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Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Dental Barrier and Sleeves." It explicitly states that the device is a physical barrier and not an AI/software device. Therefore, the questions related to AI/software performance acceptance criteria, test sets, ground truth, expert opinions, and training sets are not applicable to this document.

The document discusses regulatory aspects of a Class II medical device, including:

• Trade/Device Name: Dental Barrier and Sleeves
• Regulation Number/Name: 21 CFR 878.4370, Surgical Drape And Drape Accessories
• Regulatory Class: Class II
• Product Code: PEM, PUI
• Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.

Since the device is a physical product and not an AI or software-based system, the acceptance criteria would relate to its physical properties, material safety, effectiveness as a barrier, and manufacturing quality, rather than algorithms or data performance. Such tests would typically involve:

• Material Biocompatibility: Testing to ensure the materials are not toxic or irritating when in contact with patients or users.
• Barrier Integrity/Effectiveness: Physical testing to confirm its ability to prevent the passage of fluids, microorganisms, or other contaminants.
• Physical Properties: Tensile strength, tear resistance, and dimensions to ensure it performs as intended under typical dental use conditions.
• Sterility (if applicable, though this device is noted as non-sterile): If it were a sterile barrier, testing would confirm the absence of viable microorganisms.
• Shelf Life: Stability testing to ensure the product remains effective and safe over its intended storage period.
• Manufacturing Quality Control: Adherence to Good Manufacturing Practices (GMP) to ensure consistent quality.

None of this information is detailed in the provided FDA clearance letter, as the letter primarily serves to confirm substantial equivalence to a predicate device and outlines regulatory obligations, not to present detailed study results for a non-AI/software device.

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The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.

The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images.

The iTero Lumina Pro consists of the following main components:

• A. Scanning Wand used for intraoral scanning.
• B. Wand Cradle used to hold the Scanning Wand when not in use.
• C. Application Software that includes Graphical User Interface ("GUI").
• D. Computer platform

The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle.

The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export.

The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.

The provided text does not contain detailed information about specific acceptance criteria and a study that comprehensively proves the device meets these criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to performance data and testing methods mentioned in the "Performance Data" section to infer some aspects of device performance and the types of studies conducted.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for NIRI functionality or specific performance targets. Instead, it states that "All testing showed similar performance to the predicate system." This implies that the acceptance criterion was likely comparable performance to the predicate device across various technical attributes.

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

The document explicitly states that the company performed "bench testing" to support substantial equivalence. It does not provide details on sample sizes for the NIRI performance attributes (Field of View, Image Sharpness, etc.). It mentions ASTM standards for material testing of the wand barrier sleeve, which would imply defined sample sizes per those standards, but these are not enumerated in the text. There is no information provided about the origin or nature of the "test set" data in terms of patient population (e.g., country of origin, retrospective or prospective).

The testing described appears to be primarily non-clinical bench testing rather than clinical study data involving patient samples or diagnostic accuracy.

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

The document does not describe a process for establishing ground truth using human experts for diagnostic accuracy. The performance data presented focuses on technical and engineering performance characteristics of the device itself (e.g., optical properties, material strength, electrical safety).

4. Adjudication method for the test set

Not applicable, as there is no description of a test set involving human interpretation and adjudication of diagnostic results.

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

The document does not mention any MRMC study or AI assistance. The device is described as a "diagnostic aid" providing NIR images for a dentist's review. The NIRI functionality itself is the diagnostic aid, not an AI component assisting human readers.

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

The document does not describe any standalone algorithm performance testing. The device's NIRI functionality generates images that are then reviewed by a dentist.

7. The type of ground truth used

For the technical and engineering tests described, the ground truth would be established by the specifications and performance characteristics of the predicate device and relevant international standards (e.g., for electrical safety, biocompatibility, material properties). For the NIRI imagery itself, the comparison is made against the predicate device's image output, not against a clinical "ground truth" like pathology for caries detection in this summary.

8. The sample size for the training set

Not applicable. The document describes a medical device generating images, not a machine learning model that requires a training set.

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

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

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Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Dental Barrier and Sleeves consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

This document is a 510(k) premarket notification for a medical device called "Dental Barrier and Sleeves." It outlines the device's characteristics and compares them to a legally marketed predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This submission is for a Class II medical device, "Dental Barrier and Sleeves," which are physical barriers (polyethylene covers) for dental instruments and equipment. The document does not describe an AI/Software as a Medical Device (SaMD) and therefore doesn't contain information related to AI model performance, expert consensus on image interpretation, or multi-reader multi-case studies. The performance criteria and studies described are for the physical properties and biocompatibility of the barrier sleeves themselves.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on demonstrating equivalence in physical properties and biocompatibility with the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a surgical incise drape. It outlines the regulatory clearance of the device, its intended use, and relevant FDA regulations.

This document does not contain any information about acceptance criteria for a study proving the device meets acceptance criteria, nor does it detail any specific study design, sample sizes, expert involvement, or adjudication methods. The letter focuses solely on the regulatory approval process for the medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The information required (e.g., performance metrics, test set details, ground truth establishment) is not present in this regulatory clearance document.

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SECUREPORTIV® ADVANCED Catheter Securement Adhesive is to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. The film holds the catheter to the skin to reduce catheter movement, migration, and/or dislodgment. It is used to protect the catheter skin entry site by creating a sealant that immobilizes surface bacteria, preventing them from entering into the catheter skin entry site while a moisture barrier. SECUREPORTIV® ADVANCED is intended to be used with a transparent film dressing for the securement of short-term and long-term vascular access catheters including peripheral IVs, PICCs, and CVCs.

SecurePortIV Advanced Catheter Adhesive is a sterile, professional liquid cyanoacrylatebased adhesive containing a monomeric formulation (2-octyl cyanoacrylate) and the colorant D&C Violet #2. The device is an applicator with the formulation incorporated in an ampoule housed in a tapered plastic tube. The SecurePortIV Advanced liquid is applied as a film forming securement and sealant at the point of catheter skin entry, polymerizing in minutes.

The SecurePortIV Advanced Catheter Securement Adhesive underwent various tests to demonstrate its safety and effectiveness, leading to its clearance based on substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

• Quantitative measurements: For securement time, a specific time (14 seconds) was measured and reported.

8. Sample Size for the Training Set

This question is not applicable as the device is a physical medical product, not an AI algorithm that requires a training set.

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

This question is not applicable as the device is a physical medical product, not an AI algorithm.

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3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is indicated for use as an incise drape with continuous antibacterial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.

3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) is a sterile adhesive film that is applied pre-operatively to skin. It adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The Chlorhexidine Gluconate (CHG) contained in the adhesive provides antibacterial activity to help reduce the risk of bacterial contamination in the surgical wound.

The drape consists of a transparent, conformable, barrier film coated with an acrylic adhesive containing 2% w/w CHG. The adhesive drape is delivered on a release liner that is discarded after application.

The provided text describes the acceptance criteria and the results from non-clinical testing performed for the 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape.

Here's the breakdown of the requested information:

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)

The document primarily details non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for each individual test. The data provenance is not explicitly stated beyond being "bench testing" and "biocompatibility testing," implying laboratory-based data rather than patient data from a specific geographical location. The nature of these tests suggests they are prospective, as they were conducted specifically to evaluate the device.

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

This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. These types of tests typically rely on standardized methods and laboratory analysis rather than expert human interpretation for ground truth.

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

This information is not applicable as the document discusses non-clinical bench and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation of outputs, which is not the case 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

This information is not applicable. The device is an incise drape with antibacterial properties, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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

This information is not applicable. The device is a physical medical device (incise drape), not a software algorithm.

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

The ground truth for the non-clinical tests is established by objective measurements against predefined scientific and regulatory standards/methods. For example:

• Barrier Performance: Measured against AAMI PB70:2012 using ASTM F1670.
• Antibacterial Activity: Measured by in vitro direct time kill based on ASTM E2315, aiming for a >4 log reduction.
• Biocompatibility: Evaluated against ISO 10993-1 and FDA Guidance for biological evaluation.

8. The sample size for the training set

This information is not applicable. The document describes the testing of a physical medical device, not a machine learning model that would require a training set.

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

This information is not applicable for the same reason as point 8.

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The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries.

The L1P-1F intraoral scanner (IOS) system is intended for aid in diagnosis of caries. The L1P-1F system consists of a scanner and a detachable scanner tip which enables scanning using white and blue (fluorescence) Light Emitting Diodes (LEDs). A single-use scanner body sleeve is mounted on the scanner before being introduced into the mouth of a patient for scanning of the teeth.

The interface to the computer is handled by ScanSuite TRIOS which functions as a Hardware Abstraction Layer (HAL). The scan control of, and information from the scanner is handled by the TRIOS module software, which holds the interface to the user.

The L1P-1F system also consists of the TRIOS Patient Monitoring software which aids in diagnosis of occlusal and surface caries.

The functional principle of L1P-1F (TRIOS 5) is to collect images of the object scanned by means of focus scanning, where light from the LEDs travels through the optical system to the object being scanned and back to an image sensor. 3D true colored images of the teeth combined with 2D green and red image as an additional texture are generated by emitting blue and white light in turn.

The provided text describes the 3Shape TRIOS 5 (L1P-1F) intraoral scanner system, which is intended to aid in the diagnosis of caries. The documentation focuses on demonstrating substantial equivalence to a predicate device (DÜRR DENTAL AG – VistaCam iX "Proof" – K150672). However, it does not explicitly provide a table of acceptance criteria and reported device performance in the format requested, nor does it detail a specific study proving the device meets acceptance criteria with all the requested information.

The document discusses key performance attributes tested and compared, which serve as implicit acceptance criteria for establishing substantial equivalence. These include:

1. Fluorescence scanning
2. Color Separation
3. In vitro caries detection study
4. Spatial resolution

Based on the available information, here's an attempt to structure the response, acknowledging where specific details for the requested categories are not explicitly provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions an "In vitro caries detection study" and performance testing, but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

The document does not provide information regarding the number or qualifications of experts used to establish ground truth for any test sets.

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

The document does not specify any adjudication method used for establishing ground truth in a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

The document does not indicate that an MRMC comparative effectiveness study was done involving human readers with and without AI assistance for the L1P-1F device. The focus is on the device's standalone performance compared to a predicate device.

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

The document describes "Performance Testing" including fluorescence scanning, color separation, in vitro caries detection, and spatial resolution. These tests would inherently involve the device's standalone performance to characterize its technical capabilities, which is then concluded to be "as safe and effective as a legally marketed device." While not explicitly termed "standalone performance study," the non-clinical data and performance testing sections describe the device's intrinsic capabilities.

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

The document mentions an "in vitro caries detection study," which suggests that the ground truth would likely be established by a recognized method for in vitro caries assessment, such as histology, micro-CT, or a standardized artificial caries model assessed by experts, but this is not explicitly stated.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given the nature of the device (an intraoral scanner with integrated fluorescence technology), it's possible that machine learning or AI components might be involved in the "TRIOS Patient Monitoring software," but details on specific training sets are absent.

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

Since no training set details are provided, how its ground truth was established is not mentioned.

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The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended products assembled in these kits will not be changed from the manufacturer's original intended use.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Medline General Surgery Tray" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) letter is a regulatory document indicating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory requirements, classification, and general controls, rather than detailed performance study results or acceptance criteria.

The "Indications for Use" section describes how the device is intended to be used (as a single-use sterile surgical drape to isolate a surgical site) but does not provide details of any studies or performance metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for test sets.
3. Information on MRMC studies or human reader improvement.
4. Stand-alone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set or how ground truth was established for the training set.

This type of information is typically found in the full 510(k) submission, not in the public clearance letter.

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