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The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The KMTI Tesera-k SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.

When used without the locking bolt and two screws, the KMTI Tesera-k SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

The Tesera-k SC System (Tesera-k SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and cage lock. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-k SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.

The Tesera-k SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924 or are additively manufactured from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, and the bone screws and cage locks are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k SC System may be implanted as a standalone with two internal fixation screws and the cage lock and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws or cage lock but with FDA-cleared supplemental fixation.

The provided FDA 510(k) clearance letter for the Tesera-k SC System focuses on the substantial equivalence of an intervertebral body fusion device. Crucially, as this is a medical device clearance, the performance data provided relates primarily to mechanical testing of the device's structural integrity and does not involve clinical studies with human subjects or AI algorithms to interpret medical images.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this type of device clearance and the information provided.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. It states that the "results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, specific numerical acceptance criteria and precise reported device performance values are not detailed in this public summary document. The document only lists the types of tests performed.

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

• Sample Size for Test Set: Not applicable in this context. The testing involved mechanical evaluation of the device as a physical product, not an AI algorithm on a dataset.
• Data Provenance: Not applicable for AI data. The "performance data" refers to the results of standardized mechanical tests on the device, not clinical data or image data.

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 the clearance is for a physical medical device (intervertebral fusion device), not an AI/software device that requires expert-established ground truth on medical images.

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

• This question is not applicable for the same reasons as #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

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

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

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device.

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

• This question is not applicable. For this type of device, "ground truth" relates to the physical and material properties meeting engineering specifications and clinical performance criteria established through mechanical testing and comparison to predicates, rather than a diagnostic 'ground truth' from human interpretation or pathology.

8. The sample size for the training set

• This question is not applicable as the clearance is for a physical medical device, not an AI/software device that requires a training set.

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

• This question is not applicable for the same reasons as #8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Tesera-k SC System meets acceptance criteria consists of a series of non-clinical mechanical tests designed to assess the device's structural integrity, durability, and resistance to various forces it would encounter in its intended use. These tests were conducted according to recognized ASTM standards.

The specific tests performed were:

• Dynamic axial compression per ASTM F2077
• Dynamic compression shear per ASTM F2077
• Dynamic torsion per ASTM F2077
• Tensile Strength per ASTM F1147
• Shear Fatigue per ASTM F1160
• Abrasion per ASTM F1978

Conclusion of the Study:
The document states that "The results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device successfully met the performance benchmarks implicitly required for devices of its type and demonstrated equivalent or superior performance to the predicate device, K223105 (Tesera-k SC System by Kyocera Medical Technologies, Inc.). The overall technological characteristics and mechanical performance data led to the conclusion of substantial equivalence.

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The KMTI Hip Replacement System is indicated for patients suffering from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.

The Initia T3 Acetabular Hemispherical Shell System is intended for cementless applications.

The Kyocera Medical Technologies, Inc. (KMTI) Initia T3 Acetabular Hemispherical Shell System is a cementless shell intended for use in the treatment of hip disorders requiring hip replacement surgery. The Initia T3 Acetabular Hemispherical Shell System includes several components including: Initia T3 Acetabular Hemispherical Shell, Initia Acetabular Liner, Initia Bone Screw, and Delta 22.2 Femoral Head.

The Initia T3 Acetabular Hemispherical Shell is a cementless porous shell manufactured from Ti-6Al-4V ELI per ASTM F136. The Initia Acetabular Liner attaches to the inner surface of the Initia T3 Acetabular Hemispherical Shell and is available in four different configurations. The Initia Acetabular Liner is used to provide a single articulation implant option and is manufactured from Vitamin E infused UHMWPE per ASTM F2695 or UHMWPE per ASTM F648. The femoral head is manufactured from Biolox® delta and is available in two offsets.

This document clears the Initia T3 Acetabular Hemispherical Shell System for marketing. However, the provided text does not contain acceptance criteria or detailed study results in the manner requested for AI/software devices.

This FDA 510(k) clearance is for a physical medical device (an orthopedic implant), not an AI-powered diagnostic or assistive tool. The "performance data" section details various mechanical and material tests conducted on the implant itself to ensure its structural integrity, durability, and biological compatibility. It does not involve "test sets," "ground truth," "expert adjudication," or "multi-reader multi-case studies" in the context of evaluating an AI algorithm's diagnostic performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device described in the provided text.

The "performance data" described in the document relates to non-clinical (laboratory/mechanical) testing of the physical components of the hip replacement system.

If you intended to provide a different document related to an AI/software medical device, please provide that document.

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The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6Al-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-k SC System interbody spacers.

The purpose of this Special 510(k) is to introduce non-sterile plate options to the sterile packaged plates which were previously cleared and to modify the geometry of the plate's screw holes and the screw heads with minor dimensional changes.

This document is an FDA 510(k) clearance letter for a medical device called the Skyway Anterior Cervical Plate System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the kind of performance data (e.g., AI model performance metrics, clinical study outcomes) typically associated with acceptance criteria for novel software-based devices, especially those using artificial intelligence.

The information provided explicitly states: "No performance testing was required for this 510(k)." This is because the submission is a "Special 510(k)" to introduce minor changes (non-sterile plate options and minor geometric modifications) to an already cleared device. Therefore, the questions related to AI model performance, sample size for test/training sets, expert adjudication, MRMC studies, ground truth establishment, etc., are not applicable to this specific 510(k) submission.

Based on the provided text, here's an attempt to answer the questions within the scope of what is stated:

Acceptance Criteria and Device Performance for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System (K250486)

As this is a Special 510(k) for minor modifications to an already cleared device, the "acceptance criteria" primarily revolve around demonstrating that the changes do not adversely affect the foundational safety and efficacy already established for the predicate device. The "study" described is a regulatory review process to confirm this, rather than a de novo clinical or performance study of the device's functional performance in a use-case scenario.

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

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

• Sample Size for Test Set: Not applicable for this type of submission. No performance testing on a "test set" of clinical data or patient outcomes was conducted or required. The review focused on engineering changes and regulatory compliance.
• Data Provenance: Not applicable. The "study" was a regulatory review of engineering specifications and manufacturing process changes (sterilization adoption), not a data-driven performance study.

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)

• Number of Experts & Qualifications: Not applicable. Given "No performance testing was required," there was no "test set" requiring ground truth establishment by clinical experts in the context of device performance. The experts involved would be FDA reviewers (e.g., Engineer & Regulatory Specialist Nathan Wright from KMTI, and the FDA's Division of Spinal Devices staff like Colin O'Neill and Maziar Shah Mohammadi), who assess regulatory compliance and engineering specifications against predicate devices.

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

• Adjudication Method: Not applicable. There was no "test set" of performance data requiring adjudication. The FDA's review process serves as the "adjudication" against regulatory standards and comparison to predicate devices.

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

• MRMC Study: No. This device is not an AI-powered diagnostic tool. It is a physical implant (spinal plate system). Therefore, an MRMC study and AI assistance effect size are not applicable.

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

• Standalone Performance: No. This device is a physical implant, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.

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

• Type of Ground Truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission relates to established engineering principles, material science standards (e.g., ASTM F136 for titanium alloy), and regulatory requirements (e.g., ISO 17665-1 for sterilization). The substantial equivalence claim is the ultimate "ground truth" sought.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No AI model training was involved for this physical medical device.

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

• Ground Truth for Training Set Establishment: Not applicable. No AI model training was involved.

Summary of this Specific 510(k):

This 510(k) clearance (K250486) is a "Special 510(k)" for minor modifications to an existing, already-cleared device. Its purpose is to assure the FDA that changes (adding non-sterile options, minor geometric changes) do not alter the previously established safety and efficacy profiles. Therefore, it does not involve the kind of performance studies, particularly those related to AI model validation, that the questions typically imply. The core "study" is the demonstration of substantial equivalence through regulatory and engineering assessment, not a clinical trial or AI performance evaluation.

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The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Tesera-k Lumbar System (Tesera-k PL (Tk-PL) System and Tesera-k XL System (Tk-XL) System) consist of interbody fusion implants intended to provide stability and facilitate fusion in the lumbar spine.

The Tesera-k PL System implants are offered with straight or curved profiles to accommodate posterior or transforaminal surgical approaches. The Tesera-k PL implants are additively manufactured then machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001.

The Tesera-k XL System implants are offered in a straight profile for the direct lateral surgical approach. The Tesera-k XL cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V ELI) per ASTM F3001. The Tesera-k XL Bone Screws and Locking Assemblies are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k PL and Tesera-k XL Systems are non-standalone systems and must be used in conjunction with FDA-cleared lumbosacral supplemental fixation.

The provided FDA 510(k) summary does not contain the information requested regarding acceptance criteria and performance studies for a medical image analysis AI device.

The document describes a submission for the Tesera-k PL System and Tesera-k XL System, which are intervertebral body fusion devices (implants for spinal fusion surgery). This is a physical medical device, not a software or AI-driven diagnostic or image analysis tool.

Therefore, I cannot extract details about:

• Acceptance criteria and reported device performance for an AI/software device: The document focuses on mechanical testing of spinal implants (e.g., static and dynamic compression, shear, subsidence, expulsion, tensile strength, fatigue, abrasion).
• Sample size for test sets and data provenance: Not relevant to a mechanical implant test.
• Number of experts and their qualifications for ground truth: Not relevant. Ground truth for an implant is typically physical measurements and engineering standards.
• Adjudication method for test set: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable to a physical implant.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): The ground truth for this device is based on standardized mechanical testing (e.g., ASTM standards) to demonstrate structural integrity and long-term performance under simulated physiological conditions.
• Sample size for training set and how ground truth was established for the training set: Not applicable to a physical implant. The "training" for such a device is its design and manufacturing process, optimized through engineering principles and iterative testing against performance standards.

In summary, the provided text describes the regulatory filing for a physical medical implant, not an AI or software-based medical device. As such, it does not contain the information necessary to answer your prompt about acceptance criteria and study details for an AI-driven device.

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The Initia Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.

2. Correction of varus, valgus, or posttraumatic deformity.

3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for cemented use only.

The Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System is a patellofemorotibial polymer/ metal/polymer semi-constrained prosthesis intended to replace a knee joint. The system consists of femoral, tibial and patella components intended for use with bone cement. The Initia Knee System includes both posterior-stabilizing (PS) and cruciate-retaining (CR) designs.

This document is a 510(k) summary for the Kyocera Medical Technologies, Inc. (KMTI) Initia Knee System. It details the device, its intended use, and its substantial equivalence to a predicate device, the KMTI A200 Knee System.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail values. Instead, it lists various non-clinical performance tests that were conducted and states that the results were "acceptable." The implication is that the performance of the Initia Knee System met the requirements established for these tests, likely aligned with the standards cited.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. It mentions "components" and "trials" which implies multiple units were tested per category.
• Data Provenance: The data is generated from non-clinical performance tests conducted by Kyocera Medical Technologies, Inc. ("KMTI"). The provenance is therefore internal testing by the manufacturer. The document does not specify the country of origin of the data beyond the manufacturer's location in Redlands, CA, USA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate device performance.

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

This section is not applicable as the document describes non-clinical performance testing for a medical device (knee prosthesis), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" for these tests are the established engineering principles, material science properties, and consensus standards (e.g., ASTM, ISO) that define acceptable performance for orthopedic implants.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Performance is evaluated against objective engineering criteria and consensus standards, not through expert adjudication of subjective interpretations.

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 section is not applicable. The subject device is a physical knee prosthesis, not an AI or software-based diagnostic or assistive tool. Therefore, a MRMC study involving human readers and AI assistance would not be relevant.

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

This section is not applicable. The subject device is a physical knee prosthesis, not an algorithm or software. No standalone algorithm performance was assessed for this device.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on:

• Established engineering principles and biomechanical requirements: These tests assess the physical and mechanical properties of the device.
• Consensus standards: The document explicitly lists numerous ASTM and ISO standards (e.g., ASTM F1672-14 for patellar prosthesis, ASTM F1800-12 for tibial tray fatigue, ISO 7207-2 for articulating surfaces). These standards define test methodologies and acceptable performance metrics, which serve as the "ground truth" for assessing device safety and effectiveness.
• Comparison to predicate device: The fundamental basis of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. Therefore, the predicate's known safe and effective performance also acts as a reference for the "ground truth" of what is considered acceptable.

8. The Sample Size for the Training Set

This section is not applicable. The subject device is a physical knee prosthesis. There is no concept of a "training set" as there would be for an AI/machine learning model. The design and manufacturing process are informed by established engineering knowledge and previous experience with similar devices.

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

This section is not applicable for the same reasons as point 8.

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The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The KMTI Skyway Anterior Cervical Plate System is an anterior cervical plating fixation system consisting of implants and associated instrumentations to provide supplemental fixation between two adjacent cervical vertebral bodies as an adjunct to fusion or for spinal correction. The Skyway Anterior Cervical Plate System is implanted via an anterior surgical approach.

The subject devices proposed in this submission are a line extension of the Skyway Anterior Cervical Plate System (K231766) with the introduction of additional length and configuration options for the 1-Level Plates and 2-hole and 3-hole 1-Level Plates. This subject line extension also includes non-sterile bone screw and locking screw options. The Skyway Anterior Cervical Plate System plates, bone screws, and locking screws are manufactured from Ti-6Al-4V per ASTM F136.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Skyway Anterior Cervical Plate System) and does not contain information related to software, imaging, or AI studies. Therefore, I cannot extract the acceptance criteria for a device from this text, nor can I describe any study proving that the device meets such criteria because the information is not present.

The document discusses the regulatory approval of a physical medical implant (a cervical plate system) and its mechanical testing, not software performance. As such, sections related to sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth, and training set information are not applicable to the content of this document.

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The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:

• Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
• Correction of varus, valgus, or posttraumatic deformity. .
• As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
• Revision procedures where other treatments or devices have failed. ●
  This device is intended for cemented use only.

KMTI's TRIBRID® Unicompartmental Knee System is a partial knee replacement prostheses intended for application with bone cement. Partial knee replacement components include femoral and tibial components. Femoral baseplates are CoCrMo Alloy while the Tibial implants are Ti6Al4V Alloy. The Tibial bearing inserts are made from Ultra-High Molecular Weight Polyethylene (UHMWPE) variations. Components are available in a variety of designs and size ranges intended for both primary and revision applications.

This document is a 510(k) summary for the Kyocera TRIBRID® Unicompartmental Knee System, a medical device. It focuses on mechanical, non-clinical performance data rather than AI/software performance. Therefore, many of the requested criteria related to AI device performance are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that its mechanical performance is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. The document does not provide specific quantitative pass/fail values as acceptance criteria; rather, it lists the types of tests performed and concludes that the results support substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Details (based on the provided document)

Since the document describes a mechanical device and its non-clinical performance testing rather than an AI/software device, many of the typical questions for AI acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance) are not applicable.

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

   • Sample Size: Not explicitly stated in this summary. Mechanical tests typically use a small number of samples (e.g., 3-6 or more, depending on the standard) to demonstrate compliance with a standard or to compare to predicate devices.
   • Data Provenance: Not applicable. This is in vitro mechanical testing, not human data.

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

   • Not applicable. Ground truth for mechanical testing is established by engineering specifications, material properties, and industry standards (e.g., ASTM, ISO), not by expert consensus on clinical data.

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

   • Not applicable. This is for mechanical testing, not interpretation of clinical imagery or data by experts. Test results are typically compared directly to standard requirements or predicate device 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:

   • Not applicable. This is a knee implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • Mechanical Testing Standards: The "ground truth" for this type of device is compliance with industrial standards (e.g., ASTM, ISO) for mechanical properties, durability, and wear, and demonstrating substantial equivalence to predicate devices that have established safety and effectiveness through their historical use.

7. The sample size for the training set:

   • Not applicable. This is non-clinical mechanical testing, not a machine learning model.

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

   • Not applicable. As above, this is mechanical engineering testing.

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The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1 . KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMT) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6A1-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-K SC System interbody spacers.

I am sorry, but the provided text does not contain information about an AI/ML-driven medical device, its acceptance criteria, or a study proving its performance.

The document is a 510(k) premarket notification for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System, which is a spinal intervertebral body fixation orthosis. It discusses the device's indications for use, technological characteristics, and performance data based on mechanical testing (e.g., static and dynamic compression bending, static torsion).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document does not describe such a study for an AI/ML device.

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The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S 1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radio graphic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI PEEK SA ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the surgeon choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use inthe lumbar spine must be used. Supplemental fixation, cleared by the FDA for use inthe lumbosacral spine, must be used with implants ≥ 20°.

The KMTI PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System consists of PEEK cages, titanium screws, and a titanium cover plate. The KMTI PEEK SA ALIF System cages are intended to be used with the bone screws, the anterior cover plate assembly (cover plate), and do not require supplementary fixation systems unless less than four bone screws are utilized or cage lordosis is ≥20°. The screws protrude through the interbody portion of the cage implant and stabilize the vertebral body while preventing expulsion of the cage implant. The KMTI PEEK SA ALIF System offers hexalobe drive with both fixed and variable angle screw options. The fixed angle screw option provides a tighter fit with the cage than the variable angle screws while the variable angle screw option provides more clearance between the screw than the fixed screw, which allows for a small amount of screw angulation. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. The cover plate assembly and screw are part of the implant construct.

The KMTI PEEK SA ALIF System cages are available in a variety of sizes to suit the individual patient anatomical needs.

The purpose is to offer non-sterile packaging for cage sizes in the PEEK SA ALIF System (formerly S128 ALIF System) previously cleared for sterile packaging only.

The provided text is a 510(k) summary for the Kyocera Medical Technologies, Inc. PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through clinical studies or extensive standalone device performance testing.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given text, because the submission explicitly states:

"Performance testing was not required in this submission for the modifications proposed."

The primary purpose of this submission is to introduce non-sterile packaging for previously cleared cage sizes. The device's substantial equivalence is based on its technological characteristics being identical to the predicate device, not on new performance data demonstrating its effectiveness against predefined metrics.

However, I can extract what is implied regarding the "proof" of the device meeting its intended purpose for substantial equivalence based on the provided document:

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

Since this is a 510(k) submission focused on substantial equivalence and minor modifications (non-sterile packaging), the "acceptance criteria" are implied by the features demonstrated to be identical to the predicate device. "Device performance" in this context refers to the demonstration of these identical characteristics.

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

• Sample Size for Test Set: Not applicable in the context of performance testing for this submission as "Performance testing was not required." The comparison is based on the inherent design and materials of the device being identical to the predicate.
• Data Provenance: Not applicable for performance testing. The "data" pertains to the specifications and design files of the device itself and its predicate.

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. No "ground truth" establishment by experts for a test set was required for this substantial equivalence submission.

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

Not applicable. No clinical or performance test set requiring adjudication was performed.

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 physical intervertebral body fusion system, not an AI/software device.

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

Not applicable. This device is a physical intervertebral body fusion system, not an algorithm. The "standalone" aspect mentioned in the Indications for Use ("The KMTI PEEK SA ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation") refers to its mechanical functionality as an implant, not standalone algorithmic performance.

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

Not applicable. No performance data requiring "ground truth" was generated for this submission. The "truth" for substantial equivalence is based on the objective technological characteristics being identical to the predicate.

8. The sample size for the training set

Not applicable. No machine learning or AI model was developed or trained for this submission.

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

Not applicable. No machine learning or AI model was developed or trained for this submission.

Summary of "Proof" in this 510(k) Submission:

The "proof" in this document is not derived from clinical trials, observational studies, or performance testing against specific acceptance criteria. Instead, the proof that the device "meets the acceptance criteria" (in the context of a 510(k) for substantial equivalence with minor changes) is based on the following:

• Demonstration of Identical Technological Characteristics: The submission explicitly states, "The subject and predicate have identical technological characteristics. There are no differences between the subject and predicate devices that raise questions regarding the safety and effectiveness of the subject device." This is the core "proof."
• Validation for Sterilization Changes: For the minor modification of non-sterile packaging, the submission states, "Changes in sterilization were validated according to ISO 17665-1." This ensures that the new packaging method meets international standards for sterilization processes, thereby addressing any potential safety concerns related to the change.

In essence, the device is considered to "meet acceptance criteria" because it is fundamentally the same device as one already cleared by the FDA (the predicate), with a validated change to its packaging.

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The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The KMTI Tesera-K SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.

When used without the locking bolt and two screws, the KMTI Tesera-K SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.

The Tesera-K SC System (Tesera-K SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and locking bolts. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-K SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.

The Tesera-K SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924, and the bone screws and locking bolts are machined from Titanium alloy (Ti-6Al-4V) per ASTM F136.

The Tesera-K SC System may be implanted as a standalone with two internal fixation screws and the locking bolt and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws and locking bolt but with FDA-cleared supplemental fixation.

The provided text is a 510(k) summary for the Tesera-K SC System, an intervertebral body fusion device. While it details the device's characteristics, indications for use, and a comparison to predicate devices, it does not contain information related to AI or algorithm performance, nor does it refer to acceptance criteria or studies involving AI performance metrics like sensitivity, specificity, or AUC.

The "Performance Data" section solely lists mechanical testing (static and dynamic compression, shear, torsion, and subsidence) designed to demonstrate the device's structural integrity and substantial equivalence to existing predicate devices, not the performance of an AI algorithm facilitating human reading or a standalone AI.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to an AI algorithm.
2. Sample sizes and data provenance for an AI test set.
3. Number and qualifications of experts for AI ground truth.
4. Adjudication method for an AI test set.
5. MRMC study details for AI assistance.
6. Standalone AI performance.
7. Type of ground truth for AI.
8. Sample size for AI training set.
9. Method for establishing ground truth for AI training set.

The document describes a physical medical device (spinal implant) and its mechanical properties, not an AI-powered diagnostic or assistive tool.

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