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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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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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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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