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Found 23 results
510(k) Data Aggregation
(28 days)
Molnlycke Health Care US, LLC
The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.
The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.
This document does not contain information about an AI/ML device, nor does it provide the specific details required to complete your request about acceptance criteria and study data for an AI/ML device.
The document is a 510(k) summary for a Barrier EasyWarm Active Self-Warming Blanket, a medical device intended to prevent hypothermia by providing warmth to patients. It discusses modifications to a previously cleared device (K132048).
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance related to an AI/ML device.
- Sample sizes, data provenance, or details about test and training sets for an AI/ML device.
- Information on experts or adjudication for ground truth for an AI/ML device.
- MRMC studies or effect sizes for AI assistance.
- Standalone performance for an AI algorithm.
- Types of ground truth for AI.
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(227 days)
Molnlycke Health Care US, LLC
The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.
Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.
Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.
Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy.
- . Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
- . Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
- . Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
- . Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds
Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml.
Avance Solo NPWT System is intended for adults.
The provided text is a 510(k) summary for the Avance Solo Negative Pressure Wound Therapy (NPWT) System. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed.
However, the request asks for information regarding acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for test sets.
- MRMC comparative effectiveness study results (human readers improve with AI vs without AI assistance).
- Standalone (algorithm only) performance.
- Type of ground truth (consensus, pathology, outcomes).
- Training set sample size and ground truth establishment.
The provided document does not contain information related to AI/algorithm performance, human reader studies, or how ground truth for an AI model would be established (e.g., expert consensus, pathology). It focuses on the safety and effectiveness of a physical medical device (a Negative Pressure Wound Therapy system) through bench testing, biocompatibility, software validation, and electrical safety testing.
Therefore, I cannot fulfill the request using only the provided text as it does not describe an AI medical device or a study of the type requested (e.g., MRMC, standalone algorithm performance).
Specifically, the document states:
- "No clinical data was provided to support substantial equivalence." (Page {8})
- It describes "Non-Clinical Testing" which includes:
- Biocompatibility
- Bench testing (fluid transport, pressure delivery, alarm functionality, device lifetime, pressure safety)
- Software validation (IEC 62304)
- Electromagnetic compatibility and electrical safety testing (various IEC/AAMI standards)
- Human factors/usability testing.
The "Bench testing" section does mention acceptance criteria were met, but it does not provide a detailed table, sample sizes for "test sets" in the context of an AI model, expert involvement for ground truth, or MRMC studies as it pertains to the performance of a physical device.
If the request implies that the provided text describes an AI device or a study involving an AI component, that is incorrect. The device is a traditional medical device for wound therapy.
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(117 days)
Molnlycke Health Care, US LLC
The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The document provides information on the performance of several types of surgical gloves when tested for resistance to permeation by chemotherapy drugs. The acceptance criteria and the study method are based on ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The implicit acceptance criterion for these gloves, based on the Breakthrough detection time values and the common understanding in such tests, is that the gloves should demonstrate resistance to permeation by chemotherapy drugs for a reasonable duration (e.g., as long as possible, or at least a certain minimum time). While a specific "pass/fail" threshold is not explicitly stated as an acceptance criterion in minutes, the values of ">240 minutes" indicate excellent performance for most drugs. The lower values for Carmustine and Thiotepa highlight instances where permeation occurs more quickly.
The reported device performance for each glove type and chemotherapy drug is provided in the tables across the document. Below is a summary table combining this information as an example, for "Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents" (from page 3):
| Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time - implicit goal) | Reported Device Performance (Breakthrough detection time in minutes (0.01µg/cm²/mins)) |
|---|---|---|
| Bleomycin 15 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Busulfan 6 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Carmustine 3.3 mg/ml | As long as possible, ideally >240 minutes | 12.1 |
| Cisplatin 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Cytarabine HCL 100 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Dacarbazine (DTIC) 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Doxorubicin HCL 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Ellence 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Etoposide (Toposar) 20 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Fludarabine 25 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Fluorouracil 50 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Idarubicin 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Ifosfamide 50 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mechlorethamine HCl 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Melphalan 5 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Methotrexate 25 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mitomycin C 0.5 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mitoxantrone 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Paclitaxel (Taxol) 6 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Paraplatin 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Rituximab 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Thiotepa 10 mg/ml | As long as possible, ideally >240 minutes | 14.1 |
| Vincristine Sulfate 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set (number of gloves tested per drug type). It only reports the breakthrough detection time.
The data provenance is from testing conducted in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based prospective testing methodology. The country of origin of the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of study (chemical permeation testing of medical devices) does not typically involve human expert adjudication in the same way, for example, a diagnostic image interpretation study would. The "ground truth" is established by the objective, quantitative measurement of chemical permeation according to the specified ASTM standard. Therefore, there are no "experts" in the sense of clinical reviewers establishing a ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this is a laboratory test with objective measurements, not a human interpretation task requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a standalone performance test of a physical device against chemical permeation, not an AI-assisted diagnostic task involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This entire study is a standalone performance assessment of a physical device. There is no "algorithm" or "human-in-the-loop" concept involved. The performance is the intrinsic resistance of the glove material to chemical permeation.
7. The Type of Ground Truth Used:
The ground truth used is based on objective, quantitative measurements of chemical permeation using analytical methods specified or implied by the ASTM D6978 standard. The "Breakthrough detection time" is the measured outcome, indicating the time at which a quantifiable amount of the chemotherapy drug permeates through the glove material.
8. The Sample Size for the Training Set:
Not applicable. This is a direct performance test of a manufactured product, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device performance study.
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(109 days)
Molnlycke Health Care US LLC.
The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel PI Micro Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene.
The provided documents describe the acceptance criteria and the results of a study conducted to demonstrate that several Biogel® gloves meet these criteria for chemotherapy drug permeation.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for each chemotherapy drug tested is implied by the testing method as a "Breakthrough detection time" in minutes (0.01 µg/cm²/mins). The general expectation for protective gloves against hazardous substances is a breakthrough time as long as possible, ideally exceeding the typical operational exposure duration. The standard testing time of 240 minutes (4 hours) appears to be a benchmark for "safe" permeation resistance.
The tables below synthesize the acceptance criteria (testing was performed according to ASTM D6978-05 (2019)) and the reported performance for each specific glove type and chemotherapy drug.
Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 6.6 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 16.9 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI Micro tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 10.0 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 20.3 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI UltraTouch® tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 24.2 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 17.9 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 26.7 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 28.7 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI Indicator® Underglove tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 17.3 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 24.1 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of individual gloves or test replicates used for each chemotherapy drug. However, per ASTM D6978, testing generally involves multiple specimens (e.g., 3 specimens per drug as per standard recommendations for breakthrough time).
- Data Provenance: The study was a non-clinical test conducted according to ASTM D6978-05 (2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The country of origin for the data is not specified, but the use of an international standard like ASTM suggests a rigorous and replicable testing methodology. The data is prospective in the sense that the testing was performed specifically to support this FDA submission for the "tested for use with chemotherapy agents" claim.
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 study did not involve human experts establishing ground truth in a medical context. The ground truth (breakthrough time) was established through objective measurement in a laboratory setting following a standardized test method (ASTM D6978-05 (2019)).
4. Adjudication method for the test set:
This information is not applicable as the study did not involve human adjudication. The results were obtained through standardized laboratory measurements.
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. The submission describes a non-clinical in vitro permeation test for medical gloves, not an AI-assisted diagnostic or clinical device. There are no human readers or AI involved in this type of testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The submission describes a non-clinical in vitro permeation test for medical gloves. It is not an algorithm or software device.
7. The type of ground truth used:
The ground truth used was objective laboratory measurement of the "Breakthrough detection time" of chemotherapy drugs through the glove material, as defined by the ASTM D6978-05 (2019) standard. This is a direct physical measurement, not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
This information is not applicable. There is no training set for this type of non-clinical device testing, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set.
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(245 days)
Molnlycke Health Care, US LLC
The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
This document is a 510(k) summary for a medical device (surgical gloves) and not a study describing the validation of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the subject devices (Biogel® PI UltraTouch S Surgical Glove and Indicator Underglove with a Low Dermatitis Potential Claim) to predicate devices already on the market. The low dermatitis potential claim is supported by non-clinical testing.
Here's what can be extracted, although it pertains to non-AI/ML device testing:
1. Acceptance Criteria and Reported Device Performance (for the non-AI/ML medical device):
The acceptance criteria for the surgical gloves are primarily defined by adherence to recognized standards and the demonstration of "Low Dermatitis Potential."
| Test/Characteristic | Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Not an irritant |
| ISO Closed Patch Sensitization | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Not a sensitizer |
| Acute Systemic Toxicity | ISO 10993-11:2010 (Tests for systemic toxicity) | No mortality or evidence of systemic toxicity from the extracts |
| Performance Test | ||
| Low Dermatitis Potential | Modified Draize-95 Test (demonstrate reduced potential for sensitizing users to chemical additives) | Demonstrated Low dermatitis potential: reduced potential for sensitizing users to chemical additives |
| Physical Characteristics | ||
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. |
| Freedom from holes | 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5; ASTM D5151-06(2015) (Detection of Holes in Medical Gloves) | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. |
| Powder residual | ≤ 2.0 mg/glove for Powder-free designation per ASTM D3577-09(2015); ASTM D6124-06(2017) (Residual Powder on Medical Gloves) | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. |
2. Sample size used for the test set and the data provenance:
The document refers to "studies" for biocompatibility and performance, but does not specify sample sizes for these tests. The data provenance is implied to be from testing conducted by or for the manufacturer, Mölnlycke Health Care US, LLC. The testing is described as "non-clinical," meaning it does not involve human subjects in a clinical setting when assessing device performance characteristics.
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 document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring expert ground truth establishment for algorithm performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring adjudication of expert interpretations.
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 document describes the testing of a physical medical device (surgical gloves), not an AI/ML device. "Clinical data was not required" for this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the surgical gloves is established by their adherence to defined physical, chemical, and biological performance characteristics measured against industry standards (e.g., ASTM, ISO) and specific test methodologies (e.g., Modified Draize-95 Test).
8. The sample size for the training set:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set and corresponding ground truth.
In summary, the provided FDA 510(k) summary is for a traditional Class I medical device (surgical gloves) and therefore does not contain the information typically associated with the validation of an AI/ML-driven device.
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(128 days)
Molnlycke Health Care, US LLC
The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The Biogel® PI UltraTouch S Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
The provided text describes a 510(k) premarket notification for surgical gloves and does not involve AI or algorithms. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), or ground truth establishment for an AI device.
The document is a regulatory submission for medical devices (surgical gloves) which are classified as Class I. The submission is focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the performance of an AI model against specific acceptance criteria.
The "acceptance criteria" discussed in the document relate to the physical and biocompatibility properties of the gloves, such as:
- Physical Characteristics: Dimensions, tensile strength, elongation, freedom from holes, and powder residual. These are assessed against established ASTM (American Society for Testing and Materials) standards and FDA regulations (e.g., 21 CFR 800.20, ASTM D3577-09(2015), ASTM D5151-06(2015), ASTM D6124-06(2017)).
- Biocompatibility: Primary skin irritation, ISO closed patch sensitization, and acute systemic toxicity. These are assessed against ISO 10993 standards.
- Sterilization: Sterility Assurance Level (SAL) of 10-6.
Here's a breakdown of why your specific questions cannot be answered from the provided text, and what the text does provide regarding the device's performance:
Based on the provided text, the device is a surgical glove, not an AI or algorithm-based device. Therefore, the questions related to AI/algorithm performance, such as MRMC studies, standalone performance, training sets, and expert adjudication for ground truth of an AI model, are not applicable to this document.
The document describes the acceptance criteria and device performance for surgical gloves as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices.
Here's the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document presents a "Summary of Non-Clinical Testing" which effectively serves as the acceptance criteria and the reported performance against those criteria.
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Subject Device: Biogel® PI UltraTouch S Surgical Glove / Biogel® PI UltraTouch S Indicator Underglove) |
|---|---|
| Biocompatibility: | |
| Primary Skin Irritation (ISO 10993-10:2010) | Under the conditions of the study, not an irritant. |
| ISO Closed Patch Sensitization (ISO 10993-10:2010) | Under the conditions of the study, not a sensitizer. |
| Acute Systemic Toxicity Study (ISO 10993-11:2010) | Under the conditions of the study, no mortality or evidence of systemic toxicity from the extracts. |
| Physical Characteristics: | |
| Dimensions (ASTM D3577-09(2015)) | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. |
| Physical Properties (ASTM D3577-09(2015)) | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. |
| Freedom from holes (ASTM D5151-06(2015) & ASTM D3577-09(2015), 21 CFR 800.20) | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. |
| Powder residual (ASTM D6124-06(2017) & ASTM D3577-09(2015)) | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. |
2. Sample sizes used for the test set and the data provenance
The document states "Summary of Non-Clinical Testing" but does not specify the sample sizes used for each of the tests (e.g., number of gloves tested for holes, number of animals for biocompatibility). The data provenance is implied to be from laboratory testing conducted to meet the specified ASTM and ISO standards, which are international. It's not retrospective or prospective in the clinical study sense; rather, it's laboratory testing of manufactured goods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is for a physical device (surgical glove) and not an AI model. "Ground truth" here refers to established physical and biocompatibility standards, not expert interpretations of medical images or data.
4. Adjudication method for the test set
Not applicable. Testing involves conforming to predefined physical and chemical specifications, not subjective interpretation requiring adjudication.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by internationally recognized standards and regulations for surgical gloves, specifically:
- ASTM International standards (e.g., D3577, D5151, D6124) for physical properties.
- ISO (International Organization for Standardization) standards (e.g., 10993 series) for biocompatibility.
- FDA regulations (e.g., 21 CFR 800.20) for acceptable quality levels (AQL) for freedom from holes.
These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residual, AQL for holes, non-irritant response).
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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(126 days)
Molnlycke Health Care US, LLC
The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.
The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.
This document describes a 510(k) premarket notification for the Avance Abdominal Dressing Kit. It is not an AI/ML device, and therefore does not contain information about acceptance criteria for AI/ML performance, study details for AI/ML models, or ground truth establishment.
Based on the provided text, here's what can be extracted regarding the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Met criteria for intended use |
| Ability to transport fluid away from wound | Performed as intended in test setup; all predefined acceptance criteria were met. (Subject Avance Abdominal Dressing Kit performed as intended in the test setup, and all predefined acceptance criteria were met.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" but does not quantify the number of tests or samples.
- Data Provenance: Not applicable. This is bench testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" here refers to pre-defined engineering and biocompatibility standards, not expert interpretations of medical data.
4. Adjudication method for the test set
- Not applicable. Performance was assessed against pre-defined technical criteria.
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 is not an AI/ML device; therefore, no MRMC study with human readers and AI assistance was conducted or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device. The "standalone" performance relates to the dressing kit's physical and functional properties, evaluated during bench testing.
7. The type of ground truth used
- Engineering and Biocompatibility Standards: The ground truth for this device's performance evaluation were established engineering specifications for fluid transport and ISO 10993-1 standards for biocompatibility.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is based on established medical device standards and engineering principles.
Summary relevant to the prompt:
This document describes a medical device undergoing 510(k) clearance, which is a process to demonstrate substantial equivalence to a legally marketed predicate device. The evaluation focuses on the device's physical and functional properties, as well as its biocompatibility. It is not an AI/ML device, hence most of the questions related to AI/ML specific criteria (like training/test sets, expert adjudication, MRMC studies, etc.) are not applicable. The studies mentioned are "non-clinical testing" focusing on ISO standards and bench testing for fluid transport.
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(113 days)
MOLNLYCKE HEALTH CARE, US LLC
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate 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 subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large. The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847: Avance ViewPad, Avance Foam (green), Avance Transparent Film.
This document describes the FDA 510(k) clearance for the Molnlycke Health Care US, LLC Avance Foam Dressing Kit - XL. This is an add-on to an existing Negative Pressure Wound Therapy (NPWT) system. As such, the submission focuses on demonstrating that the new component (the XL foam dressing) does not negatively impact the overall system's safety and effectiveness compared to the previously cleared system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with acceptance criteria values and reported device performance. It generally states that "all predefined acceptance criteria were met" for the bench tests conducted.
2. Sample sized 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 the sample size for the bench tests. It only mentions that "Bench testing has been performed." The data provenance (country of origin, retrospective/prospective) is not mentioned.
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. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software. No experts were used to establish ground truth in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software.
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 study was conducted as this is not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be established engineering and functional specifications for the NPWT system's ability to transport fluid and deliver pressure. The document implicitly states that these functional requirements were met.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device; therefore, there is no training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
Summary of Device Acceptance Criteria and Study:
The Avance Foam Dressing Kit - XL is an addition to an existing Negative Pressure Wound Therapy (NPWT) system. The acceptance criteria focus on demonstrating that this new, larger dressing component does not negatively affect the overall system's functional performance and biocompatibility.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):
The document does not provide specific numerical acceptance criteria or performance metrics but states compliance.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993 | Shown to be biocompatible for the intended use. |
| Ability to transport fluid away from the wound | Performed as intended; predefined acceptance criteria were met. |
| Ability to deliver pressure in accordance with pump settings | Performed as intended; predefined acceptance criteria were met. |
Study Details:
- Type of Study: Non-clinical bench testing.
- Sample Size: Not specified for the bench tests.
- Data Provenance: Not specified.
- Ground Truth Establishment: For bench testing, the ground truth would be based on engineering specifications and validated test methods for fluid transport and pressure delivery within NPWT systems.
- Clinical Data: No clinical data was required or submitted to support substantial equivalence.
- AI/Machine Learning Specifics: Not applicable; this device is a physical medical dressing, not an AI algorithm.
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(111 days)
MOLNLYCKE HEALTH CARE, US LLC
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate 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 subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:
- Antimicrobial gauze dressing
- Avance Transparent Film or Avance Film with Safetac technology
- Avance ViewPad
This document is a 510(k) premarket notification for "Avance Gauze Dressing Kits," which are line additions to an existing Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the information typically associated with a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, expert involvement, and ground truth establishment) is not fully present in the document in the format you've requested for an AI model.
However, I can extract the relevant information regarding acceptance criteria and general statements about testing from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that "all predefined acceptance criteria were met" for the bench testing. However, the specific quantitative acceptance criteria are not detailed in this summary.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met (in accordance with ISO 10993) |
| Fluid Transport Efficiency | Performed as intended; did not negatively affect the ability of the NPWT system to transport fluid away from the wound. |
| Pressure Delivery | Performed as intended; pressure delivered in an acceptable manner. |
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 the sample sizes used for the bench testing. No clinical data was required or submitted, so there is no information on data provenance relating to clinical studies. The testing described is "non-clinical bench 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 and not provided. The testing described is bench testing, which typically relies on established engineering and materials science principles, not expert human assessment of images or patient data to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers, which this submission did not include.
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 MRMC study was done. This device is not an AI-assisted diagnostic tool; it is a medical dressing kit for Negative Pressure Wound Therapy.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an algorithm or AI. The bench testing performed would be considered "standalone" in the sense that it evaluated the device's physical performance independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth would be established by the requirements of ISO 10993. For fluid transport and pressure delivery, the ground truth would be engineering specifications and functional parameters for NPWT systems, where "as intended" means meeting these predefined technical requirements.
8. The sample size for the training set:
Not applicable. This document describes a medical device (dressing kits) and its non-clinical bench testing, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device submission.
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(111 days)
MOLNLYCKE HEALTH CARE, US LLC
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate 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 bums, flaps and grafts.
The subject Avance Tubing serves as the connecting link between the Avance NPWT pump and the Avance dressings, thereby delivering negative pressure wound therapy from the pump to the wound bed and facilitating the transport of fluid and exudate from the wound site to the canister. It consists of a 1.5 m length of tubing with connectors on each end to facilitate connection to other components of the Avance NPWT System.
The subject Avance Y-Connector allows connection of multiple Avance dressings to one Avance pump in order to accommodate large or multiple wounds. It consists of y-tubing with connectors on all ends to facilitate connection to other components of the Avance NPWT System. A maximum of one Avance Y-Connector may be used to connect up to two large dressing kits to a single pump.
The subject Avance ViewPad used in conjunction with the Avance dressings; it is placed on top of the wound cover (film), connected to the wound filler via a hole cut in the wound cover, and then connected to the Avance NPWT pump tubing for delivery of NPWT and transport of fluids and exudate away from the wound. The subject Avance ViewPad is similar to the existing ViewPad component of the Avance Foam Dressing Kits (K141847), with the exception of a green colorant that has been added to the connector and a modification to the design of the slide clamp.
This document describes the premarket notification for Avance Tubing, Avance Y-Connector, and Avance ViewPad, which are components of a Negative Pressure Wound Therapy (NPWT) system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the devices were evaluated through non-clinical bench testing. The general acceptance criteria were that the devices "performed as intended in the test setups, and all predefined acceptance criteria were met." Specific quantitative acceptance criteria are not explicitly detailed in this summary, but the reported performance is that they met all such criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device does not negatively affect fluid transport by the NPWT system | Performed as intended; fluid transport maintained |
| Pressure is delivered in accordance with pump settings | Performed as intended; pressure delivery maintained |
| Alarm functionality of the NPWT pump is maintained | Performed as intended; alarm functionality maintained |
| Biocompatibility (cytotoxicity, sensitization, irritation) | Non-cytotoxic, non-sensitizing, non-irritating (meets ISO 10993 criteria) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the exact sample size (number of devices or test runs) for the non-clinical bench testing. It only states that "Bench testing has been performed."
- Data Provenance: The testing was conducted as part of the premarket notification for the devices by the manufacturer, Mölnlycke Health Care. It is considered prospective data generated specifically for regulatory submission. The country of origin for the data is not explicitly stated, but the manufacturer is Mölnlycke Health Care, US LLC, located in Norcross, Georgia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable as the studies conducted were non-clinical bench tests, not clinical studies involving expert interpretation of medical data or ground truth established by medical professionals. The "ground truth" here refers to the functional performance of the device against engineering specifications and industry standards.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies conducted were non-clinical bench tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same cases to arrive at a consensus for ground truth. In bench testing, performance is measured objectively against predefined engineering 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 information is not applicable. The submission is for components of a Negative Pressure Wound Therapy system, which are physical medical devices, not an AI or computer-aided diagnostic (CAD) system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the submitted devices are physical medical device components, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing was based on predefined engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional performance requirements. These requirements dictated that the device should:
- Not negatively affect fluid transport.
- Deliver pressure according to pump settings.
- Maintain alarm functionality.
- Meet biocompatibility criteria (non-cytotoxic, non-sensitizing, non-irritating).
8. The Sample Size for the Training Set:
This information is not applicable. The tested devices are physical components, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for these physical devices.
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