(37 days)
The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.
The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained health care professional to obtain an oral fluid specimen and have the specimen contained for transport to a laboratory. The device consists of the following:
- A collector pad holder/handle with a collector pad, contained in a sealed "peel-apart" plastic envelope. . The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a predetermined amount of oral fluid has been collected.
- An Oral Fluid Collection Tube with a screw-on lid, containing preservative fluid. ..
- A clear plastic sealed envelope that contains all three of the above items. .
The provided text describes the "Osborn Laboratories Oral-Eze™ Oral Fluid Collection System." Since this is a collection device and not a diagnostic or AI-powered system, the typical acceptance criteria and study designs (like MRMC studies) for such devices are not applicable in the same way they would be for an AI algorithm interpreting medical images.
Instead, the performance evaluation focuses on direct comparison to predicate devices and ensuring the practical utility and stability of the collected specimens.
Here's an analysis based on the provided text, adapted for a medical device that collects biological samples:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Metric | Predicate Device A (Saliva Collection Device, K942435) Performance (Implied) | Predicate Device B (EpiScreen™ Oral Collection Device, K973395 and K970357) Performance (Implied) | Oral-Eze™ Oral Fluid Collection System Performance |
|---|---|---|---|---|
| Substantial Equivalence | Overall functional equivalence for oral fluid collection and preservation. | Established as safe and effective. | Established as safe and effective. | Claimed to be substantially equivalent to both predicates. |
| Specimen Collection Time | Not explicitly stated, but implies similar or acceptable collection time. | Performance not quantified. | Performance not quantified. | Tested to be comparable to Saliva-Sampler. |
| Volume Collected | Not explicitly stated, but implies similar or acceptable volume. | Performance not quantified. | Performance not quantified. | Tested to be comparable to Saliva-Sampler. |
| Specimen Stability (Environmental) | Ability of collected oral fluid specimens to remain stable under extreme temperatures (e.g., during transport). | Not explicitly stated/tested; relevant for Oral-Eze. | Not explicitly stated/tested; relevant for Oral-Eze. | Test results within acceptable accuracy limits for specimens subjected to environmental testing. |
| Indications for Use (Prescription) | Intended for use by person under supervision of trained health care professional to collect, contain, and preserve oral fluid specimens for transport to laboratory. | Yes | Yes | Yes (Matches) |
| Non-Sterility | Device is not sterile. | Saliva-Sampler: Sterile. | EpiScreen: Not sterile. | Device is not sterile. (Comparable to EpiScreen on this characteristic). |
| Specimen Storage/Transport | Ability to contain and preserve specimens effectively during transport. | Yes | Yes | Yes |
| Indicator for Sufficient Collection | Visual indicator for predetermined amount of oral fluid collected. | Not mentioned. | Not mentioned. | Blue color appears in indicator port when predetermined amount is collected. (Unique feature to Oral-Eze compared to mentioned predicates). |
Note: The text explicitly states "The test results demonstrated that the Oral-Eze device is substantially equivalent to the Saliva-Sampler predicate device" for characteristics like collection time and volume. For environmental stability, it states "The test results were considered to be within acceptable accuracy limits." The specific quantitative thresholds for these metrics are not provided in the summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text only mentions "To assess the suitability... both the Oral-Eze device and the Saliva · Sampler predicate device were tested for a number of characteristics." For environmental testing, it notes "Oral-Eze collection tubes with collector pads containing oral fluid specimens were subjected to environmental testing."
- Data Provenance: Not explicitly stated. The testing seems to be internal to Osborn Laboratories. Given it's a pre-market submission, it would typically be conducted under controlled laboratory conditions, possibly drawing from a pool of healthy volunteers for initial collection tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This level of detail is not provided. For a device like this, "ground truth" would likely involve objective measurements (e.g., volume collected, chemical analysis of preservative efficacy, stability of drugs/analytes in collected samples, if relevant, although not detailed here). The "suitability" and "acceptable accuracy limits" would be determined by laboratory professionals or engineers with expertise in medical device testing and quality control.
4. Adjudication Method for the Test Set:
Not applicable or provided. This is typically for subjective assessments (e.g., image interpretation). Performance for this device would rely on objective measurement against pre-defined engineering or performance specifications.
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. This device is a fluid collection system, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used:
For the performance testing mentioned:
- Comparison to Predicate Performance: The "ground truth" for collection time and volume was likely the observed performance of the predicate device (Saliva-Sampler).
- Defined Acceptable Limits: For environmental stability, the "ground truth" would be pre-defined "acceptable accuracy limits" for the integrity and chemical stability of the oral fluid specimens after exposure to extreme temperatures. This would usually be based on established laboratory standards or regulatory guidance for specimen transport.
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.