Search Results

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I sterile nitrile examination glove, powder free and meeting all requirements of ASTM D3578-99, ASTM 6124-97, and ISO 11137, Part 2, Sterilization of Health Care Products.

This document describes the acceptance criteria and performance of the BioExam Powder Free, Sterile Nitrile Examination Glove as presented in its 510(k) summary (K062138).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not explicitly state the exact sample sizes for each physical and chemical test. However, it indicates compliance with ASTM and ISO standards (e.g., ASTM D3578-99, ASTM D6319, ASTM D6499, ASTM F1671, ASTM D7161, ISO 11137 Part 2, ISO Closed Patch Sensitization, ISO Skin Irritation). These standards typically specify the required sample sizes and testing methodologies.
• The data provenance is internal testing performed by the applicant and external testing by NAMSA for biocompatibility. The country of origin of the data is not specified beyond "NAMSA" being a testing laboratory. The studies are prospective in the sense that they are specifically conducted to demonstrate compliance of the device with the standards.

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 to this type of device submission. The "ground truth" for examination gloves is established by conformance to predefined engineering standards (ASTM, ISO) and regulatory requirements, not through expert consensus on medical images or clinical outcomes. The tests are laboratory-based and objective against specified criteria.

4. Adjudication method for the test set:

• Not applicable. See point 3. The data is based on objective laboratory measurements against set thresholds, not on subjective interpretations 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 device is an examination glove, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

• Not applicable. This device is an examination glove, not an AI algorithm.

7. The type of ground truth used:

• The ground truth consists of internationally recognized and nationally adopted ASTM and ISO standards for physical properties, barrier integrity, biocompatibility, and sterility of medical examination gloves. These standards define the acceptable performance parameters.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device. There is no "training set" in the context of examination glove testing. The manufacturing process is subject to quality control, which involves ongoing testing, but this is distinct from a "training set" for an algorithm.

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

• Not applicable. As stated in point 8, there is no training set. The "ground truth" for glove performance is established by the accepted industry and regulatory standards.

Ask a specific question about this device

BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

The BARRIER® Surgical Drapes have been designed with an assortment of fabrics, films and other materials and have been on the market for a number of years, cleared under multiple 510(k) notifications. BARRIER® surgical drapes, drape components and assorted surgical drape packs have been developed for a variety of surgical procedures including: Angiography, Cardiovascular/Thoracic, ENT/Plastic Surgery, OB/Gynecology. Laparascopic. Laparotomy, Orthopaedic, Urology, Cranial, Nephroscopy, Pediatric and other general surgical procedures. BARRIER® Surgical Drapes have been designed with materials. which provide increased protection to help prevent possible exposure to bloodborne pathogens and other potentially infectious materials.

The Barrier® Surgical Drapes are categorized into the following product groups: Patient Drapes, Equipment Drapes and Drape Components. All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BARRIER® Surgical Drapes:

Disclaimer: The provided document is a 510(k) summary from 2005 for a medical device (surgical drapes). The nature of this document means it focuses on demonstrating equivalence to existing products and meeting regulated standards, rather than providing a detailed clinical study report typically associated with AI/ML-based devices. Therefore, many of the requested categories for AI/ML device studies will not be applicable or explicitly stated in this type of document.

Acceptance Criteria and Device Performance

Study Details (as far as discernible from the provided text)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The summary mentions evaluation of "Barrier® Surgical Drapes," "Barrier Drapes," "Patient Drapes, Equipment Drapes and Drape Components." This implies testing was performed on representative samples of different product variations within the Barrier® line.
• Data Provenance: Not specified. Standardized testing for medical devices would typically be conducted by accredited laboratories.
• Retrospective or Prospective: N/A for this type of materials performance testing.

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

• This is not applicable as the study described is a technical performance evaluation against a published standard (ANSI/AAMI PB-70:2003), not a clinical study requiring expert ground truth for interpretation (like assessing medical images). The "ground truth" is established by the specifications of the standard itself.

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

• Not applicable. This was materials testing against a standard, not a clinical interpretation study.

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. This is a 510(k) summary for surgical drapes, which are physical medical devices, not AI/ML software. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant.

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

• No. This device is not an algorithm.

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

• The ground truth for this evaluation is defined by the metrics and pass/fail criteria within the ANSI/AAMI PB-70:2003 Standard, specifically for "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."

8. The 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.

Summary of the Study Mentioned:

The primary study mentioned to demonstrate compliance is an evaluation of the BARRIER® Surgical Drapes using the ANSI/AAMI PB-70:2003 Standard (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities).

This standard assesses the liquid barrier performance of protective apparel and drapes, categorizing them into different levels based on their resistance to liquid penetration. The study showed that "All Barrier Drapes are categorized into ANSI/AAMI Level 2 or Level 4 based on material selection and construction." This compliance with a recognized standard demonstrates that the drapes meet established performance criteria for fluid resistance, which is critical for their intended use in preventing contamination during surgery.

The context of this 510(k) summary is to demonstrate substantial equivalence to previously marketed surgical drapes, building on a history of pre-amendment devices and multiple clearance notifications since 1976. The testing against ANSI/AAMI PB-70:2003 serves to confirm that the current iterations of the BARRIER® drapes maintain or exceed the performance characteristics necessary for their intended use and regulatory classification.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Mepitel is intended for the management of wounds in the granulation phase, especially painful wounds and wounds with newly formed delicate tissue such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, second degree burns, skin abrasions, lacerations, partial and full thickness grafts, and skin tears.

Mepitel is a sterile wound dressing which consists of three components: a medical grade silicone gel, a polyamide tricot net, and a low density polyethylene protective release liner. The dressing is delivered sterile in single packs and is available in the following sizes: 2" x 3" (5 cm x 7.5 cm); 3" x 4" (7.5 cm x 10 cm); 4" x 8" (10 cm x 18 cm); and 9" x 12" (20 cm x 30 cm).

This document is a 510(k) summary for a medical device called Mepitel® Non Adherent Silicone Dressing. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is the regulatory pathway for this type of device. Substantial equivalence means the new device is as safe and effective as a legally marketed device. This process typically involves comparisons of material composition, intended use, and technological characteristics, and often includes biocompatibility testing. It generally does not involve detailed performance studies with acceptance criteria in the way described in your request for AI/diagnostic devices.

Here's why the requested information cannot be found in the provided text:

• Type of Device: This is a wound dressing, not an AI, diagnostic, or image-generating device. Its evaluation focuses on biocompatibility, physical properties, and a comparison to an existing similar product, rather than performance metrics like sensitivity, specificity, or reader improvement.
• Regulatory Pathway: The 510(k) pathway for wound dressings relies heavily on demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and is as safe and effective as one already on the market. It does not typically require performance studies with detailed acceptance criteria and ground truth establishment as would be required for a novel diagnostic or AI device.

Therefore, none of the specific points you asked for (acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set information) are present in this 510(k) summary. The study mentioned ("Mepitel have been found to be non-toxic and non-irritating when tested in accordance with the ISO 10993 Part I") is a biocompatibility test, not a performance study as requested.

Ask a specific question about this device

Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.

Hypergel® 20% Hypertonic Saline Gel is a sterile solution in amorphus gel form. Hypergel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Hypergel® 20% Hypertonic Saline Gel represents a new formulation of Mölnlycke Health Care currently marketed Hypergel Protective Wound Gel product. This new formulation provides a higher viscosity. Hypergel® 20% Hypertonic Saline Gel is provided in 5 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.

I apologize, but the provided text from K984370 for Hypergel® - 20% Hypertonic Saline Gel does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested.

The document is a 510(k) summary for a medical device. It focuses on:

• Device Description: What the device is composed of and its intended function (providing a moist wound environment for autolytic debridement).
• Substantial Equivalence: Comparing the device to a previously marketed predicate device (an earlier formulation of Hypergel). The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to an existing one, meaning it's as safe and effective.
• Biocompatibility: Stating that biocompatibility was determined according to ISO 10993.
• Indications for Use: Listing the specific types of wounds for which the gel is recommended.
• FDA Communication: The FDA's letter granting clearance, including specific limitations on labeling claims (e.g., not for third-degree burns, no claims of accelerating healing).

Missing Information:

The document does not include:

1. Acceptance Criteria or Reported Device Performance: There are no specific quantitative or qualitative criteria for how well the gel should perform (e.g., rate of debridement, reduction in wound size, time to healing) or any study data reporting such performance.
2. Study Details: Crucially, there is no mention of a clinical or analytical study, its design, sample size, data provenance, ground truth establishment, or expert involvement to prove the device meets any performance criteria.
3. MRMC, Standalone, Training Set Details: Since no performance study is described, these elements (MRMC, standalone, training set, etc.) are entirely absent.

Conclusion:

Based only on the provided text, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This is typical for a 510(k) summary, as it generally relies on demonstrating equivalence to an already approved device rather than presenting extensive new clinical efficacy data unless specifically required by the FDA. The biocompatibility testing mentioned is for safety, not for the clinical performance criteria you're asking about.

Ask a specific question about this device

Normlyel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.

Normlgel® 0.9% Isotonic Saline Gel is a sterile sodium chloride solution in amorphus gel form. Normlgel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Normigel is indicated for protecting granulating wounds and maintaining a moist wound environment in open wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Normlgel® 0.9% Isotonic Saline Gel represents a new formulation of our own currently marketed Normlgel Protective Wound Gel product. This new formulation provides a higher viscosity. Normlgel® 0.9% Isotonic Saline Gel is provided in 5 gm and 15 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.

The provided text describes a 510(k) submission for a medical device called Normlgel® 0.9% Isotonic Saline Gel. This submission focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided documents. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials if the technological characteristics and intended use are similar.

Here's an analysis based on the information provided:

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

• Not applicable / Not provided. The submission does not detail specific quantitative "acceptance criteria" for device performance in a clinical setting, nor does it report such performance metrics. The focus is on demonstrating "substantial equivalence" based on materials, formulation, and intended use compared to an existing device.
• The biocompatibility testing mentioned ("in accordance with the ISO 10993 Part I") would have acceptance criteria for biological responses, but these are not explicitly detailed in terms of their thresholds or outcomes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided for clinical performance. There is no indication of a "test set" in the context of clinical performance data. The device is a gel for wound care, and its substantial equivalence is based on its composition and intended use being similar to a predicate device.
• Biocompatibility testing would involve in-vitro or in-vivo testing with a "sample size" of cells or animals, but these details are not provided.

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)

• Not applicable. Since there's no clinical "test set" described for performance evaluation, there's no mention of experts establishing a ground truth for such a set.

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

• Not applicable. No clinical "test set" and thus no adjudication method are 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 medical gel, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of product.

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

• Not applicable. As noted above, this is a medical gel, not an algorithm.

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

• Not applicable for clinical performance. The "ground truth" in a 510(k) for a device like this is primarily the established safety and efficacy of the predicate device (Normlgel® Protective Wound Gel in this case) and the scientific understanding of the ingredients and their function in wound care.
• For biocompatibility, the ground truth would be defined by the ISO 10993 standards and accepted biological responses.

8. The sample size for the training set

• Not applicable. This submission doesn't describe a "training set" in the context of machine learning or clinical trials.

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

• Not applicable. No training set is described.

Summary of Acceptance/Equivalence Rationale from the Document:

The acceptance of Normlgel® 0.9% Isotonic Saline Gel by the FDA is based on its substantial equivalence to a previously marketed predicate device, Normlgel® Protective Wound Gel. Key points supporting this were:

• Similar intended use: Both are indicated for protecting granulating wounds and maintaining a moist wound environment for various types of open wounds.
• Similar composition: The new formulation is presented as an isotonic saline gel with similar base ingredients (water, sodium chloride, etc.) to the predicate. The primary difference noted is a "higher viscosity."
• Biocompatibility: The device was tested in accordance with ISO 10993 Part I, demonstrating acceptable biocompatibility.
• Safety and Effectiveness: The FDA's 510(k) clearance implies that, based on the provided information, the new device is as safe and effective as the predicate device for its stated indications, subject to certain labeling limitations imposed by the FDA (e.g., no claims for third-degree burns, accelerated healing, long-term dressing, or treatment/cure).

Ask a specific question about this device

Alldress is intended to absorb, protect, and maintain a moist environment in open and closed wounds such as; pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, surgical incisions, superficial burns, abrasions, lacerations, and skin tears.

The Alldress Absorbent Film Dressing is a sterile moisture vapor permeable selfadhesive absorbent dressing. The Alldress dressing is individually sealed in medical grade paper pouches and packaged in cartons of ten (10) pouches each. The Alldress dressing is available in three sizes: 10x10cm (4" x 4"), 15x15cm (6" x 6") and 15x20cm (6" x 8").

This document is a 510(k) summary for the Alldress® Absorbent Film Dressing. As such, it is focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the manner of a clinical trial for a new drug or a novel AI diagnostic device.

Therefore, many of the requested categories related to device performance studies, such as sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable or not provided in this type of regulatory submission. The "acceptance criteria" here refer more to the biocompatibility and functional characteristics typically tested in laboratory settings for wound dressings, rather than diagnostic accuracy metrics.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative thresholds for "nontoxic" or "non-irritating," but rather refers to compliance with a recognized standard (ISO 10993 Part I).

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

Not applicable/Not provided. This submission describes laboratory tests for biocompatibility and functional performance of a wound dressing, not a diagnostic algorithm. There isn't a "test set" of patient data in the context of an AI device. The tests mentioned (e.g., ISO 10993) involve material testing, not data analysis.

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)

Not applicable/Not provided. As above, this pertains to material testing based on established standards, not interpretation of patient data by experts.

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

Not applicable/Not provided.

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/Not provided. This device is a wound dressing, not an AI diagnostic tool.

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

Not applicable/Not provided. This is not an algorithm or AI device.

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

For biocompatibility, the "ground truth" is defined by the established criteria and methodology outlined in ISO 10993 Part I, "Biological Evaluation of Medical Devices" with FDA modified matrix. These standards define what constitutes "nontoxic" and "non-irritating" through specific biological test procedures.

8. The sample size for the training set

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

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

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

Ask a specific question about this device

Mepilex is designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

The Mepilex is a sterile, absorbent silicone-coated dressing designed for a wide range of shallow wounds, which have low to moderate levels of exudate, e.g., leg ulcers, pressure ulcers and skin lesions.

This document is a 510(k) premarket notification for a medical device called Mepilex™, a sterile, absorbent silicone-coated wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device, the Cutinova® Foam Dressing.

The document does not describe a study involving acceptance criteria and device performance in the context of an AI/ML algorithm or software. Instead, it focuses on the substantial equivalence of and biological safety of a wound dressing. Therefore, most of the requested information regarding AI/ML study details (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not applicable.

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

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

The document does not contain a table of acceptance criteria in the sense of specific performance metrics for a device, nor does it report specific device performance data for Mepilex™ in a quantitative manner. The acceptance for this submission is based on substantial equivalence to an existing predicate device and biological safety testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes a wound dressing and focuses on substantial equivalence and biocompatibility, not an AI/ML or software device requiring a test set of data. The biological tests performed for ISO 10993 Part I typically involve in vitro and in vivo (animal) studies, not a "test set" of clinical data in the context of AI.

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. Ground truth for a test set is relevant for AI/ML device validation, which is not the subject of this 510(k) submission.

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

This information is not applicable for the same reasons as above.

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

An MRMC study is not applicable as this submission is for a physical wound dressing, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is not an algorithm.

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

This information is not applicable in the context of AI/ML ground truth. For biological safety testing, the "ground truth" would be the observed biological response to the material as interpreted by toxicologists or biocompatibility experts against established standards (ISO 10993). For substantial equivalence, the "ground truth" is the established characteristics and performance of the predicate device.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device requiring a training set.

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

This information is not applicable as this is not an AI/ML device.

Ask a specific question about this device