(157 days)
The Appraise-Cardio sample collection kit is a prescription device indicated for use for obtaining a blood specimen which can be collected at the patient's home or at a physician's office in a sample collection tube and delivered to the laboratory by mail. This specimen is then used to determine the patient's total cholesterol, triglycerides, HDL and LDL values. The results are then mailed to the patient's physician for evaluation.
The Appraise-Cardio Sample Collection Kit is a Sample Collection Kit which is sent to the patient's home after the kit has been ordered by the patient's physician. The kit consists of the following:
- A Sample Collection Tube. -
- A Sample Collection Capillary Tube. -
- -A Sample Tube Holder Box.
- A Patient Identification Card which contains the patient's name, address, Social Security Number, t information, the physician's name and phone number and a bar code number that is peeled off and affixed to the Sample Collection Tube after the sample has been taken.
- A pamphlet containing detailed information about the lipid program and instructions on how to obtain a blood sample and mail it to a laboratory.
- A plastic zip lock bag marked "Specimen Collection Envelope" into which the Sample Collection Tube is placed.
- An absorbent pad that is contained in the Specimen Collection Envelope. -
- A plastic zip lock bag marked "Waste". -
- A self-adhesive envelope in which the specimen envelope is inserted and then mailed to the preprinted address on the envelope.
- -A sterile lancet
- -An alcohol swab
- A sterile gauze pad -
- -A sterile adhesive bandage
- The mailing envelope which is used to mail the above items to the patient. .
The Sample Collection Tube, Sample Collection Capillary Tube, lancet, alcohol swab, gauze pad and adhesive bandage are all legally marketed, commercially available items.
After receiving the Appraise-Cardio Sample Collection Kit in the mail, the patient then collects a blood sample, using a lancet supplied in the kit or purchased separately by the patient. The blood sample is placed in the Sample Collection Tube as described in the instructions. The bar code sticker from the Patient Identification Card is then affixed to the Sample Collection Tube which is then placed in the Specimen Collection Envelope. The Patient Information Card and Specimen Collection Envelope are then placed in the mailing envelope. The mailing envelope is then sealed and sent to a laboratory for processing. When the blood sample is received by the laboratory the patient's total cholesterol, triglycerides and HDL values are measured using existing reagent kits.
The Osborn Group Appraise-Cardio Sample Collection Kit is a device intended for collecting blood samples at home or a physician's office, which are then mailed to a laboratory for analysis of total cholesterol, triglycerides, HDL, and LDL. The primary concern addressed by the testing was to ensure that the blood samples remain accurate even after being subjected to the extreme temperatures and humidity conditions that can occur during mail delivery.
Here's an analysis of the provided information:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or stability).
The reported device performance is: "The results were within acceptable limits." This qualitative statement indicates that the environmental testing confirmed the samples' accuracy was maintained.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Sample accuracy maintained after exposure to extreme temperatures and humidity during mail transport | Samples tested after environmental exposure (simulating mail conditions) showed results within acceptable limits for total cholesterol, triglycerides, HDL, and LDL values. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the environmental testing.
The data provenance is not explicitly stated, but the study appears to be prospective as it involved subjecting the Appraise-Cardio Sample Collection Kit to simulated environmental conditions. It is implied the samples were collected and then intentionally exposed to these conditions for testing purposes. No information is provided regarding the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. It implies that standard laboratory analytical procedures and existing reagent kits were used to measure the lipid values, but does not detail the process of defining "acceptable limits" or who verified the ground truth before and after environmental exposure.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It states that the "results were within acceptable limits," suggesting a comparison against predetermined standards or baseline measurements, but the process for making this determination is not described (e.g., whether multiple experts reviewed the results and reached a consensus).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with image-based diagnostic devices where human readers interpret results, sometimes with AI assistance. The Appraise-Cardio Sample Collection Kit is a blood sample collection and transport system, and the testing focused on sample stability rather than interpretive performance by human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The device itself is a collection kit; the analysis of the blood sample is performed by "existing reagent kits" in a laboratory. The testing focused on the integrity of the collected sample after transport, not on an algorithm's performance.
7. The Type of Ground Truth Used
The type of ground truth used is implicitly laboratory measurement data from existing reagent kits for total cholesterol, triglycerides, HDL, and LDL. The "acceptable limits" for these measurements post-environmental exposure likely referred to established clinical ranges or stability criteria for these analytes, comparing them to initial measurements of the same samples or control samples.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning components. Therefore, the concept of a training set sample size is not applicable to this device or its reported testing.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set or machine learning components, this question is 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.