SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION

• K Number: K993969
• Device Name: SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
• Manufacturer: WINCHESTER LABORATORIES LLC.
• Date Cleared: 1999-12-30 ( 37 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, bruises and minor burns prior to removal from the wound area

Device Description

30-ml. polyethylene vial containing Saline Topical Solution, 0.9% w/v Sodium Chloride Solution. Single-use.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The documents are related to a 510(k) premarket notification for a medical device called "Saljet Single Dose Sterile Saline Topical Solution" and primarily consist of an S10K Summary and an FDA letter confirming substantial equivalence.

These documents describe:

• The submitter and contact information.
• The trade name, common name, and classification name of the device.
• The predicate device.
• A description of the device.
• Indications for use.
• A statement of substantial equivalence to a predicate device.
• FDA's letter of substantial equivalence.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

Regulation Number and Section

N/A