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Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays Reference Check is recommended for use in controlling the following parameters in the normal range:

• Fibrinogen .
• Factor II .
• Factor V .
• Factor VII .
• Factor VIII:C
• vWF: antigen ●
• vWF: Ristocetin Cofactor ●
• Factor IX ●
• Factor X .
• Factor XI .
• Factor XII .
• Factor XIII ●
• Prekallikrein .
• Protein C: antigen ●
• Protein C: activity ●
• Protein S: activity .
• Protein S: total .
• Protein S: free .
• Antithrombin: activity ●
• Antithrombin: antigen .
• Alpha-2-antiplasmin .
• Plasminogen .

Reference Check is citrated human plasma collected from 20 or more carefully screened normal donors. Plasmas are pooled, buffered using 0.01M HEPES buffer, aliquoted and rapidly frozen.

The provided text focuses on the 510(k) summary for "Reference Check," a normal control plasma, and strongly emphasizes its substantial equivalence to a predicate device, "Control Plasma N (K001256)." The information details the device's characteristics and its intended use for controlling the accuracy of quantitative hemostasis assays. However, it does not contain the specifics of a study proving the device meets acceptance criteria in the manner of a typical AI/ML device submission. Instead, the "study" is an argument for substantial equivalence.

Based on the provided text, here's an attempt to answer your questions, highlighting where information is absent for this type of medical device submission:

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

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is described in terms of its characteristics and intended use being similar to the predicate.

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 provided. The submission focuses on comparing the characteristics of the Reference Check product to a predicate device rather than presenting a performance study with a test set of data. The device itself is derived from "citrated human plasma collected from 20 or more carefully screened normal donors."

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 provided. As this is a control plasma and not an AI/ML diagnostic device analyzing complex data, the concept of "experts establishing ground truth for a test set" does not directly apply in the usual sense. The "ground truth" for a control plasma is its assigned values for the analytes it controls, which would be established through laboratory methods and standardization.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., of medical images) where discrepancies need resolution. This is not applicable to a control plasma product.

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

There was no MRMC study conducted. This type of study is relevant for AI/ML diagnostic tools that assist human readers, which Reference Check is not.

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

There was no standalone performance study in the context of an algorithm. Reference Check is a physical laboratory reagent, not an algorithm. Its "standalone" performance would be its stability, consistency, and assigned values, which are inherent to its manufacturing and quality control.

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

The ground truth for a control plasma would be the assigned values (ranges) for the various analytes (e.g., Fibrinogen, Factor II, Protein C activity) determined through standardized laboratory assays. The document states both products are "assayed and provide reference ranges."

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of a manufactured control plasma. Its characteristics are determined by the pooled human plasma used in its production.

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

This information is not applicable/provided. As above, there's no training set. The "ground truth" (assigned values) for the product is established through rigorous laboratory testing and calibration methods during its manufacture. The device description mentions it is "citrated human plasma collected from 20 or more carefully screened normal donors," indicating the source material for establishing its normal range.

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Composite restorative material for: Restorations of type I, II, III, IV, and V cavities (according to Black); Fillings in deciduous teeth; Extended fissure sealing; Cervical erosions and abrasions; Cutting edge build-up; Repairing of veneers made of composite and ceramics; Inlays fabrication; Interlocking of loose teeth

REFERENCE® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth. REFERENCE® is a further development based on the experience with PERTAC® II. The material characteristics were improved to obtain better handling and wearing properties. Furthermore, REFERENCE® is able to release fluoride ions.

This request cannot be fulfilled. The document provided for analysis is a 510(k) summary, which concerns devices already on the market and does not contain information about studies proving performance criteria for a novel AI/ML device. The document is for a dental restorative material, not an AI/ML device. Therefore, it is impossible to extract the requested information like expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the provided content.

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Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.

Reference Material for Delta-9-THC-COOH in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a Reference Material for Delta-9-THC-COOH in Human Urine. This type of device is a calibration or control material used to verify the accuracy of laboratory tests (specifically GC/MS methods) for detecting a marijuana metabolite.

The information you are asking for, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment, is not typically found in a 510(k) clearance letter.

A 510(k) clearance letter primarily states that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device. This equivalence is based on the data and information provided by the manufacturer in their 510(k) submission, which would contain the study details. However, the clearance letter itself only summarizes the FDA's decision, not the full details of the supporting studies.

Therefore, I cannot provide the requested information from the given document.

To answer your questions, I would need access to the actual 510(k) submission which would include the performance data and study reports.

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The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.

The Norland Apollo™ Bone Densitometer (Apollo™) scans the os calcis (heel) using the industry standard DXA pencil beam technology to assess bone density. A water bath is not required and the scan takes less than 30 seconds. Patient dose is less than 0.5 mRem and scatter radiation is less than 0.1 mRem/hour at 3 feet.

Two reference sets are provided, one for female Caucasians and one for male Caucasians. These reference data sets allow comparison of Apollo™ BMD scan results to healthy young adults aged 20 to 42. The results of the comparison is given in terms of T-Score (the number of standard deviations from the healthy young adult value), % Young Reference (the percentage relative to the healthy young adult value), and in graphical form.

The Apollo™ Reference Population capability also includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture.

Other reference data sets will be available in the future.

Here's an analysis of the provided text regarding the Norland Apollo™ Bone Densitometer's reference population capability, structured according to your requested information.

It's important to note that the provided 510(k) summary primarily focuses on establishing substantial equivalence for a reference population capability rather than a device with a specific performance metric like accuracy or sensitivity/specificity against a ground truth. The "device" in this context refers to the software feature that allows the Apollo™ densitometer to compare BMD results against a healthy young adult population. Therefore, typical acceptance criteria that you might expect for a diagnostic algorithm (e.g., AUC, sensitivity, specificity) are not present here. Instead, the "acceptance criteria" are implied by the successful establishment of this reference population.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, this 510(k) is for a reference population capability, not an algorithm that produces a diagnostic output with typical performance metrics. The "device performance" here relates to the establishment and utilization of reference data.

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

The 510(k) summary does not explicitly describe a "test set" or a study designed to evaluate the performance of an algorithm against a specific gold standard using such a set. The document refers to "reference sets" which are effectively population normative data.

• Sample Size: Not specified for the reference sets of young normal Caucasians.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is described as "young normal Caucasian men and women."

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

This information is not provided in the 510(k) summary. Given that the submission is for a reference population capability and not a diagnostic algorithm, the concept of "experts establishing ground truth for a test set" in the traditional sense of evaluating an algorithm's output doesn't directly apply. The "ground truth" would be the derivation of the normative reference values, which typically involves statistical analysis of a healthy population, not individual expert adjudication of cases.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set that underwent adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied in this 510(k) summary. The context is not an AI-assisted interpretation but rather the provision of normative reference data for bone density measurements.

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

The "device" here is the software capability to provide reference population comparison, T-Scores, and fracture risk assessment based on WHO criteria. This is a standalone computational function of the densitometer; it doesn't involve human-in-the-loop performance for its core operation. The densitometer measures BMD, and the software then applies these reference data and algorithms to present results. However, it's not a standalone diagnostic AI algorithm in the contemporary sense.

7. The Type of Ground Truth Used

For the reference population, the "ground truth" is implicitly derived from statistical analysis of a defined "healthy young adult" population. This isn't pathology, outcomes data, or expert consensus on individual cases, but rather population-level normative data representing ideal bone mineral density for healthy young adults.

8. The Sample Size for the Training Set

The 510(k) summary does not specify the sample size for the "reference sets" (which serve as the basis for the device's capability, akin to a training set for normative data).

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

The document states: "Two reference sets are provided, one for female Caucasians and one for male Caucasians. These reference data sets allow comparison of Apollo™ BMD scan results to healthy young adults aged 20 to 42."

The method for establishing these "reference sets" (the "ground truth" for normative data) is not detailed in this summary. Typically, such reference populations are established through:

• Careful selection of individuals meeting specific health criteria (e.g., no known conditions affecting bone metabolism, within a specific age range, ethnicity).
• Measurement of their bone mineral density using the densitometer.
• Statistical analysis of this data to derive mean BMD values and standard deviations for different age groups within the defined population.

The predicates mentioned (K931996 for pDEXA™ Reference Population and K973104 for Fracture Risk Assessment) imply that established methodologies for creating and using reference populations for bone densitometers were followed for the Apollo™ system.

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Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.

Reference Material for Amphetamine/Methamphetamine in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reference material, not an AI device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets these criteria.

The document discusses:

• The FDA's determination of substantial equivalence for a "Reference Material for Amphetamine/Methamphetamine in Human Urine."
• Regulatory classifications and general controls for medical devices.
• Requirements under CLIA-88 (Clinical Laboratory Improvement Amendments of 1988).
• Contact information for various FDA departments.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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