(58 days)
The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.
The Smith & Nephew CDS System consists of a control unit with a fluid delivery module with user interface, a remote control, and a sterile, single-use fluid delivery syringe, tube set, and remote sleeve.
The provided 510(k) summary for the Smith & Nephew CDS System describes a medical device, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria through performance evaluation relevant to diagnostic accuracy or clinical outcomes.
Instead, the documentation focuses on:
- Substantial Equivalence: The primary basis for clearance is demonstrating substantial equivalence to a predicate device (Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082).
- Safety and Engineering Standards: The summary reports compliance with biocompatibility and electrical safety standards, as well as software verification and validation.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 | Compliance with established standard. |
| Electrical Safety | Meets UL 60601-1-1, IEC 60601-1-1, and IEC 60601-1-2 | Compliance with established standards. |
| Electromagnetic Compatibility (EMC) | Meets EN 55011 | Compliance with established standard. |
| Software Functionality | Software verification and validation testing performed | Indicates proper software function, but no specific performance metrics are given. |
| Bench Performance | Additional bench performance testing performed | General statement; no specific performance data or criteria provided. |
| Clinical Performance (Accuracy/Effectiveness) | Not specified | No specific clinical or diagnostic accuracy acceptance criteria or performance metrics are provided. The claim is "as safe and effective, and performs at least as well as the legally marketed devices for the same intended use" based on the above engineering and safety tests and comparison to the predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided: The summary indicates "software verification and validation testing" and "additional bench performance testing," but does not specify sample sizes for these engineering tests. There is no mention of a clinical test set, or data provenance in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: This device is for fluid dispensing and pressure monitoring during discography, not for image interpretation or diagnosis. Therefore, the concept of "ground truth" derived from expert consensus for a test set (e.g., image-based diagnosis) is not relevant to the information presented. The ground truth for functional verification would be the device's ability to accurately dispense fluids and monitor pressure, assessed through engineering and bench testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: Adjudication methods are typically used in studies involving expert interpretation (e.g., radiology reads) to establish a consensus ground truth. This is not relevant to the type of testing described for the Smith & Nephew CDS System.
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 / Not Provided: This device is a fluid dispensing and pressure monitoring system, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study and effects on human reader performance with AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This is not an algorithm-only device in the diagnostic sense. The device is an automated system for fluid delivery and pressure monitoring. Its "standalone" performance would be its ability to perform its mechanical and electronic functions as designed, which is generally covered by the software verification and validation, and bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Performance Specifications: For the reported tests (biocompatibility, electrical safety, EMC, software verification, bench testing), the "ground truth" would be the predefined engineering specifications and regulatory standards. For example, the ground truth for electrical safety is successful adherence to the parameters set forth by UL 60601-1-1.
8. The sample size for the training set:
- Not Applicable / Not Provided: As this is primarily an electro-mechanical device with specific software functions, the concept of a "training set" in the context of machine learning (AI) is not relevant or mentioned in the summary. Development would involve iterative design and testing, but not a "training set" in the common AI sense.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: See point 8. No training set is mentioned.
In summary: The provided 510(k) documentation focuses on essential safety and engineering performance standards, software validation, and demonstrating substantial equivalence to a predicate device. It defines performance in terms of meeting these foundational requirements rather than through a clinical study with detailed acceptance criteria for diagnostic accuracy or clinical outcomes that would typically be seen for devices like AI-powered imaging tools.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.