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The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).

The Dynarex Three-Way Stopcock is a multiple port and needless access device that can be attached to other intravascular administration set devices by the user at the point of use during infusion therapy or sampling. The single-use disposable device intended for use on continuous or intermittent fluid administration or withdrawal of fluids. An in-line access site and can be connected to female luer adapters to allow needless access to fluid or vascular fluid path, and can control fluid flow by rotating flow control taps. The multiple access sites can be used for administration of drugs and solutions to a common fluid path or patient vascular system through a needle or catheter inserted into a vein.

The provided text describes the submission of a medical device, the Dynarex Three-Way Stopcock, for FDA 510(k) clearance, indicating its substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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Dynarex Xeroform Petrolatum Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate.

The Dynarex Xeroform Petrolatum Dressing is a sterile, single use, non-adherent dressing consisting of non-woven absorbent gauze saturated with Xeroform with 3% Bismuth Tribromophenate in a petrolatum blend. Packaged in paper metalized chevron pouches and available in Sizes: 2" x 2" ( Item #: 3051), 1" x 8" ( Item #: 3052), 4" x 4" ( Item #: 3053), 5" x 9" ( Item #: 3054). Dynarex Xeroform Petrolatum Dressing gauze is a type of medical dressing and has ingredients finely wovens mesh medical gauze infused with a blend of petrolatum and 3% Bismuth Tribromophenate.

This document is a 510(k) premarket notification for the Dynarex Xeroform Petrolatum Dressing, claiming substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating similarity to an existing device rather than presenting a novel clinical study with acceptance criteria in the typical sense for algorithm performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/algorithm, cannot be fully provided from this document. The document describes the device's physical and biological properties and compares them to a predicate device to establish substantial equivalence.

However, I can extract information related to "acceptance criteria" and "studies" from the perspective of demonstrating the device's safety and effectiveness compared to a predicate device, as required for a 510(k).

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" largely refer to demonstrating the new device's characteristics are similar to or meet the performance of a legally marketed predicate device. The performance is reported by showing that the new device meets established standards or has similar characteristics.

• Material 1: 3% Bismuth Tribromophenate
• Material 2: Petrolatum | - Substrate: Cotton Gauze
• Material 1: 3% Bismuth Tribromophenate
• Material 2: Petrolatum |
  | Single Use | Yes | Yes |
  | Color | Yellowish | Yellowish |
  | Dimensions | 1x8"/2x2"/4x4"/5x9"/4"x3yds | 1x8"/2x2"/4x4"/5x9" |
  | Sterility | Sterile ISO 11137-2: 2013 to a 10^6^ SAL | Sterile ISO 11137-2: 2013 to a 10^6^ SAL |
  | Pouch Packaging | Metalized chevron pouches | PET / ALPET / PE (implicitly demonstrating equivalence or acceptable difference) |
  | Biocompatibility | Meets all applicable requirements per ISO 10993-3, -4, -5, -10, -11 (as implied for the predicate device to be legally marketed). | Meets all of the requirements, as applicable, to ISO 10993-3: 2014 Genotoxicity, ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation. ISO 10993-11: 2006 Systemic Toxicity. |

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

• Sample Size: Not applicable in the context of an AI model's test set. The submission focuses on device characteristics and compliance with standards. For biocompatibility, the sample sizes are determined by the specific ISO 10993 tests (e.g., cell cultures for cytotoxicity, animal models for systemic toxicity), but these details are not provided in this summary.
• Data Provenance: Not applicable for an AI model. The data relates to material testing and standard compliance.

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

• This is not applicable as this is a medical device (petrolatum dressing), not an AI/algorithmic device that requires expert-established ground truth for performance evaluation in a clinical setting. Standard testing is done in labs.

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

• Not applicable for this type of medical device 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 as this is not an AI/algorithmic device.

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

• Not applicable as this is not an AI/algorithmic device.

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

• For the aspects tested (biocompatibility, sterility, physical properties), the "ground truth" is established by:
  • International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11137-2 for sterilization.
  • Material Specifications: Chemical composition (3% Bismuth Tribromophenate, petrolatum), physical forms (cotton gauze).
  • Validated Test Methods: Procedures for inspecting appearance, coating, cutting edges, size, heat sealing, weight, and count (as described in Quality Assurance Testing).

8. The sample size for the training set

• Not applicable as this is not an AI/algorithmic device.

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

• Not applicable as this is not an AI/algorithmic device.

Studies that prove the device meets the "acceptance criteria" (i.e., demonstrates substantial equivalence):

The document explicitly states the studies and standards used to prove the device's characteristics and performance are comparable to the predicate device, thereby demonstrating it meets the "acceptance criteria" for substantial equivalence:

• Biocompatibility Testing (Section 18):

  • Standards Used: ISO 10993-3: 2014 Genotoxicity, ISO 10993-4: 2006 / ASTM F756: Hemolysis, ISO 10993-5:2009 Cytotoxicity, ISO 10993-10: 2010 Skin Sensitization and Primary Skin Irritation, ISO 10993-11: 2006 Systemic Toxicity.
  • Result: "The device meets all of the requirements, as applicable, to [these ISO standards]." This demonstrates the device is acceptably biocompatible.

• Sterilization Validation (Section 17):

  • Standard Used: ISO 11137-2: 2013.
  • Result: The dressing is sterilized via gamma radiation to a 10^6^ SAL (Sterility Assurance Level), complying with the standard.

• Quality Assurance Testing (Section 15):

  • Methods: "Documented testing procedures are in place." Initial inspection includes visual characteristics (appearance, coating, cutting edges, size, heat sealing). Final inspection includes these tests plus weight and count inspection.
  • Results: These tests "demonstrate the device meets its defined specifications."

• Physical Properties (Section 14):

  • Proof: "Certificates of Analysis showing the standards / testing referenced by the manufacturer which would define the physical properties of the petrolatum and 3% bismuth tribromophenate used in the device manufacturing are attached." (These certificates are referenced but not included in the provided text).

The overarching "study" is the compilation of these tests and their results, which collectively aim to demonstrate that the Dynarex Xeroform Petrolatum Dressing is substantially equivalent to the Kendall Xeroform Petrolatum Wound Dressing, based on their similar intended use, design, materials, and performance, as summarized in the "Table of Comparison" (Table 1) and confirmed by compliance with relevant standards.

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The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye.

The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The cup is non-sterile and is re-usable.

The provided document describes the Dynarex Eye Cup (K151575) and its equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, a specific study proving those criteria, or details regarding sample sizes, expert involvement, ground truth, or comparative effectiveness studies.

The document makes a claim of "substantial equivalence" based on similar intended use, design, and biocompatibility testing. The "biocompatibility testing" is presented as the study proving safety and effectiveness, but no detailed results or comparative data against specific acceptance criteria for performance are provided.

Here's a breakdown of the information that is and is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's function (washing/flushing the eye). The equivalence is largely based on material safety and basic design.
• Reported Device Performance: No quantitative performance metrics are provided. The "performance" is implicitly tied to its function of holding eyewash solution and being placed over the eye.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

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 an eye cup, not an AI-powered diagnostic tool requiring human reader studies.

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

7. The type of ground truth used: Not explicitly stated, as no performance study is detailed. The "ground truth" for the substantial equivalence claim relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set: Not applicable, as this is a physical device and not an AI algorithm.

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

Summary of Bio-compatibility Testing (as presented as the "study"):

The document states one "study" was conducted, focusing on biocompatibility.

• Study Name/Type: Biocompatibility testing.
• Tests Performed: Acute Systemic Toxicity, In-Vitro Cytotoxicity, Ocular Irritation, and Maximization (sensitization).
• Results: "Results of the biocompatibility testing showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response."
• Conclusion: "All materials used in the manufacture of the Dynarex Eye Wash Cup have demonstrated to be substantially equivalent in regards to safety and effectiveness to the predicate device and are safe for its intended use."

Comparison Table as provided in the document (illustrates equivalence, not performance against criteria):

The document focuses on demonstrating that the Dynarex Eye Cup is substantially equivalent to a predicate device, as opposed to providing detailed performance data against specific, quantitatively defined acceptance criteria for its function. The "study" mentioned pertains solely to the biocompatibility of the materials.

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The Dynarex Intermittent Catheter is intended for use in male, female, and pediatric patients (children, adolescents and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those who have a significant volume of residual urine following a natural bladder-voiding episode. The catheter should not be retained in the human body for more than 24 hours.

The Intermittent Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector (drain funnel) is attached to the opposite end of the PVC tube.

Here's a breakdown of the acceptance criteria and study information for the Dynarex Intermittent Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to the predicate device (Self Catheter, K100878). This is a common pathway for Class II devices where the FDA has not established specific performance standards or special controls. The "study that proves the device meets the acceptance criteria" is largely the comparison to the predicate device through the described technological characteristics, biocompatibility, and physical testing.

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

• Test Set Sample Size: Not explicitly stated as "test set" in the context of a clinical performance study with human subjects. The evaluation conducted involved material characterization (biocompatibility) and physical testing. For these types of tests, specific sample sizes are determined by the test standards (e.g., ISO 10993, ASTM 10555, ASTM F-623), but the exact number of units tested is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data. The data provenance for the physical and biocompatibility testing would be from the manufacturer's own testing laboratories or contracted labs. These are typically controlled laboratory environments.

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

• Not Applicable. This 510(k) relies on demonstrating substantial equivalence through material properties, physical performance, and biocompatibility, not on a diagnostic accuracy study requiring expert consensus on a test set.

4. Adjudication Method for the Test Set

• Not Applicable. As there is no diagnostic accuracy study with a "test set" of cases, no adjudication method is relevant here.

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

• No. This submission is for an intermittent medical catheter, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant or performed.

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

• No. This device is hardware (a catheter), not a software algorithm.

7. The Type of Ground Truth Used

• Established Standards and Predicate Device Performance: The "ground truth" for this submission comes from:
  • Recognized International Standards: ISO 10993 (for biocompatibility) and ASTM (for physical testing like force to break and flow rate). Meeting these standards against defined criteria serves as the ground truth for these aspects.
  • Predicate Device Characteristics: The performance and characteristics of the legally marketed predicate device (Self Catheter, K100878) serve as the benchmark or "ground truth" against which the new device is compared for substantial equivalence. For instance, if the predicate device is known to have a certain flow rate range, the new device must fall within that acceptable range.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI device.

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

• Not Applicable. This is not a machine learning or AI device.

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Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective prenatal scans.

Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver.

Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only.

Contraindications: Not for use with defibrillators.

Dynarex Ultrasound Gel is a viscous, clear blue, water soluble gel. Typical packaging configurations for the Dynarex Ultrasound Gel is 250 ml plastic bottle, 1 Liter plastic bottle and 5liter plastic container. Other sizes may become available.

The provided text describes a 510(k) premarket notification for Dynarex Ultrasound Gel, seeking substantial equivalence to a predicate device, LiquaSonic Ultrasound Gel. The study focuses on demonstrating the new device's technological characteristics are comparable to the predicate.

Here's an analysis based on your requested information:

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

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Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.

The provided document is a 510(k) summary for the Dynarex Sterile Lubricating Jelly, asserting its substantial equivalence to a predicate device (E-Z Lubricating Jelly, K041060). It does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of measuring device performance against a predefined threshold.

Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence for a Class I medical device (patient lubricant). This process primarily involves comparing the new device's characteristics to those of a legally marketed predicate device.

However, I can extract the information and present it in the requested format, interpreting "acceptance criteria" as the shared characteristics and test results that enable the claim of substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present or not applicable to this type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are the characteristics of the predicate device, which the new device (Dynarex Sterile Lubricating Jelly) must match or be substantially equivalent to. "Reported device performance" refers to the new device's characteristics and test results, demonstrating this equivalence.

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

• Sample size for the test set: Not explicitly stated as a "test set" in the context of performance metrics for an AI/ML device. For physical and biocompatibility testing, standard laboratory sample sizes would have been used, but specific numbers are not provided in this summary.
• Data provenance: The data is generated from testing of the Dynarex Sterile Lubricating Jelly and comparison to the predicate device. It is not "data" in the sense of patient records or imaging. The testing would have been conducted by the manufacturer or contracted laboratories. It is prospective testing on the device model. Country of origin not specified for the testing itself, but the submitter is based in the USA.

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

• This concept is not applicable to a submission for a sterile lubricating jelly demonstrating substantial equivalence. There is no "ground truth" established by experts in the sense of clinical annotations or diagnostic interpretations. The "truth" is established by laboratory testing standards (e.g., ISO 10993 for biocompatibility).

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

• Not applicable. There is no "adjudication" in this context. The determination of "pass" for tests like biocompatibility or sterility would follow established testing protocols and expert interpretation of those results by the testing laboratory, aligning with regulatory 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

• Not applicable. This is not an AI/ML device, nor is it a diagnostic imaging device that would involve human readers.

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

• Not applicable. This is not an AI/ML algorithm.

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

• For this device, the "ground truth" (or basis for acceptance) primarily stems from established international standards and regulations for medical device safety and performance, specifically:
  • ISO/AAMI 11137 for sterilization validation.
  • ISO 10993 for biocompatibility testing.
  • Pharmacopoeial standards (implied for purity, viscosity, pH, preservative effectiveness).
  • The characteristics and regulatory history of the predicate device (E-Z Lubricating Jelly, K041060) serve as the benchmark for "truth" in the context of substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set.

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

• Not applicable. There is no training set.

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The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.

Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the sense of a clinical or image-based dataset. The testing described focuses on material properties and physical conformance.

• Sample Size for testing: Not explicitly stated for each test (e.g., number of devices tested for Luer taper inspection). However, it implies testing was conducted on samples of the Dynarex Enteral Feeding Sets.
• Data Provenance: The testing was conducted by Dynarex Corporation to demonstrate substantial equivalence to the predicate device. The document does not specify a country of origin for the data beyond Dynarex being a US-based company, and the nature of the tests suggests laboratory or bench testing rather than patient data. It is therefore prospective with respect to the device's design and testing.

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

Not applicable. This is a medical device clearance based on substantial equivalence to a predicate device, primarily through material and functional characteristic comparison, and safety testing (biocompatibility, physical standards). It does not involve expert interpretation of medical images or patient outcomes in the way an AI/ML device would.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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/ML device, nor does it involve human readers interpreting cases.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on established industry standards and validated test methods for material biocompatibility (Class VI USP) and physical performance (AAMI/ANSI ID54.1996/(R)2005). The comparison is also made against the specifications and performance of the legally marketed predicate device (Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use K012147), which serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. See point 8.

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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
These gloves are tested for use with Chemotherapy Drugs.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21CFR 880.6250, Patient Examination Glove 80 LZA, and meets all requirements of ASTM Standard D6319-00a e3

Here's a summary of the acceptance criteria and the study details for the Dynarex / Tillotson Nitrile Powder Free Blue Patient Examination Glove:

1. Acceptance Criteria and Reported Device Performance:

The device's performance is primarily assessed against the requirements of ASTM Standard D6319-00a £3 (later referenced as ASTM D6319-00ae3-2001) for patient examination gloves and specific permeation testing for chemotherapy drugs per ASTM D 6978-05. The table below combines the acceptance criteria (implied by the ASTM standards and "Passes" results) with the reported device performance.

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

• Sample Size for Physical/Performance Tests (Water Leak, Dimensions, Tensile Strength, Elongation): "Inspection level S-2, AQL 4.0 pinholes at AQL 2.5" is mentioned. This refers to the sampling plan within ASTM D6319-00ae3. It's a standard statistical sampling plan, but the exact number of gloves tested is dependent on the batch size and the specific inspection level and AQL. The document does not provide the explicit sample count.
• Sample Size for Biocompatibility Tests (Dermal Sensitization, Primary Skin Irritation): Not explicitly stated in the document. These tests typically involve a limited number of human subjects or animal models, but specific numbers are not provided.
• Sample Size for Permeation Testing: Not explicitly stated, but ASTM D6978-05 outlines specific requirements for the number of glove samples and the duration of testing with various chemotherapy drugs.
• Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the submitter is Dynarex Corporation (USA). The testing would have been conducted to international standards (ASTM) generally accepted in the US for regulatory submission. The device description mentions the predicate device is from "Shijiazhuang Tillotson Rubber Products Co., Ltd., China," which suggests some manufacturing or relationship there, but the testing itself is submitted by the US company. The tests are retrospective in the sense that they were completed prior to the 510(k) submission.

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

This type of device (patient examination glove) does not typically involve "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth. The "ground truth" for the performance criteria is defined by the ASTM standards themselves (D6319-00ae3 and D6978-05), which are developed by expert consensus in the field. The results are then objectively measured against the specified thresholds within these standards.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device. Performance is measured against objective, predefined parameters in ASTM standards, not through subjective human interpretation requiring adjudication.

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

Not applicable. This device is a physical barrier, not an interpretative AI device where human readers interact with AI for diagnostic tasks.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical product, not a software algorithm. The "performance" is its physical and chemical properties and barrier integrity.

7. Type of Ground Truth Used:

The ground truth used is based on established industry standards and objective measurements. Specifically:

• Physical properties (dimensions, tensile strength, elongation) are measured objectively against thresholds defined in ASTM D6319-00ae3.
• Barrier integrity (water leak test for pinholes) is measured objectively against AQL levels defined in ASTM D6319-00ae3.
• Biocompatibility (dermal sensitization, irritation) is assessed through standardized tests with predefined pass/fail criteria.
• Chemotherapy drug permeation is determined objectively by measuring drug breakthrough times and rates as per ASTM D6978-05.

8. Sample Size for the Training Set:

Not applicable. This device is a manufactured product, not a machine learning model. There is no concept of a "training set" for the purpose of this 510(k) submission. Manufacturing processes are subject to quality control, which involves ongoing testing, but this isn't a "training set" in the AI sense.

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

Not applicable, as there is no training set for a machine learning model.

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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.

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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.

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