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The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

• Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
• 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
• Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
• Advanced Sterilization Products STERRAD 100S system
• Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
• Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) for a maximum of 180 days or until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:

• 1- The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
• 2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
• 3-The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.

PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

The provided text describes the acceptance criteria and the comprehensive non-clinical testing performed for the PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each test set. However, it indicates that the testing was non-clinical. This implies that the data provenance is from laboratory testing and not from human patient data. The origin of the data is implicit in the "non-clinical" nature and the use of ISO/ASTM standards for testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for sterilization wraps and their performance is established through adherence to recognized international standards (ISO, AAMI, ASTM, EN) and empirical laboratory testing, not through expert consensus from human observation (e.g., radiologists).

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations are based on objective laboratory measurements against predefined technical specifications and standards, not on subjective interpretations requiring adjudication.

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

This information is not applicable as the device is a sterilization wrap, not an AI-powered diagnostic or assistive tool for human readers.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (algorithm only without human-in-the-loop performance), as they focus on the intrinsic properties and performance of the sterilization wrap itself against established technical and biological criteria. The "algorithm" in this context refers to the defined device specifications and its physical/chemical interactions, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used is primarily based on established industry standards and regulatory requirements for medical device sterilization and packaging, including:

• Biological indicators (for sterilant penetration and sterility maintenance) which have a known, predictable response.
• Physical and chemical property specifications (e.g., burst strength, air permeability, pH, leachable content) that are objectively measurable and defined by standards.
• Biocompatibility standards that define acceptable levels of cytotoxicity, irritation, and sensitization.
• Package integrity criteria for maintaining a sterile barrier for a specified duration.

8. Sample Size for the Training Set

This information is not applicable. The device is a sterilization wrap, not an AI/ML-based algorithm that requires a "training set" of data. The development and validation process for this device involves material science, engineering, and microbiology, not machine learning.

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

This information is not applicable for the reasons stated in point 8.

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PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

PRIMED Surgical masks and PRIMED Procedure masks are single use, non-sterile masks composed of a melt-blown filter layer placed between layers of non-woven inner and SS outer layer(s) material. PRIMED Medical Products Inc. offers various models in two main categories: Procedure masks with ear loops and Surgical masks with head ties. The level of protection varies based on the basis weight of the inner layer and the number of outer layers used in the mask's construction, in accordance with ASTM F2100:2023 specifications.

The provided text is an FDA 510(k) summary for PRIMED Surgical Masks and PRIMED Procedure Masks. It describes the acceptance criteria and the study that proves the device meets those criteria. However, it does not include information about a complex AI-driven medical device, a multi-reader multi-case (MRMC) study, or detailed information about ground truth establishment by experts as would be relevant for an AI/CADe system.

Therefore, the following response will be tailored to the information available in the provided document, which pertains to a physical medical device (surgical masks) and its performance against established standards, rather than an AI/software device.

Here's the information as extracted and interpreted from the document:

Acceptance Criteria and Device Performance for PRIMED Surgical Masks and PRIMED Procedure Masks

The device under review is PRIMED Surgical Masks and PRIMED Procedure Masks. The performance of these masks is evaluated against established physical and biocompatibility standards rather than a typical AI/CADe performance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are derived from ASTM F2100-23 standards for medical face masks and other relevant ISO and CFR standards for biocompatibility and flammability.

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The PRIMED Sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a health care provider via the following:

• Pre-Vacuum Steam at 270°F/ 132°C for 4 minutes. The wrap has been validated for dry time of 20 minutes for P100 and P200 and dry time of 30 minutes for P300, P400, P500 and P600.
• 100% Ethylene Oxide Sterilization with a concentration of 725-735 mg/L at 131°F/55°C and 40% 80% relative humidity for 60 minutes. Validated for aeration times of 8 hours at 55°C or 12 hours at 43.3°C.
• Lumen. Non-Lumen. and Flexible Cycles in the STERIS V-PRO maX/maX2 and STERIS V-PRO 60/s2 low temperature Sterilization Systems.
• Advanced Sterilization Products STERRAD 100S system
• Advanced Sterilization Products STERRAD NX [Standard Cycle, Advanced Cycle]
• Advanced Sterilization Products STERRAD 100 NX [Standard Cycle, Flex Cycle, Express, Duo Cycle]

PRIMED Sterilization wraps are available in 6 models and different sizes ranging from 12" X 12" to 54" X 90" and are intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. PRIMED Sterilization wraps are validated for use with above listed sterilization systems with the intended loads as described below.

The PRIMED Sterilization wraps are made of SMS (Spunbond) Polypropylene with addition of a master batch pigment for coloration and are available in three separate product offerings:
1-The Fused one colour double layer bonded wrap is comprised of two sheets ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
2- The Fused two colours double layer bonded wrap is comprised of two sheets of purple and blue fabrics ultrasonically bonded on two parallel sides. The wrap fabrics are composed of polypropylene with the addition of purple or blue pigment. This product allows convenient simultaneous wrapping of medical devices to be sterilized in accordance with standard healthcare practices.
3- The Single layer one colour wrap is comprised of a single nonwoven sheet. The standard purple wrap is composed of polypropylene with the addition of a purple pigment. Two sheets are used to sequentially wrap medical devices to be sterilized in accordance with standard healthcare practices.

PRIMED Sterilization wraps are available in various dimensions ranging from 12″ x 12″ x 90″ and six different weights as detailed in table 1.

The provided document is a 510(k) Summary for the PRIMED Sterilization Wrap. It outlines the device's technical characteristics, intended use, and a comparison to a predicate device, along with a summary of non-clinical testing.

However, the document does not describe an AI/ML-enabled medical device. It pertains to a physical sterilization wrap. Therefore, the questions related to AI/ML model performance, such as:

• Sample sizes for test and training sets
• Data provenance
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC studies and effect sizes
• Standalone AI performance
• Type of ground truth

cannot be answered from the provided text. The document focuses on demonstrating substantial equivalence of a physical product to a predicate device through non-clinical testing of its physical, chemical, and functional properties related to sterilization and sterility maintenance.

Here's an analysis of the acceptance criteria and study as presented for this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document refers to "non-clinical testing" and does not specify a "test set" in the context of data for an AI/ML model. Instead, it refers to tests performed on the physical sterilization wraps.
• The sample sizes for each specific physical test (e.g., number of wrap samples for sterilant penetration, integrity, etc.) are not provided in this summary.
• Data provenance is not applicable in the AI/ML sense; the data is generated from laboratory testing of the physical device. The country of origin for the data (where the tests were conducted) is not specified, but the manufacturer is based in Canada.

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

• Not applicable to this device. Ground truth, in this context, refers to established scientific and engineering standards and methods for assessing the performance of sterilization wraps, not expert interpretation of images or clinical data.

4. Adjudication method for the test set:

• Not applicable to this device. Testing is based on established laboratory protocols and quantitative or qualitative measurements leading to pass/fail criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not applicable. This device is a physical sterilization wrap, not an AI/ML-assisted diagnostic or treatment aid for humans.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used:

• For this device, the "ground truth" is established by adherence to recognized international and national standards for medical device sterilization and packaging. These include:
  • ANSI/AAMI ST79 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities)
  • ANSI/AAMI/ISO 11138-7 (Sterilization of health care products - Biological indicators - Part 7: Biological indicators for ethylene oxide sterilization processes)
  • ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
  • AAMI TIR12 (Guidance for establishing product family groupings for sterilization)
  • ANSI/AAMI ST77 (Sterilization of health care products - Sterile device packaging - Requirements)
  • ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
  • ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
  • EN 868-2 (Packaging for terminally sterilized medical devices - Part 2: Sterilization wraps - Requirements and test methods)
  • Various ASTM (American Society for Testing and Materials) standards for fabric properties (D3776, D737-04, D3786, D5034-09, D5587-15)
  • AATCC127-2014 (Water Resistance: Hydrostatic Pressure Test)
  • NWSP 160.1 (Nonwoven Standard Procedure for linting)
• These standards define the methodologies and acceptable performance limits.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML model.

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

• Not applicable.

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The PRIMED level 1 Pediatric Facemask is a single use, disposable device that is intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to provide a barrier for the respiratory tract from microorganisms, body fluids and particulate material.

The PRIMED level 1 Pediatric Facemask is a single use, disposable device intended to be used by patient/child 4 to 12 years old in healthcare setting under an adult supervision to prevent the transmission of microorganism.

PRIMED Pediatric Mask (PG4-1680) is composed of 4 layers of non-woven material bounded together and pleated to form a mask. This mask is appropriately sized to the smaller faces of children between ages of 4 to 12 years old. PRIMED pediatric mask meets the requirements of ASTM F2100 for level 1 procedure mask while providing a lower differential pressure this mask is single use, disposable and is provided non-sterile. All of materials used in this device are typical materials commonly used in the construction of legally marketed surgical/ procedure masks with a safe history of use. The mask is not made with natural rubber latex.

The provided text describes the regulatory clearance (510(k)) for the PRIMED Pediatric Facemask, classifying it as a Class II medical device (Surgical Apparel, product code OXZ). The document details the device's indications for use and presents a comparison to predicate devices, along with performance data demonstrating compliance with relevant standards.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the PRIMED Pediatric Facemask are based on meeting or exceeding the performance requirements for a Level 1 procedure mask as per ASTM F2100. The table below summarizes these criteria and the reported performance of the device.

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

The document does not explicitly state the sample sizes used for each individual test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the performance results.

The data provenance is implied to be from laboratory testing performed by the manufacturer or accredited testing facilities, as evidenced by the reference to specific ASTM, EN, ISO, and CPSC standards. The document does not specify the country of origin of the testing data, nor does it indicate if the data is retrospective or prospective in the context of clinical trials. These are performance tests on the device itself, not clinical data from human subjects.

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

This information is not applicable to this document. The "ground truth" for the performance tests of a medical facemask (like BFE, PFE, fluid resistance) is established by the validated and standardized test methods themselves (e.g., ASTM F2101 for BFE). These are objective measurements in a laboratory setting, not subjective assessments by human experts.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective laboratory measurements, not subjective assessments 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:

This information is not applicable. The device is a pediatric facemask, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance for human readers is 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. The device is a physical medical product (facemask), not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" for the device's performance is based on objective measurements obtained through standardized laboratory tests according to recognized international and national standards (ASTM, EN, ISO, CPSC). This is an objective, quantitative ground truth for the physical and functional properties of the mask materials and construction.

8. The sample size for the training set:

This information is not applicable. As a physical medical device (facemask), there is no 'training set' in the context of machine learning. The design and manufacturing processes are refined through engineering principles and testing to meet specifications, not through machine learning training.

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

This information is not applicable for the same reasons as point 8.

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PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material.

The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below:

• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal),
• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL),
• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL),
• PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL),
• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)

PRIMAGARD AAMI PB70:2012 Level 3 gowns are non-sterile, single use isolation gowns intended to be worn by healthcare professionals in isolations. These gowns are made of SMS non woven material, contain ultrasonic seams, provide full coverage (level 3 as per PB70) and are not made with natural rubber latex. The proposed isolation gowns come in 5 different models as described in the Indications for Use.

This document describes the premarket notification for the PRIMAGARD Isolation Gown (AAMI PB70 Level 3). It does not describe an AI/ML powered medical device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies related to AI/ML device performance.

The document focuses on demonstrating the substantial equivalence of the PRIMAGARD Isolation Gown to predicate devices based on a comprehensive set of non-AI related performance, safety, and physical property tests.

Here's an overview of the information that is available related to the device's performance based on the provided text, adapted to the requested table format where applicable, but acknowledging that it doesn't fit the AI/ML context:

1. A table of acceptance criteria and the reported device performance (for the non-AI device):

The following information is not applicable or available as the device is not an AI/ML product:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) for an AI/ML device:
Not applicable. The document refers to testing according to various ASTM, AAMI, AATCC, ISO, and 16 CFR standards for physical, chemical, and biological properties of the gown material, not patient data for an AI algorithm. The sample sizes for these material tests are not specified in the provided text, and data provenance in terms of "country of origin of data" or "retrospective/prospective" is not relevant for materials testing in this context.

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. Ground truth in the context of expert consensus is not relevant here as there is no AI/ML model being evaluated against expert opinions on medical images or diagnoses. The "ground truth" for this device is established by the specified performance standards (e.g., AATCC 127 for hydrostatic pressure).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving expert review of data where discrepancies need resolution. This is not pertinent to the material and barrier performance testing 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 is a medical device (isolation gown), not an AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product (isolation gown), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the physical device, the "ground truth" is defined by the acceptance criteria specified in recognized industry standards (e.g., AAMI PB70, ASTM standards for material properties, ISO standards for biocompatibility). The device's performance is measured against these established, objective metrics, not against subjective expert consensus or pathology data.

8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established:
Not applicable. As there is no AI/ML model, there is no training set or a process for establishing its ground truth.

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PRIMAGARD Delta Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

These surgical masks are deltoid shape, waterfall-pleated devices manufactured from selected non-woven materials (polypropylene and wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative to the degree of protection required during intended use.

This document is a 510(k) premarket notification for a surgical mask (PRIMAGARD Delta Surgical Mask, K092012) and, as such, does not describe the acceptance criteria, specific study details, or performance results in the way a clinical study report or a detailed validation study would.

The provided text focuses on the regulatory submission process, declaring substantial equivalence to a predicate device (K081633), and outlining the intended use and technological characteristics.

Therefore, most of the information requested in your prompt (1-9) about acceptance criteria and study details cannot be extracted directly from this 510(k) summary and the accompanying FDA letter.

However, based on the context of a surgical mask 510(k) submission, we can infer some general points and identify what is not present:

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

This information is not present in the provided document. For surgical masks, acceptance criteria would typically relate to standardized tests مثل (but not limited to) bacterial filtration efficiency (BFE), particulate filtration efficiency (PFE), differential pressure (breathability), fluid resistance, and flammability. The document only mentions "optimal breathability, particulate filtration and a fluid-penetration barrier" as design goals but provides no specific quantitative criteria or performance data.

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 present in the provided document.

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 present in the provided document. The device is a physical product (surgical mask), not an AI/diagnostic tool requiring expert-established ground truth for a test set.

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

This information is not present and is not applicable for a physical product like a surgical mask.

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 present and is not applicable. MRMC studies are relevant for diagnostic devices (e.g., AI algorithms for interpreting medical images), not for surgical masks. There is no AI component mentioned or implied for this device.

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

This information is not present and is not applicable. This is not an algorithm or AI device.

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

This information is not present. For surgical masks, "ground truth" would correspond to the results of standardized biological, physical, and chemical tests to measure barrier properties and breathability, not expert consensus on medical images or pathology.

8. The sample size for the training set

This information is not present and is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not present and is not applicable for the reasons mentioned in point 8.

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PRIMAGARD™ Surgical Masks are surgical apparel as identified in 21 CFR 878.4040 and are intended to be worn by operating room personnel during surgical procedured to protect both the surgical patient and the operating room personnel from transfer of microcogniss is, body fluids, and particulate material. The PRIMAGARD™ Surgical Masks may also be worn outide of the operating room for non-surgical procedure use.

These surgical masks are rectangular, waterfall-pleated or soft-bill devices manufactured from selected non-woven materials (polypropylene or wet-laid cellulose) designed to provide optimal breathability, particulate filtration and a fluid-penetration barrier relative, to the degree w of protection required during intended use.

The provided text is a 510(k) summary for a surgical mask. It describes the device, its intended use, and its technological characteristics compared to a predicate device. The document also includes an FDA letter confirming substantial equivalence.

However, the provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data in the format of the requested table. Surgical masks are typically cleared based on performance testing against recognized standards (like ASTM F2100 for medical face masks), which measure things like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, and breathability. These are typically bench tests, not clinical studies involving human subjects in the way AI/ML devices are.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, provenance, experts, adjudication, MRMC studies, standalone performance, ground truth types, or training set details, as this information is not present in the provided document for this type of medical device.

The document indicates that the device (PRIMAGARD™ Surgical Mask) is "technologically similar to the predicate device (K001951)" and "The PRIMAGARD™ Surgical Masks are an improvement in that non-woven materials production technologies have advanced and there is a better understanding of the physical aspects of the filtration capability. Accordingly, the non-woven products utilized in the PRIMAGARD™ Surgical Masks, when used in specific weight (gsm, grams per square meter) combinations are able to provide defined fluid resistance (as measured by the ASTM F2100-07 Standard Synthetic Blood Fluid Resistance test)."

This statement implies that the device likely meets acceptance criteria defined by standards like ASTM F2100-07 for parameters specific to surgical masks, but the actual performance data and explicit acceptance criteria are not detailed in this 510(k) summary.

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