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The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.

The Device is a light-cured, flowable, resin-based sealant for prophylactic sealing of pits and fissures as well as for micro-restorative procedures. The Device is light-curable under standard power (600 mW/cm²) and contains filling agents which cause the Device to release and recharge beneficial ions (fluoride and calcium).

The provided text describes the 510(k) clearance for the "Parkell Pit and Fissure Sealant." However, the clearance letter and accompanying 510(k) summary pertain to a physical dental device (a sealant), not an AI/software medical device.

Therefore, many of the requested criteria regarding AI/software performance studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and are not mentioned in this document.

The document focuses on the physical and chemical properties of the sealant and compares them to a predicate device. The performance data is based on non-clinical, in-vitro testing of these physical properties.

Below is the information that can be extracted from the provided text, adapted as best as possible to the requested format, with clear indications where information is not applicable (N/A) due to the nature of the device.

Acceptance Criteria and Device Performance for Parkell Pit and Fissure Sealant

This device is a physical dental sealant, not an AI/software medical device. Therefore, the performance evaluation focuses on physical and chemical properties and biocompatibility, not algorithmic performance on image data.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The testing was non-clinical (in-vitro).
• Data Provenance: Non-clinical physical property testing. Not applicable for geographical or retrospective/prospective distinctions.

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

• N/A. This is a physical dental material. "Ground truth" in this context typically refers to objective measurements from laboratory testing equipment (e.g., universal testing machines for strength, viscometers for viscosity, etc.), not expert interpretation of data like in AI/imaging studies.

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

• N/A. As above, this is laboratory-based physical property testing, not subjective assessment 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

• N/A. This is not an AI-assisted device. No MRMC study was performed.

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

• N/A. This is not an algorithm. Standalone performance is not applicable.

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

• Laboratory Standard Measurements / In-vitro physical property testing. The performance criteria (e.g., strength in MPa, shrinkage in %, viscosity in Pa.s) are based on standardized tests for dental materials.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device. No training set was used.

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

• N/A. As above, no training set was used.

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The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

Based on the provided FDA 510(k) clearance letter and summary for the "Vessel Sealer Curved" device, it is important to note that this document pertains to a surgical instrument (hardware), not a medical device with an AI/software component that would involve "acceptance criteria" and "studies" as typically understood for AI-based diagnostic or prognostic devices.

The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission. The 510(k) summary clearly outlines the types of testing performed: mechanical, reliability, software (presumably related to the electrosurgical generator and da Vinci system, not AI), biocompatibility, shelf-life, transit, and animal studies focusing on functional performance like burst pressure and thermal spread.

Therefore, I cannot extract the information requested in the format provided because the device and its clearance process do not involve AI performance evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the engineering and preclinical validation tests detailed in Section VI "Performance Data" (Design Verification, Shelf-Life, Transit, Biocompatibility, Design Validation via animal testing).

Here's how to address the prompt given the nature of the device:

Acknowledgement of Device Type:
The Vessel Sealer Curved is a physical surgical instrument (bipolar electrosurgical instrument) used with a compatible da Vinci Surgical System and an electrosurgical generator. It is not an AI/software-based diagnostic or imaging device.

Why the Requested Information is Not Applicable:
The majority of the questions in the prompt (e.g., acceptance criteria for AI, sample sizes for test/training sets for AI, expert ground truth, MRMC studies, standalone AI performance) are relevant to the regulatory pathway for AI/Machine Learning-enabled medical devices. Since the Vessel Sealer Curved is a hardware device focused on mechanical and electrosurgical performance, these metrics are not part of its 510(k) submission.

Information that is relevant and can be inferred from the document:

The acceptance criteria for a device like this would be tied to its functional performance, safety, and substantial equivalence to a predicate device.

• Overall Goal: To demonstrate substantial equivalence to the predicate device (Vessel Sealer Extend K183107) in terms of intended use, technological characteristics, safety, and performance.

• Key Performance Indicators (Acceptance Criteria): While not explicitly stated in a table format with specific percentages for AI performance, the document implies the following types of performance criteria based on the tests conducted:

  • Mechanical Integrity: The device must withstand expected forces and remain functional (e.g., ability to grasp, dissect, and transect tissue).
  • Reliability: Consistent performance over its intended lifespan/usage.
  • Sealing Effectiveness: Ability to seal vessels up to 7mm effectively, preventing burst at a certain pressure (Burst Pressure Testing).
  • Controlled Thermal Spread: Minimizing unintended thermal damage to surrounding tissue (Thermal Spread on Vessels).
  • Compatibility: Seamless function with the da Vinci Surgical System and E-200 electrosurgical generator.
  • Biocompatibility: No adverse biological reactions when in contact with tissues.
  • Shelf-Life and Transit Stability: Maintaining sterility and functional integrity throughout its shelf-life and during shipping.

Study Proving Device Meets Criteria (Based on Document):

The performance data listed in Section VI outlines the studies conducted:

• Design Verification:
  • Mechanical bench testing
  • Reliability Testing
  • Force to Jaw Failure
  • Software Verification (likely for the control system, not AI)
  • Testing in accordance with IEC60601-1 and IEC60601-1-2 (electrical safety)
  • Usability Testing
• Shelf-Life Verification: In accordance with ASTM F1980.
• Transit Verification: In accordance with ASTM D4169-16.
• Biocompatibility: In accordance with ISO 10993-1 and FDA guidance.
• Design Validation (Animal Testing):
  • Burst Pressure Testing
  • Thermal Spread on Vessels
  • Chronic Animal Study

Addressing Specific Prompt Questions (as far as applicable):

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

   • As explained, specific quantitative acceptance criteria for AI performance are not relevant here. The acceptance criteria would be successful completion of the listed engineering and preclinical tests, demonstrating that the device's functional outputs meet design inputs and that it performs safely and effectively comparable to the predicate. The document states, "The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs."

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for bench or animal testing in this summary and would vary by test (e.g., number of units tested mechanically, number of animals in the design validation study, number of vessels sealed).
   • Data Provenance: Not specified regarding country of origin. The studies are described as engineering bench tests and animal studies. These are prospective experiments conducted to validate the device.

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

   • Not applicable in the AI sense. Ground truth for a surgical instrument would be established through direct measurement of physical performance (e.g., pressure at which a seal bursts, precise measurements of thermal spread, visual inspection for mechanical integrity), and observation of physiological effects in animal models by veterinary or surgical experts. These wouldn't be "experts establishing ground truth for an AI assessment."

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

   • Not applicable as it's not an AI-based diagnostic assessment. Performance is measured objectively.

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

   • Not applicable. This is for evaluating AI assistance in diagnostic tasks, which is not the function of this device.

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

   • Not applicable. This device is a surgical instrument operated by a human surgeon via the da Vinci system. Its "performance" is inherently tied to human use.

7. The type of ground truth used:

   • The "ground truth" for this device's performance is based on direct physical measurements (e.g., force, pressure, temperature, electrical parameters), observational data from preclinical animal studies (e.g., successful vessel sealing, lack of adverse tissue reactions, long-term tissue response in chronic studies), and adherence to established engineering and biocompatibility standards.

8. The sample size for the training set:

   • Not applicable. This device is not an AI model that undergoes "training."

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

   • Not applicable.

In summary, the provided document details the regulatory clearance for a conventional surgical instrument, not an AI-enabled device. Therefore, the performance criteria and validation methods are entirely different from those required for AI software.

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Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Injectable Root Canal Bioceramic Sealer (nRoot SP) is suitable for use in the single cone and lateral condensation technique.

Injectable Root Canal Bioceramic Sealer (nRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. nRoot SP is an insoluble, radiopaque on a calcium silicate composition, which requires the presence of water to set and harden. nRoot SP does not shrink during setting and demonstrates excellent physical properties.

nRoot SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. nRoot SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. Injectable Root Canal Bioceramic Sealer (nRoot SP) is available in five preloaded syringe mode that provide different in specification in 5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.

The performance of the Injectable Root Canal Bioceramic Sealer (nRoot SP) conforms to ISO 6876:2012 Dentistry - Root canal sealing materials.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Injectable Root Canal Bioceramic Sealer (nRoot SP)". This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that "No clinical study is included in this submission."

Therefore, based only on the provided text, it is not possible to describe the acceptance criteria and a study that proves the device meets those criteria from the perspective of an AI or human-in-the-loop performance evaluation. The device in question is a dental material, not an AI or imaging device that would typically undergo such a study.

The questions you've asked (about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth, and training sets) are highly relevant for AI/ML-based medical devices or devices that require human interpretation of data for their function.

Given the content of the provided 510(k) clearance letter, I cannot fulfill your request for details regarding AI/ML-specific acceptance criteria and study designs because the device is a dental material, and the provided document explicitly states no clinical studies were performed.

If you intended to provide a different document related to an AI/ML medical device, please provide that document.

However, to directly address the intent of your questions, and assuming hypothetically that such a device (an AI/ML device) were being submitted and these details would be present in its submission, here's what could be inferred about the type of information that would be necessary to answer your questions, based on typical regulatory submissions for AI/ML devices:

Hypothetical General Information for an AI/ML Medical Device (Not Applicable to the Provided Document)

• Device Type: This type of information (acceptance criteria, test sets, experts, MRMC, etc.) is typically provided for AI/ML-based diagnostic or assistive devices, especially those that analyze medical images (e.g., AI for detecting pneumonia on X-rays, or AI for stroke detection on CT scans).
• Regulatory Pathway: For such devices, a 510(k) submission would typically include a detailed performance study section.

If this were an AI/ML device, the answers to your questions would typically be structured as follows (but again, this is not information present in the provided document):

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

   • Acceptance Criteria Examples (for an AI/ML device): Sensitivity > X%, Specificity > Y%, AUC > Z, F1 score > A, meeting non-inferiority/superiority to a predicate/human experts on certain metrics, etc.
   • Reported Device Performance: The actual measured metrics from the validation study.

2. Sample sized used for the test set and the data provenance:

   • Sample Size: e.g., N=1000 cases.
   • Data Provenance: e.g., Multi-center, retrospective study from hospitals in the US, UK, and Germany. Or, prospective study collected from 3 different clinics in China.

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

   • Number of Experts: e.g., 3 independent board-certified radiologists.
   • Qualifications: e.g., All were board-certified radiologists with at least 5 years of experience in [relevant sub-specialty], specializing in [medical condition] diagnosis.

4. Adjudication method for the test set:

   • Method: e.g., 2+1 (two experts independently read, a third adjudicates disagreements). Or, consensus panel of 3 experts, or majority vote.

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

   • MRMC study: Yes/No.
   • Effect Size: e.g., "Human readers improved their diagnostic accuracy by an average of 15% (p

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The ONE TRAY® Container is a reusable rigid sterilization container intended to be used to enclose reusable medical devices that are to be steam sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed devices and maintenance of sterility of the enclosed devices during storage, transport and until used. This container is compatible for use in the following sterilization modalities in the configuration listed below:

• Prevac Steam
• 270°F, 4 min exposure
• 15-minute dry time

ONE TRAY® is validated to process a twenty five pound (25 lb) gross weight load (single container plus contents). This includes sterilization of lumens (Stainless Steel and Titanium) 1 mm in diameter or larger with lengths of up to 500 mm.

DO NOT STACK ONE TRAY® CONTAINERS DURING STERILIZATION

Examples of validated materials that can be processed within the ONE TRAY®- Metals: Stainless Steel, Titanium, Aluminum, Thermoplastics: PEEK, Polypropylene, Radel, Thermosetting Polymers: Silicone, Phenolic

The ONE TRAY® sealed sterilization container consists of a line of rigid reusable containers listed in the table below. Healthcare Facilities should follow steam sterilization cycle and storage guidelines as stated in AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

The ONE TRAY® Sealed Sterilization Container is a sealed rigid container with a lid and base containing a rectangular patterned group of perforations to permit steam penetration of sterilant. Single use SMS filters cover each vented area and are held firmly in place by a perforated stainless steel filter cover. This assembly permits the penetration of steam during the sterilization process and serves as a bacterial and fluid barrier at the conclusion of the sterilization cycle.

ONE TRAY® Sealed Sterilization Containers are a reusable device whose base and lid are composed of anodized aluminum to prevent corrosion.

The gaskets used in the ONE TRAY® Sealed Sterilization Containers are made from medical grade silicone material identical to that used by predicate containers. The lid is firmly secured to the base with a cam-locking latch at each end.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (sterilization container) and its performance, not an AI/software-as-a-medical-device (SaMD) or diagnostic device that would typically involve a "test set," "ground truth," expert adjudication, or MRMC studies.

Therefore, many of the requested details about acceptance criteria and study design (especially those related to AI/SW performance) are not applicable to this type of device and the information presented in this document.

However, I can extract the relevant acceptance criteria and study information provided for the physical sterilization container.

Analysis of Acceptance Criteria and Study for ONE TRAY® Sealed Sterilization Container System

The device under review is the ONE TRAY® Sealed Sterilization Container System, a reusable rigid sterilization container. The studies described are nonclinical tests to demonstrate the safety and effectiveness of the container in maintaining sterility of enclosed medical devices during steam sterilization, storage, and transport. The criteria and studies are designed for a physical device, not an AI/SW product.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable/Not Provided (due to the nature of the device)

The following points are typically relevant for AI/SW performance studies, but the provided document describes a physical medical device (sterilization container). Therefore, the information for these points is not applicable (N/A) in this context, or the details are not explicitly provided as they would be for an AI/SW submission.

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

  • Sample size: Not specified in terms of "test set" for data-driven models. The studies involve multiple sterilization cycles, microbial challenges, and material compatibility tests, but the exact number of cycles/samples for each test is not detailed in this summary.
  • Data provenance: N/A for a physical device. These are laboratory performance tests.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth is established by objective scientific measurements (e.g., biological indicator growth, weight difference, visual inspection, cytotoxicity assays), not expert readers.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication is not relevant for these types of objective performance tests.

• 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: N/A. This is not an AI/SW device.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, and its function is standalone in terms of sterilizing/maintaining sterility.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance studies is based on established sterilization efficacy standards (e.g., biological indicator sterility/growth, physical measurements like weight change, absence of moisture, and material biocompatibility testing). It is objective performance data, not subjective human assessment or pathology.

• 8. The sample size for the training set: N/A. This is a physical device, not an AI/ML model that requires a training set.

• 9. How the ground truth for the training set was established: N/A. See point 8.

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The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows:

• Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads.
• Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F).

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.

The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.

I'm sorry, but the provided FDA 510(k) Clearance Letter for "Self Sealing Sterilization Pouches" does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or software-based medical device.

The document is a clearance letter for a physical medical device (sterilization pouches) and details its intended use, sterilization methods, material properties, and maximum load capacity. It also outlines regulatory requirements for such devices.

There is no mention of AI, algorithms, software, ground truth, expert readers, retrospective/prospective studies, or any of the other specific questions related to AI/software device performance evaluation.

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

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The Pre-B. Seal Lung Biopsy Plug System is indicated for sealing pleural punctures to reduce the risk of pneumothoraces (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy needle entry site for visualization during surgical resection.

The Pre-B. Seal Lung Biopsy Plug System is indicated for use in adult patients (age > 21 years).

The Pre-B. Seal Lung Biopsy System is a sterile single-use medical device comprised of the following components:

• Prefilled Hydrogel Syringe
• Delivery System 15cm length, 16cm length, 20cm length

The model numbers are:

• Pre-B. Seal Lung Biopsy Plug System 15cm (Model # FG0001)
• Pre-B. Seal Lung Biopsy Plug System 16cm (Model # FG0002)
• Pre-B. Seal Lung Biopsy Plug System 20cm (Model # FG0003)

The Delivery System is comprised of an introducer pre-assembled with a delivery needle, with depth markings on the external surface of the introducer. The delivery needle and introducer are both constructed of stainless steel. A pebax white depth marker ball sits on the introducer and may be used in addition to the markings as a depth indicator. The delivery system is ethylene oxide (EO) sterilized and is patient contacting (≤ 24 hours (includes transient contact).

The prefilled syringe contains a sealant (hydrogel) which acts as an absorbable lung biopsy plug. The hydrogel plug consists of gelatin, saline and hyaluronic acid. The plug is provided in ready to use configuration within a prefilled hydrogel syringe. The hydrogel is biodegradable.

The prefilled hydrogel is steam sterilized. The hydrogel is patient contact (> 30 days (i.e., permanent)) The syringe is indirect patient contacting.

These components have been designed for use during a CT-guided transthoracic lung biopsy procedure. The syringe is attached to the delivery system and then purged using a standard hypodermic purging technique outside of the patient. The distance from the skin to the pleura surface is measured using CT imaging, and using this information, the device is advanced to the intended deployment location within the lung under CT guidance. The hydrogel plug is deployed via the prefilled syringe below the surface of the lung through the delivery system. The hydrogel plug creates a seal around the delivery system through which a biopsy is conducted. When the biopsy is complete, the delivery system is withdrawn, and the hydrogel plug remains in place to fill the void and marks the biopsy needle entry site for visualization during surgical resection. The hydrogel plug is biodegradable and resorbs over approximately 49 days.

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a GLP animal study that demonstrates the Pre-B Seal Lung Biopsy Plug System meets these criteria. Since the device is a physical medical device (lung biopsy plug) and not an AI/Software as a Medical Device (SaMD), several of the requested questions related to AI (e.g., number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Selio Medical Limited Pre-B Seal Lung Biopsy Plug System are largely derived from the requirements specified in the Special Controls (21 CFR 878.4755) for absorbable lung biopsy plugs and demonstrated through comparative testing with the predicate device (Bio-Seal Lung Biopsy Tract Plug System, DEN090007).

Table 1: Acceptance Criteria and Reported Device Performance

• Description & Principles of Operation
• Device Design
• Performance Testing (Bench)
• Usability Testing
• GLP Animal Study.
  Conclusion: Device design and materials are appropriate for and consistent with the intended use. |
  | SC(2): Performance testing demonstrates deployment as indicated in labeling, including with indicated introducer needles, and demonstrates expansion/resorption in a clinically relevant environment. | Demonstrated through:
• Performance Testing (Bench - Injection Force, Component Compatibility, Insertion/Withdrawal Force, Simulated Use, etc.)
• Usability Testing
• GLP Animal Study (plug visibility, deployment accuracy, expansion/resorption characteristics, compatibility with biopsy device).
• Instructions for Use.
  Conclusion: The device successfully deploys, and its expansion/resorption characteristics are acceptable and visually confirmed in animal model. |
  | SC(3): In vivo evaluation demonstrates performance characteristics, including ability of plug to not prematurely resorb or migrate, and the rate of pneumothorax. | Demonstrated through:
• GLP Animal Study.
  Conclusion: "The data from this study demonstrated that the performance characteristics, including the ability of the plug to not prematurely resorb or migrate, of the Pre-B. Seal Lung Biopsy Plug System were acceptable. The rate and severity of pneumothorax was less than the predicate device." |
  | SC(4): Sterility testing demonstrates sterility and effects of sterilization process on physical characteristics of plug. | Demonstrated through:
• Sterilization Validation studies (EO for delivery system per ISO 11135:2014, Steam for hydrogel per ISO 17665:2024), achieving SAL of 10-6.
• Effects on physical characteristics shown via Performance Testing (Bench), Usability Testing, GLP Animal Study.
  Conclusion: Device is sterile, and sterilization methods do not adversely affect physical characteristics. |
  | SC(5): Shelf-life testing demonstrates shelf-life of device including physical characteristics of plug. | Demonstrated through:
• Shelf-life testing performed.
  Conclusion: Shelf-life testing was successfully completed, demonstrating acceptable shelf-life and physical characteristics. |
  | SC(6): Device demonstrated to be biocompatible. | Demonstrated through:
• Biocompatibility Testing per ISO 10993-1:2018.
  Conclusion: "Test Results Passed. The results... demonstrates that the proposed device is biocompatible." |
  | SC(7): Labeling includes detailed summary of complications, warnings, and identification of compatible introducer needles. | Demonstrated through:
• Review of Instructions For Use (IFU).
  Conclusion: Labeling meets these requirements. |
  | Overall Substantial Equivalence to Predicate | Demonstrated through:
• Extensive side-by-side comparison (Table 1 in 510(k) Summary) showing similar intended use, indications for use, device class, product code, target population, anatomical site, ability to determine depth, environment of use, absorbable nature, sealing function, plug retention at site, and marking function.
• Differences in components (pre-filled vs. dehydrated hydrogel) and deployment procedure were addressed with supporting data (bench, animal, usability, biocompatibility) to show no new questions of safety/effectiveness.
• Different resorption time compared to predicate (49 days vs. 20 months) was deemed acceptable based on GLP animal study.
• Different hydrogel and delivery system materials were supported by biocompatibility testing.
• Sterilization methods (steam for hydrogel vs. EO for predicate) were validated.
  Conclusion: The proposed device is as safe, effective, and performs as well as the predicate device. |

Study Details for Device Performance

The core study proving the device meets the acceptance criteria is the GLP (Good Laboratory Practice) Animal Study, complemented by various non-clinical bench testing.

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Animal Study): A swine model was used. The exact number of animals or specific 'sample size' for the test set is not explicitly stated in numerical terms (e.g., "n=X animals") within this document. The document states a comparison was done between the proposed device and the predicate device in the swine model.
   • Data Provenance: The study was a prospective animal study, conducted in a GLP (Good Laboratory Practice) environment. The country of origin is not specified, but GLP implies a standardized, regulated conduct of non-clinical safety studies.

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

   • Not Applicable (N/A): This refers to Human Factors/AI studies. For a physical device like a biopsy plug, the "ground truth" for performance (e.g., pneumothorax rate, migration, resorption) is established by direct observation, measurement, and pathological analysis in the animal model by trained veterinarians, pathologists, and study scientists in a GLP setting, not through expert consensus on images.

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

   • N/A: Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from human reader interpretations (e.g., in radiological studies). In an animal study, endpoints are typically objectively measured and evaluated by the study team, often including pathological assessment. Discrepancies would be resolved through standard GLP study procedures and internal review processes, not specifically these reader adjudication models.

4. 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, N/A: This is not an AI/SaMD study, but a physical medical device. Therefore, MRMC studies are not relevant for proving the performance of the Pre-B Seal Lung Biopsy Plug System. The comparison was the proposed physical device vs. the predicate physical device in an animal model.

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

   • No, N/A: This pertains to AI performance. The device is a physical product designed for human interaction and use during a medical procedure.

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

   • For the GLP Animal Study, the ground truth for device performance and safety endpoints (e.g., device visibility, deployment accuracy, expansion/resorption characteristics, incidence of pneumothorax, hydrogel plug migration, degradation, embolization, biocompatibility: local and systemic effects, overall animal health) was established through:
     • Direct observation and measurement during the procedure.
     • Imaging (CT guidance for visibility, positioning, deployment).
     • Pathological assessment (for degradation/resorption, local effects, embolization, etc.) by qualified personnel (e.g., veterinary pathologists).
     • Outcomes data based on the animal's health and post-procedure observations.

7. The sample size for the training set:

   • N/A: This term applies to machine learning or AI models. This is a physical device developed through traditional engineering design and testing, not by training an AI model.

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

   • N/A: As above, this is for AI models. The design of the Pre-B Seal Lung Biopsy Plug System was based on engineering principles, material science, and testing against pre-defined specifications and regulatory requirements, not a training set.

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Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low pressure foam-filled 100% silicone rectal retention balloon fixed to the distal end of a soft collapsible silicone catheter tube with a labelled white inflation port and an auto Inflate valve, Luer lock inflation syringe, an ENFit connector for irrigation/medication port with an ENFit compatible syringe, cinch clamp, date formatted labels, a sub-assembled self-closing quick connector to the catheter end, a matching collection bag, and "Diamonds" gelling and odor control sachets (4 sachets per kit). The components are contained in a rigid thermoformed plastic clamshell.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Flexi-Seal AIR (with ENFit Connector). While it details the device, its intended use, technological comparisons, and the rationale for substantial equivalence to a predicate device, it does not contain information about specific "acceptance criteria" for a study that proves the device meets these criteria in the way you've outlined.

Specifically, the document states:

• "Performance testing for Flexi-Seal Air™ was conducted for functional and structural parameters. In this testing, the device's performance has been found to be substantially equivalent to the predicate device both functionally and structurally (balloon, auto inflate valve, joint strength, mechanical properties, odor barrier, etc)."
• "The device has also been evaluated for biocompatibility in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO 10993-1:2018, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process’, issued September 8, 2023, and has been found safe in such respect for its intended use."

This indicates that various performance tests (functional, structural, biocompatibility) were done to demonstrate substantial equivalence to a predicate device, which is the primary requirement for 510(k) clearance. However, it does not specify:

• A table of explicit "acceptance criteria" and "reported device performance" in a quantitative manner as you've requested.
• Sample sizes for a test set proving a specific performance goal.
• Data provenance, number of experts, adjudication methods, or ground truth establishment as would be present in a clinical performance study for an AI/ML device or a device requiring specific clinical performance metrics to be proven.
• MRMC studies or standalone algorithm performance.

The document is a regulatory submission for a medical device that appears to be a physical product (fecal management catheter), not an AI/ML software device. Thus, the questions regarding "AI vs. without AI assistance," "standalone (algorithm only) performance," and ground truth establishment for a training set are not applicable here.

Therefore, I cannot extract the information you've requested as it is not present in the provided text.

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Permanent obturation of root canals of the secondary dentition in combination with root canal points.

AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.

This document is a 510(k) summary for the AH Plus Endodontic Sealer. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested categories for AI/digital health devices are not directly applicable or are not explicitly detailed in this type of submission for a traditional medical device like an endodontic sealer.

However, I can extract the information related to performance testing as described for this device, specifically those aspects that function as "acceptance criteria" for the device's physical properties.

Acceptance Criteria and Study for AH Plus Endodontic Sealer (K243546)

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)

This information is not provided in the document. The document describes non-clinical bench testing, not a clinical study involving patients or data provenance in that sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the ground truth for the performance tests (radiopacity, solubility, etc.) is established by the physical and chemical properties measured against the ISO standard, not by expert interpretation.

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

This is not applicable. The "test set" here refers to samples of the device material undergoing physical and chemical tests, not diagnostic cases 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

This is not applicable. This is a submission for an endodontic sealer, which is a physical material, not an AI-powered diagnostic device. No human reader or AI assistance is involved.

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

This is not applicable. This device is not an algorithm or software.

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

The "ground truth" for the performance tests is the specified limits and methodologies defined within the ISO 6876:2012 standard for dentistry-root canal sealing materials. For biocompatibility, the ground truth is adherence to the specified ISO 10993 series and USP standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set."

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

This is not applicable.

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i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.

Here's a breakdown of the acceptance criteria and the study details for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, some of the requested information (like effect size of human readers with vs. without AI, number of experts for ground truth, adjudication methods, details on training set) are not applicable. The information provided relates to a traditional medical device's performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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ArtiSeal Vessel Sealing System-ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on veins) up to and including 7 mm. It is indicated for use in general surgery.

The ArtiSeal Vessel Sealing System - ArtiSeal Generator is a high-frequency electrosurgical device used in conjunction with disposable hand-controlled electrosurgical instruments, known as ArtiSeal Instruments. It provides radiofrequency (RF) energy to ligate vessels and tissue bundles. This energy platform automatically detects the connected instrument and immediately performs safety and diagnostic functions for the instrument. It is indicated for use in general surgery.

ArtiSeal Vessel Sealing System - ArtiSeal Instruments

The ArtiSeal Vessel Sealing System - ArtiSeal invasive invasive instruments which are used with electrosurgical generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired.

When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies a high frequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation.

During a procedure with this product, the jaw opens, and jaw closes if the grip lever pulled. In addition, the jaw is also bent up, down, left, and right within a range of ±80° or more by moving the grip up, down, left, and tight, and the jaw can also turn 360° when rotating the grip.

ArtiSeal Vessel Sealing System - ArtiSeal Generator

The ArtiSeal Vessel Sealing System - ArtiSeal Generator supplies RF energy to the ArtiSeal Instruments. This energy supply device uses a touchscreen interface and features a unique instrument connecting the ArtiSeal Instrument. By connecting the connector on the ArtiSeal Instrument connection socket, the energy supply device can provide energy to the electrode.

The provided text describes a 510(k) premarket notification for the ArtiSeal Vessel Sealing System and outlines its indications for use and a summary of non-clinical/clinical tests. However, it does not contain detailed information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods in the manner typically presented for AI/ML device studies. The text focuses on establishing substantial equivalence to predicate electrosurgical devices through performance in animal studies rather than rigorous statistical evaluation of an AI component.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can and cannot be answered:

What can be extracted/inferred:

• Study Type: Non-clinical (animal) studies were conducted.
• Purpose of Study: "To evaluate the vessel sealing performance and tissue effects of ArtiSeal Instruments and ArtiSeal Generator. The evaluations included the device's ability to seal vessels of various sizes and types, its effect on tissue damage, as well as the device's safety and efficacy."
• Performance Metrics Mentioned (Qualitative): "complete vessel sealing was achieved without rebleeding as well as problematic macroscopic complications." "evaluation of sealing quality parameters such as tissue adhesion, transparency, desication, and damage to adjacent tissue."
• Ground Truth Type: Inferred to be a combination of direct observation in animal models and evaluation of sealing quality parameters.
• Data Provenance: Conducted in "pigs."

What cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance: The document only provides qualitative statements about performance, not a table of specific numerical acceptance criteria or results.
• Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document mentions "pigs" but no specific numbers for the sample size, nor details on the country of origin or whether it was retrospective/prospective.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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 electrosurgical system, not an AI/ML-driven diagnostic or assistive tool for human readers.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no mention of a standalone algorithm component for diagnostic or interpretive purposes. The "automatic detection" and "safety and diagnostic functions" refer to hardware/firmware functions, not an AI algorithm generating standalone performance metrics.
• The sample size for the training set: Not mentioned (and likely not applicable in the context of an electrosurgical device without a distinct AI training phase for data interpretation).
• How the ground truth for the training set was established: Not mentioned.

Summary based on the provided text:

The provided document describes the clearance of an electrosurgical device, the ArtiSeal Vessel Sealing System. The "study" mentioned is a non-clinical (animal) evaluation to demonstrate the physical performance of the device in sealing and dividing vessels, and its safety. This is distinct from the type of performance study typically conducted for AI/ML-driven diagnostic devices, which would involve detailed metrics of sensitivity, specificity, AUC, and human reader performance with and without AI assistance.

Hypothetical Table (Illustrative, as data is not available in the text):

If this were an AI device, the table would look something like this, but the data below is purely illustrative of what would be present if the document contained AI study details and is NOT from the provided text:

In conclusion, based solely on the provided text, it is not possible to describe the acceptance criteria and study proving the device meets them in the context of an AI/ML device per your detailed request. The device in question is a traditional electrosurgical system, and the provided documentation focuses on its physical performance and safety in animal studies, not statistical validation of an AI algorithm against a specific set of rigorous metrics.

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