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The TITANEX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX® Screw Systems contain cannulated bone screws and general instrumentation as a reconstruction solution for foot and ankle applications. The screws are provided in various diameters and lengths with headed, headless, partially, and fully threaded configurations. The implants are composed of titanium alloy. The instrumentation are composed of stainless steels. The devices are provided non-sterile and are intended to be steam sterilized prior to use.

I am sorry, but the provided text from the FDA 510(k) Premarket Notification does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-based medical device.

The document pertains to the "TITANEX® Screw Systems," which are metallic bone fixation fasteners, and focuses on demonstrating substantial equivalence to already marketed predicate devices. The non-clinical tests performed (e.g., torsional properties, driving torque, axial pullout strength, sterilization, biological evaluation) are typical for mechanical orthopedic implants.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualification of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone AI performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample size.
9. Ground truth establishment method for the training set.

This information is not present in the provided document because the device in question is a physical orthopedic implant, not an AI/ML-based diagnostic or therapeutic device.

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The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

The key performance characteristics of this applicator set are as follows:

• . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
• 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
• The tandems and the pivot assembly are made from strong, lightweight titanium.
• Four different ovoid sizes to allow for varying anatomy.
• . Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
• . Ability to image the patient using CT imaging.
• Ability to image the patient using MR imaging.
• Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
• . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
• Can be manually or machine cleaned, disinfected and steam sterilizable.
• Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
• Suitable for patient contact for a period of less than 30 days

This document is a 510(k) Premarket Notification for the Titanium Flexible Geometry FSD Applicator Set (GM11013400). It does not describe an AI/ML powered device. The information provided focuses on the substantial equivalence to a predicate device through non-clinical performance testing. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, etc.) are not applicable to this submission.

Here is the information that can be extracted relevant to the performance and acceptance criteria for this medical device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission concerns a physical medical device (applicator set), not an AI/ML model for data-driven analysis. Performance testing likely involved physical prototypes or units, but specific "sample sizes" in the context of data analysis are not presented.
• Data Provenance: Not applicable in the context of clinical data used for AI/ML development. The testing described is non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, mechanical, human factors).

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

• Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the type of device and testing described. The "ground truth" for this device's performance is established by objective engineering and safety standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication is typically for resolving discrepancies in expert labels for AI/ML ground truth.

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

• No. This is not an AI-powered device.

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

• No. This is not an AI-powered device.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is based on objective engineering standards, regulatory requirements, and validated test methods. This includes:
  • Compliance with ISO 10993 for biocompatibility.
  • Compliance with ASTM standards for MR compatibility.
  • Demonstrated effectiveness for cleaning, disinfection, and sterilization.
  • Usability verification through human factors studies (IEC 62366).
  • Verification and validation against design specifications and risk management (21 CFR §820, ISO 13485, ISO 14971).

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.

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The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy.

The Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.

The Titanium Fletcher-style Applicator Set – Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.

The Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.

This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use.

The provided text describes a 510(k) premarket notification for a medical device, the "Titanium Fletcher-Style Applicator Set Defined Geometry" and "Smit Cervical Sleeves" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/software-based device meets specific acceptance criteria through a clinical study.

The acceptance criteria and study information requested in your prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth types for training/test sets) are highly relevant for AI-powered medical devices (software as a medical device - SaMD). However, this 510(k) submission is for a physical medical device used in brachytherapy, not an AI or software device.

Therefore, many of the specific questions in your prompt are not applicable to this non-AI medical device submission. The document details the device's technical specifications, intended use, indications for use, and a comparison to a predicate device to argue for substantial equivalence. The "performance testing" mentioned is primarily non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, human factors, mechanical/acoustic testing), focusing on the device's physical properties and safety, not its diagnostic or therapeutic performance in a statistical sense that would require large clinical studies with ground truth derived from experts or pathology.

Here's a breakdown based on the provided text, addressing the points where information is available and noting where it's not applicable:

Acceptance Criteria and Device Performance (for a non-AI physical device)

The concept of "acceptance criteria" for this type of physical device is framed around demonstrating that its design and performance characteristics are equivalent to or do not raise new questions of safety and effectiveness compared to a legally marketed predicate device. The "performance" is primarily assessed through non-clinical laboratory testing to ensure physical integrity, material compatibility, and functionality within its intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred for a non-AI device through a 510(k))

Study Information (as applicable to a non-AI physical device 510(k) submission):

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

   • N/A (for clinical performance data): This is a submission for a physical device, not an AI/software device requiring a clinical test set for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to non-clinical lab tests (biocompatibility, MR, mechanical, sterilization, human factors).
   • For the non-clinical tests (e.g., sterilization cycles, human factors study), the sample size would be determined by the specific ISO/ASTM standards referenced, but typically isn't a large "test set" in the sense of clinical cases. The document does not specify these sample sizes.
   • Data Provenance: Not applicable in the context of clinical data for a physical device. Testing is conducted in a laboratory environment, not on patient data from specific countries.

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

   • N/A: Ground truth established by medical experts is not listed as a component of this non-AI device's performance testing for 510(k) clearance. The device's "performance" is assessed through engineering testing against physical and safety standards and comparison to a predicate.

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

   • N/A: Not applicable as there is no clinical test set requiring expert adjudication for accuracy or performance.

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

   • No: This is not an AI-powered device, so an MRMC study comparing human performance with and without AI assistance was not conducted.

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

   • N/A: This is a physical medical device, not an algorithm.

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

   • N/A: "Ground truth" in the sense of clinical reference standards (pathology, expert consensus) is not applied to this type of 510(k) submission for a non-AI physical device. The "truth" or reference is established by engineering specifications, material standards, and functional test results (e.g., "does it sterilize correctly?", "is it MR compatible?").

7. The sample size for the training set:

   • N/A: This is not a machine learning/AI device, so there is no training set in the AI sense.

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

   • N/A: Not applicable.

In summary: The provided document is a 510(k) letter for a physical brachytherapy applicator set, demonstrating substantial equivalence to a predicate device. The regulatory pathway for such devices involves rigorous non-clinical testing (e.g., material testing, mechanical testing, sterilization validation) and a comparison of technical characteristics to a predicate, rather than large-scale clinical performance studies or AI-specific validation methods outlined in your prompt.

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The TitanPico Laser Workstation is indicated for the following at the specified wavelength:

532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

TitanPico Laser Workstation is a laser system that delivers energy in the 532nm and 1064nm wavelength. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed.

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device. Therefore, much of the requested information regarding specific acceptance criteria, study design, and performance metrics for the proposed device is not explicitly stated in the provided text.

However, based on the document, I can extract information related to the comparison with the predicate devices and the non-clinical tests performed to demonstrate substantial equivalence.

Here's a breakdown of the information available and what is not explicitly stated in this FDA submission:

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

The document does not explicitly define "acceptance criteria" in the sense of quantitative performance targets for the new device itself. Instead, it aims to show substantial equivalence to predicate devices by comparing technical specifications. The "reported device performance" is mainly shown through the comparison table to the predicates and the assertion that non-clinical tests met standards.

Indications for Use (TitanPico Laser Workstation):

• 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat red, yellow, and orange tattoo colors.
• 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat black, brown, green, blue, and purple tattoo colors.
• Also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

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 states that no clinical tests were performed for the proposed device. The company "believes that the proposed device TitanPico Laser Workstation products does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference."
• Therefore, there is no explicit test set sample size or data provenance provided for the proposed device in this submission. The "test set" in this context refers to non-clinical bench tests.

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

• Not applicable, as no clinical tests were performed for the proposed device and therefore no ground truth was established by experts for a test set. Non-clinical tests typically rely on established engineering and safety standards.

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

• Not applicable, as no clinical tests or expert interpretation of results for a test set were conducted. Non-clinical tests are evaluated against predefined physical and engineering standards.

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 laser workstation, not an AI-assisted diagnostic or interpretation system. No MRMC study was performed.

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

• Not applicable. This device is a hardware laser system. The "software verification and validation" mentioned refers to the device's control software, not a standalone diagnostic algorithm.

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

• For the non-clinical tests, the "ground truth" is adherence to established international and national standards for medical electrical equipment, laser safety, and biocompatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, ISO 10993 series). Performance was assessed against the specifications of these standards and the equivalence to the predicate devices.
• For the clinical effectiveness implied by substantial equivalence, the ground truth would have been established through the clinical studies conducted for the predicate devices, which are not detailed in this submission.

8. The sample size for the training set

• Not applicable, as this is a hardware device and not an AI/machine learning system that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

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Titan Dental Design is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of Titan Dental Design requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software. This software is for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients. The Titan Dental Design software allows users to upload digital scans of patient's dentition to the system, manipulate and move teeth in the dentition scan to create treatment plans for malocclusion, and export or send treatment planning files for physical production of orthodontic appliances such as thermoplastic aligners with the use of 3D printers.

The provided text is a 510(k) summary for the "Titan Dental Design" software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study, especially not one that involves human readers or clinical outcomes.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and performance metrics (especially those related to AI assistance or standalone performance) are not present in this document.

This document describes a software device that provides tools for managing orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options. It is not an AI-assisted diagnostic tool in the sense of detecting or identifying conditions from medical images, which is typically where the detailed performance metrics you've asked for (e.g., sensitivity, specificity, MRMC studies) are most relevant. This software is more of a design and planning tool for orthodontists.

Here's what can be extracted and what cannot:

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

The document does not provide a formal table of quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, or precision), nor does it report specific numerical performance data against these criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing indications for use, technological characteristics, and stating that software validation testing was successfully performed.

The "Summary of Performance Data and Substantial Equivalence" section states:
"Utilizing FDA Guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (issued May 11, 2015) the Proposed Device, Titan Dental Design underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use."

This is the reported "performance" - a qualitative statement confirming it "passed testing" and "performed per its intended use," rather than specific quantitative metrics.

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

The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing.

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

The document does not mention the use of experts to establish a "ground truth" for a test set, as its validation appears to be primarily software-centric (integration, verification, validation) rather than based on a clinical performance study with human readers.

4. Adjudication method for the test set

Not applicable, as no clinical test set with human adjudication is described.

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

No such study is mentioned or implied. This device is described as a "medical front-end device providing tools for management... treatment simulation and virtual appliance design options," not an AI-assisted diagnostic tool that aids human readers in interpretation.

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

The document describes the device as "Stand Alone Software" under "Technological Features," but this refers to the software's operational independence (i.e., it doesn't require other specific hardware or software beyond OS/RAM/CPU) rather than a "standalone performance study" in the context of an AI algorithm's diagnostic accuracy. The entire device functions as "algorithm only" in the sense that it is software, but performance data like sensitivity/specificity are not provided.

7. The type of ground truth used

Not explicitly stated. The validation appears to be against functional requirements and intended use, rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set size, implying that this is not a machine learning model that requires a distinct "training set." It's more of a rule-based or calculational software tool for dental design.

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

Not applicable, as no training set or machine learning components are detailed.

In summary, the provided FDA document is a 510(k) clearance letter and summary for a dental software device that functions as a design and planning tool, not an AI-driven diagnostic or assistive technology. Therefore, it does not contain the detailed performance study information typically found in submissions for AI/ML-based diagnostic devices, such as acceptance criteria based on accuracy metrics, test set characteristics, expert ground truthing, or MRMC study results.

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The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.

The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.

All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.

This document describes the TITANEX™ MICROBEAM Screw System and TITANEX™ ARTEMIS Screw System, comparing them to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to mechanical testing per a standard (ASTM F543-17) and computational analysis, implying that the performance met the requirements set forth by these methods and their associated thresholds. The discussion section states, "the testing supports that these differences do not raise any new questions of safety and effectiveness," indicating successful performance without providing specific numerical results.

However, based on the provided text, we can infer the tested performance aspects:

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 specify the sample size for any of the mechanical or computational tests, nor does it provide information on the data provenance (country of origin, retrospective/prospective).

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

This is a medical device (screw system) that relies on mechanical and computational testing, not diagnostic performance tied to interpretations by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable here. The "ground truth" would be established by the engineering standards and validation protocols used in the mechanical and computational analyses.

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

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., medical image reading). This document describes performance testing of a physical medical device (bone screws) and computational analyses. Therefore, an adjudication method in this context is not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) that involve human interpretation of cases. The TITANEX™ systems are bone fixation screws, and their acceptance is based on mechanical and computational performance, not diagnostic accuracy or human reader performance.

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

This question is not applicable to the TITANEX™ Screw System. The device is a physical implant, not an algorithm. The "standalone performance" here refers to its mechanical integrity and function as a standalone product. The performance data does describe standalone (algorithm-only) performance in the context of the computational analysis, which includes "Cross sectional Analysis" and "Axial Pullout per Chapman et al." These computational models would run independently without human-in-the-loop performance for their execution, although their validation and interpretation would involve human engineers.

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

For the mechanical testing, the "ground truth" would be the physical properties and behavior of the screws measured against established engineering standards and specifications (ASTM F543-17). For computational analysis, the "ground truth" would be the mathematical models and scientific principles (e.g., Chapman et al. for axial pullout) that govern the expected behavior of the device under simulated conditions. It's not expert consensus, pathology, or outcomes data in the traditional medical sense, but rather adherence to validated engineering and scientific principles.

8. The sample size for the training set

The concept of a "training set" is applicable to machine learning or AI models. Since the TITANEX™ Screw System is a physical medical device (bone screws) and not an AI/ML product, there is no "training set."

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

As there is no training set for this device, how its ground truth was established is not applicable.

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The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.

The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.

Here's a breakdown of the acceptance criteria and the study details for the TITAN 3-D Wedge System, based on the provided text. Please note that the document is a 510(k) summary for a medical device (an implant for bone fixation), not an AI/software device. Therefore, many of the requested categories related to AI performance, such as expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Device Name: TITAN 3-D® Wedge System

Device Type: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (Implantable device)

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an implantable device, the acceptance criteria are not for diagnostic performance (like sensitivity/specificity) but rather for safety and mechanical performance. The document describes performance testing related to MR Safety and mechanical properties.

Note: "Pass" implies that the device met the specified requirements of the respective ASTM standards or verified that the changes did not negatively impact safety or effectiveness.

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

The document does not specify a "test set" in the context of patient data or images. Instead, the testing involves physical samples of the device for mechanical and MR safety testing.

• Sample Size for Testing: Not explicitly stated as a number of devices, but implies testing was performed on representative samples for each test (e.g., multiple wedges for mechanical testing, a representative wedge for MR testing).
• Data Provenance: Not applicable as this refers to physical device testing, not clinical data or images from specific countries.

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

Not applicable. This device is an implant, not a diagnostic AI/software tool. Ground truth for its performance is established through standardized laboratory testing (e.g., ASTM standards) conducted by qualified engineers and technicians, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Laboratory test results are typically objective measurements against a standard, not subject to subjective adjudication.

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

No. This is an implantable medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for its evaluation.

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

Not applicable. This is an implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on established engineering principles, material science, and performance standards (e.g., ASTM standards for mechanical properties and MR compatibility). It's scientific measurement and verification against defined criteria, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic study.

8. The Sample Size for the Training Set

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

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

Not applicable. See explanation for #8.

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The Titanium Turbine is intended for the following applications:

Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).

The Titanium Turbine is an air-driven dental handpiece used by qualified dental professionals. The Titanium Turbine is connected to a dental unit via a coupling and uses supplied compressed air to rotate a dental bar attached to its tip at a high speed (380.000-450.000 min-') to enable dental treatment.

Titanium Turbine is mainly made of titanium and can be reused by reprocessing. This device is equipped with a Clean Head System that reduces suck-buck into the head and exhaust line, thereby reducing cross-contamination of the air lines. Titanium Turbine is also equipped with a quick stop system that reduces the time required to stop rotation, thereby improving oral cavity safety, and reducing suck-buck.

The provided text describes the 510(k) premarket notification for a dental handpiece called "Titanium Turbine." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

However, the information requested regarding acceptance criteria and a study proving the device meets the acceptance criteria (specifically related to AI/algorithm performance and human reader studies) is not present in the provided document. This document pertains to a Class I dental handpiece, which is a mechanical device, not an AI or algorithm-driven medical device. Therefore, the concepts of sensitivity, specificity, MRMC studies, human-in-the-loop performance, and ground truth establishment for AI models are not applicable to the information given.

The document focuses on demonstrating substantial equivalence to predicate dental handpieces based on:

• Mechanical and operational characteristics: Head size, weight, head angle, rotation speed, torque, noise level, chuck design, bur type, power, device features (Clean Head System, Quick Stop System).
• Material properties: Coating (DURAGRIP vs. Sand blasting finish/Plasmatec coating), direct/indirect patient contacting materials (Titanium vs. Stainless Steel).
• Sterilization and lubrication: Methods and compatible products.
• Performance testing against established standards: ISO 14457:2017 ("Dentistry Handpieces and motors") and ISO 17665-1:2006 ("Sterilization of health care products - Moist heat").
• Biocompatibility testing: According to ISO 10993-1:2018.

Therefore, I cannot populate the requested table and study details as they are outside the scope of this FDA submission for a mechanical dental device.

Summary regarding the absence of requested information:

• No AI/Algorithm Component: The device, "Titanium Turbine," is a mechanical dental handpiece. It does not involve any artificial intelligence, machine learning algorithms, or image analysis components.
• Acceptance Criteria: The "acceptance criteria" for this device are its compliance with recognized performance standards (ISO 14457, ISO 17665-1) and biocompatibility standards (ISO 10993-1), and demonstrating substantial equivalence to predicate devices based on its physical and functional characteristics. These are not performance metrics like sensitivity/specificity for AI.
• Study Proving Acceptance: The "study" proving acceptance is the series of non-clinical performance and biocompatibility tests conducted according to the listed ISO standards. No clinical study was required for this 510(k).
• Irrelevant Metrics: All the specific points requested (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set ground truth establishment) are relevant to the validation of AI/ML-based medical devices, not mechanical devices like a dental handpiece.

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Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.

The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.

All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.

The subject device is available for NP and RP implant platforms.

The subject device is used by dental healthcare professionals in dental offices and dental laboratories.

The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.

It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.

The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.

This document is a 510(k) summary for the Titanium Abutment Blank Nobel Biocare N1™ TCC. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of "acceptance criteria" for the overall device. Instead, it details various non-clinical performance tests conducted and indicates that the device met established performance specifications. The "reported device performance" is described through the outcomes of these tests.

However, based on the non-clinical test data section and the comparison table (Table 2), we can infer certain performance aspects that were evaluated against reference points (predicates or standards).

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

The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., number of abutments for fatigue testing, or number of software test cases). It refers to tests being conducted on "the worst-case system" for fatigue testing.

The data provenance is internal testing conducted by the manufacturer, Nobel Biocare AB. The document does not specify a country of origin for the data itself, but the submitter is based in Sweden. These are retrospective tests conducted to support the premarket notification.

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

This information is not applicable as the document describes non-clinical engineering and performance testing of a physical and software device, not a diagnostic or AI-driven decision support system requiring expert-established ground truth from patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

An MRMC study was not done. This device is a component for dental implants and does not involve human readers or AI in the context of comparative effectiveness for diagnostic or interpretive tasks.

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

This concept is primarily relevant for AI/ML-enabled diagnostic or decision-support software. While the device utilizes CAD/CAM software, the "standalone performance" in this context refers to the software's ability to accurately design and a milling machine's ability to accurately produce the customized abutment according to the design parameters and restrictions. The "Software verification and End-to-end workflow validation" addresses this by demonstrating that the software ensures applicable restrictions are in place and cannot be modified by the user, and that damage to the connection geometry is avoided during milling. It implicitly assesses the algorithm's performance within the manufacturing workflow.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Cleaning and Sterilization: The "ground truth" is adherence to established FDA guidance and validated protocols.
• Biocompatibility: The "ground truth" is compliance with ISO 10993 standards.
• Fatigue Testing: The "ground truth" is compliance with FDA guidance for dental implants and abutments and demonstrated substantial equivalence to the mechanical properties of predicate devices. This involves mechanical testing to failure or for a specified number of cycles under defined loads.
• Software Verification and End-to-end Workflow Validation: The "ground truth" is the established design parameters, manufacturing specifications, and the functionality requirements for the software (e.g., locking restriction zones, avoiding damage to connection geometry). It's based on engineering specifications.
• MRI Compatibility: The "ground truth" is the established MR Conditional specifications from the referenced K212125 clearance.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device manufactured using a CAD/CAM workflow, not an AI/ML system that requires a "training set" in the conventional sense. The CAD/CAM software would have been developed and validated through its own software lifecycle, but that is distinct from an AI model training set.

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

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

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1. The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
   Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid
   arthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,
   separated from its blood supply or where the surgeon's experience indicates that alternative methods
   of treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not
   acceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:
   Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended for
   cemented use only.
2. The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe
   arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint
   must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is
   necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including
   proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to
   gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of
   screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body
   component is intended for cementless use.
3. The Ascension HRA System is intended for resurfacing of the humeral head due to:
   Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,
   osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:
   Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:
   Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,
   crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

• joint destruction or subluxation visible on x-ray
• resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
  Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone
  stock inadequate.

The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.
There are no other changes proposed in this submission. The following aspects of the devices are not impacted by
the additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.
• Intended Use/Indications for Use
• Contraindications
• Design and Dimensions
• Performance Specifications
• Materials
• Biocompatibility

The provided document is a 510(k) summary for the Smith & Nephew TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), and Katalyst Bipolar Radial Head System (Katalyst).

However, the document does not contain information about an AI/ML-based medical device or any study demonstrating its performance against acceptance criteria. Instead, it focuses on the addition of MR Conditional information to the labeling of existing predicate devices. The "Non-Clinical Performance Data" section describes the testing performed to ensure MR compatibility, which is a different type of performance testing than what would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device from this document. The document describes a traditional medical device submission for orthopedic implants.

To answer your request, if this were a document about an AI/ML device, I would look for sections describing:

• Clinical Performance Study: Details about how the AI/ML model's output was evaluated, often involving a comparison to a ground truth or human expert readings.
• Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, accuracy.
• Acceptance Criteria: Predetermined thresholds for these metrics that the device must meet to be considered effective.
• Test Set Description: Information on the size, source, and characteristics of the data used for testing.
• Ground Truth Establishment: How the definitive diagnosis or finding for the test data was determined (e.g., expert consensus, pathology, long-term follow-up).
• Reader Study Information: If applicable, details about human reader performance with and without AI assistance.

Since the provided document does not contain this type of information, I must state that it is not possible to fulfill the request based on the given input.

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