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SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.

The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.

The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method

Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)

at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.

The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.

The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method

Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)

at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

This FDA 510(k) clearance letter for the SWEDEN & MARTINA SURGICAL TRAYS focuses on establishing substantial equivalence for a medical device that organizes, sterilizes, and transports dental surgical instruments. It is not an AI/ML powered device, and therefore the majority of the requested information (related to AI model performance, training data, ground truth, expert adjudication, etc.) is not applicable to this document.

The document primarily addresses the device's functionality related to steam sterilization.

Here's the relevant information that can be extracted:

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

The document provides information on the validated sterilization parameters. It doesn't present a table with explicit "acceptance criteria" versus "reported performance" for the device itself in the typical sense of a diagnostic or predictive AI model. Instead, it describes the conditions under which the device's sterilization function was validated.

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

• Sample size: Not explicitly stated in terms of a "test set" for performance evaluation in the context of AI. The validation was likely performed on representative samples of the surgical trays following established sterilization protocols.
• Data provenance: Not explicitly stated. However, the validation was "completed by" the manufacturer, Sweden & Martina S.p.A., and is part of their submission to the FDA. The tests would have been performed in a laboratory or clinical setting to a recognized standard.

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 typically established. The "ground truth" here is adherence to sterilization standards and physical integrity of the device after sterilization.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device 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.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device relates to the effectiveness of sterilization and the structural integrity of the trays after undergoing the specified sterilization cycles. This would be established through:

• Microbiological testing: E.g., using biological indicators or process challenge devices (PCDs) to confirm sterility after the cycle.
• Physical and functional integrity testing: Inspecting the trays for damage, deformation, or impaired function after repeated sterilization cycles.
• Adherence to recognized standards: Compliance with international or national standards for sterilization (e.g., ISO, AAMI).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable.

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SWEDEN & MARTINA SURGICAL TRAY (Model "ZSHORTY-INT") is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.

The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 ℃ (273 ℃) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

The validated load weight is 230 grams.

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The provided text is related to an FDA 510(k) clearance for a surgical tray. It discusses regulatory matters, product classification, and indications for use. It does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a medical device (a surgical tray) and not on the performance evaluation of an AI-powered or diagnostic device that would typically have acceptance criteria and associated study details as outlined in your prompt.

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PRAMA White Implant Systems are intended for both one- and two-stage surgical procedures. PRAMA White Implant Systems, endosseous implant and abutments, 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. PRAMA White Implant Systems are intended to be used in fully edentulous or partially edentulous maxillary and/or mandibular arches.

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This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental implant system (PRAMA White Implant Systems), which primarily details the regulatory approval of the device and its intended use.

Therefore, I cannot provide the requested information.

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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.

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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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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 Implant Systems-SHELTA Implant Systems (Premium TG, Premium TG, Premium SP, Shelta and Shelta SL) 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.

Not Found

The provided document is an FDA 510(k) clearance letter for dental implant systems. It does not contain information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or multi-reader studies). The letter primarily addresses the substantial equivalence determination for the device based on its indications for use.

Therefore, I cannot provide the requested information from this document. The document focuses on regulatory approval rather than technical performance studies.

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EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CCP in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250.

EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP using the EliA IgG method.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to one month on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to be measured in defined ranges to check whether the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

This document is a 510(k) summary for the EliA™ CCP and EliA™ CCP Control devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the sense of clinical performance metrics like sensitivity, specificity, etc., against a defined ground truth.

However, based on the provided text, we can extract information relating to the "study" conducted for equivalence.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, Axis-Shield Diastat Anti-CCP (510(k) number: K023285). The reported "performance" relates to the comparability study.

Study Details

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "a data set" for comparability but does not provide specific numbers for the comparison study, clinically defined sera, or apparently healthy subjects.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinically defined sera" and "samples from apparently healthy subjects," which implies human samples, but details are missing. It is likely retrospective, as it involves comparing the new device's results with an existing predicate, and "clinically defined sera" suggest samples with known diagnoses.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. This type of device (an in-vitro diagnostic for antibodies) primarily relies on the predicate device's established performance as the benchmark for "ground truth" in an equivalence study, rather than expert consensus on images or clinical assessments for the test set itself. The "clinically defined sera" would have their ground truth established by established clinical diagnostic criteria for rheumatoid arthritis (RA).

3. Adjudication method for the test set: Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically for subjective assessments (e.g., image interpretation). For an immunoassay, the readouts are quantitative or semi-quantitative and are directly compared.

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. This is an immunoassay device, not an AI-powered diagnostic that assists human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself, EliA™ CCP, is a standalone in-vitro diagnostic immunoassay system. It performs its measurement and provides results without human interpretive assistance in the direct measurement process, though human interpretation of the results in conjunction with clinical findings is required for diagnosis. The study described is a standalone performance comparison.

6. The type of ground truth used:

   • For the comparability study against the predicate device, the "ground truth" for the new device's performance is essentially the results obtained from the predicate device.
   • For the clinically defined sera, the ground truth would be the established clinical diagnosis of rheumatoid arthritis (RA) or healthy status, likely based on a combination of clinical findings, established diagnostic criteria (e.g., ACR/EULAR criteria for RA), and other laboratory tests.
   • For samples from apparently healthy subjects, the ground truth is their healthy status.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. It's a biochemical assay.

8. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this type of device.

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The Varelisa ReCombi CTD Screen EIA kit is designed for the qualitative determination of ten antinuclear antibodies in human serum or plasma to aid in the diagnosis of systemic rheumatic diseases such as SLE (systemic lupus erythematosus), drug-induced lupus, scleroderma (progressive systemic sclerosis), MCTD (mixed connective tissue disease), SS (Sjögren's syndrome) and polymyositis/dermatomyositis. The Varelisa ReCombi CTD Screen detects antibodies against dsDNA, RNP (RNP70,A,C), Sm (B,B',D), SS-A/Ro(52 kDa,60 kDa), SS-B/La, Scl-70, CENP-B, Histone, Ribosomal P Protein and Jo-1 in a single microwell.

The new device is an enzyme-linked immunosorbent assay (ELISA) using microtiter plates as the solid phase. The plate wells are coated with antinuclear antigens, which allow anti-nuclear antibodies (sample) to react with the immobilized antigens. The conjugate is rabbit anti-human IgG horseradish peroxidase (HRP), which uses 3, 3'5, 5' tetramethylbenzidine dihydrochloride (TMB) as substrate. The kit contains calibrator and negative control. The kit also contains sample diluent, wash buffer concentrate and stop solution.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Varelisa ReCombi CTD Screen, organized according to your requested information:

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "sensitivity must be > X%" or "specificity must be > Y%") for the Varelisa ReCombi CTD Screen. Instead, the study aims to demonstrate laboratory equivalence and substantial equivalence to a predicate device (Varelisa® ReCombi ANA Screen K993108). The performance metrics reported are focused on the agreement between the new device's results and clinical definitions of samples, compared to the predicate device.

Implicit Acceptance Criteria (based on the provided information):

• Substantial Equivalence: The primary "acceptance criterion" is to demonstrate substantial equivalence to the predicate device. This is achieved through comparability in intended use, assay principle, and performance characteristics.
• Comparable Performance: The agreement rates for both positive (CTD) and negative (control) samples should be comparable to the predicate device, with differences falling within acceptable confidence intervals (though specific thresholds for these intervals are not explicitly stated as acceptance criteria). The presented data suggests the differences are deemed acceptable for substantial equivalence.
• "Performs according to state-of-the-art expectations": This is a qualitative statement in the summary implying that the device's overall performance is considered modern and effective for its purpose.

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

• Test Set Size:
  • Clinical Samples: 183 CTD (Connective Tissue Disease) samples.
  • Control/Negative Samples: 100 disease controls, plus "samples from apparently healthy subjects (normal population)" (specific number not given for the normal population, but the "100 disease controls" are used for the negative agreement calculation).
  • Total: At least 283 samples (183 CTD + 100 disease controls). The text also mentions "clinically defined sera and for international reference sera" and "samples from apparently healthy subjects (normal population)," suggesting the reported numbers might be a subset of a broader validation set.
• Data Provenance: Not explicitly stated, but the manufacturer is based in Germany, implying the study could have been conducted there or in collaboration with other European institutions. The mention of "international reference sera" suggests a diverse set of samples. The study appears to be retrospective, as it analyzed "results obtained for clinically defined sera."

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

The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth. It refers to "clinically defined sera" and "clinical definitions of samples," implying that the ground truth for CTD status (positive/negative) was established through clinical diagnosis, likely by physicians or rheumatologists, based on a comprehensive set of clinical criteria, medical history, and other diagnostic tests.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described. Given that the ground truth is derived from "clinical definitions," it likely represents a consensus clinical impression rather than a specific adjudication process between multiple readers of the assay results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed. This device is an in vitro diagnostic (IVD) kit for lab testing, not an AI-assisted diagnostic tool that helps human readers interpret images or complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The reported "Agreement (%)" for both positive and negative samples (87.4% and 79.0%, respectively) represents the performance of the Varelisa ReCombi CTD Screen itself when tested against clinically defined samples, without human intervention in the result interpretation beyond standard lab protocols for reading ELISA plates (e.g., using a microplate reader). The ELISA kit itself is the "algorithm" in this context.

7. Type of Ground Truth Used

The ground truth used was clinical definitions/diagnosis of systemic rheumatic diseases. The text mentions "clinically defined sera" and "clinical definitions of samples," indicating that the diagnosis of CTD (or lack thereof for control samples) was established through medical evaluation of patients.

8. Sample Size for the Training Set

The document does not specify a training set size. This is common for traditional IVD kits as their development often involves iterative optimization and validation rather than a distinct "training set" in the machine learning sense. The "development" of the new device is mentioned in comparison to the predicate, implying an engineering and chemistry-focused development process rather than algorithmic training.

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

Since a specific "training set" is not mentioned, the method for establishing ground truth for such a set is also not specified. If any internal validation or optimization was done during development, the ground truth would likely have been established similarly to the test set: through clinical definitions and classification of samples.

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