Search Results

The Technozvm ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet poor human citrated plasma. The assay is intended to be used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA).

The Technozym ADAMTS13 Activity assay is an enzyme linked immunosorbent assay (ELISA) used for detection of ADAMTS13 activity in citrated human plasma. The assay contains: ADAMTS13 Activity anti-GST coated test plate microplate coated with anti-GST antibody, ADAMTS13 Activity GST-VWF73 reagent that contains GST tagged peptide of 73 amino acids from the A2 domain of VWF with specific cleavage site for ADAMTS13 and serves as the in vitro substrate for ADAMTS13, ADAMTS13 Activity Calibrators-consists of six vials containing lyophilized plasma, each with a different level of ADAMTS13 activity, ADAMTS13 Activity Controls consists of two vials of lyophilized plasma, each with high or low levels of ADAMTS13 activity, ADAMTS13 Activity Conjugate - reagent that contains horseradish peroxidase (HRP) conjugated monoclonal antibody directed against the neoepitope exposed due to cleavage of GST-VWF73 by ADAMTS13 present in plasma, ADAMTS13 TMB substrate reagent contains tetramethylbenzidine (TMB) substrate for HRP, ADAMTS13 Activity Stop Solution reagent contains 2.5% sulfuric acid for stopping the conversion of TMB substrate.

The Technozym ADAMTS13 Activity assay is a manual enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet-poor human citrated plasma. It is used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA). The assay's clinical cutoff for TTP diagnosis is 0.1 IU/mL ADAMTS13 activity.

Acceptance Criteria and Device Performance

The primary acceptance criteria for this device appear to be related to its analytical performance (precision, specificity), and its clinical performance (sensitivity and specificity for TTP diagnosis).

Here's a table summarizing the reported device performance, which implicitly serves as the acceptance criteria based on the successful De Novo grant:

Ask a specific question about this device

The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid annulus.

The Tri-Ad 2.0 Adams, Model 900SFC, consists of an MP35N polished and formed wire stiffener fitted with 2 end caps. The band is covered with a braided polyester fabric. The stiffener runs from the posteroseptal commissure to the anterior segment distal to the anteroposterior commissure. The stiffener helps remodel and stabilize the enlarged portion of the tricuspid annulus. The band has 3 radial green markers to locate the following 3 areas of the band:

• The end of the stiffener section at the posteroseptal commissure.
• The anteroposterior commissure. ●
• The end of the stiffener section in the anterior segment of the band. ●
  A green demarcation suture runs around the middle of the band in the stiffener region. The band size refers to the dimension of the band where the implantation sutures are placed, except in the stiffener region. The internal stiffener, and the radiopaque core in both fully flexible ends of the band, provide radiographic visualization along the entire circumference of the band is available in the following sizes: 26 mm, 28 mm, 32 mm, 34 mm, and 36 mm.

The provided document is a 510(k) summary for a medical device called the "Tri-Ad™ 2.0 Adams Tricuspid Band." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way one might see for novel technologies or AI algorithms.

Therefore, the document does not contain the acceptance criteria or a study proving it meets those criteria in the traditional sense of a clinical trial or performance validation for an AI device. Instead, the submission describes the device, compares it to a predicate device, and lists the types of verification testing performed to demonstrate fundamental safety and performance.

Here's an analysis based on the information provided, explaining why certain sections cannot be filled:

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

   This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence through design characteristics and verification testing, rather than setting specific performance criteria (e.g., sensitivity, specificity, accuracy) that an AI device would typically have, or reporting specific clinical outcomes against quantitative targets.

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 applicable/not present in the document. The "tests" mentioned (Visual Inspection, Biocompatibility, Sterilization, Design Validation / Human Factors Engineering) are engineering and technical verification tests, not clinical performance studies that would involve test sets of patient data.

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 information is not applicable/not present. Ground truth, in the context of clinical performance, is not discussed as there were no clinical performance studies involving interpretation of data by experts. The "ground truth" for the device's characteristics would be established through engineering specifications and material testing standards.

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

   This information is not applicable/not present. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for a diagnostic or AI-assisted task. This document details a medical device, not an AI diagnostic tool.

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

   This information is not applicable/not present. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance. The Tri-Ad™ 2.0 Adams Tricuspid Band is an annuloplasty ring, a physical implantable device, and not an AI-powered diagnostic or assistive tool for human readers.

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

   This information is not applicable/not present. This refers to the performance of an AI algorithm in isolation. The described device is a physical medical implant.

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

   This information is not applicable/not present in the context of clinical performance. For the engineering tests mentioned (Biocompatibility, Sterilization, etc.), the "ground truth" would be established by validated test methods and established standards confirming material properties, sterility, etc.

8. The sample size for the training set

   This information is not applicable/not present. "Training set" refers to data used to train an AI model.

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

   This information is not applicable/not present. This refers to the process for annotating data for AI model training.

Summary of Device Acceptance/Equivalency:

The document focuses on demonstrating substantial equivalence to a predicate device (Tri-Ad™ Semi-Flexible Tricuspid Annuloplasty Ring, K093903). The "acceptance criteria" are implied by the regulatory framework for 510(k) submissions: the device must be as safe and effective as a legally marketed predicate device.

The study that "proves" the device meets these (implied) criteria consists of:

• Comparison to Predicate Device: The document highlights that the Tri-Ad 2.0 Adams tricuspid band is "identical" to the predicate in Intended Use, Principles of Operation, Sterilization, Shelf Life, Packaging, and Size Range. Minor modifications are noted in product labeling but are deemed substantially equivalent.
• Verification Testing: A list of performed studies is provided:
  • Visual Inspection
  • Biocompatibility
  • Sterilization
  • Design Validation / Human Factors Engineering

The conclusion states that "Based upon the testing performed, the modifications to the Tri-Ad 2.0 Adams do not affect the intended use of the devices or alter the fundamental scientific technology of the devices. No change has been made to the implantable band. Therefore, Tri-Ad 2.0 Adams is substantially equivalent to the currently marketed predicate device."

In essence, the "acceptance criteria" here are regulatory (substantial equivalence), and the "study" is a combination of direct comparison to a predicate and basic engineering verification tests demonstrating that the device itself, and the minor modifications, do not introduce new questions of safety or effectiveness.

Ask a specific question about this device

The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).

Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The ADAMS A1c HA-8180V is intended for Professional Use Only.

The CALIBRATOR 80 is for the calibration of the ADAMS A1c HA-8180V system used for the quantitative determination of hemoglobin A1c in human whole blood and hemolysate samples.

For In Vitro Diagnostic Use Only.

The ADAMS A1c HA-8180V system is a fully automated analyzer that uses ion exchange high performance liquid chromatography (HPLC) technology to separate glycated (labile A1c(L-A1c) and stable A1c (S-A1c)) and non-glycated (HbA0) forms of hemoglobin.

Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The subject device consists of the ADAMS A1c HA-8180V test analytical instrument and CALIBRATOR 80, which is used to calibrate the HA-8180V. The ADAMS A1c HA-8180V system is for use in professional clinical laboratory settings.

This method is certified by the National Glycohemoglobin Standardization Program (NGSP).

Hemoglobin test samples are prepared by automated dilution of anticoagulated whole blood in Hemolysis Washing Solution 80H. Alternately, hemolysis samples may be prepared "off-line" by manual dilution of anticoagulated whole blood with Diluent 80. The sample is then injected into the column, which contains a filter to remove sample impurities. The differing polarity and ionic charges of the released hemoglobin fractions bind with variable strength to the negatively charged stationary phase of the column. The mobile phase, consisting of three eluents of increasing ionic strength, is injected into the column. Hemoglobin fractions eluted from the column are identified and quantified using light absorption, and are measured at 420 nm and 500 nm. The dual wavelength colorimetric analysis of the separated peaks is processed by a microcomputer to obtain peak identification and hemoglobin fraction quantitation. All pre-analytical and analytical steps are performed automatically by the ADAMS A1c HA-8180V system. Tests may be ordered in batch or for STAT measurement.

HbA1c and HbF results are reported in the presence of HbC, HbD, HbE, or HbS. A result of the detected HbC or HbS, and a peak resulting from HbD or HbE is also listed in the peak information. When a peak resulting from HbD or HbE is detected, a 'V' is listed in the peak information. HbA1c and HbF results are not reported when the instrument detects other peaks that affect HbA1c measurement value. The identification of any of these variants is not intended for use in diagnosis of hemoglobinopathies.

This document describes the validation study for the ADAMS A1c HA-8180V system, a device for quantitative determination of hemoglobin A1c.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample sizes used for the test set and data provenance

• Precision Study:
  • Sample Size: 4 EDTA whole blood samples from different donors at approximate HbA1c concentrations of ~5.0%, ~6.5%, ~8.0%, and ~12.0%, and 3 quality control materials. Each sample was run in duplicate in two runs per instrument per day for 20 days across three instruments and three reagent lots.
  • Data Provenance: The study was conducted at ARKRAY, USA, Edina, MN. It is a prospective study, as samples were "utilized in the study" and data "collected at ARKRAY."
• Method Comparison Study:
  • Sample Size: 143 variant-free whole blood K2-EDTA samples.
  • Data Provenance: The samples were collected from donors in an unspecified country (likely the US, given the study location in Minneapolis, MN) and were "variant-free." The study is likely prospective, involving the collection and testing of these specific samples.
• Hemoglobin Variant Study:
  • Sample Size: 165 samples known to contain Hemoglobin variants A2, C, D, E, F, or S.
  • Data Provenance: Not explicitly stated, but implies a collection of samples with known variants, likely from a clinical setting. It's a retrospective analysis of samples or prospective collection of specific variant samples.

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

Ground truth for the test set was not established by human experts in a subjective manner as it is an in vitro diagnostic device for quantitative measurements.

• Precision Study: The ground truth was based on the device's own measurements of samples at known approximate HbA1c concentrations and quality control materials.
• Method Comparison Study: The ground truth (reference method) was established by a secondary NGSP reference laboratory using a previously cleared HPLC method (Tosoh G8), which is itself standardized and traceable.
• Hemoglobin Variant Study: The ground truth (reference method) was a method "that has been demonstrated to be free from the hemoglobin interference being tested." This implies an established and validated reference method for comparison, not expert consensus.

4. Adjudication method for the test set

Not applicable. This is a quantitative diagnostic device, and ground truth is established by reference methods or material characteristics, not subjective human assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic (IVD) system, not an imaging or interpretive device that typically involves human readers.

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

Yes, the studies presented are standalone performance evaluations of the ADAMS A1c HA-8180V system. It is an automated analyzer, so its performance is inherently standalone (algorithm/instrument only) without human-in-the-loop performance affecting the results.

7. The type of ground truth used

• Precision Study: Intrinsic measurement from known samples and quality control materials.
• Method Comparison Study: The "gold standard" or reference method was the results from a secondary NGSP reference laboratory using a previously cleared HPLC method (Tosoh G8), which is traceable to IFCC and DCCT.
• Hemoglobin Variant Study: A "reference method that has been demonstrated to be free from the hemoglobin interference being tested."
• Linearity/Reportable Range: Theoretical values based on dilution factors of samples with known low and high HbA1c concentrations.

8. The sample size for the training set

This device does not utilize a "training set" in the context of machine learning. It is a chemical analyzer based on ion exchange HPLC technology. Its performance characteristics (precision, accuracy, linearity, interference) are evaluated directly through studies, rather than by training a model on data.

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

Not applicable, as there is no "training set" in the machine learning sense for this type of IVD device.

Ask a specific question about this device

Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions.

The ADAMANT ZIRCONIA DISC is a ceramic block, composed of partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) (Y-TZP) that can be cut/milled for forming dental restorations such as crowns and bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. The ADAMANT ZIRCONIA DISC is designed for milled production on commercial CAD/CAM systems. After milling the disc, it is final sintered, so the Zirconia Disc is transformed into the object as dental restorations.

The provided text describes a 510(k) premarket notification for the "ADAMANT ZIRCONIA DISC," a dental ceramic material. This means the filing is to demonstrate substantial equivalence to existing legally marketed devices, rather than a de novo approval requiring extensive clinical efficacy trials. Therefore, the information provided focuses on non-clinical performance data and comparison to predicate devices, not on detailed acceptance criteria for a diagnostic AI device or a comparative effectiveness study with human readers.

Based on the provided document, here's what can be extracted:

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

The document doesn't provide a typical "acceptance criteria" table for a diagnostic AI device. Instead, it details performance criteria against international standards for dental ceramic materials and biocompatibility:

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

The document does not specify sample sizes for individual tests. It refers to "non-clinical testing" and lists various tests, but without quantifying the number of samples or specimens used for each. There is no information regarding data provenance (country of origin, retrospective/prospective), as these are material property tests rather than clinical data.

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 section is not applicable to this device. The ADAMANT ZIRCONIA DISC is a material for dental restorations, not a diagnostic device requiring expert interpretation or ground truth establishment based on clinical judgment. The "ground truth" for its performance is determined by adherence to scientific and engineering standards (ISO 10993, ISO 6872) through physical and chemical laboratory tests.

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

This is not applicable. The tests performed are laboratory-based material characterizations, not assessments requiring expert adjudication of clinical findings.

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:

This is not applicable. The device is a dental ceramic material, not an AI-powered diagnostic system. No human reader studies, with or without AI assistance, were performed or are relevant to its approval.

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

This is not applicable. The device is a physical material, not an algorithm.

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

The ground truth for the performance of the ADAMANT ZIRCONIA DISC is based on established international standards for dentistry ceramic materials (ISO 6872) and biological evaluation of medical devices (ISO 10993). These standards define the acceptable physical, chemical, and biological properties a material must possess. The "ground truth" is therefore derived from the specifications and testing methodologies outlined in these widely recognized standards.

8. The sample size for the training set:

This is not applicable. The ADAMANT ZIRCONIA DISC is a material, not a machine learning model. There is no "training set."

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

This is not applicable. As there is no training set for a material, there is no ground truth established for it in this context.

Ask a specific question about this device

The Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not so severe as to require total valve replacement.

The decision to undertake valvuloplasty can be made only after visual analysis of the lesion present. The most favorable conditions for valvuloplasty using an annuloplasty ring are a combination of a distended natural valve ring associated with supple valve cusps and normal chordae tendineae.

The remodeling valvuloplasty technique with a prosthetic ring may be used in all acquired or congenital mitral insufficiencies with dilatation and deformation of the fibrous mitral annulus.

For Type I mitral insufficiencies with no subvalvular lesions and normal valvular movements, this ring technique used alone is sufficient. However, the ring technique must be associated with mitral valvuloplasty repair in Type II insufficiencies with prolapsed valve due to elongation or rupture of the chordae tendineae and in Type III insufficiencies with limitation of valvular movements due to fusion of the commissures of chordae tendineae, or chordal hypertrophy.

The Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring, model 4100 (IMR ETlogix) is constructed of titanium alloy and has a sewing ring margin that consists of a layer of silicone rubber covered with a woven polyester cloth.

This 510(k) premarket notification for the Carpentier-McCarthy-Adams IMR ETlogix Mitral Annuloplasty Ring, model 4100, does not contain information about specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details regarding diagnostic performance.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria. The key sections stating this are:

• Comparative Analysis: "It has been demonstrated that the Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is comparable to the predicate devices in design, intended use, materials, and principal of operation."
• Functional/Safety Testing: "The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring has successfully completed design verification testing."
• Conclusion: "The Carpentier-McCarthy-Adams IMR ETlogix mitral annuloplasty ring is substantially equivalent to the predicate devices."

Therefore, I cannot populate the table and answer your specific questions about acceptance criteria, study details, and performance metrics as they are not present in the provided text. The document does not describe a study involving diagnostic performance, human readers, or ground truth establishment.

A 510(k) submission typically aims to show that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove novel performance against specific quantitative criteria, especially for Class II devices like this annuloplasty ring. The "design verification testing" mentioned would primarily ensure the device meets its own internal design specifications and safety requirements, rather than a diagnostic performance study.

Ask a specific question about this device

The ADAM amplifier system is intended for recording routine EEG and EEG associated with long term monitoring for epilepsy. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

The ADAM amplifier system is an EEG Amplifier System.

The provided text is a 510(k) summary for the Grass-Telefactor ADAM EEG Amplifier System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot populate the table or answer the questions you've posed based on the given input text. The 510(k) summary is primarily concerned with establishing substantial equivalence, not with detailing performance studies with specific statistical metrics and ground truth methods.

Ask a specific question about this device

Ask a specific question about this device