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This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

This surgeon's glove is a device made of polyisoprene rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The provided text is a 510(k) clearance letter from the FDA for a surgical glove. It does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document is a regulatory approval for a medical device, specifically a surgical glove, based on its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text.

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This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa.

This surgeon's glove is a device made of Flexylon.

This document is a 510(k) premarket notification for Finessis Zero Flexylon Powder Free Sterile White Surgical Gloves, tested for use with chemotherapy drugs. It is a Class I device, regulated under 21 CFR 878.4460 (Surgeon's Glove), with product codes KGO and LZC.

The study presented focuses specifically on the glove's resistance to breakthrough by various chemotherapy drugs, as tested according to ASTM D6978-05.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a general sense within the document, but the performance is presented as the breakthrough detection time for each chemotherapy drug. The implicit acceptance criterion for a glove "tested for use with chemotherapy drugs" is that it should demonstrate a reasonable and safe resistance to permeation by these cytotoxic agents. For most drugs, the goal is "No Breakthrough up to 240 min."

Note: The FDA's overall determination of substantial equivalence for the device based on all presented information, including this performance data. The "Do Not Use" recommendation for Carmustine and Thiotepa directly addresses the drugs where breakthrough occurred rapidly.

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

• Sample Size: For each chemotherapy drug, the test set involved 3 specimens of the glove, as indicated by "Specimen 1/2/3" in the "BREAKTHROUGH DETECTION (Specimen 1/2/3) (Minutes)" column.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the testing was conducted per ASTM D6978-05, which is an American Society for Testing and Materials standard. The study seems to be a prospective evaluation, as new gloves were tested against specific chemicals to determine their performance.

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

This device is not an AI device or one that requires clinical expert interpretation for its core functionality. The "ground truth" here is the physical property of the glove's resistance to chemical permeation, which is measured objectively through a standardized laboratory test (ASTM D6978-05). Therefore:

• Number of Experts: Not applicable in the context of expert human interpretation; the "ground truth" is established by the results of a standardized chemical permeation test.
• Qualifications of Experts: Not applicable. The test relies on standardized methodology and instrumentation rather than expert opinion.

4. Adjudication Method for the Test Set

Not applicable. This is a scientific, objective laboratory test. The measurement of breakthrough time for each specimen is a direct outcome of the test procedure, not subject to human adjudication in the sense of reconciling differing opinions.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the goal is often to see how AI assistance improves reader performance. This document describes the chemical resistance of a surgical glove, which is a material property test.

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

Yes, in a conceptual sense, a "standalone" performance evaluation was done. The device (the surgical glove) was tested without any human "in-the-loop" influencing its chemical resistance or the measurement of that resistance. The test itself measures the intrinsic property of the glove material.

7. The Type of Ground Truth Used

The ground truth used is objective physical measurement data obtained through a standardized laboratory test (ASTM D6978-05). Specifically, it measures the "breakthrough detection time" of various chemotherapy drugs through the glove material.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The performance data is derived from direct physical testing of the glove material.

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

Not applicable, as there is no training set for this type of device and study.

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This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.

Finessis Zero Flexylon Powder Free Sterile White Surgical Glove

This document is an FDA 510(k) clearance letter for a surgical glove. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the format requested. The document primarily focuses on the regulatory clearance of a medical device (surgical glove) and confirms its substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance), or ground truth establishment.

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This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa Chemical Resistance Data per ASTM D 6978-05

This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.

The provided document is an FDA 510(k) clearance letter for a surgical glove. It contains information about the device's name, regulation number, product code, and intended use, specifically highlighting its resistance to certain chemotherapy drugs.

However, the document does NOT contain information about an AI-powered medical device, nor does it detail acceptance criteria, study methodologies for proving device performance (such as test set sample sizes, data provenance, expert qualifications, or ground truth establishment), or MRMC studies.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the clearance of a physical medical device (surgical gloves) based on material properties and chemical resistance, not an AI or software as a medical device (SaMD) that typically undergoes the type of performance evaluation described in your request.

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This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.

Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for "Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves," along with an "Indications for Use" statement.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail:

• Specific acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity) for the gloves.
• Results from a study proving the device meets these criteria.
• Sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from any such study.

The letter explicitly states, "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act." This implies that while the device is cleared for market based on equivalence, the detailed performance study information requested is not provided in this regulatory document.

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This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination.

FINESSIS ZERO Flexylon Powder Free Sterile White Surgical Glove. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.

The provided text is related to an FDA 510(k) clearance for a surgical glove. It describes the clearance of "FINESSIS ZERO Flexylon Powder Free Sterile White Surgical Glove" and states that it has been deemed substantially equivalent to legally marketed predicate devices.

However, the document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria for device performance, or details of a study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory approval based on substantial equivalence, not on specific performance data or a study design.

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A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)

FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves

The provided text is a U.S. FDA 510(k) clearance letter for a medical device: "FINESSIS VIOLET Element Polyisoprene Powderfree Sterile Surgical Gloves."

This document does not contain information about acceptance criteria, device performance, study design, or ground truth establishment for a medical imaging or AI-based device. Instead, it's a regulatory clearance for a physical medical product (surgical gloves) based on substantial equivalence to a legally marketed predicate device.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details) from the provided text.

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A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)

FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

This document is a 510(k) clearance letter from the FDA for two types of surgical gloves: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves and FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This means the device has been cleared based on substantial equivalence to existing predicate devices, not through a study involving acceptance criteria and performance metrics specifically for this device in the way a new, novel AI or diagnostic device would.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not applicable to this type of regulatory submission and clearance.

Here's why and what can be deduced:

1. A table of acceptance criteria and the reported device performance: Not applicable. The FDA's 510(k) process for devices like surgical gloves primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing against recognized standards (e.g., ASTM standards for glove integrity, tensile strength, etc.) that the predicate device also met, rather than setting new, specific acceptance criteria for this device's clinical performance in the way an AI diagnostic would. The document does not contain these specific performance details.

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. There is no "test set" in the context of a clinical study for this device as would be seen for an AI diagnostic. Performance testing for gloves typically involves laboratory testing (e.g., for pinholes, physical properties) rather than a clinical trial with a "test set" of patients/cases. The document does not provide details of such testing.

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 "ground truth" establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.

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 surgical gloves, not an AI diagnostic algorithm for human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for surgical gloves typically relates to meeting physical and biological performance standards (e.g., sterility, barrier integrity, biocompatibility), which are measured objectively, not through human expert consensus on diagnostic images or outcomes data.

8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is involved.

9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Name: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.
• Regulation Number: 21 CFR 878.4460
• Regulation Name: Surgeon's Glove
• Regulatory Class: I
• Product Code: KGO
• Indications for Use: "A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination."
• Clearance Type: 510(k) - Substantial Equivalence to legally marketed predicate devices.
• No specific acceptance criteria or performance study results for the device itself are detailed in this regulatory letter. The letter confirms that based on the submitted information (which would include performance data against established standards), the device is substantially equivalent to existing market devices.

To obtain the specific "acceptance criteria" (likely referring to the performance standards met) and the detailed "study" (likely referring to laboratory performance testing) that led to this clearance, one would need to refer to the actual 510(k) submission document (K123629) itself, which is not provided here. The letter only summarizes the outcome of the FDA's review.

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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

FINESSIS PERSONAL Latex Powder Free Sterile Surgical Gloves with Protein Claim.

This document is related to the FDA's 510(k) premarket notification for "FINESSIS PERSONAL Latex Powder Free Sterile Gloves with Protein Claim." This is a regulatory clearance document for a medical device (surgical gloves), not a study report for an AI/ML powered medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text because the text describes the regulatory clearance of surgical gloves, not an AI/ML device and its performance study.

The document discusses:

• The trade/device name: FINESSIS PERSONAL Latex Powder Free Sterile Gloves with Protein Claim.
• Regulation Number and Name: 21 CFR 878.4460, Surgeon's Glove.
• Regulatory Class: I.
• Product Code: KGO.
• Indications for Use: A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth are typically asked for AI/ML diagnostic or prognostic devices that perform specific analyses on data (e.g., images, physiological signals), where "performance" relates to diagnostic accuracy (sensitivity, specificity, AUC) or similar metrics. This document does not describe such a device or study.

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