Search Results

This device is used as a physical barrier for mouth to mouth resuscitation
The use of this device does not guarantee complete protection from disease transmission.

The CPR Shield with One Way Valve and Barrier Filter, Model 4921 is a mouth to mouth barrier that offers protection to the person performing CPR to a patient from vomitus and oral secretions. The device is to be used by persons trained in CPR techniques. The device is labeled as a single use device and should be disposed of after one use. The CPR Shield includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directed the exhaled gases away from the rescuer and into the atmosphere.

The provided document is a 510(k) premarket notification for the Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921. It describes the device and claims substantial equivalence to a predicate device, the Eagle Health Supplies 4-02 Jr. (CPR Mouth Barrier), 510(k) #: K945177.

This document does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance metrics. Instead, it focuses on demonstrating substantial equivalence through a comparison of physical characteristics and successful biocompatibility testing. Therefore, I cannot generate a table of acceptance criteria and reported device performance from this document for the types of studies you've requested (e.g., MRMC, standalone algorithm performance), because this type of information is not present.

The document mainly highlights:

• Device Description and Intended Use: The Dynarex CPR Shield is a physical barrier for mouth-to-mouth resuscitation, offering protection to the person performing CPR.
• Predicate Device: Eagle Health Supply 4-02 Jr.
• Comparison of Characteristics: A table comparing material composition (Mouthpiece Housing, Mouthpiece Filter, Mouthpiece Gasket, Protective Face Shield), Sterility, and Packaging between the Dynarex CPR Shield and the predicate device, showing them to be similar or equivalent.
• Biocompatibility Testing: The device underwent biocompatibility testing to FDA recognized standards for Cytotoxicity, Skin Irritation, and Skin Sensitization. It also passed tests related to ASTM F920-93 and ASTM D6499-00 inhibition ELISA.

Based on the provided information, I can answer some of your points by stating that the information is not available in the document, as the submission relies on substantial equivalence rather than a new performance study against specific acceptance criteria for AI or diagnostic performance.

Here's a breakdown of what can be derived from the document:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or diagnostic accuracy studies. For this type of device (CPR shield), acceptance criteria are primarily related to material safety (biocompatibility) and functional equivalence to a predicate device.
     • Biocompatibility: Passed FDA recognized standards for Cytotoxicity, Skin Irritation, and Skin Sensitization.
     • Functional Equivalence: Demonstrated through material and design similarity to the predicate device and the presence of a one-way valve and barrier filter for protection.
   • Reported Device Performance:
     • Biocompatibility: "successfully performed to FDA recognized standards for Cytotoxicity, Skin Irritation and Skin Sensitization." "tested to all applicable portions of ASTM F920-93." "Additional testing to ASTM D6499-00 Inhibition ELISA was also conducted and found to be acceptable."
     • Functional: "The CPR Shield includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directs the exhalled gases away from the rescuer and into the outside atmosphere."

   (Note: No numerical performance metrics for diagnostic accuracy or AI are applicable or available in this document as it is not an AI/diagnostic device.)

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 for this type of device and submission. The "test set" here refers to the samples used in biocompatibility testing, not a diagnostic or AI performance study. Details on the number of samples or data provenance for biocompatibility testing are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on images, pathology results) is not relevant for this CPR shield submission. The "truth" for biocompatibility is determined by laboratory testing against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of submission.

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-powered diagnostic device, and no MRMC study was conducted or mentioned.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is established by standardized laboratory tests evaluating cellular toxicity, irritation, and sensitization responses as per recognized FDA standards (e.g., ISO 10993 series, or the specific ASTM standards mentioned).

8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Ask a specific question about this device

The Dynarex Vaginal Specula is used to expose the interior of the vagina.
Indications For Use: This device is used to expose the interior of the vagina.

The Dynarex vaginal speculum is a non-metal (polystyrene), non-lubricated, hand held device used to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.

The provided document is a 510(k) summary for the Dynarex Vaginal Speculum. It relies on demonstrating substantial equivalence to a predicate device (Dukal Vaginal Speculum, K020726) rather than presenting a study with explicit acceptance criteria and corresponding performance data. Therefore, many of the requested fields cannot be directly answered as they pertain to a different type of device evaluation (e.g., performance studies for novel devices or AI/software-as-a-medical-device).

Here's the information as it can be extracted from the document:

1. 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)

• Not applicable. This device relies on substantial equivalence to a predicate, not performance testing with a specific test set.

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 was established by experts for a test set in this 510(k) 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 is a non-AI, manual medical instrument.

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

• Not applicable. This is a non-AI, manual medical instrument.

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

• Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device (Dukal Vaginal Speculum, K020726), demonstrated through its prior FDA clearance.

8. The sample size for the training set

• Not applicable. This device is not an algorithm requiring a training set.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only.

The Dynarex lodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex lodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex lodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.

The provided document is a 510(k) premarket notification for the Dynarex Iodoform Packing Strip. This document asserts substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this type of submission.

Here's a breakdown of the available information based on the provided text, and where information is missing for your specific requests:

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

• Acceptance Criteria/Performance: Not applicable. The document does not define specific performance acceptance criteria or report performance data for this device. The basis for clearance is "substantial equivalence" to a predicate device, meaning it is considered equally safe and effective.

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

• Sample Size/Data Provenance: Not applicable. No test set or study data is presented in this 510(k) submission.

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

• Experts/Qualifications: Not applicable. No ground truth was established for a test set as no study was performed.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set or adjudication was performed.

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

• MRMC Study: No. This device is a physical product (Iodoform Packing Strip), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not applicable. No ground truth was established as no study was performed.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/algorithm-based device; therefore, no training set was used.

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

• Training Set Ground Truth: Not applicable. No training set was used for this device.

Summary of Device and 510(k) Basis:

• Device Name: Dynarex Iodoform Packing Strip
• Intended Use: Device for general use in wound packing and management, as an antibacterial barrier. Indicated for external use only.
• Basis for Clearance: Substantial equivalence to already marketed predicate devices. The submission states: "The Dynarex Iodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Iodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex Iodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured."

This type of 510(k) submission does not typically involve detailed performance studies against specific acceptance criteria, but rather a robust comparison to an existing, legally marketed device to demonstrate equivalence.

Ask a specific question about this device

The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.

The Dynarex Towel Drape is composed of nonwoven fabric or polyethylene film and are of various configurations appropriate for General Surgical procedures. These devices use nonwoven and film materials as a protective patient covering during surgical procedures. These barrier materials are essentially impervious to fluids and microorganisms, thus function to isolate the operative site from the surrounding area. Dynarex Towel Drapes may feature tape adhesive to temporarily bind the drape to the periphery of the operative site. Fluid collection pouches are attached to the drape for collection of operative wound solid and liquid effluents. The Dynarex Towel Drape will be subjected to a sterilizing dose of gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10-6. This towel drape is a single use, disposable provided in a sterile package.

The provided text is a pre-market notification for a medical device called the "Dynarex Towel Drape." This document is a 510(k) submission to the FDA, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.

Based on the information provided, this submission is not for an AI/ML-driven device that would have the typical acceptance criteria and study designs you've listed. Instead, it's for a physical medical product (a surgical towel drape). Therefore, many of the requested fields are not applicable in this context.

Here's an analysis of the available information in relation to your questions:

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

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

This information is not provided in the document. The submission relies on demonstrating similarity to predicate devices rather than clinical trial data for performance. For a physical product like a drape, testing would typically involve material integrity, barrier effectiveness, and sterility validation, which usually don't involve "test sets" in the AI/ML sense.

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 is not applicable as the submission is not for an AI/ML device that requires expert-established ground truth for a diagnostic task.

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

This is not applicable for the same reasons as above.

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 as the device is not an AI-driven diagnostic or assistive tool.

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

This is not applicable as the device is not an algorithm.

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

For this type of device, the "ground truth" would relate to its physical properties and performance characteristics, such as:
* Material specifications: Conformance to intended material (nonwoven fabric or polyethylene film).
* Sterility: Conformance to SAL 10^-6, verified by microbiological testing and sterilization validation.
* Imperviousness: Performance as a barrier to microorganisms, likely tested according to established standards for barrier materials.
* Functional design: Direct comparison and manufacturing to mimic the design of predicate devices.

The document states compliance with ANSI/AAMI ST39-1991 for sterilization validation, which would constitute a form of "ground truth" based on recognized standards.

8. The sample size for the training set

This is not applicable as there is no "training set" for a physical product like this.

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

This is not applicable as there is no "training set." The "ground truth" for demonstrating substantial equivalence for this device is primarily established by adherence to existing material standards, sterilization protocols, and direct comparison to legally marketed predicate devices.

Ask a specific question about this device

The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.

The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.

This document is a 510(k) premarket notification for the Dynarex Umbilical Cord Clamp. It serves to establish substantial equivalence to a predicate device rather than to describe a study proving the device meets acceptance criteria. As such, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth methodologies associated with a device performance study are not present in this document.

The document states:

• "The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market."
• "Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices."
• "The Dynarex Umbilical Cord Clamp is indicated for use to compress the umbilical cord and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured."

Therefore, based on the provided text, there is no information available to answer the specific questions about acceptance criteria and a study proving their fulfillment. The manufacturer is asserting equivalence to an existing device rather than providing new performance data.

Ask a specific question about this device

Non-Woven sponge for wound dressing prepping and scrubbing.

Non-Woven Sponge, Sterile

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a Non-Woven Sponge, indicating that the device is substantially equivalent to legally marketed predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on the regulatory clearance process and does not delve into the detailed technical or clinical studies that might be associated with evaluating the device's performance against specific criteria.

Ask a specific question about this device

Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.

Sterile Drain Sponges

The provided document is a 510(k) clearance letter from the FDA for a device described as "Sterile Drain Sponges." This type of document does not contain any information regarding acceptance criteria, device performance studies, or AI/software analysis.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device, falling under the "Unclassified" regulatory class. It outlines general regulatory requirements but makes no mention of performance metrics or specific studies, as these types of devices (drain sponges) are typically cleared based on material composition and intended use rather than clinical performance studies.

Therefore, I cannot provide the requested information based on the input document.

Ask a specific question about this device

A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.

Tracheostomy Sponge

The provided document is a 510(k) clearance letter from the FDA for a device called "Dynarex Tracheostomy Sponge." This type of document does not typically contain the detailed information necessary to answer your questions about acceptance criteria and a study proving a device meets those criteria.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on new clinical performance data in the way a PMA (Premarket Approval) would require.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the tracheostomy sponge, nor does it provide a table of reported performance. Its purpose is to state that the device is substantially equivalent to existing ones.
2. Sample size used for the test set and the data provenance: Not applicable, as a clinical study with a test set is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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. This device is a physical medical dressing, not an AI-assisted diagnostic tool.
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 concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document only states the device's Indications for Use: "A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids." The FDA's determination is based on the device being "substantially equivalent" to predicate devices already on the market, implying that it performs similarly for these stated indications.

Ask a specific question about this device

Ask a specific question about this device