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The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The CeQur Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.

The provided text is a 510(k) summary for the CeQur Simplicity™ On-Demand Insulin Delivery System. It describes the device, its intended use, and states that performance data demonstrates its safety and effectiveness. However, the document does not contain specific acceptance criteria, reported device performance metrics in tabular form, details of a study with sample sizes, expert qualifications, or adjudication methods.

The 510(k) summary states generalized information such as "The performance data reported in this 510(k) demonstrate that the proposed device modifications do not raise different questions of safety and effectiveness than those for the predicate device is as safe and effective as the predicate device." but lacks the detailed information requested in the prompt.

Therefore, I cannot provide the requested information from the given text. The text does not detail:

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

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The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.

The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.

The provided document does not contain specific acceptance criteria or details of a study proving the device meets said criteria.

Instead, it describes the CeQur Simplicity™ On-Demand Insulin Delivery System and its substantial equivalence determination by the FDA based on modifications to labeling allowing for extended wear time (up to 4 days/96 hours, compared to 3 days/72 hours for the predicate device).

Here's a breakdown of the information that is and is not present, with regards to your request:

1. A table of acceptance criteria and the reported device performance:
* Not provided. The document states that "Verfication and validation data reported in this 510(k), including those assessing biocompatibility, and human factors, demonstrate that the proposed change in labeling does not raise different questions of safety and effectiveness than those for the predicate device, and that the subject device is as safe and effective as the predicate device." However, it does not specify what those acceptance criteria were or what performance metrics were achieved.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not provided. The document mentions "Verfication and validation data" but does not detail the sample sizes, data provenance, or whether the studies were retrospective or prospective.

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/Not provided. This device is an insulin delivery system, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set in the way you describe. The "ground truth" for its performance would likely relate to objective measurements of insulin delivery accuracy, biocompatibility, and user-factor performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. As with point 3, adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology image interpretation) to establish a consensus ground truth. This is not directly relevant to the testing of an insulin delivery device's technical specifications or user experience.

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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic systems where human readers interpret cases. This device is an insulin delivery system, not an AI diagnostic tool, so such a study would not be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a manual, user-filled, positive volume displacement bolus dosing pump, not an algorithm. Therefore, "standalone" algorithm performance testing is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* Not explicitly stated in detail. For a medical device like this, the "ground truth" for performance would generally involve:
* Objective measurements: E.g., insulin delivery accuracy (volume delivered vs. intended), flow rates, mechanical integrity, battery life (if applicable).
* Biocompatibility testing: In vitro and in vivo tests to ensure the materials are safe for contact with the body.
* Human factors validation: User studies to ensure safe and effective operation by typical users.
* The document generally refers to "biocompatibility, and human factors" data.

8. The sample size for the training set:
* Not applicable/Not provided. This device is an electro-mechanical system, not an AI/machine learning model that undergoes "training."

9. How the ground truth for the training set was established:
* Not applicable. As above, there is no "training set" for this type of device.

In summary: The provided FDA 510(k) clearance letter and summary are focused on establishing substantial equivalence to existing predicate devices for an insulin delivery system, primarily based on a labeling change (extended wear time). It asserts that "Verfication and validation data" were submitted for biocompatibility and human factors, demonstrating that the change does not raise new safety or effectiveness concerns, but it does not provide the specific details of these studies, including acceptance criteria, sample sizes, or performance metrics.

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The intended use of the Simplicity Easy P Soft Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy P Soft designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into the tissue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Soft Infusion Set, K020912 and Soft YP Infusion Set, FDA 510 (k) K011187.

The Simplicity Easy P Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912 and it has the same intended use.

The device consists of four main parts: (1) infusion catheters made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.

The Simplicity Easy P Soft Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Soft Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.

The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling cannulas formed from PTFE. The connecting tubing is made from a polyethylene tube.

The indwelling cannulas formed from PTFE are introduced below the skin using and insertion ring with AISI 304 stainless steel needle is attached to the hub fixed to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is comected to the connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.

The provided document is a 510(k) Summary for a medical device (Simplicity Easy P Soft Infusion Set) seeking substantial equivalence to a predicate device. It primarily discusses the device's features, intended use, and a list of standards and regulations it complies with to demonstrate performance and safety.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in detailed performance studies. This is a common characteristic of 510(k) summaries, which focus on demonstrating equivalence to existing legally marketed devices rather than presenting novel performance studies against predefined acceptance criteria for a new clinical claim.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's what can be addressed based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided directly. The document lists compliance with various standards (e.g., ISO, CDRH regulations) for catheters, sterilization, packaging, and biological evaluation. These standards inherently contain performance requirements and acceptance criteria for specific aspects (like sterility, material compatibility, strength), but the document does not explicitly state these criteria or report specific device performance values against them. It simply states that the device "meets the catheter requirements of" and "adhered to" these standards.

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

• Cannot be provided directly. The document does not describe specific testing sample sizes for any performance evaluation, nor does it mention data provenance (country of origin, retrospective/prospective). The studies implied are likely bench testing or compliance evaluations against engineering standards, not clinical trials with "test sets" in the sense of patient data.

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

• Not applicable. This question pertains to studies involving expert review for establishing ground truth, typically in image analysis or diagnostic performance studies. The provided document is for an infusion set and does not describe such a study.

4. Adjudication method for the test set:

• Not applicable. Same reasoning as point 3.

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 is a medical device for fluid infusion, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This device is an infusion set, not an algorithm.

7. The type of ground truth used:

• Cannot be directly answered in the context of typical "ground truth" for diagnostic studies. For a device like an infusion set, "ground truth" would relate to its physical and biological properties. The "performance data supporting substantial equivalence" refers to compliance with established technical standards (e.g., ISO for sterility, material properties, packaging integrity, biocompatibility), rather than a "ground truth" established by an expert panel or pathology for a diagnostic claim.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. Same reasoning as point 8.

Summary of available information from the document:

The document focuses on demonstrating substantial equivalence to existing predicate devices (Simplicity Easy Soft Infusion Set, K020912, and Soft YP Infusion Set, K011187) by stating that:

• The new device is similar in all significant respects, has the same intended use, and similar materials and manufacturing processes as the predicate device.
• The primary difference is the indwelling catheter connector, designed for use with the MiniMed Paradigm pump, which is equivalent to the YP connector on an existing Sterling Medivations infusion set (K011187).
• Performance Data Supporting Substantial Equivalence: The device "meets the catheter requirements of" a list of national and international standards and regulations. These standards implicitly define acceptance criteria for various performance aspects (e.g., sterility, biocompatibility, material strength, packaging integrity).

List of Standards and Regulations the device reports to meet:

• CDRH 21 C.F.R. Section 880.5440 Intravascular administration set
• ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements)
• ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters)
• ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization
• ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization
• ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices
• ISO 11607: 1997 Packaging for terminally sterilized medical devices
• ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin
• FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end product endotoxin test
• ODE Blue Book Memorandum #K90-1
• ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing
• The design process adhered to Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001).

In essence, the "study" proving the device meets implied acceptance criteria is the demonstration of compliance with these listed standards and regulations, which are recognized for ensuring safety and performance of such medical devices. The document does not provide a separate, detailed "performance study report" with specific data points or statistical analyses.

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The intended use of the Simplicity Easy Access P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access P designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into thssue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Access Infusion Set, K014062 and Soft YP Infusion Set, FDA 510 (k) K011187.

The Simplicity Easy Access P Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use.

The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.

The Simplicity Easy Access P Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.

The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube.

The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.

The provided document is a 510(k) premarket notification for a medical device called the "Simplicity™ Easy Access P Infusion Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a formal study with detailed acceptance criteria and performance data as might be found for a new and novel device.

Therefore, much of the requested information (acceptance criteria in terms of performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or not present in this type of regulatory document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly presented in the typical format of performance metrics and thresholds. Instead, the "acceptance criteria" are compliance with established medical device standards and the "reported device performance" is the demonstration that the device meets these standards, thus proving substantial equivalence.

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

• Sample Size: Not specified. The document states that the device "meets the catheter requirements of" various ISO standards and FDA guidelines, implying that relevant tests were conducted. However, the specific sample sizes for these tests are not provided in this summary.
• Data Provenance: Not specified, but implied to be from internal testing conducted by Sterling Medivations, Inc. to ensure compliance with the listed standards. This would be prospective testing for regulatory submission.

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

• This type of information is not relevant for a 510(k) submission concerning an infusion set. Ground truth, in the context of diagnostic or AI devices, refers to a definitive correct answer for a medical condition. For an infusion set, compliance is demonstrated through engineering and biocompatibility testing against established standards, not expert clinical assessment of "ground truth."

4. Adjudication method for the test set

• Not applicable/not specified. Adjudication methods are typically employed in clinical trials or studies where there's subjectivity in outcome assessment, often involving multiple expert readers. This is not reported for the testing of an infusion set.

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 an infusion set, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

• Not applicable. This device is an infusion set, not an algorithm.

7. The type of ground truth used

• Not applicable in the conventional sense of clinical ground truth (e.g., pathology for a diagnosis). The "ground truth" for this device's performance is adherence to established engineering specifications, material standards (e.g., AISI 304 stainless steel), biocompatibility criteria (ISO 10993-1), sterility standards (ISO 11135), and regulatory requirements. The tests verify that the device physically functions and is manufactured safely according to these pre-defined standards.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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The intended use of the Simplicity QD Easy P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity™ QD Easy P Infusion Set is designed to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to the MiniMed Paradigm infusion pump or syringe.

The Simplicity QD Easy P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMed Paradigm infusion pump or syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP connector is attached to the medication reservoir.

The device consists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector.

The Simplicity QD Easy P Infusion Set is an infusion administration set, connecting to the Paradigm reservoir by means of a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector and subcutaneously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Sterling Medivations Simplicity QD Easy P Infusion Set may be used with any paradigm infusion device that delivers continuous or intermittent flow. The connecting tubing is made from a polyethylene tube.

The 25 gauge-indwelling catheter is introduced into the subcutaneous tissue by a removable 27-gauge insertion needle formed from a lumen made of AISI 304 stainless steel. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector needle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector for connection to a MiniMed Paradigm pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the needle hub connector.

This 510(k) submission (K021296) for the Simplicity™ QD Easy P Infusion Set is not a submission for an AI/ML powered device. It is for a medical device that facilitates the delivery of fluids subcutaneously. As such, concepts like AI assistance, human reader improvement, and ground truth establishment for a training set are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices through compliance with established performance standards for intravascular administration sets.

Here's an analysis of the provided information, tailored to the type of device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by its adherence to various established standards for medical devices, particularly those for intravascular administration sets, and its functional similarity to predicate devices. The "reported device performance" is implicitly demonstrated by meeting these standards and showing substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Information (Not Applicable for AI/ML Device)

Since this is not an AI/ML device, the following points are not applicable in the traditional sense of an AI performance study. However, I can interpret them in the context of a medical device submission:

2. Sample size used for the test set and the data provenance: Not directly applicable. The "test set" for this kind of device is the physical product itself, which undergoes various standardized tests (e.g., integrity tests, sterility tests, biocompatibility tests) as defined by the listed ISO standards and FDA regulations. There isn't a "data provenance" in the sense of patient data. The provenance for the performance data would be the testing laboratories and manufacturing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for establishing "ground truth" in an AI/ML context. However, the development and approval of such a device involve experts in:

   • Engineering/Materials Science: For design, material selection, and manufacturing processes.
   • Quality Assurance/Regulatory Affairs: To ensure compliance with all relevant standards and regulations.
   • Medical Professionals/Clinicians: To define user needs and evaluate the device's functionality and safety in a clinical context (though not explicitly detailed in this summary, it's inherent in medical device development).
   • The FDA reviewers (e.g., Timothy A. Ulatowski, Director of the Division of Dental, Infection Control and General Hospital Devices) act as experts who assess the submitted evidence for "substantial equivalence."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable in the context of multi-expert adjudication for AI results. Adjudication in medical device testing typically refers to the process of resolving discrepancies in test results or ensuring that test methods and results are correctly interpreted against the acceptance criteria. This is usually managed through a robust Quality Management System (QMS) as specified by FDA 21 CFR 820.30 and ISO 9001.

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 is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for "ground truth" in an AI/ML context. For this device, the "ground truth" or reference for performance is established by the compliance with recognized standards and regulations. For example:

   • Sterility: Absence of viable microorganisms as per ISO 11135 and ISO 11138-2.
   • Biocompatibility: No adverse biological reactions as per ISO 10993-1.
   • Physical Integrity/Functionality: Ability to withstand various forces, maintain fluid path, prevent leakage, and connect properly as per ISO 10555 parts 1 and 5, and product-specific testing.

8. The sample size for the training set: Not applicable. There is no artificial intelligence "training set" for this physical device.

9. How the ground truth for the training set was established: Not applicable.

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The intended use of the Simplicity Easy Access II Infusion Set is to provide a means & for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "Simplicity Easy Access II Infusion Set". It states that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment. The document primarily focuses on regulatory clearance and compliance.

Therefore, I cannot provide the requested information based on the input text.

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SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.

SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.

SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.

SIMPLICITY™ 2 is an acetone based adhesive that is dependent on the prepared surface of its conditioner (SIMPLICITY™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER system. Applying the SIMPLICITY™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) submission for SIMPLICITY™ Dental Materials:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not explicitly state a specific sample size for the "physical testing observations and analysis." It generally refers to "physical testing observations."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a dental adhesive, this type of testing is typically prospective, conducted in a lab setting rather than on human subjects.

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

• The document does not mention the use of experts to establish ground truth for the physical testing. Instead, the ground truth is based on the measured physical properties (e.g., shear bond strength) and comparison to the predicate device.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for this type of device is based on quantifiable physical and chemical properties, not expert consensus requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. SIMPLICITY™ is a dental adhesive, and its performance is assessed through physical property testing, not human interpretation of cases.

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

• Not applicable. SIMPLICITY™ is a physical dental material, not an algorithm or AI system. Its performance is inherent to its material properties and chemical composition.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for SIMPLICITY™ is based on quantifiable physical and chemical properties, specifically "shear bond strength to dentin and enamel." The performance of the predicate device, ECLIPTOMER, serves as the benchmark against which the new device (SIMPLICITY™) is compared.

8. The Sample Size for the Training Set

• Not applicable. SIMPLICITY™ is a physical dental material and does not involve AI or machine learning algorithms that require a training set.

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

• Not applicable. As SIMPLICITY™ is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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The intended use of the Simplicity Easy Soft Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Soft Infusion designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to a external pump or syringe. The device consists of four main parts: (1) infusion catheters are made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and threaded reservoir connector and (4) an insertion needle ring. The Simplicity Easy Soft Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/svringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling cannula formed from PTFE. The connecting tubing is made from a polyethylene tube. The PTFE indwelling cannula are insertion needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The insertion needle is removed and the connector needle is attached to the hub fixed to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.

The provided document is a 510(k) summary for the Symplicity™ Easy Soft Infusion Set. It details the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence. However, this document does not contain a study that proves the device meets specific acceptance criteria in the format requested.

Instead, it lists the acceptance criteria as compliance with various FDA regulations and international standards for medical devices, particularly those related to intravascular administration sets, sterilization, and material safety. The document states that the device "meets the catheter requirements of" numerous standards and regulations, implying that performance data was collected to demonstrate this compliance. However, it does not provide the specific results of those tests or detailed performance metrics.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will fill in what information is available and note where information is missing.

1. Table of Acceptance Criteria and 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)

This information is not provided in the document. The document refers to meeting standards but does not detail the specific test methodologies, sample sizes, or provenance of the data collected to demonstrate compliance with these standards.

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

This information is not applicable / not provided. The document describes a medical device seeking substantial equivalence based on meeting engineering and safety standards, not a diagnostic algorithm requiring ground truth established by medical experts. The compliance with standards would typically be assessed by engineers, quality control personnel, and regulatory bodies, not by medical experts establishing ground truth in a clinical context.

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

This information is not applicable / not provided. Adjudication methods are typically relevant for clinical studies or studies evaluating diagnostic performance where subjective interpretation is involved. This document refers to compliance with objective performance and safety standards, where adjudication in this sense is not typically used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable / not provided. The device is an infusion set, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant.

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

This information is not applicable / not provided. The device is an infusion set, not an algorithm.

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

This information is not applicable / not provided. For this type of medical device (an infusion set), "ground truth" refers to meeting established engineering, safety, and performance specifications as defined by the listed ISO standards and FDA regulations. There isn't an equivalent of clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of proving the basic functional and safety compliance of such a device for regulatory submission.

8. The sample size for the training set

This information is not applicable / not provided. The device is a physical medical device, not a machine learning algorithm, so there is no "training set."

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

This information is not applicable / not provided. As explained in point 8, there is no "training set" for this physical medical device.

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The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

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The provided text is related to a 510(k) premarket notification for a medical device called "Simplicity Soft QD II Infusion Set". This document is an FDA letter granting substantial equivalence, which means the device can be marketed.

However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about the study, as this information is not present in the provided text.

The document is purely administrative, confirming the FDA's review and substantial equivalence determination for marketing the device.

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The intended use of the Simplicity Simplex Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Simplicity™ Simplex Soft Infusion Set." This document does not contain information about acceptance criteria or a study proving the device meets them. Instead, it informs the manufacturer that their device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

The letter discusses regulatory classifications, general controls, and compliance requirements, but it does not include details on performance metrics, study designs, sample sizes, or ground truth establishment relevant to the request.

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