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The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post- therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.

The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance

The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.

Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
   • Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
   • Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
   • Freeze/Thaw Stability: Not explicitly stated how many samples were used.
   • Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
   • Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
   • Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.

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

   • This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
   • For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
   • For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.

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

   • No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.

4. 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 MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).

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

   • Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.

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

   • For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
   • For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.

7. The sample size for the training set:

   • This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.

8. How the ground truth for the training set was established:

   • As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.

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The Vectors Temporary Anchorage System is a threaded titanium dental implant screw intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.

The Vectors Temporary Anchorage System consists of sterile, single-use titanium screws that are available in 6, 8, 10, and 12mm lengths which are designed to aid in dental movement by providing a rigid skeletal fixation point. They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The selfdrilling thread design allows for easy insertion and removal with the use of the system's driver. The product is sterilized using gamma radiation.

The provided text is a 510(k) summary for the Sybron Dental Specialties Vectors Temporary Anchorage System. This document focuses on establishing substantial equivalence to existing legally marketed devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself.

Therefore, many of the requested items (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable (N/A) because the regulatory pathway chosen (510(k)) does not require such studies for this type of device.

The core of this submission is to demonstrate that the new device is as safe and effective as pre-existing, legally marketed devices. This is typically done by comparing materials, design, intended use, and general performance characteristics, not through new clinical trials with detailed performance metrics.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not Applicable (N/A) - No specific test set for performance evaluation is described.
• Data Provenance: Not Applicable (N/A) - The submission is based on comparison to existing predicate devices, not on new data from a test set.

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

• Number of Experts: Not Applicable (N/A)
• Qualifications of Experts: Not Applicable (N/A)

4. Adjudication Method for the Test Set:

• Adjudication Method: Not Applicable (N/A)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was an MRMC study done? No.
• Effect size of human readers with AI vs. without AI assistance: Not Applicable (N/A) - This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.

6. Standalone (Algorithm Only) Performance Study:

• Was a standalone study done? No. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not Applicable (N/A) - The "ground truth" in a 510(k) for this type of device is the safety and effectiveness of the predicate devices to which equivalence is claimed.

8. Sample Size for the Training Set:

• Sample Size (Training Set): Not Applicable (N/A) - No training set is relevant for this type of device submission.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not Applicable (N/A) - No training set is relevant for this type of device submission.

Summary of Relevant Information from the Document:

While the document doesn't provide the requested study details, it does contain the following pertinent information:

• Device Name: Vectors Temporary Anchorage System
• Intended Use: To serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.
• Predicate Devices:
  • Medicon eG. Aarhus Anchorage System
  • Dentaurum, Tomas Pin
  • Imtec Corporation, Ortho Implant
  • Mondeal Medical Systems, Lomas Quattro
• Substantial Equivalence Claim: The Vectors Temporary Anchorage System is composed of the same material (titanium) and is substantially equivalent in application and function to the listed predicate devices.

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TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used successfully for many years in the symptomatic relief and management of chronic, intractable pain. The model 4900 series of Transcutaneous Electrical Nerve Stimulation (TENS) devices are user-interactive, microcontrolled-stimulators designed to provide lowfrequency, non-invasive electrical stimulating therapy to patients for the management of chronic, intractable pain. The model 4900 series design meets the latest electromedical standards and safety requirements, including the Performance Standard for Electrode Lead Wires and Patient Cables. The devices are microprocessor controlled and contain six preprogrammed therapy modes. The TENS devices (model 4900 series) firmware memory functions include: a nonvolatile read-only memory (ROM), last therapy recall, low battery notification and a self-check feature, which notifies the operator when a service condition exists. The ROM is designed to provide the therapy-mode accessibility, while providing the safety features, such as, zero amplitude at "startup" or when an "open channel condition is identified. The 4900 series of TENS devices are "user friendly" with a user interactive, softkey pad and a clearly visible, two-line, sixteen character, liquid crystal display (LCD) to show the operating parameters. The Model 4900S TENS device(s) are portable, personnel and designed to be easily handled with its light weight, trim (0.875" wide by 2.5" by 3.5") rectangular shaped, durable plastic shell. The device is fitted with a belt clip and can easily be worn without inhibiting the mobility of the patient. The device operates efficiently with a 9-volt battery power supply. The device delivers an output of 25 mAmp for 55 hours under a 500K Ohm load. The efficient power allocation (between the operation of the device and the electrical stimulation delivered to the patient) results from the interaction of a microcontroller; microprocessor; a crystal-controlled oscillator; RAM memory; circuit interface drivers; and a custom ROM. The crystal-controlled oscillator insures accurate timing of all pulse waveforms. The microprocessor-controller, in addition to operating the "house keeping functions", such as the LCD readouts, power on, open channel-control and the power off functions, maintains communications to the custom ROM and the variety of modalities available for the different models. The six available nreprogrammed modalities: Constant mode: SMP mode: Burst Mode: Rate Modulated Mode, Width Modulated Mode, and Multi-Modulated Mode. The physician or physical therapist may choose to use, depending on the specific model of TENS device, any one of six available modalities.

The provided document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria, sample sizes, and expert adjudications.

Therefore, the document does not contain the acceptance criteria or a study design that would typically be described for a new, innovative device proving its performance against pre-defined metrics. Instead, it relies on demonstrating that the new device (4900 Series TENS) is substantially equivalent to existing TENS devices already on the market (predicate devices).

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Performance: The document describes the technical specifications and features of the 4900 series TENS devices (e.g., output current, battery life, operating modes, safety features) but does not present these as acceptance criteria for a study or report specific performance numbers against such criteria. The "Performance Standard for Electrode Lead Wires and Patient Cables" is mentioned, indicating compliance with general electromedical and safety standards, not a specific performance study.
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size/Ground Truth: These elements are characteristic of a clinical investigation or a performance study where a device's efficacy or accuracy is being evaluated against a known truth. The 510(k) submission for this TENS device focuses on features, design, and comparison to predicate devices, not a clinical trial to establish new claims of effectiveness. The claim is for "symptomatic relief and management of chronic intractable pain," which is a well-established indication for TENS devices, generally supported by a body of evidence for the TENS modality itself, rather than requiring a de novo clinical study for each new model.

In summary, the provided 510(k) document is a regulatory submission for market clearance based on substantial equivalence, not a report of a study designed to prove device performance against specific acceptance criteria.

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