(70 days)
The MICROTAINER® Brand Chemistry tubes with MICROGARD™ Closure are intended to collect, transport, and store skin puncture blood specimens for chemistry determinations requiring serum or heparinized plasma.
The modified MICROTAINER® Brand Chemistry Tubes with MICROGARD™ Closure are non-sterile, single use microcollection tubes. They consist of a polypropylene reservoir with an integral blood collector component, a skirted polyethylene closure with a recessed plug that reduces user exposure to blood.
This 510(k) summary describes a device, the MICROTAINER® Brand Chemistry Tubes with MICROGARD™ Closure, which is a blood collection tube. The study presented is a comparison to a predicate device, not an AI/algorithm-driven device, so many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's the breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is being compared to a predicate device, and the acceptance criteria are implicitly that the new device performs "equivalent or better" in terms of hemolysis and clotting, and demonstrates "equivalent results" for chemistry analytes, with any biases not being "clinically significant."
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hemolysis | Equivalent or better performance compared to predicate tube. | The principal device (with MICROGARD™ Closure) demonstrated equivalent or better performance compared to the predicate device. The study showed trace hemolysis in only one control tube (predicate device), implying no or less hemolysis in the principal device. |
| Clotting | Equivalent or better performance compared to predicate tube. | The principal device (with MICROGARD™ Closure) demonstrated equivalent or better performance compared to the predicate device. The study showed no clotting in any evaluation tube (principal device) or control tube (predicate device). |
| Chemistry Analytes | Equivalent results compared to predicate device, with any bias not clinically significant. | The principal device (with MICROGARD™ Closure) demonstrated equivalent results to the predicate device for most of the analytes tested. The predicate device demonstrated a positive bias for several analytes, however, this bias was not considered clinically significant. (The specific analytes or magnitude of bias are not detailed in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The summary refers to "Clinical testing" and "the study" but does not quantify the number of patients or samples involved.
- Data Provenance: Not explicitly stated, but clinical testing implies human samples. The country of origin is not specified, but the submission is to the US FDA, so US-based data is plausible. The study design sounds prospective as it involved comparing a new device against a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device (blood collection tube) comparison study, not an AI diagnostic study requiring expert ground truth establishment in the traditional sense. The 'performance' relates to physical and chemical properties of blood samples.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of diagnostic findings. Performance was likely assessed through laboratory analysis (e.g., spectrophotometry for hemolysis, visual inspection for clotting, automated chemistry analyzers for analytes).
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 is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-driven device.
7. The Type of Ground Truth Used
The "ground truth" here is the direct measurement of clinical performance outcomes related to blood collection:
- Presence/absence and degree of hemolysis
- Presence/absence of clotting
- Measurements of various chemistry analytes in plasma using a device like the Johnson and Johnson Vitros 250 Chemistry Analyzer.
The comparison is against a legally marketed predicate device, effectively using its established performance as a benchmark for "equivalence."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.