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ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.

ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets.

The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

The ACCU-CHEK® LinkAssist Plus is an insertion aid for automatic application of ACCU-CHEK® infusion sets equipped with a compatible adapter. The ACCU-CHEK® LinkAssist device is non-invasive, non-sterile and intended for multiple uses by the same patient.

The provided text describes the 510(k) summary for the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device. Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific failure rates. Instead, the acceptance criteria appear to be met through demonstrating functional equivalence to a predicate device and successful completion of functional and human factors testing, implying performance within expected parameters for such devices.

Therefore, the table below reflects the qualitative acceptance criteria and the summary of the performance as reported:

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

• Test Set Sample Size: The document does not specify a numerical sample size for the functional testing or the human factors usability testing. It mentions "individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set," but no specific number is provided.
• Data Provenance: The studies were prospective. The human factors usability testing involved individuals participating in evaluations, implying it was conducted specifically for this device submission. The in vitro functional and biocompatibility testing similarly suggests newly generated data for the device. The country of origin of the data is not explicitly stated, but the submitter is Disetronic Medical Systems AG in Switzerland, and the US contact is Roche Diagnostics in Indianapolis, Indiana. The studies would likely have been conducted according to international standards (e.g., ISO) and possibly in relevant regions (e.g., Europe, US).

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

• Number of Experts: Not applicable/not specified. For this type of device (infusion sets and insertion devices), the "ground truth" is typically established by engineering specifications, regulatory standards, and clinical user experience rather than expert consensus on diagnostic images or pathology. The human factors usability testing involved patients who routinely use such devices, serving as the user population for evaluating intended use.
• Qualifications of Experts: Not applicable in the traditional sense for diagnostic accuracy. The "experts" involved would be regulatory specialists, engineers, and potentially clinicians involved in setting the performance specifications, but their numbers and specific qualifications are not detailed. For the human factors testing, the "experts" were the intended users themselves (patients), providing user experience validation.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., image reading) where differences in expert opinions need to be resolved. For functional and usability testing of a medical device like an infusion set, the "ground truth" is determined by objective performance against specifications and direct user feedback, not by adjudicating conflicting expert 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI algorithms, comparing human reader performance with and without AI assistance. The ACCU-CHEK® FlexLink Plus and LinkAssist Plus are mechanical devices for insulin infusion, not diagnostic imaging tools, and do not incorporate AI.

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

• Standalone Performance: Not applicable. This device is a mechanical infusion set and insertion device. It does not involve algorithms or AI, so there is no "standalone" algorithm performance to evaluate. The device's function is inherently "human-in-the-loop" as it requires user operation and insulin pump interface.

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

The "ground truth" for this submission was established through a combination of:

• Engineering Specifications and Design Requirements: For functional testing (e.g., luer connector compatibility, needle retraction mechanism, operating conditions).
• Biocompatibility Standards: For material testing.
• Predicate Device Performance: Demonstrating substantial equivalence to a legally marketed predicate device (ACCU-CHEK® Ultraflex infusion set and ACCU-CHEK® LinkAssist insertion device) served as a primary "ground truth" for device design and expected performance.
• User Feedback and Usability Standards: For human factors testing, the "ground truth" was whether the device met "customer requirements" and "primary operating functions" as assessed by target patients, and whether it operated safely (e.g., no needle stick injuries).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of data used to train an algorithm. The development of the device would have involved internal design, prototyping, and iterative testing, but not an AI training set.

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

• Ground Truth for Training Set: Not applicable, as there is no AI training set. The "ground truth" during the device's development would have been based on engineering principles, regulatory requirements, intended use specifications, and potentially patient and healthcare professional feedback, guiding the design and testing phases.

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ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

This document is a 510(k) summary for the ACCU-CHEK Ultraflex Infusion Set. It states that the device meets the requirements for its intended use and is substantially equivalent to a predicate device. However, it does not contain any data, acceptance criteria, or study details about device performance.

Therefore, I cannot provide the requested information. The document explicitly states:

"Testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the ACCU-CHEK Ultraflex Infusion Set is substantially equivalent to the predicate device."

This is a summary statement, not a presentation of the actual data or the study design. To answer your questions, I would need access to the full test report or detailed data provided within the 510(k) submission, which is not present in the provided text.

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The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.

The Accu-Chek LinkAssist is an insertion aid for automatic application of the Accu-Chek infusion sets with compatible adapter. It permits introduction of the infusion set cannula into the subcutaneous fatty tissue.

The Accu-Chek LinkAssist is made of plastic and stainless steel components and has spring loaded mechanisms. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The connection between the Accu-Chek LinkAssist device and the infusion set is established by means of a compatible sterile adapter.

This 510(k) submission for the Accu-Chek LinkAssist, K063146, does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance.

Here's why and what information is available:

The document explicitly states: "Performance and functional testing of the Accu-Chek LinkAssist have been verified and validated and no new issues were raised regarding safety and effectiveness." However, it does not provide the specific acceptance criteria, the study design, or the results of this testing.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert involvement, or comparative effectiveness.

Information that can be extracted from the provided text:

510(k) Summary for Accu-Chek LinkAssist (K063146)

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

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 (Test Set): Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as no specific human expert evaluation in performance testing is described for establishing ground truth.

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

• Not specified.

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. This device is a mechanical insertion aid, not an AI or imaging diagnostic device that would involve human "readers."

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

• This device is a standalone mechanical device. Its performance testing would be focused on its mechanical function, not an algorithm.

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

• Not specified. For a mechanical device, ground truth would typically refer to objective measurements of its function (e.g., proper insertion depth, force, ease of use).

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning model that requires a "training set."

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

• Not applicable.

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The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.

The ACCU-CHEK Spirit Insulin Infusion Pump is an ambulatory, battery operated insulin pump designed for continuous delivery of insulin. The design allows for delivery of 0.0 to 25.0 units of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per meal or meal bolus. The pump is made of impact resistant plastic. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. The ACCU-CHEK Spirit Insulin Infusion Pump is equipped with an IR-Interface in order to enable data transmission between the pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.

This 510(k) submission (K060876) for the ACCU-CHEK® Spirit Insulin Infusion Pump is a Special 510(k) for a modification to an already cleared device (K042887). The modification primarily concerns the addition of the "ACCU-CHEK Insulin Pump Configuration Software" which facilitates monitoring and programming of pump settings.

The document states that the software has been verified and validated and that no new issues were raised regarding safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. However, the core acceptance criterion for this Special 510(k) is substantial equivalence to the predicate device (K042887).

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

The document mentions "software testing performed" and that the software "has been verified and validated." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data).

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The testing approach appears to be focused on software verification and validation rather than clinical performance adjudicated by medical experts.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method as it primarily concerns software verification and validation, not a clinical study involving human judgment on cases.

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 MRMC comparative effectiveness study was mentioned. The device is an insulin pump and software, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.

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

The "ACCU-CHEK Insulin Pump Configuration Software" itself would be considered a standalone component, as it performs its functions independent of direct human intervention in the data processing, although it facilitates monitoring and programming by a human. The verification and validation of this software would essentially be demonstrating its standalone performance against its specifications. However, the document does not explicitly describe this as a "standalone study" in the context of typical AI/CAD device evaluation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):

For the "software testing," the ground truth would likely be defined by the software requirements and design specifications. This would involve verifying that the software functions correctly, calculates values accurately, and displays information as intended, rather than clinical ground truth like pathology or expert consensus on a medical diagnosis.

8. The Sample Size for the Training Set:

The document does not mention a training set sample size. This is expected as the software likely follows traditional software development and testing methodologies (verification and validation) rather than machine learning or AI paradigms that require distinct training sets.

9. How the Ground Truth for the Training Set was Established:

As no training set is mentioned or implied, this information is not applicable/provided.

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The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.

The ACCU-CHEK Spirit Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows the delivery of 0.1 to 25.0 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal or meal bolus.

The provided text does not contain specific acceptance criteria, study details, or performance metrics for the ACCU-CHEK Spirit Insulin Infusion Pump.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.

The only statement related to device performance is a general claims that "Testing of the ACCU-CHEK Spirit demonstrated that the device meets the resuirements for its intended use. The data also demonstrates that the ACCU-CHEK Spirit is substantially equivalent to the predicate devices." No specific criteria or reported performance values are given.

Therefore, I cannot provide the requested table and detailed information about the study as the necessary data is not present in the provided text.

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The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician. It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professionals experienced in insulin pump therapy.

The D-TRONplus Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows settings of 0.0 to 25.0 units in 0.1 unit increments of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per bolus in 0.1, 0.2, 0.5, or 1.0 unit increments.

The provided text is a 510(k) summary for the Disetronic D-TRONplus Insulin Infusion Pump. It states that "Testing of the D-TRONplus demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the D-TRONplus is substantially equivalent to the predicate device." However, the document does not contain the specific acceptance criteria or the detailed results of the study that proves the device meets those criteria.

Therefore, I cannot provide most of the requested information. The text does not elaborate on:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method for test sets.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Details about a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to a predicate device (Disetronic D-TRONplus Insulin Infusion Pump, K#022831) rather than detailing specific performance metrics against defined acceptance criteria.

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Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

The Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

This 510(k) summary (K033892) for the Ultraflex Infusion Set does not contain the detailed information requested regarding acceptance criteria and study particulars.

The provided document is limited to:

• A general introduction to the device and its intended use.
• A statement that "Testing of the modified Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use."
• A statement that the device is "substantially equivalent to the predicate device."
• The FDA's letter of substantial equivalence determination.

Therefore, I cannot provide the requested table and detailed study information. The document focuses on administrative and regulatory aspects, confirming that the device was deemed substantially equivalent to a predicate device, but does not disclose the specific performance data or the methodology of the studies conducted.

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The Disetronic H-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.

It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self-glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

The Disetronic H-TRONplus Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and has easy to feel buttons to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, piston rod, cartridge and adapter. The H-TRONplus Insulin Infusion Pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.

Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a DC motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or his or her health care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the three buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The submission focuses on the device's compliance with established standards rather than a clinical or performance study with a specific test set.

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

This information is not provided in the document. As noted above, the submission refers to design and testing against standards, not a ground truth clinical evaluation.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not conducted or reported in this document. The submission pertains to the substantial equivalence of an updated medical device to a predicate device based on technical standards, not a comparative study with human readers or AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study

A standalone performance study of an algorithm was not conducted or reported in this document. This device is a mechanical/electronic insulin infusion pump, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to compliance with international safety and performance standards (IEC 60601-2-24, IEC 60601-1, IEC 60601-1-2) rather than clinical outcomes or pathology data. The device was designed and tested to meet these established engineering and safety specifications.

8. Sample Size for the Training Set

This information is not applicable and not provided. This is an insulin pump, not a machine learning algorithm that requires a training set.

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

This information is not applicable and not provided.

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The Disetronic D-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.

It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

The Disetronic D-TRONplus Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter, cartridge and the optional PC software that allows convenient programming of the pump or monitoring of the therapy. Furthermore the pump's data memory can be read out and displayed by using third party diabetes management software. The D-TRONplus Insulin Infusion Pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.

Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump.

The D-TRONblus pump is equipped with an infrared interface that allows data transmission between the pump and a personal computer. Disetronic provides the DiaLog PC software as an accessory to the D-TRONplus pump that facilitates the programming and monitoring of the device.

The provided document is a 510(k) summary for the Disetronic D-TRONplus Insulin Infusion Pump. It focuses on establishing substantial equivalence to a predicate device based on design equivalency and performance/safety testing.

This document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/CADe device. Instead, it states that the device was "designed and tested in accordance with IEC 60601-2-24" for safety and that its "electronic and mechanical design is not unique and therefore the specifications fully address pump performance."

Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies (which are relevant for AI/CADe devices) is not applicable to this submission type.

Here’s a breakdown of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable. This document describes a medical device (insulin pump) submission, not an AI/CADe algorithm. The "testing" refers to meeting engineering and safety standards for the physical device, not a performance evaluation against a diagnostic dataset.

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

• Not applicable. No ground truth establishment by experts for a diagnostic test set is mentioned.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication is described.

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. This relates to an AI/CADe device, not this insulin pump.

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

• Not applicable. This is an insulin pump, not a diagnostic algorithm.

7. The type of ground truth used:

• Not applicable. For an insulin pump, "ground truth" would be related to its engineering specifications and accurate delivery of insulin according to internal controls and calibration, not a diagnostic reference standard. The document implies compliance with engineering standards (IEC).

8. The sample size for the training set:

• Not applicable. No machine learning or AI training set is mentioned.

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

• Not applicable. No machine learning or AI training set is mentioned.

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Indications For Use: as prescribed by a physician. as proombod by a prifortialin dependent diabetes Mellitus who do not have optimum it is indication partional insulin injection therapy. Patients for insulin pump blood gradose of the or beform self glucose monitoring on a frequent and regular therapy made be highty the a proper diet and exercise regiment. Patients must be capable of busic, as well and anot over also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

The Disetronic D-TRON Insulin Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and fulfills the requirements for IP X7 to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, adapter and custom reservoir kit. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a stepper motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the basal infusion each hour for twenty four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump. Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U. The D-TRON Insulin Infusion pump is equipped with an IR-Interface in order to enable data transmissions between the pump and a personal computer. The DiaLog PC-Software facilitates the monitoring and programming of the pump settings. Current pump settings can be displayed on the computer monitor, adjustments can be made and re-stored into the pump.

The Disetronic D-TRON Insulin Infusion Pump (K021225) was deemed substantially equivalent to the currently marketed D-TRON Pump (K994186) based on design equivalency and performance and safety testing.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided document does not specify a separate "test set" in the context of a clinical study with a defined sample size for evaluating the device's performance against specific clinical endpoints. The evaluation appears to be based on engineering and design verification against established international standards.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth, in this context, refers to the established safety and performance standards for infusion pumps (IEC 60601 series). These standards are developed by consensus of international experts in the field of medical device safety and functionality. However, the document does not detail specific experts involved in the K021225 submission for establishing a ground truth for a test set.

4. Adjudication Method

Not applicable, as there is no mention of a test set requiring adjudication in the context of clinical or diagnostic performance evaluation.

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

No MRMC study was mentioned or performed. This is not a diagnostic imaging device where human readers would interpret results.

6. Standalone Performance (Algorithm Only)

The device is an insulin infusion pump with associated software (DiaLog PC-Software). Its "standalone performance" refers to its ability to deliver insulin according to programmed settings and to operate safely. The submission states that "The electronic and mechanical design is not unique and therefore the specifications fully address pump performance," implying that its functionality was assessed against engineering specifications and international standards rather than a clinical standalone study in typical diagnostic AI context.

7. Type of Ground Truth Used

The "ground truth" for demonstrating the device's acceptability relies on its adherence to established international safety and performance standards for infusion pumps (IEC 60601-2-24, IEC 60601-1, and IEC 60601-1-2) and design equivalency to a legally marketed predicate device (K994186). There is no mention of pathology, outcomes data, or expert consensus in the conventional sense of establishing ground truth for a diagnostic device.

8. Sample Size for the Training Set

Not applicable. This device is an insulin infusion pump with software, not an AI/ML algorithm that requires a "training set" in the machine learning sense. The "training" for such devices typically involves engineering design, development, and testing processes.

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

Not applicable, as there is no training set mentioned in the context of machine learning. The device's design and functionality were developed and verified against engineering specifications derived from relevant medical device standards.

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