Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe.

The Simplicity Simplex 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 MiniMcd Paradigm influsion purpor syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP concector is stached to the medication reservoir. This is substantially equivalent to the predicate device and it has the same intendcd use.

The device cousists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion lub that provides the patient the capability of disconnecting the comnecting tube from the infusion catheren (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reused causes. (1) a and reservoir connector.

The Simplicity Simplex P Infusion Set is an infusion administration set, connecting to the Paradig m reservoir by means of a Simplicity YP connector consisting of a needle but and reuseble purpose and rescrvoir connector and subcutancously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Stcrling Medivations Simplicity Simplex P Infusion Set may je used with any paradigm infusion device that delivers continuous or internattent flow. The connecting tubing is made from a polyethylene tube.

The 25 gauge-indwelling catheter is introduced into the subcutancous tissue by a removable 27-gauge insertion necdle formed from a lumen made of AISI 304 stainless stecl. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector ne-dle 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 stcel 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 bub and reusable pump adapter and reservoir connection to a MiniMed Paradign pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the aecdle hub

The provided text describes a 510(k) submission for the "Simplicity™ Simplex P Infusion Set." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria and results in the way typically seen for novel or high-risk devices.

Therefore, many of the requested categories like sample size, ground truth, expert qualifications, and MRMC studies are not applicable to the information contained in this 510(k) summary. The "acceptance criteria" here refer to conformity with established standards for similar devices.

Here's an attempt to structure the available information according to your request, with significant portions marked as "Not Applicable" or "Not Specified" due to the nature of the document:

Acceptance Criteria and Study to Prove Device Meets Criteria

The Simplicity™ Simplex P Infusion Set achieved substantial equivalence to predicate devices by demonstrating conformity to various international and national standards governing intravascular administration sets, sterilization, materials, and packaging. The "acceptance criteria" are therefore defined by successful adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document indicates adherence to standards, which implies testing was conducted, but the specific number of units tested is not detailed in this summary.
• Data Provenance: Not specified, but generally refers to internal company testing and validation processes in adherence to the listed standards.

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 type of submission is conformity to established engineering and medical device standards. There is no mention of external experts or clinical judgement for performance evaluation in this summary.

4. Adjudication method for the test set

Not applicable. This is not a clinical study requiring adjudication of expert opinions.

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 assistive tool.

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

The "ground truth" implicitly used is conformity to established engineering and biocompatibility standards (e.g., ISO for sterility, materials, and intravascular catheters; CDRH regulations). This is demonstrated through various tests and validations that verify the device's physical, chemical, and biological properties meet the requirements of these standards.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model.

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

Not applicable. This is a medical device, not a machine learning model.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

The intended use of the Simplicity StarPlus 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.

Sterling Medivations, Inc.'s ("SMI") Simplicity ™ StarPlus Soft Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. The device consists of four main parts: (1) an infusion catheter made from polytetrafluorthylene (PTFE), (2) an infission hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a comecting tube and (4) a female Luer connector. The Simplicity StarPlus Soft Infusion Set is an infusion administration set, connecting to a pump or syringe and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity StarPlus Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of polytetrafluorthylene (PTFE). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling PTFE catheter is introduced into the subcutaneous tissue using an insertion needle. The insertion needle is removed and a connector housing is attached to the indwelling catheter. This connector needle part of the connector hub pierces a septum formits the infusion of medication without leakage. The connector needle is connected to the connector housing. The connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connector. The quick disconnect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.

The provided text describes a 510(k) premarket notification for a medical device called the "Simplicity StarPlus Soft Infusion Set." This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of diagnostic accuracy or clinical effectiveness. Therefore, many of the requested categories for a diagnostic device study are not applicable or cannot be extracted from this documentation.

Here's a breakdown of the available information based on your request, with an emphasis on what can and cannot be provided from this particular document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be typical for a diagnostic device. Instead, the "acceptance criteria" are compliance with various standards for medical device manufacturing, materials, and sterilization, and the "reported device performance" is the statement that the device meets these standards, thus supporting substantial equivalence.

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

This document does not describe a "test set" in the context of clinical or performance data involving patient samples. The "performance data" refers to the device meeting the specified engineering, material, and sterilization standards. Therefore, information on sample size and data provenance for a "test set" is not applicable here.

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

This information is not applicable. No ground truth establishment by experts for a clinical "test set" is described.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable. No adjudication method for a clinical "test set" 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

This information is not applicable. The device is an infusion set, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

This information is not applicable. The device is a physical infusion set, not an algorithm, so standalone algorithm performance is irrelevant.

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

This information is not applicable. For this type of submission, "ground truth" relates to the device specifications and documented compliance with recognized standards, not clinical outcomes or diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms, which this device is not.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

The intended use of the Simplicity Easy Access 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.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access Infusion Set is designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe. 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 the connecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded reservoir connector. The Simplicity Easy Access 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 infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded luer 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 with and me work is made from AISI 304 stainless steel and it is connecting tubing. The connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.

This document describes the 510(k) submission for the Simplicity™ Easy Access Infusion Set, which is a medical device for infusion and/or injection of fluids below the skin. The submission focuses on demonstrating substantial equivalence to a predicate device, the Maersk Medical Pureline™ Comfort™ Infusion Set (K972135).

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or reported device performance in the format of a table with numerical values (e.g., minimum tensile strength of X, actual measured tensile strength of Y). Instead, it states that the device "meets the catheter requirements of" a list of ISO standards and FDA regulations, implying that compliance with these standards serves as the acceptance criteria.

The "reported device performance" is essentially that the device complies with these standards, asserting substantial equivalence. There are no performance metrics provided for specific functionalities like flow rate, leakage, or durability.

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

The document does not specify a sample size for any test set (e.g., number of infusion sets tested). The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The "Performance Data Supporting Substantial Equivalence" section refers to adherence to standards, which implies in-house testing or testing by accredited labs, but no details on the specific data generated are provided.

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 applicable to this submission. The "ground truth" here is compliance with established engineering and biological standards for medical devices, not a clinical determination requiring expert consensus on a diagnostic outcome. The document relies on adherence to published standards rather than expert evaluation of a test set.

4. Adjudication Method for the Test Set

As there's no "test set" in the sense of a set of cases requiring adjudication (e.g., images for diagnostic AI), an adjudication method is not applicable and not mentioned.

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 document describes an infusion set, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted or reported.

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

Similar to point 5, this device is a physical infusion set, not an algorithm or AI system. Standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is the compliance with established international and FDA standards for medical device manufacturing, materials, sterilization, and performance characteristics (e.g., Luer taper, biocompatibility, packaging integrity). It is an engineering and regulatory "ground truth" rather than a clinical or diagnostic one.

8. The Sample Size for the Training Set

This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable and not mentioned.

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

As there is no training set for a machine learning model, this question is not applicable. The "ground truth" for the device's development (its design specifications and performance benchmarks) would be rooted in the referenced ISO and FDA standards and guidance documents.

Ask a specific question about this device