Search Results

Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

Here's a breakdown of the acceptance criteria and study details for the SeraQuest HSV Type 2 Specific IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Precision Testing: 6 serum specimens (2 negative, 4 positive) and the SeraQuest Positive and Negative Controls. Each sample/control was assayed in triplicate, on three separate occasions, at three different laboratories (Quest International and two external independent laboratories). This results in a total of 27 data points per sample/control (3 triplicates * 3 occasions * 3 labs).
   • Specificity Testing:
     • HSV 1 IgG: 9 samples
     • CMV IgG: 11 samples
     • VZV EBNA IgG: 14 samples
     • VZV VCA IgG: 17 samples
     • VZV IgG: 21 samples
     • Measles IgG: 19 samples
     • Rubella IgG: 18 samples
     • Toxoplasma IgG: 6 samples
     • Syphilis IgG: 4 samples
     • Human Papilloma Virus: 7 samples
     • Chlamydia trachomitis: 8 samples
     • Neisseria gonorrhea: 7 samples
     • Provenance: Samples positive for various related pathogens/antibodies but negative for Type 2 HSV by another legally marketed device. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections.
   • Interference Testing: Samples that were negative, weakly positive, and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of specific interfering substances. (No specific number of samples provided for this test).
   • Comparison with Predicate Device:
     • Sexually Active Adults: 164 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from a clinical laboratory in the Southeastern United States.
     • Expectant Mothers: 242 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from clinical laboratories in the Northeastern and Southeastern United States. 82% from first trimester, 8% second, 10% third.
   • CDC Panel: 100 sera (30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples). Provenance: Centers for Disease Control and Prevention (CDC) serum panel.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated for most studies.

   • For the cross-reactivity study, the samples were determined positive for various related pathogens "by other legally marketed devices" and confirmed negative for Type 2 HSV by a legally marketed device. This implies a standard diagnostic process, but no specific human experts or qualifications are mentioned for this initial determination.
   • For the comparative studies with the predicate device (Immunoblot), the ground truth was established by the predicate device itself. While the predicate device is a "legally marketed" test, it doesn't specify human expert interpretation or qualifications.
   • For the CDC Panel, the ground truth is "CDC consensus results" and the panel samples are described as "well characterized," implying established expert consensus or reference methods. No specific number of experts or their qualifications are detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. The ground truth seems to be established by reference methods or legally marketed devices rather than direct human adjudication of results in most cases. For the CDC panel, it's "CDC consensus results," which implies an agreed-upon truth, but the adjudication method isn't described.

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 involving human readers or AI assistance was conducted or reported for this device. This is an IVD (In Vitro Diagnostic) assay, not an imaging AI device.

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

   • Yes, the performance characteristics (sensitivity, specificity, precision, etc.) of the SeraQuest HSV Type 2 Specific IgG assay were evaluated as a standalone device. Its results are compared to a predicate device (Immunoblot) or a "well characterized serum panel" (CDC panel). There is no "human-in-the-loop" component described for this specific device in the context of its performance evaluation.

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

   • Precision: Internal controls and reference samples.
   • Specificity: Samples characterized by other legally marketed devices (positive for related pathogens, negative for HSV-2) and confirmed sexually transmitted infections.
   • Interference: Artificially spiked samples.
   • Comparison Studies: A "commercial HSV 2 Immunoblot test" (predicate device) was used as the reference standard for both sexually active adults and expectant mothers. This is a type of reference test ground truth.
   • CDC Panel: "CDC consensus results" from a "well characterized serum panel." This implies expert consensus or a gold standard determination for each sample in the panel.

7. The sample size for the training set: Not applicable and not mentioned. This document describes the performance evaluation of a medical device (an ELISA assay), not a machine learning or AI model that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

1. Patients with disc protrusions.
2. Patients with mild disc herniations.
3. Patients with pinched nerves.
4. Patients with limited spinal flexibility.
5. Patients with muscle spasms.
6. Patients with spinal vertebral fixations.
7. Patients with spinal facet imbrication and fixation.
8. Patients with spinal nerve root radiculitis.
9. Patients with foraminal encroachment.

The Bass Antalgic-Trak is a multi-functional traction device. It is chair like in its appearance and The Dass Amargic Truk is a mark tull sit upon a chair or recliner. The chair/table can recline the patient 90 degrees. It maintains the patient's sitting posture during the recline. the patient 90 degrees: it maintains the parchies befores 24 inches wide by 20 inches tong by I it is seat bottom is a viry? covered assist as a seat bottom, at the knee joint, the 5 inches ticep backed by 74 men pry roomes as a calf support. The cushion continues 18 inches to support the calves. This seat-bottom section can manually rotate 80 degrees left or right, support the carves. This sout ootion socure, manually flex forward and backwards 45 degrees. manually facerary and 55 asglobal to backwards 6 inches by engaging an electric The chiller motor. This is to accommodate taller patients with longer thighs. There are 3 leather/vinyl straps that secure the patient to the seat bottom. Strap 1 securers over the iliac leather vinyl straps that secure the parent stup 3td secures over the shins. The seat back of the chair is viral 2 socures over the might is 20 inches tall and 18 inches wide and 3 inches deep Chan is villy covered done roam lead is vinyl covered dense foam. It is 12 inches tall by 8 backed with 74 men pry wood. It is mounted to the mounted to the upper portion of the chair's top frame. The headpiece has a vinyl strap to secure the forehead onto the headpiece. the chair o top the chair/table is 60 inches long. In the upright posture, the chair height is 60 which rechned, the seat-bottom is powered by an electric single-columned actuator motor. The headpiece cervical traction is powered by an electric single-columned actuator motor. The thigh extension of the seat bottom is powered by an electric single-columned actuator motor. The table/chair recline is powered by an electric single-columned actuator motor. The seat-I he table/enan footine is powered of as e cervical traction may be powered manually using foot pottom fulliour traction as foot pedal for each. The traction can be "auto" cycled using the control panel. The thigh adjustment length and table/chair recline must be engaged using the control panel. The clinician must set all functions.

This 510(k) premarket notification for the Bass Antalgic-Trak is a submission for a Class II medical device (Powered Traction Table) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through an independent study with detailed performance metrics.

Therefore, the document does not contain the information required to fill out the requested table regarding acceptance criteria and performance, nor does it describe a study that would meet the specified criteria (e.g., sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details).

This type of 510(k) summary primarily:

• Identifies the device and its manufacturer.
• States the intended use and indications for use.
• Lists predicate devices to which substantial equivalence is claimed.
• Provides a brief device description.

It does not include:

1. Acceptance criteria table or reported device performance: There are no specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, effect size) reported in this document. The submission relies on claiming equivalence to predicate devices that are already approved.
2. Sample size, data provenance for a test set: No study with a test set is described.
3. Number of experts and qualifications for ground truth: No ground truth establishment is described as there's no independent study.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not performed or reported. This would typically be for diagnostic or screening devices evaluating human reader performance with and without AI assistance.
6. Standalone performance: Not performed or reported. This device is a physical traction table, not a standalone algorithm.
7. Type of ground truth used: Not applicable as no new clinical study to establish performance metrics is described.
8. Sample size for training set: Not applicable as there is no AI algorithm being trained.
9. How ground truth for training set was established: Not applicable.

Ask a specific question about this device

The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

The SCIMED Luge Guide Wire utilizes the same materials and methods of construction as currently marketed SCIMED Guide Wires (ChoICE, Sceptor and ChoICE PT Families of Guide Wires).

Here's an analysis of the provided text regarding the SCIMED® Luge™ Guide Wire, focusing on the requested information.

It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical study reports with detailed performance metrics against pre-defined acceptance criteria. Therefore, some of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, ground truth establishment for AI/ML models, and detailed adjudication methods, is not present in these documents. The device cleared is a guide wire, which is a medical device, not an AI/ML diagnostic tool, thus many of the AI/ML specific questions are not applicable.

Acceptance Criteria and Study for SCIMED® Luge™ Guide Wire

The SCIMED Luge Guide Wire's acceptance criteria and proven performance are based on its substantial equivalence to previously marketed SCIMED Guide Wires (ChoICE, Sceptor, and ChoICE PT Families). The study primarily involved non-clinical testing and comparison of design and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a clinical trial demonstrating new performance metrics. The comparison is based on the design, materials, manufacturing processes, and non-clinical testing results against existing predicate devices.
• Data Provenance: The data provenance is from non-clinical testing of the Luge Guide Wire and comparison with the design specifications and known performance characteristics of the predicate SCIMED Guide Wires. This is retrospective in the sense that it relies on established data and designs of existing products. The country of origin for the data is implied to be within the US, where SCIMED Life Systems, Inc. is located.

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

• Not Applicable. This device clearance is based on substantial equivalence to predicate devices through non-clinical testing and design comparison, not on establishing a "ground truth" for diagnostic accuracy by a panel of experts.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no clinical "test set" requiring expert judgment for ground truth, no adjudication method is described. The review process is handled by the FDA based on the submitted non-clinical data and comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study is not mentioned as part of this 510(k) submission. These studies are typically for AI/ML diagnostic devices where the performance of human readers with and without AI assistance is evaluated. This device is a guide wire, not a diagnostic AI/ML system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This device is a physical medical instrument (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" here is the established safety and effectiveness profile of the predicate devices (ChoICE, Sceptor, and ChoICE PT Families of Guide Wires) in their intended use. The Luge Guide Wire's equivalence is demonstrated against this established standard through physical and engineering comparisons.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" in the conventional sense for model development. The design and manufacturing processes are likely informed by years of experience and testing with previous guide wire designs, but not in the format of a discrete "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

Ask a specific question about this device