based on ISO 10993-4:2002 (Amd.1:2006) and ASTM F756-08:2008)
• Chemical Characterization (based on ISO 10993-1:2009 and FDA guidance) | Met "predetermined acceptance criteria applicable to the safety and efficacy of the device" for all biocompatibility aspects. (No specific results). |
  | Sterilization | - ANSI/AAMI/ISO 11135-1:2007 (Sterilization of health care products - routine control of a sterilization process for medical devices) | Test conducted, implies successful meeting of criteria. |

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

The document does not specify the sample sizes (number of units tested) for each of the performance or biocompatibility tests.
Data provenance is not applicable in the context of this device's testing, as it involves physical and chemical tests of the device itself, not data derived from patients or clinical sources. The tests are laboratory-based.

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

This is not applicable. The "ground truth" for this type of device (a mechanical adapter) is adherence to engineering and biological safety standards, not expert interpretation of clinical data or images. The "experts" involved would be engineers and scientists performing the tests and assessing compliance with the standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus on clinical data (e.g., in MRMC studies), which is not the nature of the testing described for this device.

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

This is not applicable. MRMC studies are performed for diagnostic devices (e.g., imaging AI) to assess the impact of a device on human reader performance. This device is a physical adapter for fluid management, not a diagnostic tool requiring human interpretation.

6. Standalone Performance

The "standalone performance" for this device is essentially its ability to meet the specified mechanical, chemical, and biocompatibility standards independently. The document states that "The results of the testing demonstrated that the Rotating Adapters met the predetermined acceptance criteria applicable to the safety and efficacy of the device." This implies successful standalone performance in the context of the device's function.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is compliance with established international standards (e.g., ISO 8536-4, ISO 8536-10, ISO 10993 series, ASTM F756-08, USP 36) and internal Merit Medical test protocols (Rotational Torque, Hydrostatic Pressure, Vacuum Leak). This is essentially engineering and biomaterial testing standards compliance.

8. Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm or "training set" for this physical medical device.

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

This is not applicable as there is no training set mentioned for this type of device.

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for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.

The Disposable High Pressure Injection Lines with and without Rotating Adapters are a combination of connectors and tubing bonded together for injection of radiopaque dye, saline, or other diagnostic fluids during a coronary angiography procedure. The device is designed, like other legally marketed devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe, through the high pressure line, into the catheter. The materials and properties of the device are tabled in Item 6, below.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device (Disposable High Pressure Injection Lines with and without Rotating Adapters). The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to conduct a comprehensive study on a new or innovative technology. Therefore, many of the typical acceptance criteria and study characteristics you'd expect for AI/software-as-a-medical-device (SaMD) are not applicable here.

Device: Coeur Medical, a division of Coeur, Inc. Disposable High Pressure Injection Lines with and without Rotating Adapters

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the primary difference is the manufacturer assembling components and sterilizing the devices, and that the proposed devices will offer a "more flexible device that meets the needs of the high pressure market." However, quantitative metrics for "flexibility" or how it "meets the needs" beyond the pressure rating are not provided as acceptance criteria or performance metrics directly in this summary.

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

• Sample Size: Not explicitly stated as a number of units. The document mentions "pressure testing was conducted at 1200psi to verify acceptable performance of the 'worst case' challenge," implying at least one or more units were tested.
• Data Provenance: Not applicable. These are nonclinical (bench) tests for a physical medical device, not data from patients or medical imaging.

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

• Not applicable. This relates to nonclinical physical testing, not expert-based ground truth for diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable. This relates to nonclinical physical testing, not expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No. This is a 510(k) premarket notification for a physical medical device, not an AI/SaMD product. MRMC studies are not relevant here.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Bench test results/Engineering specifications: The "ground truth" for the device's performance is against its own design specifications and functional requirements (e.g., ability to withstand 1200psi without failure, achieving a specific SAL).

8. The sample size for the training set

• Not applicable. There is no "training set" for this physical device.

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

• Not applicable. There is no "training set" for this physical device.

Summary of the Study:

The "study" described in the 510(k) summary is based on nonclinical tests to verify the functional performance of the Disposable High Pressure Injection Lines.

• Nonclinical Tests Submitted: "Verification of functional performance has been performed."
  • Pressure Testing: Conducted at 1200psi to verify acceptable performance, as this is the greatest pressure for which the device is developed ("worst case" challenge).
  • Sterilization Cycle Verification: The Coeur sterilization cycle is stated to be able to sterilize the proposed device with an SAL of 10⁻⁶, based on a comparison to products tested for inclusion in the Coeur cycle. This implies a validation of the sterilization process itself.
• Clinical Tests Submitted: "NA" (None)
• Conclusions: The testing verifies that the proposed devices are suitable for their intended use. The primary basis for substantial equivalence is that the device has similar technological characteristics (materials, intended use, sterilization method, components, pressure rating) to legally marketed predicate devices, and the nonclinical testing demonstrates equivalent performance where applicable.

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