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The Surgical Drape is intended for external use only and is used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using ethylene oxide.

Surgical drapes are intended to provide protection from microbial and other contamination. The Lucas surgical drapes described in this submission are one-piece, single use disposable sheets designed to provide an absorbent sterile barrier during surgical procedures. The drapes cover the patient and are made of an absorbent nonwoven fabric backed with a protective film that stops fluid strike-through. There are various sizes to meet the surgeon's needs. In general, the surgeon delineates with proposed field of surgery and charges the nursing team with the responsibility of draping the patient suing different types of drapes, with & without fenestration.

Lucas surgical drapes are made of nonwoven fabric composes of a three-layer composite comprised of a top layer, middle layer and bottom layer, they passed the industry standard tests that measure fluid and synthetic blood penetration, they are classified as a level 4 device under the AAMI PB 70 for barrier performance.

The document describes the acceptance criteria and the study conducted for the Surgical Drape, models 42526 and 42527, manufactured by GRIFFITH-LUCAS LLC.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "bench tests to demonstrate that the proposed device performs within its specifications" and provides a list of standards met for various tests. However, it does not explicitly state the specific sample sizes used for each of these bench tests.

The data provenance is from non-clinical (bench) testing performed by GRIFFITH-LUCAS LLC. There is no information regarding the country of origin of the data beyond the manufacturer being in China, but the tests performed are based on international standards (AAMI, CFR, ASTM). The studies are prospective in the sense that they were conducted specifically for the purpose of demonstrating the device's performance against established standards.

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

This information is not applicable as the ground truth for this device's performance is established through adherence to standardized non-clinical test methods and specified acceptance criteria (e.g., AAMI PB70 Barrier Level 4, ASTM standards) rather than expert consensus on a test set of data.

4. Adjudication Method for the Test Set:

This information is not applicable. The performance is evaluated against defined physical and chemical standards, not through expert adjudication of subjective assessments. The tests have pass/fail criteria based on objective measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The subject of this premarket submission, SURGICAL DRAPE, did not require clinical studies to support substantial equivalence."

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

This question is not applicable as the device is a physical surgical drape, not an AI algorithm or software. The "standalone performance" refers to the device's functional characteristics (e.g., barrier properties, biocompatibility) when tested independently according to established standards.

7. The Type of Ground Truth Used:

The ground truth used for performance validation is based on established industry standards and regulatory criteria. These include:

• AAMI PB70 (liquid barrier performance and classification)
• CFR Part 1610 (flammability)
• ASTM F 1670-08 (resistance to penetration by synthetic blood)
• ASTM F1929 (seal leaks in porous medical packaging)
• ASTM F1140 (internal pressurization failure resistance)
• Biocompatibility standards (cytotoxicity, irritation, sensitization, pyrogenicity)

8. The Sample Size for the Training Set:

This information is not applicable. This submission is for a physical medical device (surgical drape), not an AI/ML algorithm that requires a training set.

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

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

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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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Surgical drapes made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.

Various types of surgical drapes

The provided text is a 510(k) Premarket Notification for "Surgical Drapes." This document is focused on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) pathway for medical devices largely relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This process typically involves comparing the new device's technological characteristics and indications for use to those of the predicate device. Performance data, if included, is often used to support the claim of substantial equivalence rather than to meet specific, quantitatively defined "acceptance criteria" through a comprehensive clinical study.

Therefore, the requested information elements related to acceptance criteria, specific device performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable to this document. The document describes the device, its intended use, and compares it to a predicate device (Webster Enterprises – K864899) to demonstrate substantial equivalence, focusing on similarities in features and materials rather than statistical performance against predefined acceptance criteria.

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The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination.

The DIRRA surgical drape device kit is composed of natural or synthetic materials and intended to be used as protective patient covering, such as to isolate a site of surgical incision from microbial or other contamination. The DIRRA surgical drape device kit is to be used by medical and dental professionals when performing surgical procedures.

The DIRRA surqical drape device kit consists of the following components: Gown w/ paper towel (2), Mayo stand cover (1), Sterile sheet (1), Patient drape (1), Transparent drape (1), Adhesive strip (4), Tube holder (1), Cord drape (2), Suction tubing w/tip (1), Flat gauze (20), Round gauze sponge (5), Plastic tray (1), Transparent adhesive film (3), Connector for suction tubing (1), Kit wrapping drape (1).

All the components are wrapped in the DIRRA surgical drape device kit wrapping drape which is closed with a label.

The final measurement of the kit (not enveloped) is approximately cm.30x30x10. The kit is then enveloped in sequence and in accordance with the instructions for use. The pack is then inserted in the Sterilization plastic/tyvek pouch and the pouch is sealed. 2 Kits are put into one cardboard box along with instructions for use,. The box is then closed and sterilized by Bioster. A sterilization batch number is applied on the box after the sterilization process has been completed.

The provided document (K041080) is a 510(k) summary for a Surgical Drape Kit. It is a premarket notification for a medical device seeking clearance from the FDA by demonstrating substantial equivalence to a legally marketed predicate device.

For such a device (Class II, Surgical Drape and Drape Accessories, Product Code: LRO), direct performance studies to establish detailed acceptance criteria and prove performance as one would for a diagnostic or AI-driven device are typically not required in the same manner. The basis of clearance is substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not affect safety or effectiveness.

Therefore, the detailed information requested regarding acceptance criteria, study design (sample sizes, experts, adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of 510(k) submission for a surgical drape kit.

Here's how to address each point based on the information provided in this 510(k) summary:

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

The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance data." (Section: Comparison to predicate devices). Therefore, there are no specific performance acceptance criteria or reported device performance metrics in the format typically seen for a diagnostic device validation. The "acceptance criteria" here relate to demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics (materials, sterility, dimensions), and showing that any differences do not raise new questions of safety or effectiveness.

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

Not applicable. No performance data or test set was used for this 510(k) clearance, as explicitly stated that the determination of substantial equivalence is not based on an assessment of performance data.

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. No test set or ground truth was established for this submission.

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

Not applicable. No test set requiring adjudication was used.

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 drape kit, not an AI-driven diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. This device is a surgical drape kit, not an algorithm or AI system.

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

Not applicable. No ground truth was established as performance data was not used for the determination of substantial equivalence. The "ground truth" for this submission would essentially be the predicate device's established safety and effectiveness, to which the new device is compared.

8. The sample size for the training set

Not applicable. This device is a physical product (surgical drape kit), not a machine learning model 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 a physical surgical drape kit, no ground truth needed to be established for it.

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For use in hospitals, clinics, laboratories or other facilities where absorbent toweling may be used.

For use as absorbent toweling for cleanup, preparation or squaring off a surgical incision site. For use during surgical procedures to provide extra absorption of blood and body fluids.

For use a) to dry off surgeons, doctor or nurses hands after scrubbing, (b) to square off a surgical incision site, and (c) to absorb blood or body fluids during a surgical procedure.

Not intended for use as surgical packing.

Operating Room Towels are a 100% cotton woven towel. The are generally available in white (undyed), green or blue colors. O.R. Towels have been used throughout the Healthcare industry for a variety of purposes. These absorbent towels are utilized for hand drying, cleanup, and also for squaring off the surgical incision site, and to provide increased absorbency of blood and bodily fluids.

The provided document describes the 510(k) premarket notification for "Sterile O.R. Towels" by International Medsurg Connection. This submission is for a medical device that is a commodity product (surgical drapes/towels) and as such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices already on the market, primarily through physical performance characteristics and biocompatibility testing, rather than a clinical study involving human readers or sophisticated algorithms.

Here's a breakdown of the requested information based on the provided text:

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: The document does not specify the exact sample sizes used for the biocompatibility or physical performance tests (e.g., how many towels were tested for tear strength, absorbency). It only states that "testing" was done.
• Data Provenance: Not specified, but given the context of a 510(k) submission in the US, it's implied the testing was conducted either internally by International Medsurg Connection or by a contracted lab, with the results provided to the FDA. The tests are standard industry tests (USP, ASTM).

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 question is not applicable to this device. For a sterile O.R. towel, "ground truth" is established through standardized laboratory testing (e.g., chemical assays for cytotoxicity, physical measurements for strength and absorbency) rather than expert interpretation of data.

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

• This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The testing for O.R. towels involves direct measurement against established standards.

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 question is not applicable to this device. This is a commodity medical device (surgical towel), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.

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

• This question is not applicable to this device. This is not an algorithmic or software-based device.

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

• The "ground truth" for the performance of these surgical towels is based on established industry standards and tests:
  • Biocompatibility: USP (United States Pharmacopeia) test requirements for cytotoxicity, and standard methods for Primary Skin Irritation and Dermal Sensitization.
  • Physical Performance: ASTM (American Society for Testing and Materials) standards for a Tear Strength (ASTM D5034) and Tensile Strength (ASTM D1424), and USP standards for Absorbency.

8. The sample size for the training set

• This question is not applicable to this device. As a traditional medical product and not an AI/ML system, there is no "training set."

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

• This question is not applicable to this device. There is no training set for this type of medical device.

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