(49 days)
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.
| Test Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | - Merit Rotational Torque Test |
- 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.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.