(84 days)
Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
Para-Pak SPINCON involves passing a surfactant treated, preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.
SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml
The provided text describes a medical device called Para-Pak SPINCON used for concentrating parasites from fecal specimens. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent performance and recovery to predicate device (Para-Pak CON-Trate) | Clinical studies demonstrate equivalent performance and recovery. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "Clinical studies."
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 to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It compares the device's performance to a predicate device, but not in the context of human reader improvement with or without AI assistance.
6. Standalone Performance Study:
A standalone performance study was conducted to demonstrate the device's ability to concentrate eggs, larvae, and protozoa from preserved fecal specimens. The "Performance" section explicitly states "Clinical studies demonstrate equivalent performance and recovery" in comparison to the predicate device. This implies the device was evaluated on its own merits for this purpose.
7. Type of Ground Truth Used:
The ground truth used appears to be the detection and recovery of parasites from fecal specimens, with the predicate device (Para-Pak CON-Trate) serving as the benchmark for "equivalent performance and recovery" in clinical studies. This suggests a benchmarking against an established and validated method.
8. Sample Size for the Training Set:
The document does not provide information on a training set sample size. This device is a concentration system, not an AI or machine learning algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established:
As this is a physical device for specimen concentration and not an AI algorithm, the concept of a "training set" and establishing "ground truth for the training set" as it relates to AI is not applicable. The device's performance is likely evaluated through laboratory and clinical studies demonstrating its ability to correctly concentrate parasites from known positive and negative samples, as well as samples from clinical cases.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.