(208 days)
For use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumen allows for sump gravity, irrigation function or application of anesthetic to relieve postoperative pain.
This Axiom Multipurpose Wound Drain is simplicity of design assures effective operation with added convenience. It is a conveniently sized double Lumens Catheter made of silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 14 Fr. up to 36 Fr. coated or no coated will be offered. The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first proximal end and connected with polypropylene Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.
Here's an analysis of the provided text regarding the Axiom Multipurpose Wound Drain, focusing on acceptance criteria and study information:
Based on the provided document (K993592), there is no specific information about detailed acceptance criteria or a dedicated study with performance metrics for this device.
The document, a 510(k) Summary for the Axiom Multipurpose Wound Drain, states that the device is "substantially equivalent" to predicate devices. This type of clearance relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring a full-scale clinical trial with specific performance targets.
Here's an attempt to answer the questions based on the limited information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The core "acceptance criteria" for 510(k) clearance is showing substantial equivalence to predicate devices. | The document states: "The test results demonstrate that the device is substantially equivalent to the legally marketed predicate devices." |
Explanation: The 510(k) process focuses on demonstrating equivalence to existing devices. Therefore, the "performance" here refers to the device being able to perform the same functions (drainage, irrigation, local anesthetic application) with similar safety and efficacy profiles as the predicate devices, rather than achieving specific quantitative metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document refers to "test results" in a general sense, not a specific clinical study with a defined sample size. These "tests" would likely have been bench testing or performance testing against engineering specifications, rather than patient data.
- Data provenance: Not specified. It's highly probable that any testing conducted would have been internal, pre-market bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. For this type of device and 510(k) submission, "ground truth" established by experts in a clinical context (e.g., radiologists, pathologists) is not typically required or mentioned. The assessment would be against engineering specifications and comparison to the predicate device's design and functionality.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. Performance evaluation for this device in a 510(k) context would likely involve engineering testing and comparison to predicate device specifications, not expert adjudication of clinical outcomes.
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
- MRMC study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI or image interpretation. The Axiom Multipurpose Wound Drain is a surgical fluid management device, not a diagnostic one.
- Effect size of human reader improvement with AI: Not applicable. The device does not involve AI or human "readers" in the context of image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This device is not an algorithm. Its performance is related to its physical capabilities for drainage and irrigation. The "performance data" mentioned in the document would refer to mechanical and functional integrity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated, but for this type of device, "ground truth" would likely involve engineering specifications and functional performance metrics (e.g., flow rates, pressure resistance, material compatibility, sterility) demonstrated through bench testing and validated against the predicate device's known performance characteristics. It would not involve clinical ground truth like pathology or outcomes data in the way a diagnostic device would.
8. The sample size for the training set
- Sample size for training set: Not applicable. This device is not an AI algorithm, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as there is no training set for this device.
In summary: The provided document is a 510(k) submission which primarily focuses on demonstrating substantial equivalence to a predicate device. This process typically relies on bench testing, material characterization, and comparison to the predicate's design and intended use, rather than extensive clinical studies with detailed performance metrics or "ground truth" established by an expert panel in the way that AI-powered diagnostic devices would require.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).