(268 days)
20mL Normal Saline Topical Solution is usled for moistening and lubricating absorbent wound dressing prior to removal from the wound area.
The subiect device is a 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride. It is used for moistening and lubricating absorbent wound dressings prior to removal from the wound area. Normal Saline Topical Solution 0.9% w/v is a unit-dose low density polyethylene vial containing a. clear, colourless, aqueous solution. Normal Saline Topical Solution contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
The provided text describes a 510(k) summary for a medical device called "20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not available in the provided text.
Here's a breakdown of what can and cannot be extracted from the document:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided. The document does not define explicit acceptance criteria or report performance metrics in the way one would for a clinical or analytical study. The primary acceptance criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally marketed predicate device.
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. No test set or associated sample size is mentioned, as this is not a study reporting new performance data. The submission relies on a comparison to a predicate device.
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. No ground truth establishment is described, as there is no test set or study being conducted in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication method is described.
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. No MRMC study or AI assistance is mentioned. This device is a topical solution, not an AI-assisted diagnostic tool.
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-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No ground truth is established or used in the context of a performance study for this submission. The "ground truth" for the 510(k) equivalence claim is the performance and safety profile of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. No machine learning model or training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No machine learning model or training set is mentioned.
Summary of what is available from the document:
The document is a 510(k) summary for a medical device. The "study" (or rather, the basis for clearance) is a comparison of the subject device to a predicate device to demonstrate substantial equivalence.
- Device Name: 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride
- Intended Use: For moistening and lubricating absorbent wound dressings prior to removal from the wound area.
- Predicate Device: Brennen Medical, Incorporated's Sterile Saline Solution (510(k) K935060, cleared on January 10, 1994).
- Basis for Equivalence: The subject device is a topical sterile saline solution classified as a "liquid bandage" with the same intended use as the predicate device.
- Claimed Equivalence: "Although there are technological differences between the subject device and the predicate device, these technological differences do not raise new questions of safety and effectiveness."
The provided text simply states that a comparison was made to support substantial equivalence, but it does not detail the specific data or tests performed for that comparison, nor does it provide performance acceptance criteria beyond the general requirement of not raising new safety or effectiveness concerns.
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