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Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.

Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.

This document is a 510(k) summary for a medical device (Premium Teeth Resin) and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-based medical device.

The provided text focuses on demonstrating substantial equivalence of a new 3D printing resin (Premium Teeth Resin) to a legally marketed predicate device (VarseoSmile Temp) for dental applications. It details the product, its intended use, and compares its technological characteristics and performance to the predicate through non-clinical testing.

Therefore, I cannot extract the information required for your request from this document. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, ground truth establishment, sample sizes for AI model training/testing) are not present in this regulatory submission for a material.

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Premium Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Premium Anal Cooling Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Premium Cooling Personal Lubricant and Premium Anal Cooling Lubricant are clear, semi-viscous personal lubricants that are compatible with natural rubber latex, polyisoprene and polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

Premium Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

Premium Anal Cooling Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of Dimethicone, Dimethiconol and Menthol.

The provided FDA 510(k) summary document for "Premium Cooling Personal Lubricant" and "Premium Anal Cooling Lubricant" is for a personal lubricant, not an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and studies (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) are not applicable to this document.

However, I can extract the acceptance criteria and study information for this non-AI/ML medical device from the document.

Acceptance Criteria and Reported Device Performance

Study Information (for non-AI/ML device):

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

   • Biocompatibility Studies: Not specified in terms of sample size for living organisms. The tests performed are standard in vitro and in vivo toxicology tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). Data provenance is not mentioned.
   • Shelf-Life Study: Samples were tested at 0, 1, 2, and 3 years. The number of individual product units tested at each time point is not specified. Data provenance is not mentioned.
   • Condom Compatibility Study: Evaluated in accordance with ASTM D7661-18. The number of condoms or lubricant samples tested is not specified. Data provenance is not mentioned.

2. 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 as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Performance is assessed against scientific/regulatory standards and specifications.

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

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

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:

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

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

   • Not applicable as this is not an AI/ML device. The device itself is the "standalone" product being evaluated.

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

   • The "ground truth" here refers to established scientific and regulatory standards/specifications (e.g., USP monographs for viscosity, microbial limits, and antimicrobial effectiveness; ISO standards for biocompatibility; ASTM standards for condom compatibility).

7. The sample size for the training set:

   • Not applicable as this is not an AI/ML device that requires training data.

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

   • Not applicable as this is not an AI/ML device that requires training data.

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Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex, polyisoprene and polyurethane condoms.

Premium Warming Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

Premium Anal Warming Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz./60 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

All-In-One Warming is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

This device is composed of Dimethicone, Dimethiconol and Capsicum Frutescens Fruit Extract.

The provided text describes the 510(k) summary for the Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, and All-In-One Warming. This document is a regulatory submission to the FDA, and as such, it presents performance data to demonstrate substantial equivalence to a predicate device, rather than a "study that proves the device meets acceptance criteria" in the context of an AI/algorithm-driven device.

Given that this document is for a personal lubricant (a physical product, not an AI/algorithm), most of the requested information (like sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this type of device and submission.

However, I can extract the acceptance criteria and reported device performance from the provided "Device Specifications" table and the "Summary of Performance Data."

Here's the information that can be extracted, and where applicable, a note on why certain requested fields are not relevant for this device type:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the studies conducted, the following information is available:

• Biocompatibility Studies:

  • Tests performed: Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity, and Sensitization Testing.
  • Standards: ISO 10993-1:2016, ISO 10993-1:20019, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006.
  • Outcome: "The results of this testing demonstrated that the subject lubricant is biocompatible."

• Shelf-Life Study:

  • Design: Real-time aging study.
  • Duration: 3 years.
  • Testing points: 0, 1, 2, and 3 years.
  • Parameters tested: All device specifications listed in Table 1 (Appearance, Color, Odor, Viscosity, Antimicrobial effectiveness, Microbial counts, Pathogen presence).
  • Outcome: "The subject device met the device specifications at all time points."

• Condom Compatibility Study:

  • Standard: ASTM D7661-18 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
  • Results: "Premium Warming Personal Lubricant, Premium Anal Warming Lubricant and All-In-One Warming are compatible with natural rubber latex, polyisoprene, and polyurethane condoms."

The following requested information is NOT APPLICABLE or NOT PROVIDED for this type of medical device (personal lubricant) in this regulatory submission:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical product; refers to software/AI. The "test set" here would refer to the physical samples of the lubricant subjected to the various chemical, microbiological, and physical tests. The document does not specify the number of units tested for each specific criterion but implies standard laboratory practices were followed.
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 to a physical product; refers to AI/algorithm performance evaluation. Ground truth for these tests comes from established scientific methods, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; refers to AI/algorithm. Laboratory tests have defined endpoints and pass/fail criteria.
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; refers to AI/algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; refers to AI/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical product, "ground truth" is established through standardized laboratory testing methods (e.g., USP monographs for microbial testing, ISO standards for biocompatibility, ASTM for condom compatibility).
8. The sample size for the training set: Not applicable; refers to AI/algorithm.
9. How the ground truth for the training set was established: Not applicable; refers to AI/algorithm.

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PREMIUM-SHELTA Abutments are intended to be used in conjunction with PREMUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches. PREMIUM-SHELTA Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment screw is intended to secure the abutment to the endosseous implant. PREMIUM-SHELTA Abutments are compatible with PREMIUM-SHELTA Implants Systems

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I am sorry, but the provided text is a cover letter from the FDA regarding a 510(k) premarket notification for "PREMIUM-SHELTA Prosthetic Components". It also includes the "Indications for Use" for these components.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The text focuses on regulatory approval and general controls for a medical device.

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

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PREMIUM ONE Implant Systems are intended for both one- and two-stage surgical procedures. PREMIUM ONE Implant Systems are intended for immediate placement and 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. Multiple tooth applications may be splinted with a bar.

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the "PREMIUM ONE Implant Systems" does not contain information about acceptance criteria or the study that proves the device meets those criteria. This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device, and outlines regulatory requirements and contact information. It does not elaborate on performance studies or acceptance criteria.

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

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The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premium Plus Prophy Air Motor. Based on the document, this is a Class I medical device (dental handpiece and accessories). For Class I devices, the level of regulatory scrutiny and required evidence of "performance" to establish substantial equivalence is generally much lower than for Class II or Class III devices, especially those involving AI/ML.

The provided document describes a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove efficacy or performance in the same way an AI/ML device would be scrutinized. Therefore, the "acceptance criteria" here relate to meeting basic safety and performance standards for a simple mechanical device and demonstrating similarity to an existing device. The "study" refers to the engineering and biocompatibility tests conducted.

Most of the specific information requested in your prompt (e.g., sample size for test set regarding AI algorithms, number of experts for ground truth, MRMC studies, standalone AI performance) is not applicable or not present in this type of submission for a simple mechanical dental device. This FDA submission is not for an AI/ML device.

Here's the closest breakdown based on the provided text:

Acceptance Criteria and Device Performance for Premium Plus Prophy Air Motor (K170261)

The Premium Plus Prophy Air Motor is a Class I mechanical dental device. The "acceptance criteria" in this context are defined by compliance with recognized international standards for dental handpieces and by demonstrating substantial equivalence to a predicate device. The "performance" refers to the device meeting the specifications outlined in these standards and its functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test (e.g., "Performance Test," "Biocompatibility Test," "Validation Testings"). These typically involve testing a representative sample of devices, but specific numbers are not provided in this summary. For Class I mechanical devices, the number of units tested is generally small as standardized tests are conducted on representative samples to ensure manufacturing quality and design integrity.
• Data Provenance: The device manufacturer, Premium Plus International Limited, is located in Hong Kong, China. The testing itself is conducted to international standards (ISO) and FDA guidance, but the exact location of the testing laboratories (e.g., in Hong Kong, or a third-party lab elsewhere) is not specified. The tests are prospective in the sense that they are performed on the device being submitted for marketing.

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

This concept is not applicable here. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where there is an interpretation or classification task. For a mechanical dental handpiece, the "ground truth" is determined by objective physical measurements and adherence to engineering standards.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, often for AI/ML devices or diagnostic tests. Here, the "tests" are compliance with engineering standards and validation protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-driven ones, to assess how AI assistance impacts human reader performance. This device is a simple mechanical prophy air motor, not a diagnostic tool or an AI/ML product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of an "algorithm" was not done. This device does not contain an algorithm or AI component. Its performance is measured directly through mechanical, airflow, and material safety tests.

7. The Type of Ground Truth Used

As this is a mechanical device, the "ground truth" is established by:

• Compliance with objective engineering standards (e.g., ISO 14457, ISO 9168).
• Results from biocompatibility assays (e.g., cytotoxicity, irritation, sensitization tests per ISO 10993 standards) where "ground truth" is defined by the test's positive/negative control and specific criteria for material response.
• Results from reprocessing validation tests (e.g., protein/hemoglobin analysis, sterilization cycles) designed to demonstrate effective cleaning and sterilization.
• Direct physical and operational measurements (e.g., dimensions, weight, air pressure, operating speed, power output) compared against specifications and the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable. This device is a mechanical product, not an AI/ML algorithm. There is no "training set" for an algorithm.

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

This concept is not applicable as there is no training set.

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Premium Plus Disposable Barrier Sleeve is intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

Premium Plus Disposable Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These barrier sleeves consist of various sizes and shapes which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument travs, x-ray heads, and others. The products are sold nonsterile, prepackaged, and are disposable, single use only.

The provided text is a 510(k) premarket notification from the FDA for a device called "Premium Plus Disposable Barrier Sleeve." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific acceptance criteria through a study involving diagnostic accuracy, human readers, or AI.

Therefore, the requested information about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as would be relevant for an AI/ML-driven diagnostic device, cannot be found in this document.

The document describes the physical and material characteristics of the barrier sleeves and confirms that they meet certain safety and performance standards for barrier efficacy, not diagnostic accuracy.

Here's what can be extracted from the document regarding the device's "performance" in its specific context:

Device: Premium Plus Disposable Barrier Sleeve
Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present acceptance criteria in a quantitative diagnostic performance metric (e.g., sensitivity, specificity, AUC). Instead, it compares the new device to a predicate device ("Pac-Dent Barrier Sleeve") based on various physical and biological properties relevant to its function as a barrier. The "acceptance criteria" are implied by the "Comparison of Technological Characteristics and Performance" table, where the new device is stated to be "comparable" or "equivalent" to the predicate.

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

This document does not describe studies that would have "test sets" in the context of diagnostic performance (e.g., patient data for an AI model). The "tests" mentioned are for material properties and barrier efficacy.

• Sample Size: Not specified in terms of "test set" for diagnostic performance. For mechanical and barrier tests, samples of the material/product would have been tested according to relevant ASTM/ISO standards, but specific sample numbers are not provided.
• Data Provenance: Not applicable in the context of patient data. The tests are laboratory-based material property tests.

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

Not applicable. This is not a diagnostic device or an AI/ML device requiring expert ground truth for interpretation of medical images or patient data. The "ground truth" for this device relates to established material performance standards (e.g., a material either passes or fails a tear strength test as per an ASTM standard).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described as it's not a diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for evaluating the impact of a diagnostic tool (often AI-assisted) on human readers' performance. This device is a physical barrier, not a diagnostic tool, so an MRMC study is not applicable.

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

No. This device is not an algorithm or an AI system. Its performance relates to its physical properties as a barrier.

7. The Type of Ground Truth Used

The "ground truth" is based on:

• Physical and Chemical Properties: Material composition (polyethylene film), thickness.
• Biocompatibility Standards: ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These involve laboratory tests on cell cultures and animal models (though the document doesn't specify if human or animal data were used beyond stating "non-cytotoxic," etc.).
• Mechanical and Barrier Performance Standards: ASTM D882 (tensile strength), ASTM F1342 (puncture resistance), ASTM D1424 (tear resistance), ASTM F1670 (synthetic blood penetration), ASTM F1671 (viral penetration). These are well-defined laboratory test methods.
• Functional Testing: "Effectiveness of x-ray devices covered with Premium Plus Disposable Barrier Sleeves was performed to demonstrate the subject device does not impact the function of dental x-ray devices." This implies functional testing against a benchmark of an X-ray device operating without the barrier, but the specifics of this "ground truth" are not detailed.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is involved.

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Abutments:

PREMIUM-SHELTA Conico Abutments are intended to be used in conjunction with a PREMIUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches.

The PREMIUM-SHELTA Conico Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit the abutment screw is intended to secure the abutment to the endosseous implant.

PREMIUM-SHELTA Conico Abutments are compatible with PREMIUM-SHELTA Implants Systems. Anchorage of dentures retained by taper friction and supported by PREMIUM-SHELTA Implants Systems.

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This document is a 510(k) clearance letter from the FDA for a dental prosthetic component. It confirms that the device, "Premium Shelta Prosthetic Components," is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a technical report on performance validation.

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

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PREMIUM Implant Systems -SHELTA Implant Systems are intended for both one- and two-stage surgical procedures. PREMIUM Implant Systems-SHELTA Implant Systems are intended for immediate placement and 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. Multiple tooth applications may be splinted with a bar. Abutments: PREMIUM-SHELTA Abutments are intended to be used in conjunction with a PREMIUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches. The PREMIUM-SHELTA Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. PREMIUM-SHELTA Abutments are compatible with PREMIUM-SHELTA Implants Systems.

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The provided text is a 510(k) premarket notification letter from the FDA regarding dental implants and abutments. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot extract the requested information from this document. This document is primarily an FDA clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device. It does not detail the technical performance studies of the device beyond its stated indications for use.

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Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.

Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.

Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.

This document is a 510(k) premarket notification for a dental curing light, the Premium Plus C01/C02 LED Curing Light. It aims to establish substantial equivalence to existing predicate devices. The information provided focuses on technical specifications and safety standards rather than clinical performance or AI algorithm validation.

Therefore, many of the requested details, such as acceptance criteria based on clinical metrics (e.g., sensitivity, specificity), sample size for test sets, ground truth establishment by experts, adjudication methods, or effects of AI assistance, are not applicable or not available in this document.

The document primarily relies on comparisons of technical characteristics and adherence to recognized safety and performance standards to demonstrate substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or human improvement with AI). Instead, it relies on demonstrating that the device meets recognized industry standards and performs comparably to predicate devices based on technical specifications and safety tests.

Therefore, instead of a clinical performance table, below are the relevant technical and safety performance criteria that were met:

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

• Sample Size for Test Set: Not specified for any clinical or performance comparison study. The document refers to "Performance Tests" for Electrical Safety, EMI, LED lamps, and Depth of Cure, but the number of units or materials tested is not mentioned.
• Data Provenance: Not applicable as there's no patient data or clinical imagery discussed. All testing appears to be laboratory-based and related to device specifications and safety.

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

Not applicable. The "ground truth" here is adherence to technical standards and specifications, not clinical diagnoses or interpretations. These standards are established by regulatory bodies and consensus organizations, not individual experts in a test set.

4. Adjudication Method for the Test Set

Not applicable. There's no interpretive task that would require 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 device is a dental curing light, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device does not involve an algorithm for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is based on:

• Compliance with recognized international and national standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), ISO 10650-2 / ANSI/ADA Specification No. 48-2 (LED Curing Lights).
• Demonstrated technical equivalence in key specifications (intended use, light source, wavelength, radiant intensity, operational modes, power, environmental factors, safety standards) to already approved predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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