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TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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

• Sample Size for Test Set: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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 is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering standards.

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 an endosseous dental implant abutment, not an AI diagnostic tool.

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 dental component, not an algorithm.

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

Ask a specific question about this device

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

• · MIS C1 Conical Connection Implant (K172505, K112162)
• : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
• · Neodent Implant System GM Helix (K163194, K180536)
• : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Biocare Groovy Implants (K050258)
• : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
• · Straumann BLX Implant (K173961, K181703, K191256)
• : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
• · Straumann Tissue Level Implant (K111357)
• : 3.3(NNC)

All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific abutment is supplied with two identical screws which are used for:

(1) For fixing into the endosseous implant

(2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase screw for fixation to the implant body.

TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters. The TruBase screws are composed of titanium alloy per ASTM F136.

CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices, which are endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and results from a study proving the device meets those specific criteria in the way one might find for a novel AI/software medical device.

The document discusses performance in terms of mechanical resistance and dimensional compatibility to ensure long-term functional performance with dental implants. However, it does not outline distinct "acceptance criteria" that are then verified by a specific study with a defined sample size, ground truth, or expert adjudication as typically seen in AI/ML validation. Instead, it relies on demonstrating compliance with recognized standards and comparability to a predicate device.

Given the information provided, here's an attempt to answer the questions based on the context of this 510(k) summary, interpreting "acceptance criteria" as the performance expectations set by the applicable standards and "study" as the non-clinical testing performed:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for a comparative AI study. Instead, it refers to compliance with established standards for dental implant abutments. The closest equivalent to "acceptance criteria" for the mechanical performance is meeting the requirements of ISO 14801.

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

The document does not specify a "test set" sample size in the context of an AI/ML model for image analysis or diagnostics. The testing described is primarily non-clinical mechanical testing, dimensional analysis, and biocompatibility testing of physical devices.

• Sample Size: Not specified in terms of "number of cases" or "patients" for a diagnostic study. For mechanical testing, samples would be physical devices/constructs. The number of samples for ISO 14801 fatigue testing is typically defined by the standard itself (e.g., typically 3 samples for static and 15 samples for fatigue for each configuration).
• Data Provenance: Not applicable in the sense of patient data or images. The "data" comes from physical testing of manufactured devices.

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

This information is not applicable to the type of device and testing described. The "ground truth" for mechanical properties is established by physical measurement against engineering specifications and performance under defined load conditions, not by expert human interpretation.

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

Not applicable. There is no human interpretation or subjective assessment involved that would require an adjudication method.

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. The device is a physical dental implant abutment, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical dental implant abutment, not an AI algorithm.

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

The "ground truth" for this medical device is based on engineering specifications, material science standards (e.g., ASTM F136), and mechanical testing standards (e.g., ISO 14801). For example, mechanical strength and fatigue life are measured directly, and dimensional compatibility is assessed against design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "design" of the abutments is based on CAD/CAM systems informed by engineering principles, not machine learning from large datasets.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The knowledge base for the CAD/CAM design and manufacturing is derived from established dental and engineering principles, material science, and regulatory standards.

Ask a specific question about this device

The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

• · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
• · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
• · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

• (1) For fixing into the endosseous implant
• (2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant.

The device being discussed is "TruAbutment DS", a patient-specific CAD/CAM abutment for dental implants.

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (TruAbutment DS K170259) through non-clinical testing, primarily mechanical performance (fatigue) testing, and biocompatibility assessments. The study described focuses on non-clinical testing to meet these acceptance criteria rather than a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample size (number of abutments or implants) used for the non-clinical mechanical and dimensional tests. It mentions "worst-case constructs" for fatigue testing.
Data provenance: The testing was conducted by the manufacturer (TruAbutment Inc.) as part of their 510(k) submission to the FDA, presumably in the USA (where the company is based). The data is retrospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by meeting recognized international and national standards (ISO, FDA guidance) through non-clinical laboratory testing, not by expert consensus on clinical cases.

4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of medical images. The studies performed for this device were non-clinical laboratory tests.

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, an MRMC comparative effectiveness study was not done. This device is a physical dental implant abutment, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance is assessed by its mechanical integrity and biocompatibility when used as intended.

7. The type of ground truth used
The "ground truth" used for this device is based on established engineering and materials science principles and validated standards:

• Mechanical Performance: Defined by the specified fatigue limits and static load capabilities as per ISO 14801 and FDA guidance thresholds for dental implant abutments.
• Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series standards.
• Dimensional Accuracy: Defined by precise measurements confirming compatibility with target implant systems.

8. The sample size for the training set
This is not applicable. This device is not an AI model that requires a training set. The CAD/CAM design process for patient-specific abutments involves individual patient data rather than a large training dataset for device development in the AI sense.

9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of an AI device. The design principles for the TruAbutment DS are based on established dental implantology, engineering design, and manufacturing standards for patient-specific CAD/CAM abutments.

Ask a specific question about this device

The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

· Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm

• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
  The available range of diameters is summarized below:

Tapered Internal / Laser-Lok 3.0

Implant Ø (mm) : 3.0 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex Tapered Internal

Implant Ø (mm) : 3.4 / Implant Platform (mm) : 3.0 / Type of Implant-Abutment Connection : Internal Hex

Implant Ø (mm) : 3.8 / Implant Platform (mm) : 3.5 / Type of Implant-Abutment Connection : Internal Hex

Implant Ø (mm) : 4.6 / Implant Platform (mm) : 4.5 / Type of Implant-Abutment Connection : Internal Hex

Implant Ø (mm) : 5.8 / Implant Platform (mm) : 5.7 / Type of Implant-Abutment Connection : Internal Hex

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

(1) For fixing into the endosseous implant

(2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The provided document describes the FDA 510(k) clearance for the TruAbutment DS, a patient-specific CAD/CAM abutment. It does not contain information typically found in an AI/ML device approval, such as acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC), sample size for test sets (in the context of AI models), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm (as this is a physical device, not an algorithm), or information about training datasets.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical testing performed for the physical dental abutment device, primarily focusing on its mechanical performance and compatibility with existing implants.

Here's the information parsed from the document based on the device type:

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

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

• Sample Size for Test Set: The document mentions "finished assembled implant/abutment systems of the worst-case scenario" for fatigue testing. It does not specify a numerical sample size but implies a representative selection for worst-case evaluation. For sterilization and biocompatibility, the tests were "performed for reference device K152559 and leveraged for the subject device," without specifying its sample size.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are non-clinical, performed in a lab setting.

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

• Not applicable. The ground truth for this physical device is based on objective engineering standards (ISO standards, dimensional measurements, material properties), not expert interpretation of medical images or conditions.

4. Adjudication method for the test set:

• Not applicable, as this is not a study requiring adjudication of interpretations.

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. TruAbutment DS is a physical dental implant component, not an AI-assisted diagnostic or prognostic tool.

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

• Not applicable. This is not an algorithm. The device itself is "standalone" in function as it's a physical component.

7. The type of ground truth used:

• Engineering Standards and Measurements: The ground truth for evaluating TruAbutment DS is based on established international (ISO) and national (ANSI/AAMI) engineering standards for medical devices (specifically dental implants and abutments), material specifications (ASTM Standard F-136 for Ti-6A1-4V ELI), and precise dimensional measurements and compatibility assessments.

8. The sample size for the training set:

• Not applicable, as this is not a machine learning model.

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

• Not applicable, as this is not a machine learning model.

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