Search Results

This product is suitable for making invisible orthodontic appliances by additive manufacturing (light curing 3D printing) process. The orthodontic appliance is designed for orthodontic treatment. It uses continuous gentle force to adjust tooth position, correct malocclusion, and maintain the results of completed orthodontic treatment.

It can also be used for printing splints and night guards.

Additively Manufactured Aligner Resin is custom plastic aligner system which are a series of doctor prescribed clear removable aligners that are used as alternative treatment for the alignment of maloccluded or misaligned teeth. This series of aligners gently move the patient's teeth in small increments from their original state to a treated state.

Additively Manufactured Aligner Resin is a light-curing resin used to print orthodontic appliances. The resin is a light yellow transparent liquid. The appliance printed by a 3D printer is de-supported, cleaned and post-cured to obtain an orthodontic appliance that can correct the patient's malocclusion. This product is a light-curing 3D printing resin composed of acrylate resin oligomers and acrylate monomers as well as initiators and additives.

Additive manufacturing (light cured) orthodontic resin is a light cured acrylic resin commonly used in the manufacture of orthodontic appliances. The resin is stored in a black HDPE bottle according to the weight of the resin liquid. The color of the resin is colorless or yellowish liquid, polymerized by UV light at 385 nm or 405 nm.

The provided FDA 510(k) clearance letter details the clearance of an "Additively Manufactured Aligner Resin." This document is for a material, not a diagnostic AI device. Therefore, the information typically requested in a description of an AI device's acceptance criteria and study proving its performance (e.g., sample sizes for test and training sets, number of experts establish ground truth, MRMC studies, standalone performance) is not applicable to this submission.

The acceptance criteria and supporting studies for this material device primarily focus on bench testing (physical and mechanical properties), biocompatibility, sterility, and shelf-life. The purpose of these tests is to demonstrate that the new aligner resin is safe and effective for its intended use, comparable to already marketed predicate devices.

Here's an interpretation of the relevant information provided:

Acceptance Criteria and Performance of "Additively Manufactured Aligner Resin"

As this is a material device, the "acceptance criteria" are based on meeting established international standards for dental materials and demonstrating comparable or superior performance to existing predicate devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing, biocompatibility testing, and shelf-life testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

The primary standard referenced for mechanical characteristics is ISO 20795-2:2013 Dentistry – Base polymers – Part 2: Orthodontic base polymers. The acceptance criteria for each property are implicitly defined by the requirements of this standard, and the device's performance is reported as meeting these requirements or being comparable to predicate devices.

*Note: For Flexural Modulus and Ultimate Flexural Strength, the subject device's performance was statistically significantly higher than the predicate, which is considered an improvement and not an adverse difference in terms of safety or effectiveness for the material properties. For Water Solubility and Sorption, slight differences were observed but all conformed to the ISO standard.

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

The document does not specify the exact sample sizes for each mechanical property test (e.g., number of specimens tested for flexural strength). This level of detail is typically found in the full testing report, not the 510(k) summary. However, tests were conducted as "bench testing" meaning in a laboratory setting. The data provenance is implied to be from the manufacturer's internal testing facilities, Aidite (Qinhuangdao) Technology Co., Ltd., which is based in China. The testing is retrospective in the sense that it's pre-market validation performed on manufactured material samples.

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

This question is not applicable as this is a material device and not an AI or diagnostic device that requires expert-established ground truth for a test set. Ground truth for material properties is established by objective physical and chemical testing methods adhering to international standards (e.g., ISO, ASTM).

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

This question is not applicable as there is no human interpretation or subjective assessment being performed that would require an adjudication method. The testing results are quantitative measurements.

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 question is not applicable. An MRMC study is relevant for diagnostic AI devices where human readers (e.g., radiologists) interpret images with and without AI assistance. This submission is for a dental material.

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

This question is not applicable. There is no algorithm or software for standalone performance evaluation in this material device submission.

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

The "ground truth" for this material device is established by objective, standardized laboratory testing methods against pre-defined specifications and international material standards (e.g., ISO 20795-2:2013). This is analogous to a "gold standard" for material properties.

8. The sample size for the training set

This question is not applicable. This is a material device, not an AI/machine learning model, and therefore does not have a "training set" in the computational sense.

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

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

Ask a specific question about this device

Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-cured resin indicated for the fabrication of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges.

Additive Manufacturing (Light Curing) Crown Bridge Resin is a light-curing, hybrid dental material, composed of methacrylic acid esters, inorganic filler, photoinitiator, organic pigments, inorganic pigments and additives. It is Liquid resin for dental 3D printing of permanent single crowns in the anterior and posterior region, denture teeth, inlays, onlays, veneers and implant crown. It is also used for long-term provisional crowns and bridges. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. For use in Digital Light Processing (DLP)- 3D printers utilizing wavelengths at 385nm or 405nm.

The Subject device is packaged in black plastic bottles made of high density polyethylene (HDPE) according to the weight of the resin liquid.

There are different shades A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, BL1, BL2, BL3, BL4, and the different shades are reflected in the different colors of finished restorations.

The provided FDA 510(k) clearance letter and summary describe a dental resin, not an AI/software as a medical device (SaMD). Therefore, the information required for explaining AI/SaMD acceptance criteria and studies (such as diagnostic performance metrics, reader studies, ground truth establishment, training/test set details, etc.) is not present in this document.

The document focuses on the physical, mechanical, and biocompatibility properties of a dental manufacturing resin. As such, I cannot extract the requested information regarding AI/SaMD performance studies from this provided text.

Here's a breakdown of why the requested information cannot be provided based on the input:

• Device Type: The device, "Additive Manufacturing (Light Curing) Crown Bridge Resin," is a material used for 3D printing dental restorations. It is not an AI algorithm or software.
• Study Type: The studies performed are bench tests (Non-clinical Test Conclusion) evaluating material properties (e.g., flexural strength, water sorption, biocompatibility) against established ISO standards, and shelf-life testing. These are not studies to prove the performance of an AI model.
• Acceptance Criteria & Performance: The acceptance criteria are explicitly tied to physical and mechanical properties (e.g., Flexural Strength ≥ 50 MPa as per ISO 10477:2020), not diagnostic accuracy or other AI-related metrics.
• Missing Information Related to AI/SaMD: All specific points requested in your prompt (sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, effect size) are entirely absent because they are not applicable to the clearance of a dental resin material.

In summary, the provided document does not contain the information necessary to describe the acceptance criteria and study that proves an AI/SaMD device meets its acceptance criteria. The document pertains to a physical dental material, not an artificial intelligence product.

Ask a specific question about this device

The ADDNOX is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The provided text describes a 510(k) premarket notification for the ADDNOX device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). However, it explicitly states:

"No clinical testing was performed on the device."

This means that the submission does not include a study demonstrating device performance against specific acceptance criteria. The clearance for ADDNOX is based on its substantial equivalence to a legally marketed predicate device (SMILE) and non-clinical data (biocompatibility, electrical safety, performance, and software tests).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, nor can I provide information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical study, as these were not part of this 510(k) submission.

The document focuses on demonstrating that the ADDNOX has similar technological characteristics and performs as safely and effectively as the predicate device through non-clinical testing and comparison.

Ask a specific question about this device

Additively Manufactured Denture Resin is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.

Additively Manufactured Denture Resin is intended for continuous use in the oral environment, exclusively for professional dental work.

Additively Manufactured Denture Resin can be used in combination with a DLP 3D printers utilizing wavelengths at 385nm or 405nm. A 3D-printer is not part of the device.

Additively Manufactured Denture Resin is a light-cured one-component materials for dental professional use only and intended for the fabrication of full and partial removable dentures. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. For use in Digital Light Processing (DLP)-3D printers utilizing wavelengths at 385nm or 405nm. The specifications of this product are divided into 500g, 1000g, 5kg and 10kg according to the weight of the resin liquid.

The provided document is a 510(k) summary for a medical device called "Additively Manufactured Denture Resin." It presents information about the device's intended use, technological characteristics, and a comparison to a predicate device to establish substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and study details:

Device: Additively Manufactured Denture Resin

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to adherence to the international standard ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers for physical and mechanical properties. The specific acceptance criteria within this standard are not explicitly listed in a table, but the document states:

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

The document states "Bench Testing: Physical and mechanical properties of the subject device were evaluated according to FDA-recognized version ISO 20795-1 Dentistry - Base polymers - Part 1: Denture base polymers." It also mentions "Biocompatibility Testing was performed according to FDA currently-recognized versions of biocompatibility consensus standards..."

However, the specific sample sizes for these tests are not provided in the document. The data provenance is related to laboratory bench testing and biocompatibility testing, indicating a controlled laboratory environment rather than direct patient data. The origin of the testing (e.g., country) is not specified beyond the manufacturer being from China.

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. The document describes the testing of a material's physical, mechanical, and biological properties against established international standards (ISO 20795-1, ISO 10993 series). Ground truth in this case is defined by these standards and the protocols for carrying out the tests, rather than by expert consensus on clinical cases.

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

This is not applicable. The testing involves objective measurements against predefined criteria in laboratory settings, not clinical interpretation 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:

This is not applicable. The device is a "Denture Resin," a material used for fabricating dental prostheses, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a material, not a software algorithm.

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

The ground truth for the performance claims for the denture resin is based on established material science standards and biocompatibility guidelines (ISO 20795-1, ISO 10993, ISO 7405). These standards define the test methods and acceptance limits for various physical, mechanical, and biological properties.

8. The sample size for the training set:

This is not applicable. The device is a material product, not a machine learning model that requires a training set.

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

This is not applicable as there is no training set for this type of device.

Ask a specific question about this device

Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics.

The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.

Additive Manufacturing Zirconia Customized Restoration is an individualized dental restoration (Crown,Bridge,Veneer,Inlay) made from zirconia slurry.

Additive Manufacturing Zirconia Customized Restoration is intended to be a replacement for a natural tooth.After finalizing the Additive Manufacturing Zirconia Customized Restoration in the laboratory.t is cemented or bonded onto a tooth or artificial abutment, by a clinician,to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.

To achieve esthetic and required value and chroma of the surrounding natural teeth the Additive Manufacturing Zirconia Customized Restoration is suitable for cut-back(veneering) or stain and glaze techniques.

The design of the Additive Manufacturing Zirconia Customized Restoration is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using or supported third party CAD systems. Once the restoration is ordered, it is sent electronically to Hangzhou Thales Medtech Co., Ltd. for fabrication.

The document provided is a 510(k) summary for a dental device, "Additive Manufacturing Zirconia Customized Restoration." It describes the device, its indications for use, and a comparison to predicate devices, along with performance and biocompatibility data to demonstrate substantial equivalence.

However, the provided text does not contain any information regarding a study involving human readers or AI assistance, or any performance data related to AI algorithms or human-in-the-loop performance. The performance data section refers to mechanical and biocompatibility testing of the physical dental restoration itself, not to the performance of any AI component.

Therefore, many of the requested details about acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not available in this document.

Below is a summary of the information that is present in the document.

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

The acceptance criteria are generally implied by adherence to ISO standards for dental ceramic materials. The performance values are reported in comparison to the predicate devices.

2. Sample sized 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 sample sizes for mechanical or biocompatibility testing, nor does it refer to a "test set" in the context of data for an AI/software device. The data provenance (country of origin, retrospective/prospective) is not mentioned for any of the performance tests.

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

This information is not applicable as the device is a physical dental restoration, not an AI or imaging device requiring expert interpretation for ground truth.

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

This information 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

This information is not applicable. The document describes a physical dental device; there is no mention of an AI component or MRMC study.

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

This information is not applicable as the device is a physical dental restoration, not an AI algorithm.

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

For the mechanical and biocompatibility testing, the "ground truth" is established by the relevant ISO standards and validated laboratory test methodologies. For example, for flexural strength, the ground truth is the measured force at fracture, evaluated against the standard's requirements.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not a machine learning model.

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

This information is not applicable.

Ask a specific question about this device

ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography.

The ADD are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The ADD detector utilize a combination of propriety TFT glass and scintillators(CsI), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration.

The flat panel sensors of the ADD are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well matched to scintillators such as CsI. The response has the excellent linearity of a charge-integrating-biased photodiode.

SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing.

The provided text is a 510(k) summary for the ADD Digital Flat Panel X-Ray Detector. It establishes substantial equivalence to a predicate device (K203188) and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner expected for a clinical performance study with predefined metrics like sensitivity, specificity, or AUC, typically found in AI/CAD device approvals.

Instead, the submission focuses on non-clinical performance tests, software validation, and a comparison of technological characteristics to demonstrate substantial equivalence to the predicate device. The "clinical test summary" section explicitly states that clinical images were provided, but “these images were not necessary to establish substantial equivalence based on the differences from the predicate… but they provide further evidence… that the subject digital detector works as intended.” This implies that the primary basis for equivalence is non-clinical.

Therefore, many of the requested items related to clinical study design (sample size, expert qualifications, adjudication, MRMC studies, standalone performance with specific metrics like sensitivity/specificity) are not explicitly present or are not applicable in the context of this 510(k) summary. The acceptance criteria are primarily derived from compliance with standards and demonstrating similar performance to the predicate device.

Here's an attempt to answer your questions based on the provided text, acknowledging where information is not available:

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

The acceptance criteria are primarily based on demonstrating performance similar to or meeting the specified values of the predicate device and compliance with relevant industry standards for electrical safety, EMC, and imaging performance (DQE, MTF, resolution).

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 mentions that "Clinical images were provided" but explicitly states they "were not necessary to establish substantial equivalence." This suggests that if there was a "test set" of clinical images, it was for supplementary evidence rather than a primary determinant of substantial equivalence, and its specifics (size, provenance, retrospective/prospective nature) are not detailed in this summary. The primary basis for comparison was non-clinical technical data.

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

Not applicable or not provided. Since the clinical images were "not necessary to establish substantial equivalence," specific details about ground truth establishment by experts for a dedicated clinical performance test set are not given.

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

Not applicable or not provided. (See 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

No MRMC comparative effectiveness study is mentioned. The device is a digital X-ray detector, not an AI or CAD system designed to assist human readers. The clinical images provided were to demonstrate the detector "works as intended," not to show improvement in human reader performance.

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

The ADD is a digital flat panel X-ray detector, which captures images. It is not an algorithm for diagnosis, so the concept of "standalone performance" in the context of an AI algorithm is not directly applicable. Its performance is measured by imaging characteristics like DQE, MTF, and resolution.

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

For the non-clinical performance tests (DQE, MTF, resolution), the "ground truth" refers to established physical standards and measurement protocols, not clinical ground truth derived from expert consensus, pathology, or outcomes data. For any "clinical images" that might have been reviewed, the ground truth source is not specified because its review was stated as "not necessary."

8. The sample size for the training set

Not applicable. The ADD is a hardware device (detector) with associated software for image acquisition, correction, and preprocessing. While the software was developed and validated, this is not an AI/ML algorithm that requires a "training set" of diagnostic images in the conventional sense. The "training set" concept is typically relevant for machine learning models, which this device does not appear to be.

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

Not applicable. (See point 8).

Ask a specific question about this device

ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based radiographic diagnostic systems. Not to be used for mammography.

The ADD are wired or wireless digital flat panel detectors that have been designed for faster, more streamlined approach to digital radiography systems. The ADD detector utilize a combination of propriety TFT glass and scintillators(CsI), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration. The flat panel sensors of the ADD are fabricated using thin film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well matched to scintillators such as CsI. The response has the excellent linearity of a charge-integrating-biased photodiode. SDK-MCW is the software of Detector that performs image acquisition, image correction, and preprocessing.

Acceptance Criteria and Study for ADD Digital Flat Panel X-Ray Detector

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the ADD Digital Flat Panel X-Ray Detector (K203188) to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" for clinical performance in the typical sense of a target metric to be achieved (e.g., sensitivity, specificity). Instead, the substantial equivalence is primarily based on technological characteristics and non-clinical performance tests, with clinical images provided as supportive evidence.

The relevant performance metrics and comparisons to predicate devices (Predicate Device#1: K181631, Predicate Device#2: K102349, Predicate Device#3: K140771) are summarized below from the provided text:

The submission states, "subject device shows similar or better DQE," and generally, the "inherent technical characteristics and performance are comparable to the predicate devices."

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

The document does not specify a distinct "test set" with a quantifiable sample size in the context of a prospective clinical trial. The "clinical images" were provided as supportive evidence, but the primary basis for substantial equivalence was non-clinical testing and technological comparison.

• Sample Size for Clinical Images: Not specified. The document only mentions "Clinical images were provided."
• Data Provenance: Not specified. However, the manufacturer is H&abyz Co., Ltd. from the Republic of Korea. It is common for such supportive clinical images to be collected retrospectively or prospectively within a clinical setting, but this is not detailed. The document explicitly states: "Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate (note TFT technology with CsI scintillator that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the subject digital detector works as intended." This suggests the clinical images were not the primary means of demonstrating equivalence.

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

The document does not describe an expert-based ground truth establishment process for the clinical images. Given that the images were "not necessary to establish substantial equivalence" and were "further evidence... to show that the subject digital detector works as intended," it's highly improbable that a formal expert ground truth establishment for a test set was conducted as would be typical for an AI-enabled diagnostic device.

4. Adjudication Method for the Test Set

Since a formal expert-based ground truth establishment for a clinical test set is not described, there is no mention of an adjudication method (e.g., 2+1, 3+1).

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 done or reported. The device is an X-ray detector, not an AI software for diagnostic interpretation. The submission is focused on demonstrating the detector's image quality and technical equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The ADD is an X-ray detector, a hardware device for image acquisition, not a standalone algorithm. The software (SDK-MCW) performs image acquisition, correction, and preprocessing, but its performance is judged within the context of the detector's output, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

For the non-clinical performance tests (DQE, MTF, resolution), the ground truth is established by physical measurements and standardized testing protocols as defined by IEC 62220-1.

For the supporting "clinical images," no specific ground truth (expert consensus, pathology, outcomes data) is mentioned or implied. The purpose of these images was to "show that the subject digital detector works as intended" in a real-world context, rather than to validate diagnostic accuracy against a definitive ground truth.

8. Sample Size for the Training Set

The document does not describe a training set in the context of machine learning. The ADD is a digital X-ray detector, and its software (SDK-MCW) performs image acquisition, correction, and preprocessing. While such software is developed and refined, the submission focuses on its validation rather than a "training set" for an AI model.

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

Not applicable, as there is no mention of a training set for an AI model in this submission. The software validation followed a software development process.

Ask a specific question about this device

The Addivation Medical Cervical Interbody System is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Addivation Medical Cervical Interbody System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, and is to be implanted via an open, anterior approach.

The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The Addivation Medical Cervical Interbody System is a series of hollow, titanium interbody fusion cages intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Addivation Medical Cervical Interbody System implants are simultaneously built using Electron Beam Melting (EBM) method of additive manufacturing. Addivation Medical Cervical Interbody System Implants are provided sterile.

This document describes the marketing authorization for the Addivation Medical Cervical Interbody System. It is a cervical interbody fusion device intended for use in patients with degenerative disc disease.

Here's an analysis of the provided text in relation to acceptance criteria and study data:

1. Table of acceptance criteria and reported device performance:

   Acceptance Criterion (Type of Test)	Reported Device Performance
   Static and dynamic compression per ASTM F2077	"meets or exceeds the performance of the predicate devices"
   Static and dynamic torsion per ASTM F2077	"meets or exceeds the performance of the predicate devices"
   Subsidence testing per ASTM F2267	"meets or exceeds the performance of the predicate devices"

2. Sample size used for the test set and data provenance:
   The document does not specify sample sizes for the testing. It mentions that "Non-clinical testing was performed." These are in-vitro mechanical tests, not clinical studies with human data. Therefore, the concept of country of origin or retrospective/prospective data provenance does not apply in the typical sense for a clinical study.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
   This question is not applicable. The device's performance was evaluated through laboratory mechanical testing based on established ASTM standards, not through expert review of clinical data to establish ground truth.

4. Adjudication method for the test set:
   Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies. This document describes mechanical testing.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is a physical interbody fusion system, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:
   For the mechanical performance tests, the "ground truth" is defined by the requirements and thresholds established by the referenced ASTM standards (F2077, F2267) and the performance characteristics of the predicate devices. The device had to demonstrate comparable or superior mechanical properties under these controlled laboratory conditions.

8. The sample size for the training set:
   Not applicable. This is a physical medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for a physical implant.

Ask a specific question about this device

The Additive Port Cap is indicated for use on the medication port of Baxter VIAFLEX, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed.

The Additive Port Cap (APC) is a polypropylene, single use device designed to snap over the outside of the medication port of compatible Baxter IV container (Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA) after the addition of medication. Once closed, the device prevents the port from being accessed without causing visible damage to the IV container. The bright red coloration serves as a clear indicator that medication has been added. The APC device is non-fluid path and non-sterile. The APC device is marketed as a stand-alone device and packaged in bulk.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Additive Port Cap" (APC) device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details performance testing for engineering characteristics rather than clinical performance or AI/human reader studies. Therefore, many of the requested points related to AI, human readers, and ground truth for clinical outcomes will not be present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance testing that was conducted, and states that "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria and the exact reported performance values are not explicitly provided in detail within this summary. Instead, it lists the types of tests performed.

Here's a table based on the information available, indicating where details are missing:

Information Not Found / Not Applicable Given the Device Type:

The device, an "Additive Port Cap," is a physical medical device (plastic cap) designed for tamper evidence and visual indication. It is not an AI/software device or diagnostic imaging device. Therefore, many of the requested points related to AI/ML study design are not applicable to this submission.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It merely states that "Performance testing to demonstrate tamper evidence was conducted" and lists various tests.
• Data Provenance: Not applicable in the context of clinical data. The tests are engineering and benchtop tests of a physical product.

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

• Not applicable. This is a physical device. "Ground truth" in the sense of expert medical interpretation for a diagnostic AI is not relevant here. The "ground truth" for the performance tests would be the measurement results from the engineering tests themselves (e.g., force required to open, presence of leakage).

4. Adjudication Method for the Test Set

• Not applicable. There's no clinical "test set" requiring adjudication by multiple experts. The tests are physical measurements and observations against engineering specifications.

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

• No. This type of study is typically done for diagnostic imaging devices or AI-assisted solutions to compare human performance with and without AI. It is not relevant for a physical device like an IV port cap.

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

• Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

• Engineering Specifications and Physical Measurements: The ground truth for this device's performance would be derived from the mechanical properties, dimensional tolerances, and functional performance (e.g., ability to indicate tamper, withstand certain forces, prevent leakage) as defined by its design and intended use. This is established via physical testing.

8. The Sample Size for the Training Set

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

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

• Not applicable. There is no AI/ML device or training set.

Ask a specific question about this device

The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. It is a patient specific device.

The Additive Orthopaedics Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. This is a patient specific device which utilizes the CT scanning protocol previously cleared in K180239 by Additive Orthopaedics. These patient specific devices are manufactured within a size range of 30-80mm and are supplied non-sterile.

The subject device is manufactured from medical grade titanium alloy Ti6Al4V ELI and allows the surgeon to align and stabilize small bone osteotomies such as MPJ fusions, calcaneal osteotomies, Evans Osteotomies, opening wedge osteotomies and others. The plate is fixated using both locking and non-locking screws which were cleared in K 163593 (Additive Orthopaedics) and compatible with Additive Orthopaedics wedges (K153207 and K180239).

The provided text is a 510(k) summary for the Additive Orthopaedics Patient Specific 3D Locking Lattice Plates. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence based on:

• Device Description: The device is patient-specific plates made from Ti6Al4V ELI, indicated for alignment, stabilization, and fusion of small bones (foot and ankle).
• Comparison to Predicate Devices: The key argument is that the subject device, while patient-specific, has similar indications, geometry, materials, and manufacturing processes to its predicate devices (Additive Orthopaedics Locking Lattice Plates K170214, BIOPRO, INC. BioPro Foot Plating System K162674).
• Non-Clinical Evidence: It refers to mechanical testing (4-point bending, static torsion, static driving torque, removal torque, static axial pullout) performed on the predicate device (K170214) per ASTM standards. The rationale is that since the new device uses similar materials and manufacturing methods, and the differences are primarily patient-specific geometry based on a previously cleared CT scanning protocol (K180239), the prior testing on the predicate device is sufficient.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and submission described in the provided text.

The device is a physical implant, not an AI/ML diagnostic or therapeutic system which would typically involve the type of performance evaluation outlined in your request.

Ask a specific question about this device