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Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.

Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.

This is a 510(k) premarket notification for a Class I microbiology specimen collection and transport device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and training sets for an AI/ML algorithm is not present in this document.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that a direct comparison against a predicate device was performed, rather than an independent study with acceptance criteria and statistical analysis of performance as would be expected for an AI/ML device.

Here's what can be extracted from the document relevant to a traditional medical device submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the manner of an AI/ML device study. Instead, the FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This typically implies that the device performs comparably to the predicate device for its intended use. For
a microbiology specimen collection and transport device, acceptance criteria would likely relate to its ability to:

• Effectively separate fecal debris.
• Preserve eggs, larvae, protozoa, and juvenile nematodes for subsequent analysis.
• Be compatible with specified preservatives (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR).
• Maintain the viability or integrity of the parasites within the specified timeframes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it's a 510(k) summary focused on substantial equivalence. A detailed study protocol with sample sizes, data provenance, and study design (retrospective/prospective) would be part of the supporting documentation submitted to the FDA, but is not included in this letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "ground truth" established by experts is typically relevant for diagnostic devices that produce an output requiring expert interpretation (e.g., imaging devices, AI algorithms). For a specimen collection and transport device, the "ground truth" would be established by laboratory methods assessing the recovery and preservation of parasites, which is distinct from expert consensus on an interpretation. The document does not provide details on such a study or expert involvement in establishing performance benchmarks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable in the context of this device and the information provided. Adjudication methods are typically for resolving discrepancies in expert interpretations, which is not the primary evaluation method for a specimen collection and transport device.

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 a traditional medical device, not an AI/ML driven diagnostic.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this type of device would likely be based on laboratory-confirmed presence and condition of parasites. This would typically involve microscopic examination by trained laboratory personnel after processing the samples and comparing results from the device against a gold standard method. The document does not specify this type of detail.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a traditional medical device, not an AI/ML device.

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ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from: fecal debris in preserved fecal specimens.

Fecal specimens that have been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be mated to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen.

The filtered specimen may then be concentrated by centrifugation, and observed microscopically.

ParaCon II / Fecal Concentrator II is a filtration device.

The provided text is a 510(k) premarket notification letter from the FDA to Para Scientific, Inc. regarding their ParaCon II / Fecal Concentrator II device. This document is a regulatory approval letter and does not contain the acceptance criteria, study details, or performance data typically found in a scientific study or a detailed technical submission for a medical device.

Therefore, I cannot provide the requested information. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed based on its stated indications for use. It doesn't include the specific study details that would demonstrate how acceptance criteria were met.

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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:

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.

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