Search Results

The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The Stryker T4 Personal Protection System: Stryker Hytrel® T4 Togas.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for the Stryker T4 Hytrel® Togas, indicating that the device is substantially equivalent to a legally marketed predicate device. It defines the product and its intended use but does not contain any data from performance studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Training set sample size.
9. Method for establishing training set ground truth.

Ask a specific question about this device

This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN

This looks like a 510(k) clearance letter for a very low-risk device (nurses' bouffant cap) from 1997. It doesn't contain the extensive information you're asking for regarding acceptance criteria or detailed study results because such reports are typically not required for Class I devices cleared through predicate equivalence.

Here's why and what can be extracted:

Why the requested information is absent:

• Device Classification (Class I): Nurses' bouffant caps are classified as Class I devices. These devices are considered to pose the lowest risk to patients and users.
• 510(k) Clearance: For Class I and many Class II devices, the FDA clears them based on "Substantial Equivalence" to a legally marketed predicate device. This means the manufacturer demonstrates that their new device is as safe and effective as a device already on the market.
• Lack of Performance Studies: For low-risk devices like this, the FDA typically does not require comprehensive clinical studies or even extensive bench testing with detailed acceptance criteria and performance metrics. The demonstration of substantial equivalence often relies on:
  • Comparison of technological characteristics (materials, design, intended use).
  • Verification of manufacturing processes to ensure quality and consistency.
  • For something like a cap, basic safety (e.g., non-toxic materials, no sharp edges) and functionality (e.g., stays on, covers hair).

What can be extracted/inferred from the provided text:

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

   • Acceptance Criteria: Not explicitly stated in the provided documents. For a bouffant cap, criteria would be very basic, likely related to physical integrity, material composition, and fit.
   • Reported Device Performance: Not explicitly stated. The device is intended "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." The performance is implicitly assumed to be equivalent to existing predicate bouffant caps.

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/Not provided. Detailed test sets and data provenance for performance are not typically required for this type of clearance.

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/Not provided. There's no "ground truth" to establish for a device like this in the context of clinical performance.

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

   • Not applicable/Not provided.

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 not an AI/software device.

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

   • Not applicable. This is not an AI/software device.

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

   • Not applicable. The "ground truth" for a bouffant cap would be its ability to physically contain hair and particulate matter, and its material safety, which are typically assessed through standard material testing and visual inspection, not complex clinical "ground truth."

8. The sample size for the training set:

   • Not applicable/Not provided. There is no AI model or complex algorithm requiring a training set for this device.

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

   • Not applicable/Not provided.

Summary based on the provided document:

The document is a 510(k) clearance letter confirming that the "Nurses Bouffant Cap" is substantially equivalent to a predicate device. This clearance is based on the device's classification as a low-risk, Class I device (Product Code: LYU) and the presumption that it meets general controls for manufacturing and labeling. Formal performance studies with detailed acceptance criteria, test sets, or expert ground truths, as would be required for higher-risk or novel devices, are not present in this type of regulatory submission. The "Indications For Use" state the device's purpose: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." This functional intent is the closest equivalent to a performance goal, but no specific performance metrics are provided.

Ask a specific question about this device

Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.

Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a letter from the FDA to Far East Science & Technology Development Company, Ltd., regarding the 510(k) premarket notification for "Far-East Bouffant Caps." It states the FDA's finding of substantial equivalence for the device. The "DEVICE INDICATION FOR USE" is also provided, describing the intended purpose of the bouffant caps.

However, it does not contain any technical study details or performance data that would allow me to answer your specific questions.

Ask a specific question about this device

The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.

The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back

The provided text describes the acceptance criteria and the study for a Disposable Apron manufactured by Instrument Makar, Inc. The study focuses on viral penetration testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Viral Penetration (ASTM Method F1671-95) based on the K955835 Fluid Barrier Boot study:

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

• Sample Size for the Test Set: 32 samples (referred to as "Fluid Barrier Boot" samples, which are made from the same material as the apron).
• Data Provenance: The document does not specify the country of origin of the data. It appears to be an internal study conducted to support a 510(k) submission, suggesting it's retrospective as per common regulatory processes where testing precedes submission.

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

N/A. This study involves non-clinical testing (viral penetration testing) of a material, not human interpretation or diagnosis. Therefore, there are no "experts" establishing a ground truth in the traditional sense of clinical studies. The "ground truth" is determined by laboratory assay results (presence/absence of bacteriophage).

4. Adjudication Method for the Test Set

N/A. As stated above, this is laboratory testing, not a clinical study involving human interpretation. The outcome (presence/absence of bacteriophage) is determined by objective laboratory assays.

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

No. This is a non-clinical, material-level performance study, not a clinical MRMC study involving human readers or comparative effectiveness with or without AI.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is a non-clinical material test, not an algorithm performance study.

7. The Type of Ground Truth Used

The ground truth used is objective laboratory assay results for the presence or absence of the oX174 bacteriophage following a controlled challenge. This is a direct measurement of viral penetration through the material.

8. The Sample Size for the Training Set

N/A. This is a non-clinical performance test for a physical product (apron material), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

N/A. As there is no training set for an AI algorithm, this question is not applicable.

Ask a specific question about this device

The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

The DePuy Disposable Filter/Hood is a single use, disposable hood with faceshield. The hood is constructed of Dexter paper with spun polypropylene filter media located at the top and back of the hood. The DePuy hood is designed to fit over the Stryker Steri-Shield helmet so that all intake and exhaust air passes through the filter material.

The provided text describes a 510(k) submission for a medical device, the DePuy Disposable Filter/Hood. However, it does not contain the kind of information typically found in a study proving a device meets acceptance criteria, especially for AI or algorithmic devices.

This submission is for a disposable surgical hood and focuses on substantial equivalence to an existing predicate device (Stryker Steri-Shield Personal Protection System and DePuy Sterile View Disposable Hood/Gown). The core of the argument for substantial equivalence is based on:

1. Similar Design and Intended Use: The DePuy hood has the same hood and faceshield design, filter location, and intended use as the Stryker hood.
2. Material Comparison: The only difference is the material. The DePuy hood uses Dexter paper, which is the same material as another DePuy product (Sterile View Disposable Hood/Gown).
3. Comparative Testing: The submission states that "Comparative testing shows that the filtering efficiency of the DePuy filter material is as good as or better than the Stryker filter material for all particle sizes and flow rates tested."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for AI devices) because the provided text pertains to a different type of medical device submission (a physical product based on substantial equivalence) and does not involve AI/algorithmic performance studies.

To directly answer your request based on the provided text, many of the categories are not applicable:

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

   • Acceptance Criteria for Filtering Efficiency: "as good as or better than the Stryker filter material for all particle sizes and flow rates tested." (Implied, not explicitly quantified.)
   • Reported Device Performance: "filtering efficiency of the DePuy filter material is as good as or better than the Stryker filter material for all particle sizes and flow rates tested."

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (likely laboratory testing of materials, not clinical 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. Ground truth in this context would be objective measurements of material filtering efficiency, not subjective expert assessment.

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

   • Not applicable. This type of method is used for human expert review, not material testing.

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 for AI devices, not a surgical hood.

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

   • Not applicable. This is for AI devices, not a surgical hood.

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

   • Objective measurements of filtering efficiency based on standardized tests.

8. The sample size for the training set:

   • Not applicable. There is no AI model being trained.

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

   • Not applicable. There is no AI model being trained.

Ask a specific question about this device

Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.

Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing. The basic scientific concept that forms the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the surgical site as required intermittently during the surgical procedure.

The provided text describes a medical device, the AMMI MAGNI-GUARD™ Splash Prevention Device, and compares it to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves comparing design, materials, intended use, and performance characteristics (as shown in the provided table). It's a pre-market notification process, not a clinical trial report.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them because this information is not present in the provided text.

Based on the information given, I can only extract these general points:

• Device Type: Splash Prevention Device
• Intended Use: To provide protection to surgical staff during surgical procedures by preventing the splashing of blood across the surgical suite.
• Mechanism: A clear, rigid, see-through plastic guard with raised side walls and an extended handle.

Ask a specific question about this device

Ask a specific question about this device