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ZENEX Implant System Long is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

ZENEX Implants in the 20 mm length when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

ZENEX Implant System_Long is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.

The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).

There are 2 types of fixtures, and the dimensions are as following:

The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.

ZENEX Implant System_Long is provided sterile, and valid for 5 years.

This document describes a 510(k) premarket notification for the ZENEX Implant System Long, an endosseous dental implant. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on non-clinical testing and comparisons to predicate devices, rather than a study proving the device meets acceptance criteria in a clinical setting.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence based primarily on non-clinical testing, there isn't a direct "acceptance criterion" table in the sense of clinical performance metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are the successful completion of various non-clinical tests according to established standards, demonstrating that the new device is as safe and effective as the predicate devices.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of a clinical study. For non-clinical tests:
  • Fatigue Testing: The number of implant samples subjected to fatigue testing according to ISO 14801 is not specified (e.g., "n="). The standard usually specifies minimum sample sizes.
  • For other tests (Biocompatibility, Sterilization, Shelf Life, Bacterial Endotoxin, Surface Modification), the sample sizes are not provided as these were either leveraged from the predicate device or conducted per standard protocols without explicit counts in this document.
• Data Provenance: The document generally refers to "non-clinical testing data." Specific countries of origin for the non-clinical testing are not provided. The main submitter (Izenimplant Co., Ltd.) is from the Republic of Korea. The testing itself would typically be performed by accredited labs. The studies were retrospective in the sense that data from already cleared predicate devices were leveraged. The fatigue testing for the subject device was newly performed, making it prospective for that specific test on the new design.

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 in this context. Since this is a 510(k) submission based on non-clinical testing for substantial equivalence, there is no "ground truth" derived from expert clinical assessment of patient data (e.g., radiologists interpreting images) for a "test set" in the way it would be for an AI/CADe device. The "ground truth" for non-clinical tests is established by adhering to recognized international standards and laboratory protocols.

4. Adjudication Method for the Test Set

This information is not applicable. There was no "test set" in a clinical diagnostic sense requiring expert adjudication. Non-clinical tests typically involve objective measurements according to defined 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

This information is not applicable. The device is an endosseous dental implant, not an AI or CADe diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

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

This information is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

For non-clinical tests, the "ground truth" is defined by the established international or national standards and protocols for each test (e.g., ISO 14801 for fatigue testing, ISO 10993 for biocompatibility). The results are compared against these benchmarks or against the performance of predicate devices tested under the same conditions.

8. The Sample Size for the Training Set

This information is not applicable. The device is an endosseous dental implant. There is no concept of a "training set" as would be used for machine learning models.

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

This information is not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.

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Ti Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with Ti Link Abutment are intended to be manufactured at a Izenimplant validated milling center.

The Ti Link Abutment is a two-piece abutment intended to provide support for restorations such as crowns and bridges. The two pieces which compose the final abutment consist of the pre-manufactured titanium base component composed of titanium alloy conforming to ASTM F136, and the CAD/CAM patient matched mesostructure composed of zirconia (K091096). The diameters of the premanufactured titanium base component are 4.0/4.5mm. The final two-piece abutment is fixed to the implant with an abutment screw composed of titanium alloy conforming to ASTM F136. Ti Link Abutment is provided non-sterile, therefore must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component.

The abutments are compatible with the implants cleared under K211090.

The CAD/CAM patient matched mesostructure that is added to the pre-manufactured titanium base component to create the final abutment design should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Ti Link Abutment. The coping would be manufactured by Izenimplant only with design input using CAD/CAM Software from and by Izenimplant milling center.

CAD/CAM patient matched mesostructure is made from NaturaZ (K091096) and is cemented to the pre-manufactured titanium base component using RelyX cement (K110508) to complete the final finished abutment.

This document, a 510(k) Premarket Notification from the FDA, concerns the "Ti Link Abutment" device, an endosseous dental implant abutment. It aims to demonstrate the device's substantial equivalence to previously cleared predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets those criteria for software or AI-based medical devices. This is a hardware dental implant abutment, and the "testing" performed is for mechanical and biocompatibility properties, not algorithmic performance.

Therefore, many of the requested points related to AI/software study design (sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific FDA submission document.

However, I can extract and present the information that is relevant to the document regarding the device's acceptance criteria and the studies performed:

Acceptance Criteria and Study for Ti Link Abutment (Hardware Device)

Since this is a hardware device (dental implant abutment) and not an AI/software device, the concept of "acceptance criteria" and "performance" is based on mechanical, material, and biocompatibility standards rather than algorithmic metrics like accuracy, sensitivity, or specificity.

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 in terms of number of manufactured units tested for the fatigue, sterilization, and cytotoxicity tests. These types of tests typically follow specific ISO/ASTM standards that dictate sample sizes based on statistical methods or industry practice, but the exact numbers are not detailed in this summary.
• Data Provenance: The tests were conducted for the subject device. Biocompatibility test data was "leveraged" from a predicate device (K211090), which is owned by the applicant. This implies in-house or contracted lab testing for the subject device-specific tests, and prior testing data for the predicate. No information about country of origin for the data is provided, but it's likely originating from the manufacturer's region (Republic of Korea, as per submitter address) or contract laboratories they engaged.
• Retrospective/Prospective: The testing described (Fatigue, Sterilization, Cytotoxicity, Biocompatibility) are prospective tests specifically conducted to support this 510(k) submission.

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

• Not Applicable. This document pertains to the physical and material properties of a dental device, not an AI or software device requiring human expert annotation for ground truth. Ground truth for these tests is established by objective measurements against engineering standards (e.g., force applied, temperature, cell viability, chemical composition).

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human expert reviewers establishing observational data, there is no need for an adjudication method. Test results are typically objective measurements.

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

• No. This type of study is relevant to AI/software performance with human users. It is not applicable to a hardware dental abutment.

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

• Not Applicable. This is a hardware device; there is no standalone algorithm to evaluate.

7. The Type of Ground Truth Used:

• For mechanical, sterilization, and cytotoxicity tests: The ground truth is defined by the acceptance criteria of the relevant ISO, ASTM, and ANSI/AAMI standards. For example, the fatigue test ground truth is whether the device withstands a specified number of cycles at a specific load without failure, as per ISO 14801. Cytotoxicity is measured against living cell responses.
• For material composition: Ground truth is established by material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI).
• For biocompatibility: Ground truth is established by the safety profiles defined in the ISO 10993 series for medical device biological evaluation.

8. The Sample Size for the Training Set:

• Not Applicable. This is a hardware device; there is no AI/ML model with a "training set." The CAD/CAM design process does not involve machine learning in this context; it refers to computer-aided design and manufacturing.

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

• Not Applicable. No training set exists for this hardware device.

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The ZENEX Implant System_Short is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ZENEX Implant System Short are intended to be used in the molar region.

ZENEX Implant System_Short is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost. The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).

This is a premarket notification (510(k)) for the ZENEX Implant System Short, a dental implant device. The provided text describes the device, its intended use, and comparative information against predicate devices to demonstrate substantial equivalence. However, it does not contain acceptance criteria for device performance nor a study that directly proves it meets those criteria in the way you've outlined for an AI/software device.

Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (TS Implant System, K121585) and leveraging testing from a reference predicate (Zenex Implant System, K211090) through a series of non-clinical bench tests and analyses. These tests are designed to show that the new device is as safe and effective as the predicate, not to report on clinical performance or AI algorithm metrics.

Therefore, many of the requested points in your template are not applicable or cannot be extracted from this document, as it's not a study evaluating an AI algorithm's performance against specific acceptance criteria with ground truth.

Here's an attempt to answer your questions based on the provided text, while also noting what information is not present given the nature of this 510(k) submission:

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

The document does not present a table of specific acceptance criteria for clinical performance metrics (like sensitivity, specificity, or F1 score) that would be relevant for an AI device, nor does it report device performance in that manner. Instead, the "performance" discussed relates to meeting engineering and biocompatibility standards to demonstrate substantial equivalence to a predicate device.

The "acceptance criteria" are implicitly meeting the standards of the referenced ISO and ASTM guidelines for non-clinical testing. The "reported device performance" is that the device met these standards and demonstrated substantial equivalence.

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

• Test Set Sample Size: Not applicable in the context of an AI study. The "test set" here refers to the physical samples of the device used in bench testing. The specific number of physical implants or components tested for each non-clinical test (e.g., fatigue, shelf-life) is not detailed, beyond stating "worst-case scenario" constructs were tested.
• Data Provenance: Not applicable for an AI study. The testing is non-clinical/bench testing performed on physical devices.

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

Not applicable. This is a physical dental implant, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is a physical dental implant, not an AI algorithm study requiring adjudication of expert opinions.

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 a physical dental implant, not an AI algorithm. The text mentions "MR Environment Condition" but this refers to Magnetic Resonance (MR) safety, not Multi-Reader Multi-Case (MRMC) studies.

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

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

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

Not applicable. For this device, "ground truth" would be established by physical measurements, material properties, and biological responses according to established standards (e.g., ISO, ASTM, biocompatibility guidelines), rather than expert consensus on diagnostic images or pathology.

8. The sample size for the training set

Not applicable. This is a physical dental implant, not an AI algorithm that undergoes training.

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

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

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The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.

ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:

K number: K211090
Device Name: ZENEX Implant System (ZENEX MULTI&PLUS Fixture)
Dimension Ranges: Diameter 3.75 x 8.5, 10, 11.5, 13, 15; Diameter 4.25 x 7, 8.5, 10, 11.5, 13, 15; Diameter 4.6 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.05 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.4 x 7, 8.5, 10, 11.5, 13; Diameter 5.9 x 7, 8.5, 10, 11.5, 13; Diameter 6.75 x 7, 8.5, 10, 11.5, 13

Tolerance of dimension shall be within ± 1% range.

The dimensions of abutments are as following:

Device Name: FreeMilling Abutment
Dimension Ranges: Diameter 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0
Gingival Heights (mm): 1.3/1.8/2.8/3.8
Minimum Post height (mm): 4
Angulation: 0°

Device Name: CCM Cast Abutment
Dimension Ranges: Diameter 4.0 / 4.5
Gingival Heights (mm): 0.8 / 2.8
Minimum Post height (mm): 4
Angulation: 0°

The Abutments have below featured:

Name: FreeMilling Abutment
Uses: The Abutment is connected with fixture, and it supports prosthesis which restores tooth function.
Surface: Partial TiN coated in upper
Connection: Screw retained

Name: CCM Cast Abutment
Uses: It is an abutment that is used when making a retained / customized prosthesis.
Surface: NA
Connection: Screw retained

Tolerance of dimensions for Abutments shall be within ± 1% range.

ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.

Materials:

• FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13
• CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11

I'm sorry, but your prompt asks for details about acceptance criteria and a study proving device performance, including a table of acceptance criteria and reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC study information, standalone performance, and training set details.

However, the provided text is a 510(k) summary for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a primary clinical or non-clinical performance study. It mentions non-clinical test data for biocompatibility and sterilization, but it doesn't present performance metrics against specific acceptance criteria in the format you've requested for a device that relies on a performance study to prove its criteria.

The 510(k) summary establishes equivalence based on:

1. Indications for Use: Same as predicate.
2. Technological Characteristics: Similar design, dimensions (with minor, deemed non-critical differences), materials, and sterilization methods.
3. Non-Clinical Test Data: Biocompatibility and sterilization (often leveraged from predicate devices or performed according to recognized standards).

Therefore, I cannot extract the specific information you've requested about acceptance criteria and a study proving those criteria from the given text. The document's purpose is to argue substantial equivalence, not to present a standalone performance study with detailed acceptance criteria and results.

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The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.

The document details:

• Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
• Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
• Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
• Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
• Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.

There is no information in this document about:

1. Acceptance criteria for an AI/ML device.
2. Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
3. Sample sizes for test sets in an AI/ML study.
4. Data provenance for an AI/ML study.
5. Number or qualifications of experts for AI/ML ground truth.
6. Adjudication methods for AI/ML ground truth.
7. MRMC comparative effectiveness study results for AI/ML.
8. Standalone performance of an AI/ML algorithm.
9. Type of ground truth used for an AI/ML study.
10. Sample size for the training set of an AI/ML model.
11. How ground truth for the training set was established for an AI/ML model.

This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.

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ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region

ZENEX Implant System is consisted with ZENEX Fixtures (ZENEX MULTI Fixture and ZENEX PLUS Fixture) and Izenimplant Abutment System. The implant fixtures come in two unique systems, the I-System and the T-System, each with their own abutment compatibilities.

1. ZENEX Fixtures: This product is a dental implant which is put into the alveolar bone in order to support, or maintain the prosthetic tooth or denture when a patient's teeth are partially lost. To enhance the osseointegration with the alveolar bone, this titanium dental implant is treated with SLA surface. As a dental implant which is put into the alveolar bone to support the dental prostheses such as the artificial teeth which are used to rehabilitate a patient's masticatory function, it is used as a substructure which is implanted into the human body. This product is a dental implant fixture to be inserted into the bone and is intended to be used in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations. It is connected to the upper structure with Internal Hex fastening structure. In the surface treatment, machined surface was sanded with alumina (Al2O3) powder and acid (hydrochloric acid, sulfuric acid) etching process was applied to the surface to increase the contact surface with the bone. ZENEX PLUS is a design that adds a micro-groove at the collar compared to ZENEX MULTI.

2. Izenimplant Abutment System: Izenimplant Abutment System is compatible with the ZENEX Fixtures (ZENEX MULTI Fixture, ZENEX PLUS Fixture). Izenimplant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Separate sets of abutments are presented for compatibility with each I-System and T-System. Some subject abutments undergo Titanium Nitride (TiN) coating. Dental Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

The provided text is a 510(k) Summary for the ZENEX Implant System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technical characteristics rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-enabled device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-enabled device. The questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this document describes a traditional medical device (dental implant).

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted on the dental implant system (e.g., sterilization validation, packing validation, biocompatibility, mechanical properties, surface treatment, endotoxin batch test). The acceptance criteria for these tests are typically defined by recognized standards (e.g., ISO, ASTM, FDA guidance documents) rather than specific metrics like sensitivity or specificity for an AI algorithm.

Summary of what is present:

• Acceptance Criteria for Non-Clinical Testing: The document states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the acceptance criteria are adherence to the relevant ISO, ASTM, and FDA guidance documents for each specific non-clinical test (e.g., ISO 11137 for sterilization validation, ISO 10993 for biocompatibility, ISO 14801 for fatigue testing).
• Reported Device Performance: The document confirms that "the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the subject devices." It lists various tests performed:
  • Sterilization Validation (Gamma and User Moist Heat)
  • Packing Validation (Shelf-life and Integrity)
  • Biocompatibility Test (ISO 10993-1, 10993-5, FDA Guidance)
  • Performance (Mechanical properties, Fatigue testing per ISO 14801)
  • Surface Treatment Test (SEM, EDS, ICP, IC analysis for SLA; thickness, abrasion, roughness for TiN coating)
  • MR Environment Condition review
  • Endotoxin Batch Test (USP, USP, ANSI/AAMI ST72)
• No ML/AI Component: The device is a dental implant system. There is no mention of any AI or machine learning component, therefore the subsequent questions about AI/ML specific study designs are not relevant.

The requested table and other specific information related to an AI/ML device would be empty or inapplicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):

Inapplicability of AI/ML-specific questions:

2. Sample size for the test set and data provenance: Not applicable. This refers to physical device testing, not data-driven model evaluation.
3. Number of experts and qualifications for ground truth: Not applicable for non-clinical lab testing.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable. Ground truth for a physical device is established by validated measurement techniques and adherence to engineering and material standards.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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