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The XLR8 Plus (XLR8+) Wound Vacuum 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 XLR8 Plus (XLR8+) Wound Vacuum System is a portable, rechargeable battery powered wound suction pump with the intention to generate negative pressure to remove exudate from the wound.

This document describes a 510(k) premarket notification for the Genadyne XLR8 Plus (XLR8+) Negative Pressure Wound Therapy device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.

Therefore, the typical metrics and study designs associated with proving a device meets specific acceptance criteria via a study (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) are not present in this document. The "acceptance criteria" here are primarily met by demonstrating comparable performance and characteristics to the predicate device.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device (A4-XLR8 Wound Vacuum System, K090638). The new device, XLR8 Plus, aims to be substantially equivalent. The table provided is a comparative table, not a pure acceptance criteria table with a "pass/fail" for an independent study.

Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Note: For the 510(k) process, the new device can be better than the predicate in some aspects (like suction capacity or additional canister size) as long as it doesn't raise new questions of safety or effectiveness.

2. Sample Size for the Test Set and Data Provenance

This document does not describe a clinical study with a "test set" in the context of an AI/ML device validating performance on a dataset of patient cases. The testing conducted for this device is focused on engineering verification and validation (e.g., measuring suction, power, verifying dimensions, and confirming compliance with electrical safety standards). These tests are typically performed on a small number of production or pre-production units.

• Sample Size: Not specified in terms of patient data or clinical cases, as this is not an AI/ML driven device requiring such clinical validation. Laboratory (bench) testing of the device itself would likely involve a small number of units (e.g., 3-10).
• Data Provenance: Not applicable in the context of patient data. The provenance for the device's technical specifications would be from internal engineering and manufacturing. This is a physical medical device, not a software device processing patient data.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a negative pressure wound therapy system, not an imaging analysis or diagnostic AI/ML device requiring expert interpretation for ground truth establishment.

4. Adjudication Method

Not applicable. There is no expert review or adjudication process outlined for this type of device submission. Performance is based on engineering specifications and bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML diagnostic or assistive device that would participate in an MRMC study to compare human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable. Ground truth for an AI/ML context doesn't apply here. The "truth" for this device lies in its adherence to engineering specifications, safety standards, and functional performance metrics (like creating negative pressure). Bench testing and electrical safety compliance form the basis of "truth."

8. Sample Size for the Training Set

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

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

Not applicable. As above, no training set for an AI/ML model is involved.

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The XLR8 Plus (XLR8+) Wound Vacuum 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 XLR8 Plus (XLR8+) Wound Vacuum System is portable, rechargeable battery powered wound suction pump with the intention to deliver negative pressure to the wound. The XLR8 Plus (XLR8 +) is a modification to the existing A4-XLR8 wound vacuum system with exactly the same internal components and accessories. The XLR8+ is a lightweight, portable wound suction device. It has a rechargeable battery, LCD screen for clear viewing, membrane overlay with buttons to control the device. It has 2 therapy options, continuous therapy and variable intermittent therapy. It consists of 5 alerts to notify the users of unwanted events, i.e. leakage in the dressing, blockage in the tubing, canister is full, low battery status.

The provided text is a 510(k) summary for the Genadyne XLR8 Plus (XLR8+) Wound Vacuum System, seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new device is as safe and effective as a legally marketed device, rather than rigorously proving performance against pre-defined acceptance criteria through extensive studies in the way an AI/ML device submission might.

Therefore, the information required for acceptance criteria and the study proving it typically found in AI/ML device descriptions is not present in this document. This document details a special 510(k), which implies minor modifications to an existing device, and thus relies heavily on the equivalence of the modified device to the predicate device, rather than new performance studies.

Here's a breakdown of why each requested point cannot be fully addressed by this document:

1. A table of acceptance criteria and the reported device performance: This document doesn't define quantitative acceptance criteria for performance in the way an AI/ML device would (e.g., sensitivity, specificity, AUC). Instead, it compares technical characteristics and intended use to a predicate device. The "performance" reported is essentially that it matches the predicate.

   Table based on available comparative information (technical characteristics):

   Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (XLR8 Plus)
   Suction Capacity	3.5 liters per minute	3.5 liters per minute
   Max Vacuum	230 mmHg	230 mmHg
   Power Requirements	30W	30W
   Battery Type	Rechargeable Li-Ion	Rechargeable Li-Ion
   Dimensions	5.9" x 4" x 2.4"	5.9" x 4" x 3.4" (larger depth)
   Weight	1.5 lbs	1.65 lbs
   Canister Sizes	200, 400, 600, 800 ml	200, 400, 600, 800 ml
   Reusable	No	No
   Sterile	Non Sterile	Non Sterile
   Indications for Use	Matches predicate	Matches predicate
   Contraindications	Matches predicate	Matches predicate
   Precautions	Matches predicate	Matches predicate
   Compliance (Standards)	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2
   Storage/Transport Temp	-18°C to +43°C	-18°C to +43°C
   Storage/Transport RH	10% to 95%	10% to 95%
   Storage/Transport Atm	700 - 1060 mbar	700 - 1060 mbar
   Operation Temp	18°C to 34°C	18°C to 34°C
   Operation RH	10% to 95%	10% to 95%
   Operation Atm	700 - 1060 mbar	700 - 1060 mbar

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned. The device's substantial equivalence is primarily based on comparisons of its technical specifications to the predicate device, not on new clinical performance data from a test set. This is a common approach for "Special 510(k)" submissions for minor modifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set requiring expert-established ground truth for the performance claims.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As there's no mention of a test set requiring ground truth, no adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a wound vacuum system, not an AI/ML imaging or diagnostic device. There is no concept of "human readers" or "AI assistance" in its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of clinical validation for AI/ML devices is not relevant here. The "truth" for this submission is that its physical and functional characteristics are substantially equivalent to the predicate.

8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The "study" or justification for substantial equivalence is a comparison of technological characteristics and indications for use between the new device (XLR8 Plus) and its predicate device (A4-XLR8). The document emphasizes that "Everything in the XLR8 Plus (XLR8+) Wound Vacuum System is exactly the same as the predicate device... with the exception of an increment in depth of 1" to the back cover housing." This suggests that the "study" was primarily an engineering and design comparison, demonstrating that the minor physical change does not alter the fundamental safety and effectiveness or performance parameters of the device. The compliance with electrical safety standards (IEC 60601-1, IEC 60601-1-2) for both devices further supports this claim of equivalence.

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