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J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters SIN Cone Morse 11.5° and 16° implant lines 11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0 16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm

J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include: Biohorizons 3.5, and 4.5mm Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse

The document describes the J & P Click Attachments, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to a predicate device, the Zest High Retention Attachment System (K220252), and several reference predicates.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided text is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new clinical study. Therefore, the "acceptance criteria" here are based on comparative attributes for demonstrating substantial equivalence, and "reported device performance" refers to the characteristics of the J & P Click Attachments as compared to the predicate.

Study Proving Device Meets Acceptance Criteria:

The document describes a series of non-clinical tests and a comparison to predicate devices, rather than a single "study that proves the device meets acceptance criteria" in the sense of a clinical trial with predefined statistical endpoints. The primary method for demonstrating substantial equivalence is through comparative analysis with predicate devices and non-clinical testing.

Non-Clinical Testing Performed:

• Abutment Steam Sterilization: Done according to ISO 17665-1.
• Cytotoxicity Testing: Conducted according to ISO 10993-5.
• Reverse Engineering Tolerance Analyses: Conducted for all OEM implant systems in the indications for use. These analyses covered OEM implant body models, OEM abutment models, and OEM abutment screw models to ensure compatibility.
• MR Environment Condition (MRI Review): Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to evaluate magnetic compatibility, specifically for magnetically induced displacement force and torque, based on the entire system and material composition (Ti-6AL-4V ELI).

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 does not describe a clinical "test set" with human or animal subjects in the traditional sense of a clinical study.
• The "test set" for the reverse engineering tolerance analyses would be the designs and physical specifications of the OEM implant systems. The number of samples for these analyses is not specified beyond "all OEM implant systems in the indications for use."
• Data provenance: Not explicitly stated, but the submission is for an FDA 510(k), implying compliance with US regulatory standards. Non-clinical tests like cytotoxicity (ISO 10993-5) and sterilization (ISO 17665-1) are international standards.

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 information is not provided in the document. The substantial equivalence determination is based on comparative attributes and non-clinical engineering and biological testing, not on expert-adjudicated ground truth from a clinical data set.

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

• This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication in the context of this 510(k) submission.

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

• This information is not provided and is not applicable to this type of medical device (dental implant attachments). MRMC studies are typically used for imaging diagnostics involving human readers and AI. This device is a mechanical component, not an AI software.

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

• This information is not provided and is not applicable. This device is a physical dental component and does not involve an algorithm or AI.

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

• For the non-clinical tests:
  • Sterilization: Ground truth is defined by the requirements of ISO 17665-1.
  • Cytotoxicity: Ground truth is defined by the requirements and endpoints of ISO 10993-5.
  • Reverse Engineering Tolerance Analyses: Ground truth is the design specifications and tolerances of the referenced OEM implant systems.
  • MRI Environment Review: Ground truth is established by scientific rationale and published literature referenced (e.g., relating to magnetic properties of materials).
• For substantial equivalence: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices, as documented in their 510(k) clearances and product specifications.

8. The sample size for the training set

• This information is not provided and is not applicable. The device is a physical medical device, not an AI or software device that undergoes a training phase.

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

• This information is not provided and is not applicable (see point 8).

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JDentalCare® implant system JDIcon® is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.

JDentalCare® implant system JDIcon® is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDentalCare® implant system JDicon® 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single-stage or two-stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

JDentalCare® implant system JDIcon® is composed by a fixture and an abutment, joined together by a through screw. The connection is done through an internal hexagon.

Abutment and accessories are exclusive for JDentalCare® implant system JDIcon®

JDentalCare® implant system JDIcon® is threaded (fully treated or with a collar of 1.5 mm), rootform dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures.

JDentalCare® implants are made of grade 4 and grade 5 titanium and are tapered.

Their surface is treated through sandblasting followed by acid etching treatment.

JDIcon® implants may be placed in the oral cavity using either a single stage surgical procedure or a two-stage surgical procedure. If a single procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

The available dimensions of the JDentalCare® implant system JDIcon®, considering the Fully treated collar version and the machined collar version, are shown in the table below. Note the MACHINED COLLAR referenced is not implanted in bone, making the implantable length of these implants 1.5 mm less than the total implant length listed below.

This FDA 510(k) summary describes the JDentalCare® Implant System JDIcon® and demonstrates its substantial equivalence to previously marketed predicate devices, rather than presenting a study proving performance against specific acceptance criteria.

The document focuses on comparing the proposed device's characteristics and performance to legally marketed predicate devices. It doesn't define absolute "acceptance criteria" in the sense of predefined thresholds for a new study, but rather demonstrates that the new device meets the established safety and effectiveness profile by being similar to already cleared implants.

Therefore, the requested tables and specific study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not directly applicable or provided in this type of regulatory submission.

However, I can extract information related to how the device's performance was evaluated and how it compares to existing standards and predicate devices, which implicitly serve as "acceptance criteria" for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Implied by Comparison to Predicates):

Regarding the specific numbered questions:

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

   • This has been provided above, interpreting the comparison to predicate devices and standards as the implicit "acceptance criteria" for substantial equivalence.

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

   • This document is a 510(k) summary, which inherently relies on demonstrating substantial equivalence to already legally marketed devices. It describes engineering tests and biocompatibility assessments, rather than clinical trial data with patient samples.
   • Sample Size: Not specified in the document for any particular test. These are typically bench tests following standardized methodologies.
   • Data Provenance: Not explicitly stated as "country of origin for data." The tests are performed "according to ISO" or "in compliance with FDA guidance," implying standard laboratory or testing facility setups. There is no mention of human subject data, therefore, no retrospective or prospective study is described in this context for performance evaluation.

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. This document does not describe a clinical study where ground truth is established by experts (e.g., for diagnostic accuracy). The "ground truth" here is compliance with engineering standards and demonstration of similar functional characteristics and safety profiles to existing devices.

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

   • Not applicable. As above, this document does not describe a clinical study requiring adjudication of expert interpretations.

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

   • Not applicable. This device is a dental implant system (a physical medical device), not an AI algorithm for image interpretation or diagnosis. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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

   • Not applicable. This device is a physical dental implant system, not a software algorithm.

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

   • The "ground truth" in this context is established by:
     • Standardized Test Methods: Adherence to international standards like ISO 14801 (mechanical fatigue), ISO 10993 (biocompatibility), ISO 11137 (sterilization), and ASTM F67/F136 (materials).
     • Comparison to Legally Marketed Predicate Devices: The key "ground truth" for a 510(k) is that the device is substantially equivalent in safety and effectiveness to a device already cleared by the FDA. This relies on the established safety and effectiveness of the predicate.
     • Internal Validation: Surface validation and cleaning process validation are internally conducted and documented.

8. The sample size for the training set

   • Not applicable. This submission is for a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

   • Not applicable, as there is no training set for a physical dental implant.

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The Halo® system is an airtight and leak proof closed system drug (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The Halo® system also prevents microbial ingress for up to 7 days.

The Halo® is a Closed System Transfer Device (CSTD) for the safe handling of hazardous drugs, especially for the compounding and administering of hazardous drugs according to the National Institute for Occupational Safety and Health (NIOSH) definition of an airtight and leak proof closed system transfer device. It is a sterile singleuse device. There are five components of the Halo® system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA), Closed Line Adaptor (CLA), and Closed Vial Converter (CVC). These components integrate with industry standard luer-lock syringes, IV bags, infusion sets, and other patient connections to form a complete closed system. This system prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. In addition, the components are designed to prevent microbial ingress into the system, including maintaining sterility of drugs in the vial for up to 7 davs. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

The system uses industry compatible luer locks, bag spikes and spike ports, dual lumen spikes, single lumen needles, and dry to dry compression fit seals when connecting Halo® components together. A single lumen needle perforates the dry-to-dry compression fit seals for the transfer of drugs between Halo® components. Upon separation the needle is retracted and the seal membrane prevents transfer of environmental contaminants into the system and/or escape of drug or vapor.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance testing for various aspects of the Halo® system. The acceptance criteria are generally qualitative ("No Leaks," "Pass") or by reference to established standards.

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

The document does not explicitly state the specific sample sizes (number of devices or tests performed) for each individual test conducted on the Halo® system. It implies that these tests were conducted as part of the regulatory submission (K180574 and referencing K150486).

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The studies were conducted by J & J Solutions, Inc. d/b/a Corvida Medical and their testing partners for regulatory submission to the FDA. This is considered prospective data for the purpose of demonstrating substantial equivalence. The document doesn't specify the country of origin of the labs, but given the FDA submission, it's typically within the US or by labs adhering to US regulatory standards.

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

This section is not applicable to this type of device and study. The Halo® system is a medical device (Closed System Transfer Device) for safe handling of hazardous drugs. Its performance is evaluated through laboratory-based, objective performance testing against established engineering, biological, and chemical standards (e.g., ISO, ASTM, USP). There is no "ground truth" to be established by human experts in the context of diagnostic interpretation, as this is not a diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Adjudication methods are typically used in studies where human interpreters (e.g., radiologists, pathologists) determine a "ground truth" or make diagnoses, and discrepancies need to be resolved. The performance of the Halo® device is measured by quantitative and qualitative outcomes against predefined technical and safety specifications.

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 section is not applicable. The Halo® system is a physical medical device, not an AI or diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is irrelevant to its evaluation.

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

This section is not applicable. As stated above, this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Halo® device's performance is established through:

• Engineering and Physical Test Standards: Compliance with ISO (e.g., ISO 594, ISO 8536), ASTM (e.g., F2096, F1886, F88), and USP (e.g., USP 788) standards. These standards define the expected physical and chemical properties and performance limits.
• Biological Test Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135, ISO 11737-1, AAMI/ANSI ST72 for sterility.
• Direct Measurement of Device Functionality: Observing and quantifying performance metrics like "no leaks" in fluorescein or alcohol vapor tests, "pass" for force measurements, and direct measurement of microbial ingress protection (e.g., 7 days protection after 14 penetrations).

8. The Sample Size for the Training Set

This section is not applicable. The Halo® system is a mechanical and biological device that is validated through physical and chemical testing, not through machine learning or AI. Therefore, there is no "training set" in the context of data-driven model development.

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

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

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Sunlamp product for tanning of human skin

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a tanning booth device. It discusses regulatory matters, product codes, and indications for use.

This document does not contain any information about acceptance criteria for a medical device's performance, nor does it describe any study that proves a device meets such criteria. It is solely a regulatory approval letter for a Hex Tanning Booth.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

To answer your request, I would need a document that describes the performance evaluation of a medical device, including its acceptance criteria and the results of a study conducted to demonstrate its performance.

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JDentalCare® implant system is intended for surgical placement in the upper or lower jaw. JDentalCare® implant system is comprised of dental implant fixtures and prosthetic devices. JDentalCare® implant system provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare® implant system is intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

JDentalCare®implant system is composed by a fixture and an abutment, joined together by a through screw (JDEvolution). In this case the connection is done through an internal hexagon. Abutments and accessories are exclusive for JDentalCare®implant system. JDentalCare®implants are threaded, root-form dental implants, intended to provide a mean for prosthetic attachment in the rehabilitation of partial or total edentulism, in single tooth restorations or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. JDentalCare®implants are machined from grade 4 or grade 5 titanium and tapered. Their surface is treated with a double acid etched treatment. JDentalCare®implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be placed anywhere in the upper or lower jaw where good initial stability can be obtained.

This document is a 510(k) Summary for the JDentalCare® Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the way a clinical trial for an AI/CAD system would. Therefore, much of the requested information (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not directly applicable or available from this document.

However, I can extract the acceptance criteria as described for the device's characteristics and the "study" (which are performance tests and validation activities) demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this document is a 510(k) summary for a dental implant system (a physical medical device, not an AI/CAD software), the "acceptance criteria" are related to its physical, material, and functional properties being equivalent to legally marketed predicate devices, and demonstrating safety and effectiveness through various tests.

2. Sample Size for Test Set and Data Provenance

This document does not describe a clinical study in the format of an AI/CAD device. Instead, "tests" refer to laboratory-based performance testing of the physical implant device and its materials. Therefore, there are no "test sets" of patient data in the conventional sense.

• Sample Size for Test Set: Not applicable. Tests involve physical samples of the implant devices and materials. The number of samples for each mechanical or biocompatibility test is not specified in this summary but would be standard for such device testing.
• Data Provenance: Not applicable for patient data. The tests are laboratory-based, performed on manufactured devices.

3. Number of Experts and their Qualifications for Ground Truth

Not applicable. Ground truth for a physical medical device like a dental implant is established through validated laboratory tests against engineering standards and material specifications, not through expert clinical consensus on patient data.

4. Adjudication Method

Not applicable. No clinical expert adjudication is mentioned or relevant for the types of tests described.

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

Not applicable. This is a physical dental implant, not an AI/CAD system, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device, which refers to its performance and safety, is established through:

• Compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 14801 for mechanical fatigue).
• Material specifications (e.g., ASTM F67 for Titanium Grade 4, ASTM F136 for Titanium-6Aluminum-4Vanadium ELI Alloy).
• Laboratory test results (e.g., cytotoxicity, fatigue strength, surface analysis).
• Comparison to predicate devices with an established history of safe and effective use.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/CAD system that requires a "training set" of data.

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

Not applicable.

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The Halo system is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The Halo system also prevents microbial ingress for up to 168 hours.

The Halo™ is a Closed System Transfer Device (CSTD) for the handling of hazardous drugs, especially for the compounding and administering of hazardous drugs according to the National Institute for Occupational Safety and Health (NIOSH) definition of an airtight and leak proof closed system transfer device. It is a sterile single-use device. There are four components of the Halo TM system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA) and Closed Line Adaptor (CLA). These components integrate with industry standard luer-lock syringes, IV bags, infusion sets, and other patient connections to form a complete closed system. This system prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. In addition, the components are designed to prevent microbial ingress into the system, including maintaining sterility of drugs in the vial for up to 168 hours. The ability to prevent microbial ingress for 168 hours should not be interpreted as modifying, extending, or superseding a drug manufacturers labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations for shelf life and sterilityinformation.

The system uses industry compatible luer locks, bag spikes and spike ports, dual lumen spikes, single lumen needles, and dry to dry compression fit seals when connecting Halo™ components together. A single lumen needle perforates the dry-to-dry compression fit seals for the transfer of drugs between Halo™ components. Upon separation the needle is retracted and the seal membrane prevents transfer of environmental contaminants into the system and/or escape of drug or vapor.

The provided document for the Halo™ Closed System Drug Transfer Device (CSTD) does not contain a study of a device that meets acceptance criteria in the typical sense of an AI/ML medical device submission.

Instead, this is a 510(k) premarket notification for a traditional medical device, primarily demonstrating substantial equivalence to a predicate device (BD PhaSeal CSTD). The "acceptance criteria" here refer to performance tests demonstrating the device's functional and safety characteristics, rather than diagnostic accuracy metrics.

Therefore, many of the requested fields regarding AI/ML device studies, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance, are not applicable to the information provided in this document.

However, I can extract information related to the performance testing described.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests conducted on the Halo™ system. It states that the "Results from tests completed on the Halo TM components demonstrates that the system prevents microbial ingress and/or escape of drug or vapor through multiple reconnections of components up to 14 times and are substantially equivalent with respect to operational performance."

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

• Not Applicable in the AI/ML sense. The document describes performance testing for a physical device. Details on specific sample sizes for tests like fluorescein tests, pressure tests, or microbial ingress tests are not provided in this summary. The data provenance would be laboratory testing of the manufactured devices.

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

• Not Applicable. This is not an AI/ML device where expert ground truth is established for diagnostic accuracy. Performance tests typically rely on established protocols, measurement devices, and technical standards.

4. Adjudication method for the test set

• Not Applicable. This is not an AI/ML device with diagnostic outputs 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

• Not Applicable. This is not an AI/ML device. "Human Factors / Comparative testing" is mentioned, likely comparing user interaction with Halo™ vs. the predicate, but not in the context of an MRMC study with AI assistance.

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

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

7. The type of ground truth used

• The "ground truth" for this device's performance is based on established engineering principles, physical measurements, chemical analysis, and microbiological testing according to recognized standards (e.g., ISO 10993-1, ISO594). For instance, microbial ingress testing results (sterility) would be confirmed via microbiology assays.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

Summary of the Study:

The studies described are a series of laboratory and bench tests designed to demonstrate the functional performance and safety of the Halo™ CSTD. These tests collectively aimed to prove that the device is "as safe, as effective, and performs as well as the predicate devices" (BD PhaSeal CSTD), thereby demonstrating "substantial equivalence." The tests covered aspects such as:

• Containment: Preventing the escape of hazardous drugs/vapors and the entry of environmental contaminants (e.g., Fluorescein Test, System Pressure Test, Vapor Test, Leakage tests).
• Microbial Integrity: Preventing microbial ingress, specifically up to 168 hours for drug vial sterility (Microbial Ingress Testing, Extended Beyond-use-date drug vial sterility testing).
• Mechanical Integrity and Durability: Ensuring components connect securely, withstand forces, and maintain function over multiple reconnections (Insertion and Retention Force, Connection Force, ISO594 Luer Fitting Compliance Test).
• Biocompatibility: Ensuring materials are safe for human contact (ISO 10993-1 tests).
• Residual Volume: Minimizing drug waste.
• Chemical Properties: (Extractables/Leachables Testing).
• User Interface: (Human Factors / Comparative testing)

The document explicitly states that "Comparative testing against the predicate device confirmed there were no new questions raised regarding safety or efficacy of the Halo™device." The results from these tests demonstrated that the device performs as intended and is "substantially equivalent" to already marketed devices.

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J&S Medical Associates Sentry dipstick urine controls are intended to be used by laboratory technicians in order to verify the performance of various urine dipsticks as a part of the laboratory's quality control practices.

The three Sentry controls are prepared with human and animal proteins and with various chemical additives. These chemicals interact with the dipstick reactant pads to produce specific color changes that mimic actual normal and/or abnormal urine samples.

Here's an analysis of the provided text regarding the acceptance criteria and study for the J&S Medical Sentry Urine Dipstick Control:

The provided document is a 510(k) Summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical trial for efficacy. Therefore, much of the requested information (like specific acceptance criteria for a diagnostic performance metric, MRMC studies, or training set details) is not present. The "study" described is primarily a stability evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly related to the stability of the controls – that they continue to react "within specifications" and produce "positive" or expected results with dipsticks over time, mimicking actual urine samples. The reported device performance is that it met these stability specifications.

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

• Test Set Description: Samples of the three Sentry controls (Level 1, Level 2, and Level 3).
• Sample Size for Stability Testing: Not explicitly stated as a number of distinct "samples" or replicates beyond "Samples of the three controls." The focus is on the long-term observation of these control solutions.
• Data Provenance: The study was conducted by J&S Medical Associates. The country of origin of the data is not specified but is presumably the USA, where the company is based. The study is prospective in nature, as it involves incubating the controls and testing them at future intervals.

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

This type of information is not applicable to this submission. The "ground truth" for a urine dipstick control is its known chemical composition and intended reactivity profile. The evaluation involves comparing the control's observed reactions to these known profiles, not to an expert's diagnosis. The testing involved visual comparison to color charts and instrument readings, which are objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" (expected results for the controls) is inherent in their formulation. The stability assessment involves direct measurement and comparison to predefined specifications (visual color chart matching or instrument readings), not expert adjudication of subjective findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and therefore, an MRMC study or AI-related effectiveness analysis is entirely outside the scope of this submission. The device is intended to verify the performance of existing urine dipsticks, which include both visual and instrument-read types.

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

Not applicable. As a urine dipstick control, this device is not an algorithm. Its performance is assessed by its chemical reactivity, not by an algorithm's output.

7. The Type of Ground Truth Used

The ground truth used is the known chemical composition and expected reactivity profile of the control solutions. These controls are manufactured to elicit specific reactions on urine dipsticks. Their performance is verified by ensuring they consistently produce these expected results over time under various conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical control, not a machine learning algorithm, and thus does not have a "training set" in the computational sense. The "training" in manufacturing would relate to process control and formulation development, not data-driven model training.

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

Not applicable. See point 8.

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This device is intended to be used for physiological monitoring, biofeedback training, incontinence, relaxation training, muscle reeducation and research.

Physiological Monitoring & Biofeedback Instrument

I apologize, but the provided text from the FDA 510(k) clearance letter for the "J&L I-410 Physiological Monitoring & Biofeedback Instrument" (K971708) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a standard FDA clearance letter, which states that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information. It does not include technical specifications, performance metrics, or details of any studies conducted to validate the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text.

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