(97 days)
The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.
The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine. The Trucath Spinal Injection System is supplied as a sterile, single patient use, disposable device.
The provided document is a 510(k) summary for the Trucath Spinal Injection System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven device.
This submission is for a medical device that appears to be a physical product (a catheter/needle system), not a software or AI/ML device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information provided.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device. For physical devices like this, acceptance criteria would typically relate to performance aspects like material strength, sterility, leakage, fluid flow, dimensions, etc., which are usually covered in internal design specifications and verification/validation testing.
- Reported Device Performance: The document states: "Results of non-clinical testing demonstrated that the Trucath Spinal Injection System is safe and effective for its intended use" and "non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications." However, no specific performance metrics or acceptance criteria values are reported.
2. Sample sized 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 document refers to "non-clinical testing," which typically involves bench testing, material testing, and potentially some animal testing (though not mentioned here). It does not involve "test sets" in the context of data for AI/ML models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. For a physical medical device, "ground truth" would be established by validated test methods and measurements against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of data, which is not part of this device's submission.
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
- No, an MRMC study was not done. This type of study is specific to AI-assisted diagnostic devices where human readers interpret images or data. The Trucath Spinal Injection System is a physical interventional medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided in the AI/ML sense. For this physical device, "ground truth" for performance would likely come from established engineering and biological test standards (e.g., ISO standards for medical devices, material testing, sterility checks, etc.). The document only states "non-clinical testing" was done to validate performance against design specifications.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it's not an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable. This device does not use a training set.
In summary:
The provided 510(k) summary is for a physical medical device (Spinal Injection System) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It explicitly states that "non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications." However, it does not provide the specific performance data, acceptance criteria values, or details of the test methodologies that would be necessary to answer most of your detailed questions, as those questions are primarily relevant for AI/ML-driven medical devices.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).