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Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates.

Drapes provided as sterile and non-sterile.

Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

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Welmed Surgical Drapes are disposable sterile or non-sterile drapes used in the operating room to protect patients and staff from the transfer of bodily fluids, microorganisms, and particulates. The device's performance was evaluated through a series of tests against established standards.

1. Table of Acceptance Criteria & Reported Device Performance

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

The provided document does not specify the exact sample sizes for each test mentioned above. It simply states "Data Generated" for each test. The document does not provide information regarding the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not applicable. The device's performance was assessed against established international and national standards for material properties and biocompatibility, not against expert-established ground truth in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable. The testing involved measurements against predefined physical and biological standards, not subjective expert adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. The device is a surgical drape, and its effectiveness is determined by its physical and biological properties as tested against industry standards, not by human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's material properties and biocompatibility were evaluated independently against specified standards, without the involvement of human interpretation or AI. The tests listed in the table (Hydrostatic Pressure, Tensile Strength, Biocompatibility, etc.) represent the standalone performance evaluation of the product.

7. Type of Ground Truth Used

The "ground truth" for evaluating the Welmed Surgical Drapes was based on established industry and regulatory standards and test methods. These standards define the acceptable performance characteristics for surgical drapes (e.g., water resistance, tensile strength, flammability, biocompatibility). The device was deemed substantially equivalent to a predicate device based on its compliance with these objective standards.

8. Sample Size for the Training Set

This information is not applicable. The product is a physical medical device (surgical drape), not an algorithm or an AI-powered system that requires 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 for this device.

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The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.

The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.

Here's an analysis of the provided text regarding the Welmed Hypodermic Syringe, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device (hypodermic syringe), not an AI/software as a medical device (SaMD). Therefore, many of the requested categories related to AI development (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment) are not applicable to this type of submission. The device is a physical product, and its performance is evaluated against established physical standards.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The Welmed Hypodermic Syringe demonstrates conformance to the FDA-recognized consensus standard ISO 7886-1:1993, "Sterile hypodermic syringes for single use - Part 1: Syringes for manual use." This standard sets forth the acceptance criteria for various performance characteristics of manually operated hypodermic syringes.

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 compliance study against the ISO 7886-1:1993 standard.

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

• Sample Size for Test Set: Not explicitly stated in the 510(k) summary. For physical device testing against an ISO standard, samples of each syringe size (1, 3, 5, 10, 20, 30, and 60 ml) would have been taken to perform the various tests outlined in the standard. The sample size would be determined by the specific requirements of ISO 7886-1:1993 for each test.
• Data Provenance: Not explicitly stated. For a 510(k) submission, the testing would typically be performed by the manufacturer, or a qualified third-party laboratory, in line with Good Manufacturing Practices (GMP) and relevant quality systems. Given the US submission, the testing would likely have been conducted in the US or a facility adhering to similar international standards. The data would be prospective as it's specifically generated for the purpose of demonstrating compliance.

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

• N/A. This question is relevant to AI/SaMD devices where expert consensus is used to label data. For a physical device conforming to an ISO standard, "ground truth" is typically defined by the objective measurement and testing methods specified within the standard itself, performed by trained technicians or engineers, not by medical experts establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are used in AI/SaMD studies to resolve disagreements among human reviewers when establishing ground truth for diagnostic tasks. This is not applicable to the physical testing of a syringe against an ISO standard, where results are typically objective 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

• N/A. This is a question specifically for AI/SaMD comparative effectiveness studies and is not relevant to a physical medical device like a syringe.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• N/A. This is a question about AI algorithm performance. No algorithm is involved in the function of a manual hypodermic syringe.

7. The Type of Ground Truth Used

• The "ground truth" for the Welmed Hypodermic Syringe's performance is defined by the objective specifications and performance criteria laid out in the ISO 7886-1:1993 standard. This includes specific physical and functional tests, measurement tolerances, and material requirements. The results of these tests (e.g., leakage rate, gliding force, dimensional accuracy) directly constitute the "ground truth" for compliance.

8. The Sample Size for the Training Set

• N/A. There is no "training set" for a physical device like a syringe in the context of AI/machine learning. The device's design, manufacturing processes, and quality control are developed over time using engineering principles, not machine learning training.

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

• N/A. As there is no training set in the AI/ML sense, this question is not applicable. The design principles and manufacturing specifications for the syringe are based on established engineering practices and the requirements of relevant standards like ISO 7886-1:1993.

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Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

Gowns provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.

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The Welmed, Inc. Surgical Gowns were evaluated for their performance based on a range of established standards and testing methods. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (IMC Surgical Gowns, K052550) through similarities in intended use, materials, design, and testing methodology.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the chosen standard test methods and the expectation that the Welmed Surgical Gowns perform comparably to, or in accordance with, these recognized standards for surgical gowns. The document reports that data was "Generated" in accordance with these standards, implying that the device demonstrated performance meeting the criteria outlined in each standard for its respective characteristic.

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

The document does not explicitly state the specific sample sizes used for each of the performance tests. It only lists the test methods used to generate data. There is no information regarding the country of origin of the data or whether it was retrospective or prospective. Given the nature of these tests (material properties), they are typically conducted on new material samples.

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 the evaluation of surgical gowns based on physical and biological performance standards. The "ground truth" for these tests is established by the well-defined methodologies and criteria within the internationally recognized standards themselves, not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements of material properties and biological responses, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for the evaluation of surgical gowns. MRMC studies are typically used to assess the effectiveness of diagnostic or screening devices where human interpretation plays a significant role.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This concept is not applicable as the device is a physical surgical gown, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on established scientific and engineering standards and their predefined pass/fail criteria. For example:

• Physical Properties: The tensile strength, tear strength, hydrostatic pressure, and impact penetration are measured against the requirements specified in the respective ASTM and AATCC standards for surgical gowns to provide a barrier.
• Flammability: Assessed against CPSC CS-191-53.
• Lint Generation: Assessed against ISO 9073-10.
• Biocompatibility: Evaluated based on the criteria set forth in the ISO 10993 series, which define acceptable levels of cytotoxicity, irritation, and sensitization.

8. The Sample Size for the Training Set

There is no "training set" in the context of this submission. The device is a physical product, and its performance is evaluated directly through standardized laboratory testing, not through machine learning or AI algorithms that require training data.

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

Not applicable, as there is no training set.

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