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The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to allow the passage of a nasal endotracheal tube from the nares to the oropharynx.

The device can be used with cuffed and non-cuffed nasal endotracheal tubes.

The Rhinoguard is a nasal endotracheal tube introducer/dilator designed to ease the passage of a nasal endotracheal tube from the nares to the oropharynx. The Rhinoguard device is constructed primarily of polyvinylchloride and consists of a tube with a hollow proximal end, a tapered cylindrical body and a closed, rounded distal end. The device has markings to indicate the approximate mating location for corresponding sizes of nasal endotracheal tubes. The device is provided in a small and large size. The small Rhinoguard is intended to mate with 3.0 to 4.5 mm nasal endotracheal tubes and the large Rhinoguard is intended to mate with 5.0 to 8.0 mm nasal endotracheal tubes. The device can be used with cuffed and non-cuffed nasal endotracheal tubes. Prior to using the device, the desired size of the nasal endotracheal tube must be selected and then matched to corresponding Rhinoguard size (large or small). The device is then cut just above the indices (marks) corresponding to the selected endotracheal tube size and connected with the endotracheal tube. Once mated, the distal end of the device is introduced into the naris of choice and gently pushed forward into the oropharynx. Lastly, the distal end of Rhinoguard is grasped and removed from the mouth with the aid of a laryngoscope and McGill forceps.

The provided text describes a 510(k) premarket notification for a medical device called "Rhinoguard," which is a nasal endotracheal tube introducer/dilator. The document details the device, its intended use, comparison to predicate devices, and the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All performance testing met acceptance criteria defined in protocols." However, it does not explicitly list the quantitative acceptance criteria for each test. It only provides the purpose of each test. Below is a table summarizing the tests, their stated purpose (which implies the performance objective), and the reported outcome.

The document states, "In conclusion, the proposed device performed equivalent to or better than the predicate device. All performance testing met acceptance criteria defined in protocols."

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

• Sample Size for Test Set: The document does not specify the sample size used for any of the non-clinical (bench) tests.
• Data Provenance: The tests are described as "nonclinical (bench) test results." The document does not provide details on the location or nature of laboratories, nor does it specify if the data is retrospective or prospective. Given the nature of bench testing, it is typically prospective and controlled laboratory testing.

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

• The document does not mention using experts to establish ground truth for the performance tests. The evaluation is based on objective bench testing against pre-defined protocols and comparison to predicate devices, not expert consensus on interpretations.
• For the "Design (Usability) Validation Testing," it states it was tested "under a simulated use environment," which implies human interaction, but it does not specify the number or qualifications of users/experts involved in this validation.

4. Adjudication method for the test set

• The document does not describe any adjudication method as typically understood for medical image analysis or diagnostic studies (e.g., 2+1, 3+1). The tests are bench tests with objective outcomes (e.g., meeting a strength threshold, absence of kink, sterility level), not subjective interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is a physical medical instrument (an introducer/dilator for endotracheal tubes), not an AI/software device intended for diagnostic interpretation or to assist human "readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This question is not applicable as the Rhinoguard is a physical medical device, not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" or reference standard for performance is the pre-defined acceptance criteria specified in the test protocols and, for some tests (kink, disconnection, perforation), comparison to the performance of the predicate device. For biocompatibility, it's ISO standards. For sterility, it's an SAL. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these tests.

8. The sample size for the training set

• This question is not applicable as the Rhinoguard is a physical medical device, not an AI/software device that requires a training set.

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

• This question is not applicable as the Rhinoguard is a physical medical device, not an AI/software device that requires a training set or ground truth for training.

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Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.

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This document is a letter from the FDA to Davis Schottlander & Davis Limited regarding their device, Schottlander MATCH MASTER Low Fusing Porcelain. The letter states that the FDA has reviewed the company's premarket notification (510(k)) and determined that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the FDA's regulatory decision regarding market clearance based on substantial equivalence. Therefore, I cannot provide the requested information from the given text.

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Match Press pressable ceramic is to be used in the construction of crown substructures to be veneered with conventional porcelain. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

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This document is a 510(k) premarket notification approval letter for a dental device. It does not contain information about acceptance criteria, device performance metrics, or study details as requested. The content is an FDA regulatory approval, not a scientific study report.

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

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ENIGMA denture base is to be used in conjunction with denture teeth in the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Schottlander ENIGMA HI-BASE Denture base material

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details), or the type of ground truth used.

The document is an FDA 510(k) clearance letter for a dental device (Enigma Hi Base Denture-Base Material), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements. Attachment #4 provides the "INDICATIONS FOR USE" for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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Silk sutures are indicated for use as nonabsorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neural tissue.

Silk Non-Absorbable Surgical Sutures are composed of the organic protein fibroin which is derived from the domesticated species Bombyx mori (B.mori) of the family Bombycidae. Silk sutures are braided or twisted and available in white or dyed (black or blue). Braided sutures (except for size 8/0) are coated with silicone. Silk sutures are also available in various lengths, diameters and quantities with or without surgical needles. SILK sutures are not absorbed, progressive degradation of the proteinaceous silk fiber in-vivo may result in gradual loss of all the suture's tensile strength over time. The proposed Silk suture needle will be manufactured using an automated end stiffening process of applying the medical grade adhesive to a portion of the silk strand which is then cured and cut to length.

The provided text describes a 510(k) submission for a Silk Non-Absorbable Surgical Suture with UV-10 adhesive, focusing on the substantial equivalence to a previously cleared device. The key change is an automated needle-end stiffening process compared to a manual one.

Here's an analysis 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 "test set" in the context of a typical clinical study or a performance study with a defined sample size for the evaluation of the automated needle-end stiffening process. The primary evidence presented is biocompatibility testing.

• Sample size: Not explicitly stated for biocompatibility tests. It's usually a small number of samples required to demonstrate biological compatibility according to standards.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, biocompatibility testing is typically conducted in a laboratory setting.

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

Not applicable. This device submission primarily relies on biocompatibility testing and demonstrating substantial equivalence to a predicate device. There is no "ground truth" derived from expert review of cases in the way that might apply to a diagnostic imaging AI algorithm. The "ground truth" for biocompatibility is established by adherence to recognized standards (ANSI/AAMI 10993 and USP guidelines) and passing the specified tests.

4. Adjudication method for the test set

Not applicable. There is no "test set" that requires adjudication (e.g., clinical cases reviewed by experts).

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 surgical suture, not a diagnostic device with an AI component.

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

Not applicable. This is a surgical suture, not a diagnostic device with an AI component.

7. The type of ground truth used

For the safety assessment, the "ground truth" is based on:

• Biological standards: Adherence to ANSI/AAMI 10993 and USP guidelines for biocompatibility.
• Predicate device characteristics: The known safety and performance profile of the legally marketed predicate Silk Non-Absorbable Surgical Suture (K930590). The new device is considered "substantially equivalent" if it shares the same safety and effectiveness profile.

8. The sample size for the training set

Not applicable. This is a physical medical device (suture), not a machine learning model.

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

Not applicable. This is a physical medical device (suture), not a machine learning model.

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NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

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The provided text is a 510(k) premarket notification letter from the FDA regarding "Natura Denture Teeth" and an "Indications For Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/CAD medical device.

Therefore, I cannot extract the requested information from the given input. The document is a regulatory approval letter for a dental product, not a technical report on a diagnostic device's performance.

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ENIGMA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

Schottlander ENIGMA denture teeth

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Enigma Denture Teeth" and does not contain the detailed information required to describe acceptance criteria and a study proving device adherence to these criteria. The document acknowledges FDA's review and determination of substantial equivalence to a predicate device, allowing the product to be marketed.

To answer your request, I would need a document that includes sections on:

• Performance testing results
• Acceptance criteria definitions
• Methodology of studies (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods)
• Results of standalone device performance or comparative effectiveness studies.

The provided text focuses on regulatory clearance and indications for use, not the technical study details you are asking for.

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Indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in Cardiovascular, Ophthalmic and Neural tissue. Surgilon (polyamide), Dermalon, Ophthalon are both braided and monofilament sutures available in white or dyed (black or blue) with a Logwood extract. These sutures are available in various lengths, diameters and quantities with or without surgical needles. These sutures are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of its tensile strength.

Surgilon (polyamide) Ophthalon and Dermalon Non-Absorbable Surgical Suture are braided and monofilament sutures with a silicone coated dyed white or black with Logwood extract. These surgical sutures are composed of a long-chain aliphatic polymer Nylon 6 or Nylon 6,6. Surgilon, Dermalon and Ophthalan sutures are a class II device per 21 CFR Section 878.5020. Classification Code: 80GAR.

The provided text describes the 510(k) summary for Surgilon®, Ophthalon®, and Dermalon® Non-Absorbable Surgical Sutures, focusing on their substantial equivalence to previously marketed sutures. The core of the submission is to justify that the change from a manual to an automated end stiffening process does not alter the safety or effectiveness of the device.

Here's an analysis of the provided information, framed by your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for specific tests. It refers to testing in accordance with ANSI/AAMI ISO 10993 and compliance with USP and EP standards. These standards themselves define sample size requirements for various tests (e.g., cytotoxicity, sensitization, irritation, material characterization, mechanical properties).

• Sample Size: Not explicitly stated. The tests would have used an appropriate number of suture samples as dictated by the referenced biocompatibility and pharmacopeial standards.
• Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission from "Sherwood-Davis & Geck" (a US-based company), it's highly probable that the testing was conducted in the United States or by labs compliant with US regulatory requirements. The data would be retrospective in the sense that the tests were performed on manufactured devices for the purpose of demonstrating equivalence for this submission.

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

This information is not applicable in the context of this 510(k) summary. This document describes the testing of a physical medical device (surgical sutures) against international and pharmacopeial standards and a predicate device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are common in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. For physical device testing against established standards, the results are typically quantitative or qualitative (pass/fail) based on objective measurements and established criteria within the 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

This information is not applicable. This 510(k) submission is for a physical medical device (surgical sutures) and does not involve AI, human readers, or diagnostic interpretation.

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

This information is not applicable. This submission is for a physical medical device; there are no algorithms or standalone performance studies in this context.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is the established regulatory standards and pharmacopeial requirements, coupled with the performance characteristics of the predicate device.

• Biocompatibility: The "ground truth" is defined by the acceptable limits and methodologies specified in ANSI/AAMI ISO 10993-1.
• Physical and Chemical Properties: The "ground truth" is defined by the specifications and test methods in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures.
• Substantial Equivalence: The "ground truth" here is that the new device, despite a manufacturing change, performs equivalently to the predicate device (K930586) across all critical parameters (tensile strength, sterility, indications for use, packaging, etc.). This equivalence is assessed through comparative testing and an understanding of the impact of the manufacturing change.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning study; therefore, there is no "training set."

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

This information is not applicable. As there is no training set, there is no ground truth for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of laboratory tests and analyses demonstrating substantial equivalence to a previously cleared predicate device (K930586) and compliance with relevant standards.

The key points from the document regarding this study are:

• Comparative Assessment: The main "study" described is a comparison of the proposed sutures manufactured with an automated end stiffening process to predicate sutures manufactured with a manual process. The focus is on demonstrating that the only difference (automated vs. manual end stiffening) does not alter the fundamental characteristics or safety/effectiveness.
• Biocompatibility Testing: The "representative Surgical Sutures, with adhesive, were tested for biocompatibility in accordance to ANSI/AAMI ISO 10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."
• Pharmacopeial Compliance: The sutures were shown to "meet all requirements established by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) for surgical sutures." These pharmacopeias include specific tests for tensile strength, diameter, sterility, particulate matter, and other physical/chemical attributes.
• Argument for Substantial Equivalence: Sherwood-Davis & Geck concluded that the proposed sutures are "substantially equivalent in design, composition and intended use" to the predicate, implying that the detailed test results confirmed this equivalence. The similarities cited include: composed of long-chain aliphatic polymer, sterile, same indications for use, same lengths, diameters, quantities, colors, sizes, available with and without needles, and identical packaging.

In essence, the "study" is a comprehensive set of tests and comparisons designed to confirm that the manufacturing process change does not negatively impact the biological safety or functional performance of the sutures, ensuring they remain equivalent to existing, legally marketed sutures and meet all relevant regulatory and quality standards.

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The Quick-PICC Catheter System is designed for cases in which venous catheterization or long term I.V. administration is necessary. Placement is routinely achieved from a peripheral venous site, but the catheter may be placed via subclavian cut-down as well. The Quick -PICC may be used to administer fluids for hydration and parenteral nutrition, as well as other commonly used intravenous medications such as antibiotics, vasopressors, chemotherapy, and analgesics.

The Argyle Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC) is a sterile, single use indwelling catheter inserted into a venous access site for the infusion of fluids, medications, and/or nutritional products. The PICC is inserted via an introducer (either a splittable needle or sheath over the needle type). The catheter is composed of polyurethane material and includes a suture or stabilizing wing and an insert-molded luer-lock hub(s). The catheters will have numerical depth markings for insertion depth measurement and assessment. The polyurethane material is completely radiopaque. Additionally, the product line will include for sale the following: single catheters, single introducers, placement sets (catheter and introducer), and complete insertion trays. Complete insertion trays will contain a PICC, introducer, and common components used for the procedure.

The provided text is a 510(k) summary for the Argyle Neonatal/Pediatric Peripherally Inserted Central Catheter (PICC). It states that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating similarity to existing devices, rather than presenting novel performance studies with specific acceptance criteria as would be done for a new or high-risk device.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable in this 510(k) summary. The document focuses on demonstrating substantial equivalence through material comparison and existing biocompatibility testing, not through new clinical performance studies with specific metrics.

Here's a breakdown 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 (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This 510(k) summary does not describe a new clinical performance study with a test set. The substantial equivalence argument relies on comparing the new device to existing predicate devices and existing biocompatibility data for the materials used.

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 new ground truth establishment is described for a clinical test set.

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

• Not Applicable. No new clinical test set is described.

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 medical device, not an AI diagnostic tool. No MRMC study or AI component is mentioned.

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

• Not Applicable. This is a medical device, not an algorithm.

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

• Not Applicable. For the purpose of this 510(k), the "ground truth" for substantial equivalence is the existence and established performance/safety profile of the predicate devices and the compliance of materials with recognized biocompatibility standards. No new clinical ground truth was established for this submission.

8. The sample size for the training set

• Not Applicable. No training set for a new algorithm or performance study is mentioned.

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

• Not Applicable. No training set is mentioned.

Summary of Approach for This 510(k) Submission:

The provided document is a 510(k) premarket notification. For devices seeking clearance via substantial equivalence, the primary "study" is a comparative analysis against predicate devices. The "acceptance criteria" are demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety and effectiveness.

In this case, the manufacturer demonstrates substantial equivalence by:

• Identifying legally marketed predicate devices (Bard Access System's Per-Q-Cath PICC and Luther Medical Company's L-Cath PICC).
• Comparing materials (polyurethane vs. silicone) and noting that the polyurethane material is also used and tested in other cleared 510(k)s.
• Stating that required biocompatibility testing was performed per ISO 10993 and ANSI/AAMI 10993 for components, and these materials had also been tested and used in previously submitted and marketed 510(k)s. This leverages existing data and clearances.
• Ensuring the indications for use are consistent with the predicate devices.

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