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The RENASYS AB Abdominal Dressing Kit with Soft Port 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 RENASYS AB Abdominal Dressing Kit with Soft Port is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS™ AB Abdominal Dressing Kit with Soft Port consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polyurethane organ protection layer, six transparent film drapes and a Soft Port suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The modification to this kit is the inclusion of a Soft Port suction port, to replace the existing suction port.

The RENASYS AB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and RENSASYS EZ PLUS negative pressure wound therapy pumps and canister kits, which have been cleared under 510(k) numbers K082426 and K091470.

The provided text describes a 510(k) summary for the RENASYS™ AB Abdominal Dressing Kit with Soft Port. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. Therefore, the requested information regarding acceptance criteria and studies largely pertains to these bench tests, not clinical performance or AI algorithm validation.

Here's a breakdown of the requested information based on the provided text:

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

2. Sample sizes 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 exact sample sizes (e.g., number of tests per criterion). It states "Laboratory testing was completed" and "Testing to verify".
• Data Provenance: The tests are described as "Laboratory testing" or "Bench" tests, implying they were conducted in a controlled lab environment. No information on country of origin or whether it was retrospective/prospective in a clinical sense is provided as these are non-clinical studies.

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 question is not applicable to the provided document. The ground truth for the non-clinical bench tests would be the measured physical performance against predefined engineering specifications, not expert interpretation.

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

This question is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data. For bench tests, performance is typically measured directly against specifications.

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 question is not applicable to the provided document. The device is a medical dressing kit, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm.

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

For the non-clinical bench tests, the "ground truth" is the predefined engineering specifications and measurable performance characteristics of the device components (e.g., flow rate, connection security, performance under stress, biocompatibility).

8. The sample size for the training set

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm that requires a training set.

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

This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm that requires a training set.

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The RENASYS™ - F/-AB Abdominal Wound Dressing Kit 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.

This dressing kit is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

The RENASYS™ -FIAB Abdominal Dressing Kit consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polvurethane organ protection layer, six transparent film drapes and a suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.

The RENASYS- FIAB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and EZ PLUS negative pressure wound therapy pumps and canister kits, which have been previously cleared under 510(k) numbers K082426, K091470 and K102001.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic or AI-powered device would.

The document is a 510(k) summary for a medical device called the RENASYS™ -F/AB Abdominal Dressing Kit. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes details about:

• Biocompatibility testing: This confirms the materials used are safe for contact with the body. The table lists various tests (Cytotoxicity, Irritation, Sensitization, Implantation, Sub-acute Toxicity, Genotoxicity) completed for each kit component. These are safety standards, not performance criteria in the sense of accuracy, sensitivity, or specificity.
• Design verification testing: The document states this was conducted "to demonstrate the device meets the performance specifications, delivers negative pressure wound therapy to the wound and removes exudates." However, it does not provide:
  • A table of actual "performance specifications" or acceptance criteria.
  • Specific results from this design verification testing.
  • Details on the sample size, data provenance, ground truth establishment, or expert involvement for this testing.
  • Any information about a comparative effectiveness study (MRMC) or a standalone (algorithm only) study.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample sizes, ground truth, or study types as they are typically described for devices with measurable diagnostic or analytical performance claims.

The document concludes that the device "has successfully undergone testing to demonstrate that the device is substantially equivalent to the predicate device and effective for the intended use." This is the general statement required for a 510(k) clearance, indicating that it meets the regulatory bar for market entry, but not detailing specific performance metrics.

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The Renasys EZ is indicated for patients who would benefit from a suction device (negative pressure) as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

Examples of appropriate wound types include: Chronic, Acute, Traumatic, Sub-Acute and dehisced wounds, Ulcers (such as pressure or diabetic), Partial-thickness burns, Flaps and Grafts.

The RENASYS™ EZ NPWT device is a lightweight, portable suction device intended to deliver negative pressure to a wound at a range of pressure settings via a tube set connected to a wound dressing. The suction pump creates negative pressure and removes exudates from the wound site to a disposable canister. The device can operate either by a mains power supply or internal battery. Renasys EZ is suitable for use in both a hospital and homecare setting.

RENASYS™ EZ is compatible with existing Smith & Nephew wound dressing kits currently on the market.

The provided information does not contain details about acceptance criteria or a specific study proving the device meets those criteria beyond general statements. The document is a 510(k) summary for the RENASYS™ EZ Negative Pressure Wound Therapy system, focusing on demonstrating substantial equivalence to predicate devices.

Here's what can be extracted and what is missing based on your request:

Missing Information: Most of the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided 510(k) summary. This type of detail is typically found in the full 510(k) submission, not the summary.

Here's a breakdown of the available information:

• Device: RENASYS™ EZ Negative Pressure Wound Therapy (NPWT) system.
• Purpose of the K091470 submission: To demonstrate substantial equivalence to previously cleared predicate devices (RENASYS™ EZ NPWT System K082426 and RENASYS™ GO NPWT System K083375).
• Method for demonstrating substantial equivalence: "Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use."

What we know about the "study":

The document states: "Performance testing and electrical safety testing has been successfully completed to demonstrate that Renasys EZ is substantially equivalent to the marketed devices and is safe and effective for the intended use." This indicates that some form of testing was conducted, but it does not describe the specific study methodologies, acceptance criteria, or results in detail. The testing was likely designed to show that the new device performs comparably to the predicate devices in terms of its core functionality (creating negative pressure, removing fluids).

Based on the provided text, I cannot complete most of the requested table and sections.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given the nature of a negative pressure wound therapy device, the "test set" would likely refer to physical device testing rather than a clinical dataset of patients.

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

• Number of Experts: Not applicable/Not specified. For a device like this, the "ground truth" would likely be based on engineering specifications and direct measurement against those specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified.

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

• MRMC Study: No, this is highly unlikely for a negative pressure wound therapy device. MRMC studies are typically performed for diagnostic imaging devices where human interpretation is a key component. This device is a therapeutic device.

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

• Standalone Performance: Not applicable. This device is not an AI algorithm. Its performance is inherent to its mechanical and electronic function.

7. The type of ground truth used

• Type of Ground Truth: Likely engineering specifications and direct physical measurements (e.g., pressure gauges, flow meters). The document only broadly mentions "Performance testing."

8. The sample size for the training set

• Sample Size: Not applicable. This is not an AI/machine learning device that would require a 'training set.'

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

• Ground Truth Establishment: Not applicable.

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