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Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The EMM Surgical Drapes AAMI Level 4 are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007

Exact Medical Manufacturing Surgical Drape AAMI Level 4 are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level The base sheet fabric is a three layer composite comprised of polypropylene spunbond and a co-extruded PE film. Layers are thermally bonded together producing a single layer with various basis weights. The outer layers are non woven fabric, the inner layer is AAMI PB:70 Level 4 capable PE film.

The provided document K121919 describes a surgical drape, not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML devices (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable.

However, I can extract the acceptance criteria and performance data for this physical medical device based on the information provided.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a "Summary of Testing" described in the 510(k) submission. It states:

"Exact Medical Manufacturing Surgical Drape with AAMI Liquid Barrier Level IV is substantially equivalent and meets the same acceptance criteria as the predicate device/Drape in K102666 Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria."

Regarding AI/ML Specific Information (Categories 2-9):

As this is a physical surgical drape, the following categories are not applicable and no information is provided in the document:

2. Sample size used for the test set and the data provenance: Not applicable for a physical device undergoing non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties and performance are measured against standards, not expert consensus.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" or reference for acceptance is established by recognized international and national standards (e.g., AAMI PB70, ISO 10993, ASTM, 16CFR1610).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or nonsterile single use devices that 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. Sterile surgical gowns are to be sold directly to users after E.O sterlization and validated to ISO 11135-1:2007.

The Exact Medical Manufacturing Surgical Gowns with AAMI Level IV Liquid Barner are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007

Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or non-sterile single use devices that 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.
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV is comprised of a 3 ply laminate non woven material - outer layers are nonwoven fabric - inner layer AAMI PB:70 Level 4 capable film. The gowns consist of 100% polyester cuffs sewn to the end of the sleeves using nylon thread. The gowns have a manual closure system.

The provided text describes the 510(k) summary for the Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV. This document focuses on the regulatory submission and does NOT involve an AI/ML algorithm or a study with human readers, deep learning, or image analysis. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The device is a surgical gown, and its performance is evaluated against established standards for medical textiles, particularly AAMI PB:70 Level 4 for barrier properties.

Study Information (Not Applicable for this Device Type)

The provided document describes a device for regulatory approval (510(k) submission) for a physical medical device (surgical gown), not a diagnostic AI/ML algorithm or software. Therefore, the following points are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. Tests are conducted on physical samples of the gown material, not a "test set" of data or patient cases.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing standards define performance, not expert ground truth on cases.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" here refers to the measured physical properties of the material against established international standards.
7. The sample size for the training set: Not applicable. There is no training set for a physical device like a surgical gown.
8. How the ground truth for the training set was established: Not applicable.

Explanation of "Not Applicable" for AI/ML-specific questions:

The 510(k) summary is for a physical medical product (surgical gown), not a software or AI/ML algorithm. The performance evaluation revolves around bench testing of the physical material's properties (e.g., barrier effectiveness, strength, biocompatibility) against established industry standards (like AAMI PB:70 Level 4 and ISO 10993). Concepts such as "test set," "training set," "data provenance," "expert ground truth," "adjudication," "multi-reader multi-case studies," or "human-in-the-loop performance" are specific to the validation of diagnostic algorithms or AI-powered systems, which are not relevant to this product.

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Exact Medical Manufacturing Surgical Gown - Spunlace w/PE Layer are sterile single use devices that 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.

The Exact Medical Manufacturing Surgical Gown - Sounlace w/PE Laver are also sold as built nonsterile, single use items, to repackagerrelabeler establishments for further packaging and ethylene oxide sterilization.

Exact Medical Manufacturing Surgical Gown-SPL are single use, disposable surgical gowns using in the OR as a protective covering, for the operating room staff, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns- Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyester cuffs, Velcro neck closure, reinforced areas fabric or polyethylene

This document describes the 510(k) submission for Exact Medical Manufacturing's Surgical Gowns – Spunlace w/PE Layer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-based device. Therefore, many of the requested categories related to AI device evaluation (e.g., AI integration, multi-reader multi-case studies, training set details) are not applicable.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Pre-Conditioning: Temperature = 42°C, RH = 60%, Dwell Time = 6 hours
• EO Cycle: Temperature = 54°C, RH >= 30%, EO Concentration = 730mg/m3, Dwell Time = 9 hours
• Aeration: Temperature = ambient, Time >= 72 hours
• EO Residuals: EO

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Exact Medical Manufacturing Surgical Drape SMS w/PE Sides are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

The Exact Medical Manufacturing Surgical Drape Surgical Drape SMS w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Exact Medical Manufacturing Surgical Drapes Surgical Drape SMS w/PE Sides are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Exact Medical Manufacturing Surgical Drapes SMS w/PE Sides are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene), PE Layer, 3M Medical Adhesive Tape.

The provided text is for a 510(k) Summary for a medical device called "EMM Surgical Drape SMS w/PE Sides." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel AI or diagnostic device.

Therefore, many of the requested items related to AI/diagnostic device studies (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and how ground truth was established) are not applicable to this type of submission.

However, I can extract the acceptance criteria and the summary of testing performed to demonstrate that the device met these criteria, in comparison to a predicate device.

Acceptance Criteria and Reported Device Performance

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

Note: The reported device performance often states "Substantially Equivalent" indicating that the EMM Surgical Drape met or exceeded the performance characteristics of the predicate device, or adhered to recognized standards. For Barrier Properties, the EMM device reports a higher hydrostatic head, meeting a higher level (Level 3) compared to the stated predicate value, which implies it exceeds the predicate's performance.

Study Details (as applicable for this type of submission)

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 in this context. This submission is for a physical medical device (surgical drape) and relies on laboratory-based performance testing rather than clinical data or a diagnostic test set with patient data. The "test set" here refers to samples of the surgical drape material. The document does not specify sample sizes for each physical test, beyond stating that "All results of the testing met acceptance criteria." Data provenance (country of origin, retrospective/prospective) is not mentioned or relevant for these types of material property tests.

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 sense of expert review for diagnostic accuracy, is not relevant here. The "ground truth" for material properties is established by defined physical and chemical testing standards (e.g., ISO, ASTM, AATCC) and the results obtained from those standardized tests.

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

• Not Applicable. Adjudication methods are typically for subjective expert review of medical images or clinical cases. The testing for the surgical drape involves objective physical property 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

• Not Applicable. This is a physical medical device, not an AI or diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an AI or diagnostic algorithm.

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

• The "ground truth" for this device's performance is established by objective measurements against recognized industry standards and regulatory requirements for material properties and biocompatibility. This includes compliance with standards such as ISO 10993 (Biocompatibility), AAMI PB:70 (Barrier properties), ASTM D5587 (Tear Strength), ASTM D5034 (Tensile Strength), 16CFR1610 (Flammability), and ISO 9073-10 (Linting). The predicate device's established performance also serves as a benchmark for "substantial equivalence."

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence.

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

• Not Applicable. No training set is used.

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Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

The Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Exact Medical Manufacturing Surgical Drape -Spunlace w/PE Sides are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Exact Medical Manufacturing Surgical Drapes-Spunlace w/PE Sides are comprised of Spunlace, Polyethylene, 3M Medical Adhesive Tape.

The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "Exact Medical Manufacturing Surgical Drape-Spunlace w/PE Sides, Model 13-004".

Here's a breakdown of the requested information:

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

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 for Test Set: The document does not explicitly state the sample size for each test. However, for each test, a single "Finished Good Lot Number" (0980APA2) of the device (Model No. 13-004 Sterile) was used as the "Test Article". This suggests that samples from this specific lot were subjected to all listed tests.
• Data Provenance: The tests were conducted across several accredited laboratories:
  • Nelson Labs, Utah, USA
  • LexaMed, Ohio, USA
  • LexaMed/NAMSA, Ohio, USA
  • SCDC, Shanghai, CN
  • GOALS Sterilization Co., Jiaxing, CN
    The data appears to be prospective as it involves pre-market testing of the device against established standards.

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 type of information is not applicable to this document. The tests performed are objective, physical, and chemical performance tests for a medical device (surgical drape), not diagnostic tests requiring expert interpretation of results or ground truth derived from expert consensus. The "ground truth" is established by the specified industry standards and their defined acceptance criteria.

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

This is not applicable for the type of testing described. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, where multiple experts might disagree on an outcome. For these performance tests, the results either objectively meet or do not meet the predefined numerical or qualitative criteria of the standard.

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 is not applicable. The device is a surgical drape, not an AI-powered diagnostic tool, and therefore, MRMC comparative effectiveness studies involving human readers and AI assistance are irrelevant to its evaluation.

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

This is not applicable. The device is a physical surgical drape, not an algorithm, so the concept of standalone algorithm performance does not apply.

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

The "ground truth" for the performance tests of the surgical drape is based on recognized industry standards and their predefined acceptance criteria. This includes standards like AATCC, ASTM, ISO, and 16CFR, which specify objective measurements and thresholds for properties such as water resistance, biocompatibility, flammability, and tensile strength.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in its evaluation.

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

This is not applicable, as there is no training set for this device.

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Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination.

The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk nonsterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.

Exact Medical Manufacturing Equipment Cover- Polyethylene are single use, disposable equipment cover used in the OR as a protective covering, for the operating equipment, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Equipment Covers - Polyethylene are comprised Polyethylene with absorbent polypropylene. The Exact Medical Manufacturing Equipment Covers-Polyethylene are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization.

The provided document is a 510(k) summary for a medical device called the "EMM Equipment Cover - Polyethylene." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic or therapeutic performance. As such, many of the typical elements requested for an AI/diagnostic device study (like sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training data) are not applicable or present in this context.

However, I can extract the acceptance criteria and reported device performance from the provided "Non-Clinical Testing Summary."

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: The document does not specify the sample size for each test. It refers to a "Finished Good Lot Number: 0980APA3" for multiple tests, implying that samples were drawn from this lot.
• Data Provenance: The tests were conducted at "Nelson Labs, Utah, USA" and "SCDC, Shanghai, CN, LexaMed, Ohio, USA." This indicates the tests were conducted in the USA and China, presumably using newly manufactured equipment covers. These are non-clinical (laboratory/performance) tests, not clinical data sets.

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. The device is an equipment cover, and the "ground truth" is established by laboratory performance standards and measurements, not by expert interpretation of clinical data.

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

This information is not applicable. The tests are based on objective physical and chemical properties measured according to established standards, not on expert adjudication of ambiguous cases.

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 an equipment cover and not an AI-powered diagnostic tool. No MRMC study was conducted.

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

This information is not applicable. The device is an equipment cover and does not involve an algorithm.

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

The "ground truth" for this device's performance is defined by adherence to recognized international and national standards for material properties, barrier performance, flammability, and sterility. These are objective, measurable criteria, not subjective interpretations.

8. The sample size for the training set:

This information is not applicable. This is a manufactured product undergoing non-clinical performance testing, not a machine learning model requiring a training set.

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

This information is not applicable. As there is no training set, there is no ground truth establishment process for it.

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Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use devices that 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. The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device.

The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer met the acceptance criteria by demonstrating substantial equivalence to its predicate device (K023117) through a series of non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

All results of the testing met acceptance criteria.

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

• Sample Size: Not explicitly stated. The document mentions "All results of the testing met acceptance criteria," implying that sufficient samples were tested for each criterion according to standard testing protocols for medical devices.
• Data Provenance: The data is generated from non-clinical performance testing conducted by Exact Medical Manufacturing, Inc. It is internal testing performed for regulatory submission.

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

• This is a non-clinical device (surgical gown) and does not involve human interpretation of data where expert consensus would be required to establish ground truth such as in diagnostic imaging. The "ground truth" is established by adherence to recognized national and international standards (e.g., ISO 10993, AAMI PB:70).

4. Adjudication method for the test set:

• Not applicable. As noted above, this involves objective, quantifiable laboratory tests against established standards, not interpretation or adjudication by experts.

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 surgical gown, not an AI-powered diagnostic or assistive tool.

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

• Not applicable. This device is a surgical gown, not an algorithm.

7. The type of ground truth used:

• The ground truth is based on accepted national and international standards and specifications for surgical gowns and medical device materials, including:
  • ISO 10993 for biocompatibility.
  • AAMI PB:70 for barrier properties (Level 3).
  • Other specific test methods for tensile strength, tear strength, flammability, linting, and sterility.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

• Not applicable, for the reason stated above.

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