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The plastic and metal resheathers are placed at or near the point of use and allow one handed needle resheathing. The plastic and foam resheather/needle holder is placed at or near the point of use and allows one handed needle resheathing or allows the user to place the needle into the foam to temporarily hold it prior to disposal.

The Resheathing Devices are constructed of metal or placed securely at or near the point of use and enable the healthcare worker to single handedly recap, or hold a hypodermic syringe, blood. collection device, or IV administration set.

The provided text [0-3] is a 510(k) summary and associated FDA correspondence for "Resheathing Devices" manufactured by Sage Products, Incorporated. It details the device's identification, intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or any of the other specific items requested in your prompt regarding a study that proves the device meets acceptance criteria.

The document is a regulatory submission for a medical device (a needle resheather/holder), which is a physical product, not an AI/software-based device. Therefore, the concepts of "device performance" in terms of accuracy, sensitivity, specificity, MRMC studies, or training/test sets are not applicable to the information provided.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often based on technological characteristics and intended use, rather than extensive clinical performance studies with acceptance criteria as one might see for a diagnostic algorithm.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or any of the other detailed study information, based on the provided text.

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The Sage Sharps Disposal Containers with Screw Top Caps is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, and Blood Needles. The containers can be used in variety of healthcare settings. The containers are suitable for physician offices, dental offices, laboratories, home health and other generators of medical waste. The containers are also appropriate for patient room applications.

The Sage Products, Inc. Sharps Containers with Screw Top Caps are molded, single use, non-sterile, disposable, sharps disposal containers. The containers are designed to hold used sharps such as angio-caths, blood needles, lancets and various sized syringes. Various sizes of the container will be offered to meet customer disposal needs. The shape of the container will either be rectangular or circular depending upon its size. The only access to the container is through the screw top closure. Products will be available with or without a neck insert at the opening to limit the ability of the sharps to exit the container after disposal.

The provided text describes a Pre-Market Notification (510K) for Sharps Containers with Screw Top Caps and does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with AI/ML medical devices. The document focuses on regulatory compliance, design features, and substantial equivalence to predicate devices.

However, I can extract the "Design Features" and their "Safety and Effectiveness Basis" which can be interpreted as the functional requirements or "acceptance criteria" that the device is intended to meet. The "study" in this context refers to the rationale and regulatory references provided for each design feature, rather than a formal clinical or technical performance study with quantitative results.

Here's the information extracted from the document, framed to best answer your request:

Acceptance Criteria and Documented Device "Performance"

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

Additional Information Not Present in the Document:

The provided text is a summary for a traditional medical device (sharps containers) and does not involve AI/ML. Therefore, the following points are not applicable or cannot be answered from the provided text:

2. Sample sized used for the test set and the data provenance: Not applicable. The document discusses design features and regulatory compliance for physical sharps containers. It does not refer to a "test set" in the context of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant for this device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for these containers is their physical adherence to safety standards and regulations (e.g., puncture resistance, leak-proof).
8. The sample size for the training set: Not applicable. There is no training set for a physical sharps container.
9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" and "Proof" within this context:

The "study" that proves the device meets the "acceptance criteria" (design features) is implicitly the Pre-Market Notification (510K) submission process itself. This process requires the manufacturer to demonstrate that their device is "substantially equivalent" to predicate devices already on the market. The provided "Safety and Effectiveness Basis" for each design feature serves as the manufacturer's justification and commitment that the device meets these functional requirements, usually through adherence to established standards (like OSHA regulations) or through internal testing (e.g., "impact resistance test will provide information...").

The FDA's letter (K980490) confirms that, based on the information provided in the 510(k) submission, the device is considered substantially equivalent and can be marketed, implying that the detailed justification for each design feature (which would have included test reports or validated design specifications) was satisfactory.

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The Sage 2 Gallon Alternate Care Sharps Container is intended for single use disposal of used or contaminated medical sharps, including, but not limited to, hypodermic needles, syringes, lancets, IV Cassettes, and Blood Needles. Sage 2 Gallon Alternate Care Sharps Containers are used in both clinical and nonclinical settings.

The Sage 2 Gallon Alternate Care Sharps Container is an injection molded, single use, non-sterile, disposable, sharps disposal container. The product is designed to hold sharps such as angio-caths, blood needles, lancets and various sized syringes and non-sharps such as drug infusion cassettes.

I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance results, or any study conducted for the "2 Gallon Alternate Care Sharps Container."

The document is a 510(k) Pre-Market Notification summary, which focuses on:

• Company and Device Identification: Identifying Sage Products Inc. and the specific sharps container.
• General Description: Describing the device's basic characteristics (injection molded, single-use, non-sterile, disposable, designed to hold sharps).
• Substantial Equivalence: Listing predicate devices to which the current device is deemed substantially equivalent. This is a key part of the 510(k) process, arguing that the new device is as safe and effective as a legally marketed device.
• Design Features and Safety/Effectiveness Basis: This section lists the design features like impact resistance, puncture resistance, leak resistance, etc., and cites regulatory references (OSHA Bloodborne Pathogens 21 CFR 1910.1030) as the basis for these features. It does not provide acceptance criteria values or test results of the device against these features. It only states why these features are important.
• FDA Clearance Letter: Confirming that the FDA has reviewed the notification and determined the device is substantially equivalent, allowing it to be marketed.
• Indications For Use: Stating the intended purpose of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: No test set or study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no study is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on regulatory clearance based on substantial equivalence to existing devices, not on detailed performance study results against specific acceptance criteria.

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The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..

The Sharps Shuttle and Sharps Shuttle with Locking Mechanism are injection or blow molded, single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc. The Sharps Shuttles may be viewed as a portable sharps containment device that provides an alternative to the procedure of resheathing a needle with its original protective cover which is not a recommended practice or disposing of the sharp in a non-sharps container. The products are designed to hold sharps such as angio-caths, blood needles, lancets and small syringes.

The container is cylindrical for rigidness and has a conical taper. The product body is non colored translucent plastic and is approximately 6 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap which when snapped closed contains the biohazardous sharps for safe conveyance.

Locking and non locking versions are available. Both versions have a temporary closure which can be reopened for the placement of additional sharps prior to terminal disposal. In addition to the temporary closure, the locking Sharps Shuttle with Locking Mechanism can be permanently locked by engaging the locking tab.

Each unit is individually labeled with a biohazard label. Sharps Shuttles are available singly or packaged in a dispenser with an attached carrying handle for easy transport of unused containers. The dispenser is available for the storage of the device prior use. The dispenser does not function as an accessory for use, nor, is it intended to transport containers with biohazardous waste.

The provided document, a 510(k) summary for the Sharps Shuttle, describes the device and its intended use, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical AI/software device.

This 510(k) is for a physical medical device (a sharps container) and thus its "acceptance criteria" are related to product performance and safety, demonstrated through physical tests rather than a study with a test set, ground truth, or statistical performance metrics.

Therefore, many of the requested elements for an AI/software device study are not applicable to this document. I will extract the relevant information where possible and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Design Features" and their "Safety and Effectiveness Basis." These "Design Features" serve as the de facto acceptance criteria for this physical device, outlined by reference to OSHA regulations and general safety principles. The document describes the features but does not provide specific quantitative acceptance criteria values or detailed test results, only the basis for needing these features.

Details of the "Study" (as applicable to a physical device 510(k)):

• 2. Sample size used for the test set and the data provenance:

  • Sample size: Not specified. For a physical device, this would typically involve testing a sample of manufactured units. The document only lists design features and their safety basis.
  • Data provenance: Not applicable. This is not a data-driven device; its performance is assessed via physical testing against FDA/OSHA requirements for sharps containers. The document originates from Sage Products Inc. (Crystal Lake, IL, USA) and is a pre-market notification to the FDA in the USA.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. "Ground truth" in this context refers to the regulatory requirements for sharps containers (OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030), rather than expert consensus on interpretive data. The document implies compliance with these established regulations.

• 4. Adjudication method for the test set:

  • Not applicable. Performance is likely determined by meeting defined physical test specifications, not by subjective expert adjudication.

• 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 physical device, not an AI/software device.

• 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 AI/software device.

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

  • The "ground truth" for the requirements of this device is based on regulatory standards and safety guidelines (specifically OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030) for physical sharps containers.

• 8. The sample size for the training set:

  • Not applicable. This is a physical device, not an AI/software device that requires a training set.

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

  • Not applicable. This is a physical device, not an AI/software device.

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A medical glove worn on the hand of a healthcare worker and similar personnel to prevent contamination between healthcare personnel and patient. In addition, this glove is worn for the protection of the wearer against exposure to chemotherapeutic agents.

8 mil thick, Non Sterile, fitted or ambidextrous, Nitrile gloves with beaded cuff extending beyond the wrist.

This document does not contain information about an AI/ML device or a study comparing AI with human readers. The document is a 510(k) summary for Sage Nitrile Gloves, a medical device (examination glove), submitted to the FDA in 1997. It describes the device, its intended use, a substantial equivalence comparison to other gloves, and lists performance tests conducted according to various ASTM and FDA standards for physical properties and biocompatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, comparative effectiveness, standalone performance, ground truth, or training set details as this information is not present in the provided text.

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Containment and Counting of Sponges in the Operating Room or a hospital setting.

Pocket Count: Transparent, compartmentalized, disposable bag which allows visual confirmation of sponge count and visual estimate of absorbed fluid. Pocket Count provides partial containment of contaminated sponges, thereby, decreasing worker exposure to contents.
SafeTCount: Transparent, disposable hand shaped covering which is used to collect sponges. When the covering is turned inside out it contains the contaminated sponges thereby decreasing worker exposure to contents. The SafeTCount allows visual confirmation of sponge count and visual estimate of absorbed fluid.

This document is a 510(k) premarket notification for the "Pocket Count or SafeTCount" surgical sponge counter. It primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices. As such, it does not contain a typical study where specific acceptance criteria are set and then experimentally proven by the device.

Instead, the document details a comparison study to establish substantial equivalence based on design and intended use, rather than a performance study with quantitative acceptance criteria.

Here's an analysis of the information provided:

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

The document does not present acceptance criteria in the traditional sense of measurable performance targets (e.g., accuracy, sensitivity, specificity) with associated reported device performance. Instead, the "performance" section of the substantial equivalence comparison table (page 3, {3}) states:

This indicates the device's capacity, which is a design specification, not a performance metric that would typically be tested against acceptance criteria in a clinical study. The "acceptance criteria" here implicitly revolve around demonstrating that the new devices (Pocket Count and SafeTCount) are substantially equivalent in their intended use, design, material, and performance characteristics (like capacity) to legally marketed predicate devices.

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

• Sample Size for Test Set: Not applicable. This submission is for a physical device (surgical sponge counter) and does not involve a "test set" of data in the context of an algorithm or diagnostic device. The evaluation is based on comparing design features and stated capacities to predicate devices.
• Data Provenance: Not applicable for a typical "test set" as described for an algorithm. The data provenance would refer to the characteristics of the predicate devices themselves (e.g., "legally marketed in interstate commerce prior to May 28, 1976").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context would generally refer to a medical diagnosis or outcome used to evaluate an AI/diagnostic device. For a surgical sponge counter, the "truth" is whether it effectively contains and allows counting of sponges as designed, which is assessed through design comparison and manufacturer claims, not expert consensus on diagnostic data.

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

Not applicable. There is no test set in the sense of diagnostic data requiring adjudication. The FDA's review process determines substantial equivalence based on the submitted information comparing the device to predicates.

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 document is for a physical medical device (surgical sponge counter), not an AI or diagnostic tool that would involve human readers or cases.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. The "ground truth" for this type of device is its functional design and capacity to hold sponges, which is inherently understood through its physical properties and intended use. The comparison is against predicate devices that perform the same function.

8. The sample size for the training set

Not applicable. This is not an AI or algorithm-driven device that requires a training set.

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

Not applicable. There is no training set for this device.

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Combinations of products for the convenience and personal protection of the end user from blood, body fluids and chemicals while conducting specific procedures. The kits will include disposable, single use items for blood, drug or chemical spill clean up, drug preparation and/or drug administration.

Procedure Specific kits are non-sterile kits that bundle or package together combinations of products for the convenience of the user. This saves the end user the time and effort of retrieving the individual products each time a procedure is performed. Kit components are purchased as released finished goods in finished package form. To assemble a kit, individual products are selected, sealed in a polybag or other suitable container, and labeled with a contents label. If the finished package form is more than one unit, Sage will remove the number of units specified for the kit being assembled. The item will be repackaged in the kit without compromising the integrity of the product. There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness.

This document is a 510(k) Summary for "Procedure Specific Kits" from Sage Products Inc., dated February 14, 1997. It describes convenience kits that bundle various products for specific medical procedures.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, expert ground truth, etc.).

The document focuses on the description of the device as non-sterile convenience kits, the process of assembling them, and their substantial equivalence to predicate devices under the pre-market notification process.

Here's why the requested information cannot be provided from this text:

• Type of Device: The "device" in question is a "convenience kit" or a "procedure specific kit." These are essentially repackaged collections of existing, cleared or pre-amendment medical devices. The document explicitly states: "There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness."
• Regulatory Pathway: The submission is a 510(k) pre-market notification, which seeks to demonstrate substantial equivalence to a predicate device. It is not a submission for a novel, high-risk device requiring extensive clinical trials or performance studies with the detailed metrics you've asked for.
• Focus of the Document: The content emphasizes that the individual components bundled in the kits are already cleared or exempt devices, and the packaging of these components does not affect their safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, expert involvement, or AI performance because the provided document does not contain this type of information. It falls outside the scope of this particular 510(k) submission, which is more about administrative bundling of pre-existing, cleared components rather than demonstrating novel device performance.

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Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination

The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Zinc and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position. Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifuge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.

The provided document describes the Pre-Market Notification for the STPTM System - PVA with Zinc, a fixative-preservative for intestinal parasite examination. The study described focuses on the functional performance of the device.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides qualitative acceptance criteria and a statement of successful performance against those criteria. It does not provide quantitative metrics such as sensitivity, specificity, accuracy, or a numerical "reported device performance" value.

Study Details:

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

   • Sample Size: Not explicitly stated. The document mentions "Specimens were evaluated at independent clinical laboratories," but does not specify the number of specimens or the number of product units tested.
   • Data Provenance: Not explicitly stated. The evaluation was done at "independent clinical laboratories," but the geographic location is not specified. It is likely prospective, as it describes a "performance evaluation" of the product.

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)

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The document states "microscopic evaluation," implying trained laboratory personnel, but no specific professional titles or experience levels are provided.

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

   • Adjudication Method: Not specified. The evaluation involved subjective assessment of "satisfactory" or "unsatisfactory" functional performance, but the process for reaching this determination (e.g., single reader, consensus, majority vote) is not described.

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

   • MRMC Study: No. This study is a functional performance evaluation of a medical device (specimen collection and preservation system), not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable.

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

   • Standalone Performance: Not applicable. This device is a manual specimen collection and preservation system, not an algorithm. Its performance is entirely dependent on human-in-the-loop procedures for preparation and microscopy.

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

   • Type of Ground Truth: The ground truth for functional performance was established by observing ideal characteristics of microscopy slides. Specifically, it was determined by observing:
     • Adherence of the smear to glass slides.
     • Well-fixed cells with typical morphology and color, examined under a microscope.
   • The "presence of parasites" (mentioned in the conclusion) is the ultimate diagnostic goal, but the study focused on the functional performance of the fixative to allow for that examination, using white blood cells as a proxy for parasites in the testing methodology.

8. The sample size for the training set

   • Sample Size for Training Set: Not applicable. This pre-market notification describes a performance evaluation of a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

   • Ground Truth for Training Set: Not applicable, as there is no training set in this context.

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Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination

The product is comprised of a conical shaped centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. A stand is provided to keep the tube in the upright position. A spoon is attached to the cap and contained within the tube. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifinge tube and the cap/spoon assembly is securely closed. The collection tube is shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The tube also contains an integral filter which separates large debris from the specimen and facilitates concentration of the specimen. The sample can be used for permanent staining, concentration, and/or wet mount procedures. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tube containing the sample.

The provided text describes a pre-market notification for the STP™ System - SAF, a fixative-preservative for intestinal parasite examination. The goal is to demonstrate substantial equivalence to Meridian's Para-Pak® SAF Fixative.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state quantitative acceptance criteria in terms of specific percentages or thresholds (e.g., "sensitivity of X%"). Instead, the acceptance is based on a qualitative functional evaluation that aims to ensure the device performs comparably to established methods for preparing stool specimens for parasite examination.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The text mentions "Specimens were evaluated at independent clinical laboratories," but does not provide the number of specimens or the number of units of the device tested.
• Data Provenance: Not explicitly stated. It mentions "independent clinical laboratories," but the country of origin is not specified. The study appears to be prospective in nature as it describes a specific testing procedure for evaluating the functional performance of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The evaluation involved "microscopic evaluation of permanent slides and wet mounts," implying trained laboratory personnel or medical professionals, but their specific qualifications (e.g., medical technologists, parasitologists) are not detailed.

4. Adjudication Method

• Adjudication Method: Not described. The evaluation concluded with a binary outcome ("satisfactory or unsatisfactory"), but the process by which this determination was made, especially if multiple evaluators were involved, is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the functional performance of the device itself rather than comparing human reader performance with and without AI assistance. The context is a device for specimen preparation, not an AI diagnostic tool.

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

• Standalone Study: Yes, in a sense, a standalone device performance study was done. The evaluation assessed the device's ability to fix and preserve specimens, leading to well-prepared slides suitable for microscopic examination, without human variability being the primary focus of the performance measure. The "algorithm" here is the physical and chemical mechanism of the fixative and filter, not a computational AI algorithm. The performance was assessed based on the quality of the prepared slides directly attributed to the device's function.

7. The Type of Ground Truth Used

• Ground Truth: The ground truth for evaluating the device's performance was based on artificially spiked samples and expert interpretation of the quality of the prepared slides. White blood cells (buffy coat from uncoagulated human blood) were used "in lieu of parasites" and added to human stool specimens. The "ground truth" for the device's function was that these added cells should be well-fixed, display typical morphology and color, and allow for thorough microscopic examination. This is an objective assessment of the device's preservation and preparation capabilities.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. This device is a physical product (fixative-preservative system), not a machine learning model that requires a training set. The "training" in this context refers to standard laboratory procedures and established chemical principles.

9. How the Ground Truth for the Training Set was Established

• Training Set Ground Truth: Not applicable. As mentioned above, this is not an AI/ML device requiring a training set with established ground truth. The "ground truth" for its development would be the known efficacy of SAF solution and the physical design for specimen collection and preparation.

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Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination

The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Mercury and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position. Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifyge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.

The provided document describes the STP™ System-PVA with Mercury, a fixative-preservative for intestinal parasite examination. The purpose of the study was to evaluate the functional performance of this system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Based on the "Performance Test Summary," the acceptance criteria and reported performance can be interpreted as follows:

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of tubes/specimens) used in the performance evaluation. It only states that "Specimens were evaluated at independent clinical laboratories" and that "white blood cells [...] are added to product tubes containing human stool specimens."
• Data Provenance: The document does not explicitly state the country of origin. It mentions "independent clinical laboratories," but their location is not specified. The study appears to be prospective in nature, as it describes a controlled method for evaluating the functional performance of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document does not specify the number or qualifications of experts who established the "ground truth" (i.e., evaluated the slides and wet mounts) for the test set. It states that "microscopic evaluation of permanent slides and wet mounts" was performed, but does not detail who conducted these evaluations.

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

• The document does not describe any adjudication method for the test set. It only states that product function was "evaluated as either satisfactory or unsatisfactory."

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the functional performance of a fixative-preservative system, not on evaluating human reader performance, AI assistance, or diagnostic accuracy in the context of reader studies.

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. This device is a component of a manual laboratory procedure, and therefore, an "algorithm only" study is not applicable. The evaluation relies on human observation and interpretation of prepared slides.

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

• The "ground truth" for evaluating the functional performance appears to be expert microscopic evaluation of prepared slides and wet mounts, based on predefined criteria for "satisfactory" fixation and morphology (i.e., well-fixed cells, typical morphology and color, good smear adherence). It's based on the observable quality of the preserved cellular material. The study explicitly uses white blood cells "in lieu of parasites" to assess the preservation capabilities of the system.

8. The sample size for the training set

• This concept is not applicable to this type of device and study. The STP™ System is a medical device (fixative-preservative), not an AI algorithm that requires a training set.

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

• This concept is not applicable as there is no training set for this medical device.

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