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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.

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MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.

The devices of this submission are orbital volume replacement implants formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.

This document is a 510(k) summary for a medical device (MEDPOR® Plus Orbital Volume Replacement Implants) and, as such, it does not contain the type of detailed information about acceptance criteria, study design, and performance metrics typically found in clinical trial reports or validation studies for AI/ML devices.

The information provided describes the device, its intended use, and its substantial equivalence to previously cleared devices. It confirms that the device is cleared for marketing but does not include any performance data or clinical study results in the manner requested by your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert qualifications, effect sizes of AI assistance, etc.).

Therefore, I cannot extract the requested information from this document. The prompt asks for details that are not present in this 510(k) summary.

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The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Polymedco HbA1c Test, an in vitro diagnostic device. It does not contain any information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria.

The letter primarily focuses on the substantial equivalence determination of the device to legally marketed predicate devices, which allows it to proceed to market. It outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot extract the requested information from the provided input. The document is a regulatory approval notice, not a performance study report.

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Components of the Inter-Op™ HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement.

While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component.

Diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System include:

• revision of a previously implanted acetabular prosthesis;
• patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and,
• inflammatory joint disease; e.g., rheumatoid arthritis.

The Inter-Op™ HA Porous Acetabular System consists of a Ti-6Al-4V alloy (ASTM F136) shell which utilizes a polyethylene snap-in liner. Hydroxylapatite (HA) coated Cancellous Structured Titanium™ (CSTi™) porous coating provides biological fixation in a cementless application. The shells are available in a variety of sizes and designs to address different clinical situations in both primary and revision arthroplasties. Inter-Op HA Porous Acetabular Components are recommended for use with all Sulzer Orthopedics total hip replacement devices.

The system includes two primary designs: (1) a hemispherical shell with an offset outer radius in the rim region, which permits the loads to be transmitted to the periphery of the outer surface; and (2) a hemispherical shell with two plugged screwholes. The plugs may be removed intraoperatively for additional screw fixation, if desired. A dome hole plug is also provided.

Two multi-holed shells designed for screw application are provided for those clinical situations in which deficient bone stock exists in the acetabulum. Those screwholes that are not utilized may be plugged after implantation. This shell is available in two designs: (1) a standard hemispherical cup, and (2) a protrusio cup which adds 10mm of thickness of the medial wall over a standard hemispherical cup to address protrusio deficiencies in the acetabulum. A dome hole plug is also provided.

All the shell designs share identical internal geometry and locking mechanism thereby accepting any of the acetabular liners designed for this system. The acetabular liner is manufactured from Ultra-High Molecular Weight Polyethylene, or UHMWPE (ASTM F648) and is offered in various configurations in order to address different clinical situations. The liners are also available in a variety of sizes to accommodate available femoral head components.

The provided document is a 510(k) summary for a medical device (Inter-Op™ HA Porous Acetabular System), primarily focused on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or a detailed engineering validation might.

Instead, the document states that the device is "substantially equivalent" to existing marketed devices. This regulatory pathway means that extensive new clinical efficacy studies with predefined acceptance criteria are typically not required, as the safety and effectiveness are presumed to be similar to the established predicate devices.

Therefore, most of the information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this type of regulatory submission. The focus is on demonstrating similar characteristics and intended use.

However, I can extract what limited relevant information is present:

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

The document doesn't explicitly state acceptance criteria in a quantitative table with specific metrics that were "met." It rather states:

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

Not applicable/Not provided. The document does not describe a clinical "test set" in this context. The evaluation was likely based on engineering tests and comparison to predicate device specifications.

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):

Not applicable/Not provided. Ground truth establishment for a diagnostic device or a comparative clinical study is not described.

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

Not applicable/Not provided.

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/Not provided. This is a medical device (hip prosthesis), not an AI-assisted diagnostic tool for human readers.

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

Not applicable/Not provided. This is not an algorithmic device.

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

Not applicable/Not provided in the context of a "test set" for performance evaluation. The "ground truth" for this device would be its ability to provide biological fixation and function as a hip replacement, which is inferred through its similarity to predicate devices and general knowledge of orthopedic implants.

8. The sample size for the training set:

Not applicable/Not provided. This type of device does not involve a "training set" in the context of machine learning.

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

Not applicable/Not provided.

Summary based on the provided text:

The submission for the Inter-Op™ HA Porous Acetabular System is a 510(k) premarket notification. The core of this submission is a demonstration of substantial equivalence to legally marketed predicate devices, rather than an independent demonstration of meeting new, specific acceptance criteria through a clinical study. The only performance aspect explicitly mentioned is the integrity of the locking mechanism, which "compares favorably to other currently marketed devices," implying a comparison against established industry standards or predicate device performance, rather than a novel, quantitative acceptance criterion. The FDA's letter explicitly states, "The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation only)."

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