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The Nisus ONE Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management.

The Nisus ONE Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004)

The Nisus ONE Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

Cork Medical has developed a negative pressure wound therapy (NPWT) system with the same intended use as the predicate device (K140022). The subject device features a modified user interface, and an adjusted feature set intended to support ease of use, while maintaining the same fundamental therapeutic function and performance characteristics as the predicate device. The Nisus ONE Negative Pressure Wound Therapy System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes.

The device display is limited to presenting critical operational parameters, including therapy mode, battery status, and target pressure settings. Visual and audible alarms are consistent with the predicate device (K140022) and alert critical battery, pressure leakage, system blockage, and full canister occur. While the Nisus ONE NPWT System's interface differentiates from the predicate Cork NPWT system, the mechanical components and therapy application are identical. The new model is intended to enhance accessibility by aligning with the needs of a broad and diverse patient population across various care settings.

The components included within the Nisus ONE NPWT System are:

• Nisus ONE Negative Pressure Wound Therapy Pump (OCMPP-100)
• Nisus ONE Pump Battery Charger (NIS-CHRG-A-18)
• Nisus NPWT Canister 500-mL (CPC-500)
• Nisus NPWT Canister 250-mL (CPC-250, previously cleared in K140022)

Accessory components are required to operate the device. Injection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The Nisus NPWT Canister 250-mL design was previously cleared in the Nisus NPWT system 510k application (K140022). The Nisus NPWT Canister 500-mL is based on the same design as the Nisus NPWT Canister 250-mL. The dimensions were enlarged to provide a larger reservoir for patient convenience. Thus, the subject and predicate canisters have substantially equivalent characteristics.

The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. Integrated with the pump mechanism, these components ensure the safe and efficient removal of wound exudate. NPWT Accessories were previously cleared in K132004. Our application for the Nisus ONE NPWT system includes no revisions to these previously cleared components.

The provided FDA 510(k) clearance letter for the Nisus ONE Negative Pressure Wound Therapy System does not contain information related to an AI/ML-based device performance study.

The document details the substantial equivalence of the Nisus ONE system to a predicate device, focusing on changes to the user interface, physical dimensions, and technical specifications of a powered suction pump. The "Nonclinical Tests" section describes bench performance testing of the pump's functionality (e.g., pressure, alarms, flow rate) using simulated wound exudate and a test bed fixture, as well as software verification and validation, electrical safety, EMC, and usability testing. These are standard engineering and regulatory tests for medical devices, not performance studies of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample size, data provenance, expert qualifications, and adjudication methods for a test set related to an AI/ML algorithm.
• Details on MRMC studies or standalone AI performance.
• Information on training set size or ground truth establishment for an AI/ML algorithm.

The document explicitly states: "No Clinical Testing was required to support these 510(k) submissions. No clinical testing has been performed." This further indicates that no studies involving human data or expert review for AI/ML performance were conducted or reported in this submission.

If you have a document describing an AI/ML device, please provide that, and I would be happy to analyze it according to your criteria.

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The RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are intended to be used in conjunction with Smith + Nephew traditional Negative Pressure Wound Therapy (tNPWT) RENASYS system.

The Smith + Nephew RENASYS NPWT system is indicated for patients who would benefit from a suction pump (Negative Pressure Wound Therapy), as it allows for wound management via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Appropriate wound types include:

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

RENASYS Foam and Gauze Wound Dressing Kits with AIRLOCK Technology and Soft Port are accessories intended for use in conjunction with RENASYS TOUCH, RENASYS GO and RENASYS EDGE Negative Pressure Wound Therapy systems.

Based on the provided text, the document is a 510(k) summary from the FDA for a medical device called "RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port." This document does not describe an AI/ML device or its performance criteria. It pertains to a physical medical device used for negative pressure wound therapy.

Therefore, I cannot provide the requested information as the document does not contain details regarding acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets those criteria. The original text only mentions non-clinical tests (simulated wound model tests, human factors validation, biological evaluation) and explicitly states "No clinical performance data was necessary" for this particular device.

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The Genadyne DUO Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

· The Genadyne DUO NPWT System, in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. • Instillation therapy is indicated for patients who would benefit from vacuum assisted drainery of topical wound treatment solutions and suspensions over the wound bed.

The Genadyne DUO Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub acute and dehisced wounds, partial- thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

The Genadyne DUO NPWT is a Negative Pressure Wound Therapy unit with instillation option. The DUO NPWT features an interface touch panel which provides user selectable therapy modes (continuous mode and variable mode) and multi pressure options from 40 m m H g to 200 mmHg). The DUO NPWT is packaged in a box that includes a universal charger, power cable, a user manual and a user carry bag. The dressing kits includes the transparent film dressings, the Genadyne foam dressing and the Genadyne Port. The DUO NPWT is designed to be used with a canister collection system. The canister will have 3 sizes available (600cc, 800cc and 1100cc). All the dressings and canisters are single use disposable items. To help ensure safe and effective use, the DUO NPWT are to be used only with the Genadyne supplied dressings and canisters. There is an instillation option on the device for instillation therapy for the patient that requires it. The installation option provides a controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The instill mode consists of NPWT combined with the automatic, controlled delivery and removal of wound treatment solutions to and from the wound bed. It offers a more conducive dressing environment for wound bed management with adjustable target pressure, vacuum time, instill volume, and soaking time. With the adjustable target pressure, negative pressure in mmHg is applied to the wound.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Genadyne DUO NPWT), but it does not include details about acceptance criteria, specific study results proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

The document primarily focuses on:

• Device Description and Indications for Use: What the device is and what it's used for.
• Substantial Equivalence: How the device is similar to a legally marketed predicate device.
• Regulatory Compliance: Information about general controls, quality system regulations, UDI, and adverse event reporting.
• Non-clinical Testing: Mentions that bench tests were performed per ISO10079-1 to show the device functions appropriately, including "Pressure precision test, absorption test, alert capacity test, instill therapy test." It also mentions software documentation and a "Moderate" level of concern for software.

It does not provide the quantitative results or the methodology of these tests in detail, nor does it define acceptance criteria for these tests or relate them to clinical performance metrics. The information needed for a detailed description of acceptance criteria and the study proving performance (as outlined in your request) is simply not present in the provided text.

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The VERSA Negative Pressure Wound Therapy System 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 excess exudates, infectious material, and tissue debris.

The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) and the VERSA NPWT 100ml Canister.

The VERSA Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

The Cork Medical VERSA Negative Pressure Wound Therapy System is designed to provide gentle powered suction to treat and promote wound healing by aiding in the removal of excess exudates, infectious material, and tissue debris. The single button design makes applying negative pressure wound therapy for patients and physicians without compromising the power and performance demanded for wound management.

The VERSA NPWT System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes. One button power on and off the pump and the other button switches pressure settings from 75 mm/Hg and 125 mm/Hg continuous and a 10 second hold on this button switches the pump to a variable intermittent mode, unlike its predecessor Cork NPWT System which uses multiple buttons and menus to adjust settings.

The VERSA NPWT System includes a therapy pump, 100 ml collection disposable canister, and carrying bag. The VERSA NPWT System is only intended to be used with the Cork NPWT Wound Dressing Kit.

The provided document is a 510(k) premarket notification for a medical device, the VERSA Negative Pressure Wound Therapy System (VCMPP-100). This submission is for a modification to an already cleared device (predicate device K230677), specifically to allow for home use and to implement a firmware update.

Based on the provided text, the device in question (VERSA Negative Pressure Wound Therapy System) is not an AI/ML device. The document describes a powered suction pump used for wound healing and does not mention any artificial intelligence or machine learning components. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them (including elements like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) cannot be extracted from this document as it pertains to an entirely different type of medical device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a change in environment of use and a minor firmware update. The "Nonclinical Tests" section details a series of bench performance tests for alarm functions and usability testing, which are standard for traditional medical devices, not AI/ML systems.

Therefore, I am unable to provide a response that directly addresses the specific requirements for an AI/ML device's acceptance criteria and study, as the provided input does not describe such a device or its evaluation.

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The Negative Pressure Wound Therapy Device is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed.

The Negative Pressure Wound Therapy Device is indicated for the following wound types: chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.

The Negative Pressure Wound Therapy Device is a portable, rechargeable, battery powered pump capable of delivering bespoke continuous and/or intermittent negative pressure intended to allow wound management by draining and removing wound exudates, infectious material, and tissue debris from the wound bed. The Negative Pressure Wound Device is packaged and provided with the following components: Negative Pressure Wound Therapy Pump and Collection Canister.

Patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps, and grafts may benefit from this system.

The Negative Pressure Wound Therapy Device used with wound dressings can produce a negative pressure environment in either intermittent or continuous mode. This allows the user to program the specific pressure ranging from 50mmHg to 200mmHg (V-Move) and 0 to 200 mmHg (V-Grand).

In intermittent mode, the pump will alternate between applying pressure for 5 continuous minutes and reducing pressure to 0 for 2 minutes for V-Move. In intermittent mode, therapy pressure, operating time, and interval time can be adjusted for V-Grand.

The Negative Pressure Wound Therapy Device is compatible with the Longterm NPWT Foam Dressing Kit (K211571).

The device is used in professional medical facilities.

The Negative Pressure Wound Therapy pump accessories that are included in this 510(k) submission and will be commercialized separately are the following: 300cc Collection Canister 500cc Collection Canister 1000cc Collection Canister

The provided document is an FDA 510(k) clearance letter for a Negative Pressure Wound Therapy Device (V-Move, V-Grand). It does not contain any information about acceptance criteria or a study proving the device meets those criteria (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).

The document primarily focuses on:

• Substantial Equivalence: Comparing the new device to existing predicate devices (K132225 and K162159) based on indications for use, contraindications, principle of operation, vacuum modes, negative pressure ranges, canister sizes, prescription use, sterility, weight, user life, energy source, tubing material, and battery type.
• Non-Clinical Testing: Mentioning that non-clinical tests were conducted for safety (ANSI AAMI ES60601-1, IEC60601-1-2), biocompatibility (not required as components are not tissue contacting), performance (bench tests including safety, environmental, device performance, and function tests), and software validation.
• Absence of Clinical Study: Explicitly stating that "No clinical testing was required to support substantial equivalence."

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because such information is not present. The device is cleared based on substantial equivalence to predicate devices rather than direct performance metrics derived from clinical or AI-driven studies.

To address your request, if this were a device involving AI or complex performance metrics, the missing information would typically include:

1. Table of Acceptance Criteria and Reported Device Performance: This would specify quantitative metrics (e.g., accuracy, sensitivity, specificity, precision, F1-score) and the threshold they needed to meet for acceptance, along with the actual performance achieved in a test set.

2. Sample Size and Data Provenance: Details on the number of cases/patients in the test set, their country of origin, and whether the data was collected retrospectively or prospectively.

3. Number and Qualifications of Experts for Ground Truth: The number of human experts (e.g., radiologists, pathologists) who reviewed the test data to establish the correct diagnoses or labels, along with their professional qualifications and experience.

4. Adjudication Method: How disagreements among experts were resolved to arrive at a definitive ground truth (e.g., majority vote, senior expert arbitration).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: If human readers were involved, whether a study was conducted to assess the improvement in human performance (e.g., diagnostic accuracy) when assisted by the AI device compared to unassisted human performance, and the calculated effect size.

6. Standalone Performance: Data on the device's performance (e.g., diagnostic accuracy) when operating without human intervention.

7. Type of Ground Truth: Whether the ground truth was established by expert consensus, surgical pathology, long-term patient outcomes, or other definitive methods.

8. Training Set Sample Size: The number of cases/patients used to train the device's algorithm.

9. Training Set Ground Truth Establishment: How the ground truth for the training data was determined.

In summary, the provided document does not contain the specific information requested about acceptance criteria and performance study results because it details a 510(k) clearance based on substantial equivalence, not a performance study with detailed AI or clinical metrics.

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The RENASYS™ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids, wound exudate and infectious materials. Appropriate wound types include:

• Chronic
• · Acute
• · Traumatic
• Sub-acute and dehisced wounds
• · Ulcers (such as pressure or diabetic)
• · Partial-thickness burns
• · Flaps
• Grafts

The RENASYS™ EDGE pump is compatible with the following accessory dressing kits:

• RENASYS™ Foam Dressing Kits
• · RENASYS™ Foam Dressing Kit XL
• · RENASYS™ Gauze Dressing Kits
• · RENASYSTM Abdominal Dressing Kit
• · RENASYS™ Y Connector Kit
• · RENASYSTM White Foam Wound Dressing

When used with the RENASYS™ AB Abdominal Kit with Soft Port, the RENASYS EDGE™ pump is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome. The use of RENASYS™ AB Abdominal Kit with Soft Port is intended for use in acute hospital care settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS™ EDGE device is a software controlled suction device consisting of an electric motor driven, diaphragm, vacuum pump. The device is designed to provide Negative Pressure Wound Therapy at a range of pressure settings between 25-200mmHg to a closed environment over one or two wounds. The device removes exudate from the wound site(s) to a disposable container, which may promote wound healing via removal of fluids, including irrigation of body fluids, wound exudates and infectious materials.

RENASYS™ EDGE can be operated by either a mains power supply or internal battery. The RENASYS™ EDGE device is compatible with Smith & Nephew RENASYS™ Dressing Kits.

The provided text is a 510(k) summary for the RENASYS™ EDGE device. This document focuses on demonstrating substantial equivalence to a previously cleared device, not an AI/ML powered device, and thus does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of the prompt, which are typically associated with performance studies for AI/ML medical devices.

The submission is specifically for adding "RENASYS™ White Foam dressing kits" as compatible accessories to the existing RENASYS™ EDGE negative pressure wound therapy system. It explicitly states: "No clinical data was provided to support the demonstration of substantial equivalence."

Instead, the document details non-clinical tests performed to demonstrate that the overall system performance of the RENASYS™ EDGE device is not impacted by the use of the new dressing. These tests are:

• Simulated wound model tests: To ensure satisfactory performance, including fluid management and Negative Pressure Wound Therapy (NPWT) delivery.
• EMC Testing: In accordance with IEC 60601-1-2 and RTCA DO-160G.
• Cybersecurity testing: In accordance with FDA guidance "Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff".
• Software design and testing: In accordance with the framework set out in IEC 62304:2006.
• Low air pressure environment testing: EMC testing (RTCA DO-160G) and NPWT wound model testing were carried out to support the new environment for use (aircraft).

Therefore, I cannot provide a response for the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document.

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The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The 3M™ ActiV.A.C.™ Canister - 300ml with Gel is a component of the ActiV.A.C.™ Negative Pressure Wound Therapy System, also referred to as the ActiV.A.C. ™ Therapy System. The ActiV.A.C. ™ Therapy System consists of:

• · an ACTIV.A.C. ™ Therapy Unit,
• · a disposable canister which collects wound exudate (the subject of this submission),
• · a wound interface dressing,
• · a semi-occlusive wound drape, and
• · a sensing pad and lumen.

The 3M™ ActiV.A.C. ™ Canister - 300ml with Gel is a single use disposable component of the ActiV.A.C. ™ Therapy System and is sold separately from the ActiV.A.C. ™ Therapy Unit. It is provided in either a 5 pack or 10 pack configuration.

The Canister is attached to the therapy unit and collects wound exudates. The distal end of the Canister tubing attaches to the dressing tube set using rigid connectors. The Canister has volume graduations and contains a gel pack for fluid solidification and a tubing pinch clamp.

The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically the 3M™ ActiV.A.C.™ Canister - 300ml with Gel. This device is a component of a Negative Pressure Wound Therapy (NPWT) system.

The core purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This means the device is as safe and effective as a device already on the market and does not introduce new questions of safety or effectiveness.

Crucially, this type of submission does not typically involve the kind of clinical study data with acceptance criteria and ground truth that would be found in a novel device approval or a software as a medical device (SaMD) submission. Instead, it relies on demonstrating equivalence through comparison of technical characteristics, intended use, and performance data if there are significant changes.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document because it's not required for a 510(k) submission for this type of device (a medical device component, specifically a canister for NPWT).

The document explicitly states:

• "There was no performance data or biocompatibility performed to demonstrate equivalence." (Page 7)
• "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence." (Page 7)

The change being reviewed for this specific 510(k) (K241134) for the 3M™ ActiV.A.C.™ Canister - 300ml with Gel is that the "Canister will be provided entirely non-sterile. All other design features remain identical." (Page 6). This is a change in the sterilization method/status, not a new or significantly changed functional device or a software product requiring AI performance metrics.

In summary, none of the specific details you requested (acceptance criteria table, study sample sizes, expert details, adjudication, MRMC, standalone performance, etc.) are available in this document because the nature of the 510(k) submission for this device did not require such studies.

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The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended for use in acute, extended and home care settings.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The Prospera Spectruum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C. Drape components from the V.A.C. Therapy Wound Dressing kit.

The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) is a component of the Prospera Spectruum Negative Pressure Wound Therapy (NPWT) System.

The Prospera Spectruum™ Negative Pressure Wound Therapy System consists of:

• · Prospera Spectruum™ Negative Pressure Wound Therapy Unit
• · Disposable canister which collects wound exudate
• Prospera Spectruum™ Contour Dome

The Prospera Spectrum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C.Drape components from the V.A.C. Therapy Wound Dressing kit.

The Prospera Spectruum™ Negative Wound Therapy Unit (NP-7000) is a portable, rechargeable battery and mains powered, reusable, software-controlled unit used with a can provide continuous or variable applications of negative pressure to a wound in the user defined range between 25mmHg. The Prospera Spectruum™ Negative Pressure Wound Therapy System is designed for use in home, acute or extended care settings.

The compatible dressing components include a wound interface dressing applied to the wound covered with a semi-occlusive drape and is connected to the canister of the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) via a dual lumen dressing connection. This connection allows for the distribution of negative pressure to the wound bed and removal of wound exudate which is transported to the collection canister via the lumen.

The software within the Prospera Spectrum™ Negative Pressure Wound Therapy Unit (NP-7000) provides and maintains the prescribed pressure within the user defined range as well as alarming as neduced below the defined threshold. The alarms alert the user to conditions such as tubing blockages, a full canister, inactive therapy, low battery, and leaks in the system.

Additional features include:

• GPS for optional inventory management support
• Therapy history report via USB data port
• · Pre-set therapy options
• Event Log
• · User interface with flat buttons requiring depression for activation to reduce unintentional screen changes

• Confirmation screen to provide a visual notification to the user prior to device shutdown. The Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000) will continue delivering therapy and will not power off until the user stops therapy and acknowledges via user interface that the intent is to power off the unit.

This document is a 510(k) premarket notification for a medical device, the Prospera Spectruum™ Negative Pressure Wound Therapy Unit (NP-7000). The document focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of clinical efficacy or a multi-reader multi-case study for an AI algorithm.

However, based on the information provided, we can extract details regarding the non-clinical acceptance criteria and the bench testing conducted to support the device's functional performance. The document explicitly states "Clinical Tests: Not Applicable," meaning no direct clinical study was performed to assess patient outcomes or comparative effectiveness against human readers.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set (Bench/Usability): The document does not provide specific numerical sample sizes for the bench testing. For usability testing, it mentions "lay users who represent patients and lay caregivers" and "clinicians" but does not give a number for how many participated.
• Data Provenance: The tests described are non-clinical bench tests and usability tests conducted by the manufacturer (DeRoyal Industries, Inc.). The document does not specify country of origin for test data beyond indicating the company is based in Tennessee, USA. All testing appears to be prospective in nature, as it was conducted to support the 510(k) submission for this specific device.

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

• Non-Clinical Nature: This section is not applicable in the traditional sense of establishing ground truth for a clinical dataset using experts (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests is based on engineering specifications, regulatory standards (e.g., IEC 60601-1), and expected functional performance.
• Usability Testing: For usability testing, "clinicians" and "lay users" were involved, serving as the "evaluators" against usability criteria. Their specific qualifications beyond "clinicians" are not detailed.

4. Adjudication Method for the Test Set

• Not Applicable: Given the non-clinical nature of the tests (bench testing, software assessment, usability testing against predetermined criteria), there was no adjudication method involving multiple experts establishing a "ground truth" for ambiguous cases, as would be common in diagnostic AI studies. Performance was assessed against predefined pass/fail criteria or expected functionality.

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

• No, not performed. The document explicitly states: "Clinical Tests: Not Applicable." This device is a Negative Pressure Wound Therapy Unit, not a diagnostic imaging AI algorithm, so an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

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

• Not Applicable (Different Device Type): This is not an AI algorithm performing a diagnostic task. The device does contain software that controls its function (maintains pressure, activates alarms). Therefore, "standalone performance" refers to the device operating according to its specifications without human intervention, which is assessed through the functional bench testing and software assessment. The document confirms these tests show its function as intended.

7. The Type of Ground Truth Used

• Engineering Specifications and Regulatory Standards: For functional performance, the "ground truth" is defined by the device's design specifications (e.g., negative pressure range, alarm thresholds) and adherence to recognized industry standards (e.g., IEC 60601-1).
• Usability Criteria: For usability testing, the "ground truth" is established by the usability requirements and design principles outlined in standards like ISO 62366-1 and ANSI/AAMI HE 75.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device that requires a "training set" in the context of learning from data to perform a task like image interpretation. The software controls the device based on pre-programmed logic and parameters, not trained algorithms.

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

• Not Applicable: As there is no "training set" in the AI/ML sense, this question is not relevant to this device submission.

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