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The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The provided text is an FDA 510(k) premarket notification for the Accu-Chek Safe-T-Pro Uno Lancing Device. It does not describe a study with acceptance criteria in the manner typically found in clinical trials or AI/software validation studies. Instead, it details a "non-clinical bench testing" approach to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance for specific metrics. Instead, it refers to "design verification and validation testing" performed per "applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)." The conclusion states the device "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

The closest approximation to "device performance" mentioned is:

• The Accu-Chek Safe-T-Pro Uno lancing device is designed for a single use only and has a sharps injury prevention feature where the lancet is retracted and concealed before and after use, and is rendered inoperative after use.
• It uses a 28 Gauge needle with a 1.5 mm depth and is spring-driven.
• Loading/priming is not required; activation is via a press release button.

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

The document does not specify a "sample size used for the test set" or "data provenance" in terms of subject populations or data collection methods (retrospective/prospective). This is because the described testing is "non-clinical bench testing," meaning it was likely conducted in a laboratory setting on the device itself, rather than on human subjects or clinical data.

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

This is not applicable as no "ground truth" established by experts for a test set is mentioned. The testing involves mechanical and design verification, not expert evaluation of results from human or image data.

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

Not applicable. No adjudication method is mentioned as there's no expert review of outcomes.

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. A MRMC comparative effectiveness study is relevant for AI or diagnostic imaging devices evaluating human performance. This document is for a medical device (lancing device) and does not involve AI or human readers.

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

Not applicable. This is not an AI or algorithm-based device.

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

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical bench testing would be engineering specifications, regulatory standards (like ISO or FDA special controls for sharps injury prevention), and the performance characteristics of the legally marketed predicate and reference devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary of what is present:

• Type of Study: Non-clinical bench testing (design verification and validation testing).
• Purpose: To demonstrate the mechanical functions, safety (sharps injury prevention), and performance are suitable for use and are substantially equivalent to legally marketed predicate and reference devices.
• Applicable Standards: FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850).
• Conclusion: The device is "safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices."
• Clinical Testing: "Not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately."

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Genadyne UNO Negative Pressure Wound Therapy System is in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Ulcers (such as diabetic or pressure)
• Flaps and grafts
• Closed Surgical Incision
  Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.

The Genadyne UNO Negative Pressure Wound Therapy System is a single patient use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO Negative Pressure Wound Therapy System has a pre-determined lifespan. The unit has an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and has selections of Continuous Mode at 80mmHg/ 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Negative Pressure Wound Therapy System Therapy Kits include a therapy unit. 200 ml and 300 mL canisters, and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO Negative Pressure Wound Therapy System can be provided separately. The dressing is intended to be used for a maximum of 3 days. Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes. Disposable components of the Genadyne UNO Negative Pressure Wound Therapy System, including the foam dressing and drape, are packaged sterile (Ethylene Oxide) and not made with natural rubber latex. All disposable components of the Genadyne UNO Negative Pressure Wound Therapy System are for single use only. The Genadyne UNO Negative Pressure Wound Therapy System dressings are to be used only with the Genadyne UNO Negative Pressure Wound Therapy System.

This document is a 510(k) Summary for the Genadyne UNO Negative Pressure Wound Therapy System, seeking FDA clearance for a modified version of an existing device (K190028). The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with detailed performance metrics. Instead, it relies on demonstrating compliance with recognized electrical safety and electromagnetic compatibility standards, and on a comparison of technical specifications with a legally marketed predicate device.

However, based on the non-clinical testing mentioned and the comparison table, we can infer the acceptance criteria are met by demonstrating conformity to relevant standards and maintaining equivalent performance to the predicate device for critical specifications.

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

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for performance. The testing involved compliance with IEC standards for electrical safety and EMC. These standards typically involve a defined set of tests on representative units of the device rather than a "sample size" in the statistical sense for clinical studies. The number of devices used for these engineering tests is not disclosed.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are described as "non-clinical" and implicitly prospective as they were performed on the new device model to demonstrate compliance.

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

This information is not applicable as the submission relies solely on non-clinical testing (electrical safety, EMC) and comparison to a predicate device's specifications. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes for this submission.

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

This information is not applicable as there was no clinical study with a test set requiring adjudication of findings. The assessment was based on engineering test results against established compliance standards.

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

This information is not applicable. No MRMC comparative effectiveness study was performed as this is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic imaging device. The changes relate to the pump's power source and housing, not its interaction with clinical interpretation.

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

This information is not applicable. This device is a Negative Pressure Wound Therapy System, which is a physical medical device, not an algorithm or software. No standalone algorithm performance was evaluated.

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

The concept of "ground truth" as typically understood in the context of diagnostic AI or clinical studies (e.g., pathology, expert consensus) is not applicable to this submission. The "ground truth" for the non-clinical tests would be the established requirements and limits defined by the IEC 60601-1 and IEC 60601-1-2 standards. The device's performance (e.g., maintaining 125 mmHg vacuum) is directly measured and compared against its own specifications and the predicate device's specifications.

8. The sample size for the training set:

This information is not applicable. This device is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set."

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

This information is not applicable for the reasons stated in point 8.

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Ask a specific question about this device

The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

The Accu-Chek Safe-T-Pro Uno lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Uno lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only.

The provided text describes a 510(k) summary for the Accu-Chek Safe-T-Pro Uno Lancing Device. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about a study that proves the device meets those criteria, such as sample size, data provenance, expert qualifications, or adjudication methods.

The document outlines the device's indications for use, its description, and compares it to a predicate device (SurgiLance Safety Lancets) to establish substantial equivalence. It states that "Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification & validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device." A "Verification Summary" is mentioned as an attachment, which presumably contains the detailed test results, but this summary is not provided in the given text.

Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than detailing a specific performance study with acceptance criteria and results.

Disclaimer: Without the "Verification Summary" mentioned in the document, it is impossible to provide the requested details about acceptance criteria and reported performance. The information below is based solely on what is explicitly stated or can be inferred from the provided text, which is limited regarding specific performance metrics.

Based on the provided text, the following information can be extracted or inferred:

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

The provided text does not explicitly state specific acceptance criteria or reported device performance metrics in a quantifiable manner. It mentions "nonclinical bench testing" and "design verification & validation testing" were performed to ensure risks were appropriately managed and verify mechanical functions are suitable for use over the lifetime of the device. The conclusion states the device "performs as well or better than the legally marketed predicate device," which is a general statement rather than specific performance data with corresponding acceptance criteria.

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

The text does not provide any information about the sample size used for the test set, data provenance, or whether the study was retrospective or prospective. It only refers to "nonclinical bench testing" and "design verification & validation testing."

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 as the provided text describes non-clinical bench testing for a lancing device, not a study evaluating human interpretation or a diagnostic algorithm requiring expert ground truth establishment.

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

This information is not applicable as the provided text describes non-clinical bench testing for a lancing device and does not involve adjudication of results from multiple reviewers.

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 as the device is a lancing device and does not involve AI assistance or human readers.

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

This information is not applicable as the device is a lancing device and does not involve an algorithm.

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

This information is not applicable in the traditional sense of medical image analysis or diagnostic algorithms. For a lancing device, "ground truth" would refer to established engineering and mechanical standards, as implied by "design verification & validation testing" and compliance with "FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)."

8. The sample size for the training set

This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.

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

This information is not applicable as the device is a lancing device and does not involve machine learning or a training set.

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UNO 30 is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. UNO 30 is a single patient use device.

The UNO 30 is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound. The unit provides negative pressure at either 80mmHg or 125mmHg in continuous mode and 80mmHg/30mmHg or 125mmHg/30mmHg in variable mode. The UNO 30 NPWT system includes dressing and canister.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UNO 30 device:

The provided text is a 510(k) Premarket Notification for the UNO 30, a Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to predicate devices, rather than a novel claim requiring extensive clinical trials or an AI's performance evaluation. Therefore, the information you're asking for, particularly concerning AI performance metrics, clinical study design, and expert adjudication, is not present in this document. The device is a physical medical device (pump, dressings, canister), not an AI-powered diagnostic or assistive tool.

However, I can extract the relevant information available for the device as described.

Acceptance Criteria and Device Performance (Based on "Technological Characteristics" and "Discussion of nonclinical and clinical testing" sections)

This document doesn't present "acceptance criteria" in the typical sense of performance thresholds for an AI or diagnostic device. Instead, it focuses on demonstrating that the UNO 30 maintains similar technical characteristics and safety/effectiveness as its predicate devices, primarily the Genadyne UNO (K180840) with an extended use-life.

The key "performance" aspect evaluated here is the extended device lifespan to 30 days while maintaining the functionality of the predicate.

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)

This document describes bench testing, not a clinical study involving patients or data sets. Therefore, there's no "sample size for the test set" in the context of patient data, nor a country of origin for such data. The tests were performed on the device itself.

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. This device is a physical pump, not an AI or diagnostic tool requiring ground truth established by experts for performance evaluation. The "ground truth" here is the expected physical performance of the device (e.g., maintaining pressure, battery life, proper shutdown).

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

Not applicable. As this is bench testing of a physical device, there's no expert adjudication involved in the sense of reviewing outputs or diagnoses.

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 document is about a physical NPWT device, not an AI or diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance is provided.

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

Not applicable. This is not an algorithm or AI. The software component mentioned is for device control and functionality, not for standalone diagnostic or assistive performance.

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

The "ground truth" for the bench tests was the engineering specifications and expected functional performance of the device (e.g., a pressure reading close to 125 mmHg, battery lasting for a certain duration, a specific alert triggering correctly). This is based on established engineering principles and the device's design requirements.

8. The sample size for the training set

Not applicable. There is no AI or machine learning model that requires a "training set" described in this document.

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

Not applicable, as there is no training set for an AI model.

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Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed surgical incision. Genadyne UNO is a single patient use device.

The UNO Negative Pressure Wound Therapy System is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound.

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and study information for the Genadyne UNO Negative Pressure Wound Therapy System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" for performance tests in a tabular format with corresponding reported values. Instead, it states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, based on the non-clinical testing discussion, we can infer the types of performance aspects tested.

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

The document mentions "A clinical case series from 15 patients with closed surgical incisions were provided as supplementary performance data in support of the safety of the device."

• Sample Size for Test Set: 15 patients
• Data Provenance: Not explicitly stated, but clinical case series generally imply prospective or retrospective data from a clinical setting.
  • Retrospective/Prospective: Not specified, but "case series" can be either.

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

This information is not provided in the document. The document refers to a "clinical case series" as "supplementary performance data," but it does not describe how the outcomes for these 15 patients were adjudicated or evaluated by experts to establish a 'ground truth' for device performance in the context of an AI/algorithm. This device is a physical pump, not an AI diagnostic tool, therefore, the concept of "ground truth" as typically applied to image analysis or diagnostic algorithms doesn't directly apply in the same way. The "ground truth" here would relate to the patient's actual wound healing and safety outcomes, which would likely have been determined by the treating clinicians.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As noted above, this isn't an AI diagnostic device where expert adjudication of outputs would typically be required. The "clinical case series" would involve patient follow-up and clinical assessment by healthcare professionals.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation where multiple readers evaluate cases with and without AI assistance). The Genadyne UNO is a Negative Pressure Wound Therapy System, which is a therapeutic device, not a diagnostic one.

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

Not applicable. The Genadyne UNO is a physical medical device (a powered suction pump for wound therapy), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the clinical case series, the "ground truth" would be the clinical outcomes observed in the 15 patients regarding wound healing, removal of exudates/infectious material, and absence of adverse events associated with the device's use. This would be based on clinical assessment and patient follow-up by healthcare professionals. For the bench tests, the ground truth would be based on objective measurements of physical parameters (pressure, absorbance, alert function) against predefined engineering specifications.

8. The Sample Size for the Training Set

Not applicable. As the Genadyne UNO is a physical medical device and not an AI/Machine Learning algorithm, there is no "training set." The device's performance is established through bench testing and clinical observations, not through a learning process from data.

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

Not applicable, as there is no training set for this device.

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The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump.

The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.

The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump.

The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps.

The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System.

The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.

The Comfort Subcutaneous Infusion Sets are sterile, non-pyrogenic, single use subcutaneous infusion sets. The current sets are designed to be used with commercially available infusion devices or are indicated for a specific pump where the set has a proprietary pump reservoir connection (e.g. Medtronic, Asante). Each has two basic components provided for each device. The first is a stand-alone subcutaneous indwelling Soft Cannula. This component of the set is provided as an integral assembly with a PFOA-Free PTFE soft cannula, adhesive backed fixation tape, an injection port and the female portion of a proprietary plastic "click-lock" connector. The assembly comes with a stainless-steel insertion needle. The insertion needle is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion needle comes to the user inserted through the injection port and the inner lumen of the soft cannula with the needle end protruding past the tip of the soft cannula. The male connector is locked to the female connector on the indwelling soft cannula. A needle protector is assembled over the soft cannula and the insertion needle. A separate male portion of the proprietary connector without the insertion needle is provided in the package. This component is used to attach to the female connector after the indwelling soft cannula has been inserted and the steel insertion needle has been withdrawn and protects the indwelling cannula when the infusion set is not attached. Each Soft cannula set comes individually packaged in its own blister pack sealed with paper lid stock.

The second component is the infusion tubing set. The infusion tubing set for all sets are comprised of a co-extruded tube with a stainless-steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. The proximal end of the current Comfort set terminates in either a standard luer lock connector or a proprietary connector compatible with the specified pump. The sets come individually packaged in blister packs sealed with paper lid stock.

This document describes the 510(k) premarket notification for several subcutaneous infusion sets. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly concerning a change in the sterilization facility and the adoption of a PFOA-free PTFE soft cannula.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states "The following verification testing was performed" but does not provide specific sample sizes for each test. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable in this context. The study is a series of engineering/performance verification tests for a medical device (infusion sets), not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements (e.g., flow rate, leak detection, pull force, bend cycles) with clear pass/fail criteria, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or AI-assisted clinical decision support systems, which is not the nature of this device.

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

Not applicable. This device is a physical medical device (infusion set), not an algorithm or AI system. Its performance is inherent to the device itself.

7. The Type of Ground Truth Used:

The ground truth or reference standard for these tests are the established engineering specifications and physical properties of the materials and assembled device. For example:

• Flow/Leak/Pull Tests: Engineering specifications for flow rates, pressure resistance, and tensile strength.
• Bend Test: Durability and integrity requirements under mechanical stress.
• Biocompatibility: Established ISO standards (ISO 10993) for material safety and equivalence.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context would refer to internal manufacturing process optimization and quality control, not data for an algorithm.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" for manufacturing and quality (if considered analogous) would be established through industry standards, regulatory requirements, and internal design specifications, often validated by extensive testing and risk analysis during the device development lifecycle.

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Genadyne UNO is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates and infectious material.

Appropriate wound types include:

• Chronic
• Acute
• Traumatic
• Subacute and dehisced wounds
• Partial-thickness burns
• Ulcers (such as diabetic or pressure)
• Flaps and grafts

Genadyne UNO is a single patient use device.

The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Genadyne UNO Negative Pressure Wound Therapy System:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical trial. As such, detailed human clinical study data proving the device meets acceptance criteria in the same way a new drug or novel device might is not typically included in these summaries. The "acceptance criteria" here largely refer to comparison against the predicate device's characteristics and meeting relevant safety standards.

Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" for this 510(k) submission is demonstrating that the Genadyne UNO is substantially equivalent to the predicate device, the Pico Single Use Negative Pressure Wound Therapy System (K151436), and that it meets applicable safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The document primarily describes non-clinical testing to support substantial equivalence.

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

• Test Set Sample Size: Not specified for individual tests. For the non-clinical testing, sample sizes would typically refer to the number of units tested per bench test (e.g., n=3, n=5, n=10 devices). The document states "Bench testing was done with in house protocol to establish ensure the performance and outcome."
• Data Provenance: The testing appears to be prospective bench testing conducted in-house by Genadyne Biotechnologies, Inc., and potentially by third-party labs for standards compliance (e.g., biocompatibility, IEC). The country of origin for the data generation would likely be the USA, as this is a US-based company submitting to the FDA.

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

• This information is not provided in the document. For bench/non-clinical testing, "ground truth" is typically established by engineering specifications, recognized standards (e.g., ISO, IEC), and scientific principles, not by expert medical consensus on individual cases.

4. Adjudication method for the test set:

• This is not applicable to the type of non-clinical, bench testing described. Adjudication methods like 2+1 or 3+1 are used for reviewing patient cases, often in diagnostic studies to establish a consensus ground truth.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The Genadyne UNO is a therapeutic negative pressure wound therapy system, not a diagnostic imaging device with AI interpretation.

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

• No, this is not applicable. The Genadyne UNO is a medical device (a powered suction pump) used directly on patients for wound therapy, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is its functional operation (e.g., maintaining negative pressure, managing exudate).

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

• For the non-clinical testing described, the "ground truth" or reference standards used would be:
  • Engineering specifications for device function (e.g., vacuum pressure, battery life).
  • International standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility).
  • Predicate device characteristics as a benchmark for comparison.

8. The sample size for the training set:

• Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm.

Summary of Device Meeting Acceptance Criteria:

The document concludes that the Genadyne UNO meets its acceptance criteria by demonstrating substantial equivalence to the predicate device and by passing relevant safety and performance non-clinical tests.

• Biocompatibility Testing: The dressing kit (silicone foam dressing, PU film strips) met accepted criteria.
• Electrical Safety & EMC Testing: The pump successfully met acceptance criteria for all applicable IEC testing.
• Bench Testing: In-house protocols were used to ensure the device's performance and outcome were as expected.
• Design & Function Comparison: While some technical specifications differ (e.g., max vacuum, battery type, canister use), these differences are highlighted and determined not to raise new issues of safety or effectiveness. The fundamental intended use, indications, and contraindications are presented as similar to the predicate.

The basis for acceptance is that the device is as safe and effective as a legally marketed predicate device, as evidenced by these non-clinical comparisons and standard compliance.

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The AquaC UNO H Portable Water Purification System is a reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies.

The AquaC UNO H can be connected to hemodialysis equipment used in hospitals, clinics and in home environments. This device is intended to be a complete water purification system, and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by posttreatment devices as well, to meet current AAMI/ANSI and FDA recognized U.S. standards.

The AquaC UNO H Water Purification System is a microcontrolled, fully automatic reverse osmosis system with heat disinfection function which uses pretreated soft water for the production of highly deionized water, also called permeate.

The intended use of the reverse osmosis device is to remove organic and inorganic ions and microbiological contaminants from the feed water to fulfill the requirements of ISO 13959 'water for haemodialysis and related therapies'.

The feed water must be of drinking water standard, filtered, free of iron, softened and free of chlorine. Potentially critical limits must be monitored by regular checks.

Bacterial growth in the system must be prevented by continuous operation of the system with a minimum of idle times and by preventive measures such as chemical or heat disinfection.

The device consists of a water inlet section where the inflowing volume of water is volumetrically measured. The water is stored in a break tank and is used by the pump to generate high pressure. The pump generates the high pressure and transports the water to the membrane.

The permeate flows from the membrane through the conductivity cell to the permeate outlet into the ring main. The ring main can be connected directly to a dialysis machine.

The concentrate is discarded via the drain valve to the drain.

The provided text describes the AquaC UNO H Water Purification System, a device intended for hemodialysis, and its premarket notification to the FDA. While it states that performance tests demonstrate compliance with various standards and that the device meets specifications, it does not provide detailed acceptance criteria or the specific results of a study in a manner that would allow for the direct completion of a table detailing "acceptance criteria" and "reported device performance."

Instead, it broadly states that:

• "The results of all these tests show that all specifications and requirements have been met."
• "The AquaC UNO H Water Purification System is capable to meet relevant standards and specifications for the use in haemodialysis and related therapies."
• "The information and performance data provided indicates that the AquaC UNO H is safe and effective and performs at least as well as the predicate devices when used in accordance to the instruction of use."

Given the information provided, it's impossible to create a table with specific numerical acceptance criteria and reported performance values. The document focuses on declaring that the device meets standards and specifications rather than detailing what those specific thresholds and measured outputs were.

Therefore, I cannot fulfill all parts of your request directly from the given text.

However, I can extract information related to the studies performed and other contextual details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be fully generated. The document states that performance testing was conducted "according to the specifications of the device" and that "all specifications and requirements have been met." However, it does not list these specific specifications or the measured performance values.

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

• Sample Size: Not specified. The document mentions "non-clinical tests" and "Performance testing" but does not provide a sample size (e.g., number of units tested, duration of tests).
• Data Provenance: The tests were performed by "internal and external testing laboratories." Given the manufacturer is based in Germany (Vivonic GmbH, Sailauf, Germany), it is highly probable that the data provenance is Germany or other European countries where these laboratories are located. The document does not specify whether the data was retrospective or prospective.

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

• Not applicable / Not specified. This type of information (experts, ground truth, qualifications) is typically associated with clinical studies involving human interpretation or pathology, not with performance testing of a water purification system's technical specifications (like chemical, microbiological, electrical safety, or usability performance).

4. Adjudication method for the test set:

• Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for expert review of medical images or outcomes where there might be disagreement. This is not reported for the technical performance testing of a water purification system.

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. MRMC studies and "human readers with/without AI assistance" are relevant to AI/imaging diagnostics, not to a water purification system.

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

• Not applicable. This relates to AI algorithms, not a physical water purification system. However, the software validation (according to IEC 62304) implies that the device's control algorithms were tested in a standalone manner. The document does not provide details on the performance outcomes of this specific testing.

7. The type of ground truth used:

• Measurement against established standards and specifications. For chemical and microbiological testing, the ground truth would be the thresholds defined in ISO 13959 and ISO 23500. For electrical safety, it would be IEC 60601-1. For performance testing, it would be "the specifications of the device." These are objective, measurable standards, not expert consensus or pathology in the typical sense.

8. The sample size for the training set:

• Not applicable. The device is a physical water purification system; it does not involve machine learning or AI models that require training sets in the customary sense.

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

• Not applicable. See point 8.

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The BEVER™ intermittent catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for men, women and children, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip. The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water packet, it becomes slippery and thus reduces friction against the urethra.

The provided text describes the regulatory submission for the BEVER™ Intermittent Catheter, primarily focusing on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria related to clinical performance. The "Device Performance" section refers to compliance with EN standards, and then details a series of biocompatibility tests.

Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not provided in this regulatory submission document.

However, I can extract the information relevant to the acceptance criteria and performance as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are based on compliance with established standards (EN and ISO) and the qualitative outcomes of the conducted tests (e.g., no cytotoxicity, non-irritant, no sensitization, no tearing). There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy mentioned as this is a medical device (catheter) and not an AI/diagnostic device.

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

• Cytotoxicity Test: L-929 mouse fibroblast cells were used. The specific number of replicates or wells is not explicitly stated but implied by the use of "a 96-well microplate." Data provenance is laboratory testing.
• Irritation Test: Test articles were contacted with vaginal tissue (animal model implied). The number of test subjects (animals) is not specified. Data provenance is laboratory testing.
• Sensitization Test: Ten test guinea pigs (per extract) for the test group and five control guinea pigs (per vehicle) for the control group were used. Data provenance is laboratory testing (animal study).
• Packaging Shipment Testing: 2 pieces of packaged-products were submitted for testing. Data provenance is laboratory testing.
• Shelf Life Testing: The sample size for accelerated and real-time aging studies is not specified in the provided text. Data provenance is laboratory testing.

The country of origin for the data (tests) is not explicitly stated, but the submitter is based in Hangzhou, China, suggesting the testing was likely conducted there or overseen by the Chinese manufacturer. All studies appear to be prospective studies conducted for regulatory submission.

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

• Not applicable. The tests performed are laboratory-based assays (e.g., cell viability, tissue examination, animal skin reaction, physical integrity) whose "ground truth" is determined by the experimental results and established biological/physical standards, rather than expert consensus on complex diagnostic images or clinical scenarios. No human expert interpretation to establish a ground truth is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the tests are laboratory-based with objective measurements (e.g., cell viability assays, macroscopic/microscopic tissue examination, visual inspection for tearing). There is no mention of a subjective "test set" requiring adjudication in the context of clinical or diagnostic performance.

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 document describes a medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or human reader improvement with AI are not relevant.

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

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Ground truth was established based on the results of standardized biological assays interpreted against pre-defined criteria in ISO 10993 standards and the control groups. For example, cell viability percentage for cytotoxicity, macroscopic and microscopic evaluation for irritation, and skin reaction scoring for sensitization.
• Physical/Material/Packaging/Sterility/Shelf Life: Ground truth was established by demonstrating compliance with specific EN and ISO standards and by meeting the device specifications after various tests (e.g., physical inspection, sterility indicator, stability testing).

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The manufacturing processes and material selection might be informed by historical data or R&D, but not a formally defined "training set" for an algorithm.

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

• Not applicable, as there is no training set mentioned for this medical device.

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