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Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the ImmunoCAP™. Allergen ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAPTM Specific IgE in vitro diagnostic assays.

It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjynction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

The Allergen ImmunoCAP™ consists of a cellulose sponge matrix to which allergenic components are covalently coupled. The matrix is encased in a small round plastic capsule. This capsule is at tha same time a holder of the matrix for convenient automation and a reaction chamber.

The sponge matrix is manufactured from activated cellulose derivative to which allergen extract solution is added under defined optimized conditions for the allergen coupling. This solid phase is an excellent carrier of allergens and provides favorable reaction conditions.

The Allergen ImmunoCAP™ m4 contains allergens from the mold Mucor racemosus, Allergen ImmunoCAP™ m8 from Helminthosporium halodes (both spores and mycelium). Identical sources and extracts are used for both the predicate device Phadebas RAST Paper Disc and ImmunoCAP™

The Allergen ImmunoCAP™ k70 contains allergens extracted from the Green Coffee Bean. Identical source and extract is also used for both the predicate device Phadebas RAST Paper Disc and ImmunoCAP™

Acceptance Criteria and Device Performance for Allergen ImmunoCAP™ m4, m8, k70

Study Details:

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

   • The document states that "Positive and negative sera from patients with and without specific IgE to each of the three allergens have been tested in all three test systems." However, the exact sample size (number of patients or serum specimens) used for the test set is not specified in the provided text.
   • The data provenance is retrospective, as existing "positive and negative sera" were used for the comparison studies. The country of origin of the data is not specified.

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

   • The document does not mention using experts to establish ground truth for the test set. Instead, the predicate device, Phadebas RAST® Allergen Paper Discs, served as the comparative standard.

3. Adjudication method for the test set:

   • No adjudication method is described. The comparison was made directly between the new device's results and the predicate device's results.

4. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • No MRMC comparative effectiveness study was mentioned or performed. This device is an in vitro diagnostic assay, not an imaging or diagnostic device typically requiring human reader interpretation.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • The study described is a standalone performance comparison of the new ImmunoCAP™ assays against the predicate Phadebas RAST® assays. There is no human-in-the-loop component for interpreting the results of these automated immunoassay systems.

6. Type of ground truth used:

   • The "ground truth" for the comparison study was the results obtained from the predicate device, Phadebas RAST® Allergen Paper Discs. This is a comparative study where the new device's performance is measured against an established, legally marketed device.

7. Sample size for the training set:

   • The document does not specify a separate "training set" or its sample size. This type of immunoassay development typically involves optimization and validation rather than machine learning training sets in the conventional sense. The "comparison studies" effectively serve as validation.

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

   • As no specific training set is mentioned in the machine learning context, the method for establishing its ground truth is not applicable here. The overall "ground truth" for the device's accuracy is based on its correlation with the predicate device.

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UniCAP Phadiatop Assay is an in vitro qualitative assay for the differential determination of IgE antibodies specific to inhalant allergens in human serum and plasma. UniCAP Phadiatop Assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

UniCAP is a fully integrated and automated system for the determination of total and specific IgE in human serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the differential determination of IgE antibodies specific to inhalant allergens.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets them:

Acceptance Criteria and Device Performance Study for UniCAP Phadiatop Assay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal, quantitative acceptance criteria for the UniCAP Phadiatop Assay. Instead, the study's goal was to demonstrate "substantial equivalence" to a predicate device. The performance metric used was agreement with the predicate device on the classification of samples as positive or negative.

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

• Sample Size: 180 serum samples (150 positive, 30 negative).
• Data Provenance: Not explicitly stated, but it is implied to be clinical human serum samples. The country of origin and whether the data was retrospective or prospective is not mentioned.

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

• The ground truth for the test set was not established by human "experts" in the traditional sense. Instead, the predicate device (Pharmacia CAP System Phadiatop FEIA) was used as the reference standard/ground truth. Therefore, the concept of "number of experts" and their "qualifications" is not directly applicable in this context.

4. Adjudication Method for the Test Set

• No adjudication method was mentioned as the reference standard was another device, not human expert interpretation. The comparison was a direct readout between two assay systems.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study focused on comparing the new device's performance against a predicate device, not on how human readers' performance would improve with or without AI assistance. This device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool for interpretation.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the UniCAP Phadiatop Assay was evaluated independently against another instrument/reagent system without human intervention in the classification aspect. The study compared the direct output (positive/negative) of the new system to the direct output of the predicate system. The performance of the UniCAP Phadiatop Assay was assessed on its own ability to classify samples compared to the established method.

7. Type of Ground Truth Used

• Ground Truth: The ground truth was established by a predicate device, specifically the "Pharmacia CAP System Phadiatop FEIA used with Pharmacia CAP System instrumentation." This means the results from the established, legally marketed device were considered the correct classification for comparison.

8. Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" or its size. This type of device (in-vitro diagnostic assay) typically undergoes development and validation, but the concept of a "training set" in the machine learning sense is not applicable here. The comparison study describes the testing of the final, developed device.

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

• As a training set is not explicitly mentioned or applicable in the context of this traditional in-vitro diagnostic assay validation, the method for establishing its ground truth is not detailed. The "ground truth" for the comparison study itself was the predicate device's output.

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UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the measurement of allergen Specific IgE in human serum or plasma. UniCAP Specific IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

Information Specific to Latex k82 Allergen

UniCAP Specific IgE Assay, Latex k82 test result may be used as an aid in the clinical diagnosis of patients with suspected latex allergy.

The allergen of interest, in this case Latex, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient serum specimen. After washing away non-specific IgE, enzyme labelled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the greater the quantity of specific IgE present in the specimen. To evaluate the test results, the response for the patient sample is compared directly to the response for the calibrators.

UniCAP 100 instrument with built in software processes all steps of the assay and prints results automatically after the assay is completed.

Here's a breakdown of the acceptance criteria and study information for the UniCAP Specific IgE, Latex Allergen ImmunoCAP k82, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage threshold form. However, the study aims to demonstrate substantial equivalence to a predicate device and good clinical performance as measured by sensitivity, specificity, and overall agreement. For this type of submission, demonstrating comparable or better performance than the predicate is often the implicit acceptance criterion.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 182 patients
  • 96 patients diagnosed as clinically allergic to latex with a positive latex skin test.
  • 86 patients clinically negative with a negative latex skin test.
• Data Provenance: The text states, "Serum samples from a total of 182 patients from three clinical sites were tested..." It does not specify the country of origin of these clinical sites. The data is retrospective in that it's using existing patient samples.

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

The ground truth was established by "clinical diagnosis as defined by clinical history and latex skin test (SPT) results." The document doesn't specify the number of experts involved in these clinical diagnoses nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it generally implies that these diagnoses were made by qualified clinicians as part of standard medical practice at the "three clinical sites." The latex skin test is a well-established diagnostic tool.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for establishing the clinical diagnosis, which served as the ground truth. It simply states the diagnosis was based on clinical history and latex skin test results. It does not mention any disagreement resolution process among multiple clinicians for individual patient diagnoses in this summary.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an in-vitro diagnostic assay (an automated lab test), not an AI-powered diagnostic imaging or decision-support system that human readers would interact with.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this was a standalone performance study. The UniCAP Specific IgE FEIA Assay is an automated immunoassay system that provides a result (specific IgE levels for latex) directly. The reported performance metrics (sensitivity, specificity, overall agreement) reflect the algorithm/assay's performance in isolation, compared against the clinical diagnosis (ground truth). It is not designed to be used with a human-in-the-loop for result interpretation, beyond a clinician using the quantitative result to aid in diagnosis.

7. The Type of Ground Truth Used

The ground truth used was clinical diagnosis, defined by a combination of:

• Clinical history
• Latex skin test (SPT) results

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of submission for an immunoassay typically focuses on the performance of the finalized assay against a clinical reference standard rather than detailing the training of a machine learning algorithm. The "training" of such a system would involve the assay's development and optimization, but distinct "training sets" in the AI sense are not mentioned.

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

Since no distinct training set is mentioned in the context of an "AI training/ground truth" in this document, this question is not applicable to the provided information. The assay itself embodies the established chemical and biological principles for IgE detection.

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MasterCAP AM 5.0 is a software tool for Assay Management designed to support the set up of an in vitro diagnostic assay run. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x, or Windows '95 Environment.

MasterCAP AM 5.0 handles sample lists, and creates worklists for the related Pharmacia & Upjohn diagnostic equipment. MasterCAP AM 5.0 also evaluates and calculates the assay results and generates laboratory reports. It can import and export results to main frame computers.

MasterCAP AM 5.0 includes a driver function which can send and receive patient data from UniCAP 100 diagnostic equipment.

MasterCAP RM 5,0 is a software tool for Request Management designed to be used together with MasterCAP AM 5.0. MasterCAP RM 5.0 includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP RM can store requests, requestor information and test panels, and also provides backup and restore functions.

1. MasterCAP AM 5.0 is a software tool for assay management designed to support the set up of an in vitro diagnostic immunoassay. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x or Windows '95 Environment. The following Pharmacia CAP System diagnostic equipment and related devices may be used with MasterCAP AM: AutoCAP, Positioning Guide 96, RoboCAP Version 2.0, Fluorocount 96, Assay Washer 96, UniCAP 100.

When using the UniCAP 100 Device Driver Function of MasterCAP AM with UniCAP 100, you can transfer sample list data to, and import evaluated assay results from, one or more connected UniCAP 100 devices.

MasterCAP AM 5.0 software directs the diagnostic equipment to perform the following functions:

• import sample lists from a main frame computer or enter the information manually

• • create an assay run
• • distribute samples and tests
• • process an assay
• • collect raw data
• • evaluate and calculate the results
• • export the results to the main frame computer
• • define assay methods and method groups

2. MasterCAP RM 5.Q is a software tool for Request Management designed to be used with MasterCAP AM 5.0 for laboratories running in vitro diagnostic assays. MasterCAP RM includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP AM and MasterCAP RM are designed to be used with Pharmacia CAP System and UniCAP 100 diagnostic equipment and related devices.

MasterCAP RM can perform the following functions:

• • create sample lists
• • store requests, requester information and test panels
• • create laboratory, result and patient test reports
• • perform database queries
• • provide backup and restore functions

The provided document is a 510(k) summary for the MasterCAP AM 5.0 and MasterCAP RM 5.0 software programs. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and describes the intended use and general features of the software for managing in vitro diagnostic assay runs and requests.

Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The document is a regulatory submission for premarket notification, which describes the device and its intended use to the FDA for a determination of substantial equivalence. It does not typically include detailed performance study data such as those requested in your prompt (e.g., specific performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert consensus, etc.).

Therefore, I cannot populate the table or answer the specific questions about performance studies based on the provided text. The document states that "Several improvements have been made to the updated software resulting in more convenient and versatile software," but it does not quantify these improvements or provide data to support specific performance claims beyond functionality.

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UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative measurement of circulating total IgE in human serum or plasma. UniCAP Total IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as, physician office laboratories. Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.

UniCAP is a fully integrated and automated system for the determination of total IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the measurement of total IgE, and Pharmacia Total IgE Control LMH. The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests; samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended. UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced.

Here's an analysis of the provided text regarding the UniCAP Total IgE device, focusing on the acceptance criteria and the study performed:

Acceptance Criteria and Device Performance Study for UniCAP Total IgE

The provided document describes the UniCAP Total IgE Fluoroimmunoassay system, demonstrating its substantial equivalence to the Pharmacia CAP System IgE FEIA. The primary "acceptance criterion" for this 510(k) submission is established through demonstrating strong correlation with an already legally marketed device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 150 serum samples.
• Data Provenance: The document does not explicitly state the country of origin for the samples or whether they were retrospective or prospective. It only mentions they were "serum samples."

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

This document describes a comparison study against a predicate device, not a study involving expert human interpretation of results to establish ground truth in the traditional sense. The "ground truth" here is effectively established by the predicate device's measurements. Therefore, this section is not applicable in the context of expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. The study compares the device's measurements directly to those of a predicate device, not to human adjudications.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the device itself by comparing it to another device, not on how it aids human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this study is a standalone performance study. The UniCAP Total IgE Fluoroimmunoassay is an automated, in vitro diagnostic device, and the comparison was between its automated measurements and those of a predicate automated system. There is no human-in-the-loop performance described in this comparison study.

7. The Type of Ground Truth Used

The "ground truth" in this context is the quantitative total IgE values obtained from the predicate device, the Pharmacia CAP System IgE FEIA. This represents a reference measurement standard rather than pathology or expert consensus.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or machine learning. This device is an immunoassay system, and its development would typically involve reagent formulation, instrument calibration, and analytical validation rather than machine learning training sets.

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

As no training set (in the machine learning sense) is mentioned, this section is not applicable. The device's calibration and analytical performance are based on established biochemical and immunological principles, likely validated against known standards and internal controls. The document mentions "A new calibration curve is run once a month, and/or when a new lot number of Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced," which suggests ongoing calibration and quality control rather than a one-time "training set" ground truth.

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UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the 1. measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.
2. UniCAP 100 is a fully integrated and automated instrument including software for immunodiagnostic testing. UniCAP 100 is a user friendly instrument designed to handle all steps from sample and reagent handling to processing of results.
3. UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to. a connected mainframe computer or network server.
4. Pharmacia Specific IgE Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE and Pharmacia CAP System™ RAST® RIA/FEIA.
5. Pharmacia Specific IgE Negative Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE, Pharmacia CAP System™, RAST® RIA/FEIA and Phadebas RAST® RIA/FEIA and Phadebas RAST®/Phadezym®.

UniCAP is a fully integrated and automated system for the determinantion of specific IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP reagents, in this submission reagents for the measurement of allergen specific IgE; UniCAP RM External Software; and Pharmacia Specific IgE positive and negative Controls.

The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Specific IgE Conjugate is introduced.

Here's an analysis of the provided text regarding the UniCAP 100 device and its acceptance criteria, structured according to your request:

K962274: UniCAP 100 Specific IgE Assay and Instrument

This submission describes the UniCAP 100 system, an automated in-vitro diagnostic system for the determination of specific IgE in human serum or plasma. It seeks to demonstrate substantial equivalence to the previously cleared Pharmacia CAP System.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the comparison study's objectives. While explicit numerical acceptance criteria (e.g., "must be greater than X%") are not stated as such, the reported performance serves as the basis for demonstrating substantial equivalence.

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

• Sample Size: More than 7,000 patient samples.
• Data Provenance: Not explicitly stated regarding country of origin. The study is a retrospective comparison as it uses existing patient samples to compare the performance of the new device (UniCAP 100) against an already established device (Pharmacia CAP System).

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 document. The "ground truth" in this context is established by the results from the predicate device (Pharmacia CAP System RAST FEIA), not by a panel of human experts interpreting the results.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the comparison is between two automated systems, there is no explicit adjudication method involving human experts. The comparison relies on the numerical outputs and classification of both systems.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated in-vitro diagnostic system for specific IgE measurements, not an AI-assisted diagnostic tool for image interpretation or similar tasks that would typically involve human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

Yes, a standalone performance evaluation was implicitly done. The entire comparison study assesses the UniCAP 100 system (instrument and reagents) as a standalone automated system (algorithm only, without human intervention in the result generation process) against another standalone automated system. The reported percentages are for the device itself.

7. The Type of Ground Truth Used

The "ground truth" in this comparison study is the results obtained from the predicate device, the Pharmacia CAP System RAST FEIA. The UniCAP 100's performance is measured by its agreement with the existing, cleared system, establishing substantial equivalence rather than absolute biological truth (e.g., pathology or long-term outcomes).

8. The Sample Size for the Training Set

The document does not specify a separate training set. The descriptions focus on the comparison study performed with "more than 7,000 patient samples." It's possible that the "training" (e.g., calibration and optimization) of the UniCAP 100 was done internally by the manufacturer prior to this comparison study, but details about such a training set are not included in this summary.

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

Since a dedicated training set is not explicitly described, the method for establishing its "ground truth" is not provided. If an internal development/optimization phase occurred, it would likely have also relied on comparison to established methods or clinical samples, but this is speculative given the provided text.

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