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K Number
K024148
Device Name
SALINUM, ORCLAIR
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2003-09-15

(273 days)

Product Code
LFD
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K981693,K991938
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.

Over the counter Labeling stipulates that ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Device Description

SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the format requested.

The document is a 510(k) summary for a medical device called SALINUM® / ORACLAIR, an artificial saliva intended for the relief of dry mouth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown of why the requested information is absent:

  1. Acceptance Criteria Table and Reported Device Performance: This information is not present. The submission states, "Functional and performance testing has been conducted to assess the safety and effectiveness of SALINUM® and all results are satisfactory." However, it does not specify what those criteria were or detail the performance metrics.
  2. Sample Size for Test Set and Data Provenance: No details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.
  3. Number of Experts and Qualifications for Ground Truth: Since no performance study against a ground truth is described, there is no mention of experts or their qualifications.
  4. Adjudication Method: Not applicable as no adjudication process is detailed.
  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study, or any comparison to human reader performance, is mentioned.
  6. Standalone Performance Study: While "functional and performance testing" is mentioned, no specific standalone algorithm performance study with detailed results, metrics, or methodology is provided. The submission primarily focuses on equivalence.
  7. Type of Ground Truth Used: No ground truth is described for a performance study.
  8. Sample Size for Training Set: This is not applicable as SALINUM® / ORACLAIR is a pharmaceutical product (saliva substitute), not an AI/algorithm-based device that would require training data.
  9. How Ground Truth for Training Set Was Established: Not applicable for the reasons stated above.

The document is a regulatory submission for a physical medical device (oral solution), not an AI/software device that would typically involve the type of performance evaluation outlined in your request. The "Tests and Conclusions" section simply states that "functional and performance testing has been conducted... and all results are satisfactory," without providing details of these tests, criteria, or results.

N/A