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Cervical Plate System is intended for anterior interbody screw fixation from C2 to T1 and is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2)trauma (including fractures); 3)tumors: 4)deformity(defined as kyphosis, lordosis,or scoliosis); 5)pseudoarthrosis; 6)failed previous fusions

Cervical Plate System consist of anterior cervical spine plate II, anterior cervical spine plate IV and screws. The anterior cervical spine plate is fixed to the front of the cervical vertebrae by screws to play an auxiliary role in maintaining the stability of the surgical segment and preventing the fusion implant from coming out. Screws are available for fixed angle or variable angle implantation.

Bone plates in Cervical Plate System are made of unalloyed titanium following ASTM F67 and titanium alloy following ASTM F1472 as well as ASTM F1295, and bone screws in Cervical Plate System are made of titanium alloy following ASTM F136.

Cervical Plate System is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

This document, K223753, is a 510(k) premarket notification for a Cervical Plate System. It seeks to demonstrate substantial equivalence to a legally marketed predicate device (K141632 ZEVO™ Anterior Cervical Plate System).

The request asks for acceptance criteria and a study that proves the device meets these criteria. However, the provided text does not contain information about an AI/ML-based medical device, nor does it describe a study involving human-in-the-loop performance, expert consensus on images, or training/test sets for an algorithm.

Instead, this submission details the regulatory approval process for a physical orthopedic implant used in spinal surgery. The "acceptance criteria" discussed are primarily related to biocompatibility and mechanical testing of the physical device to ensure its safety and efficacy, not performance metrics of an AI algorithm.

Therefore, I cannot provide the requested information. The document explicitly states:

• "No clinical performance data was provided to demonstrate substantially equivalence." (Section 5.8)
• The non-clinical performance data focuses on biocompatibility testing (ISO 10993-1) and mechanical testing (ASTM F1717) for the physical implant (Static compression bending test, Static torsion test, Dynamic compression bending test).

To explicitly answer your questions based only on the provided text, and acknowledging the mismatch with your request for AI/ML study details:

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

   • Acceptance Criteria (Implied from tests performed): The Cervical Plate System must demonstrate biocompatibility and mechanical performance (static compression bending, static torsion, dynamic compression bending) that is substantially equivalent to the predicate device, as per ASTM F1717 and ISO 10993-1.
   • Reported Device Performance: The document states these tests were "performed... to demonstrate substantially equivalent of safety and efficacy with the predicate device," but it does not provide numerical results or specific performance metrics from these tests. It only states that the information provided "demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device." This implies the acceptance criteria were met, but the specific data is not in this summary.

2. Sample sizes used for the test set and the data provenance: This is not applicable to this document as it does not describe an AI/ML study with test sets of data. The "test set" here refers to physical samples of the cervical plate subjected to mechanical and biocompatibility tests. No information on the number of physical samples tested is provided, nor is the "provenance" of such samples described in terms of geographical origin or retrospective/prospective collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. Ground truth, in the context of an AI/ML study, would involve expert labeling of medical images or data. No such process is described for this physical device. The "ground truth" for a physical device is its material properties and mechanical behavior under stress.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is not applicable as there is no data labeling or consensus-building process for an AI/ML system.

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 to this submission. The device is a physical implant, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. There is no algorithm described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, "ground truth" refers to established material properties and biomechanical standards. The document refers to ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ISO 10993-1 (Biological evaluation of medical devices). These standards serve as the "ground truth" for evaluating the physical and biological characteristics of the device.

8. The sample size for the training set: This is not applicable as there is no AI/ML model or training set.

9. How the ground truth for the training set was established: This is not applicable as there is no AI/ML model or training set.

In summary, the provided document is a 510(k) summary for a physical medical device (Cervical Plate System) and does not involve AI/ML technology or studies with expert reading of medical images.

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The 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, or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The Cervical Plate System is an anterior cervical plating system that consists of plates and selftapping screws. The implants are available in a variety of shapes to accommodate the anatomical condition of patients. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

Here's a breakdown of the acceptance criteria and study information for the Cervical Plate System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the mechanical performance data leads to the conclusion that the device is "substantially equivalent" to the predicate device. However, it does not explicitly provide numerical acceptance criteria or specific numerical results for these tests. It only states that the device's strength is "sufficient" and comparable to predicate devices.

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The studies mentioned are mechanical performance tests (in vitro), not clinical studies involving human patients or data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

4. Adjudication Method for Test Set

This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a physical medical device (Cervical Plate System) through in vitro testing, not on evaluating the effectiveness of an AI algorithm or human reader performance.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The device described is a physical implant (Cervical Plate System), not an algorithm or AI-driven system.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by ASTM F1717 standards for static and dynamic mechanical properties of spinal intervertebral body fixation orthoses. The document states "The Cervical Plate System has been tested in the following test modes: - Static compression bending per ASTM F1717 . - Static torsion per ASTM F1717 ● - Dynamic compression bending per ASTM F1717".

8. Sample Size for Training Set

This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI or machine learning system that requires training data.

9. How Ground Truth for Training Set Was Established

This information is not applicable for the same reason as above; there is no training set mentioned or implied for this mechanical device.

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The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:

-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies)

-Spondylolisthesis

• -Fracture
  -Spinal stenosis

-Tumors (primary and metastatic)

-Failed previous fusions

-Pseudoarthrosis

-Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

The Eisertech, LLC. Cervical Plate (K113170) is a spinal internal fixation device which is provided in a variety of sizes ranging from 20mm in length. The device is designed to accommodate fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. Instrumentation to facilitate implantation of the cervical plate is included with the device. This instrumentation is the subject of the present Traditional 510(k) submission. Specifically, the present Traditional 510(k) submission seeks to add two additional base material options as well as a surface treatment to all previously cleared instruments for use with the cervical plate system. The purpose of the surface treatment is to add scratch resistance and hydrophobicity to the instruments. There are no changes to the implants and the surface treatment is not being applied to the implants.

This document is a 510(k) summary for a medical device called a "Cervical Plate". However, the submission K190565 is not for the cervical plate itself, but rather for instrumentation to facilitate implantation of the cervical plate. Specifically, it seeks to add two additional base material options and a surface treatment to these previously cleared instruments. The core cervical plate device, identified as the predicate, is K113170.

Therefore, the performance testing and acceptance criteria described in the document are focused on demonstrating that the changes to the instruments do not negatively impact safety and effectiveness, nor do they raise new questions. It does not describe a study proving the performance of the cervical plate itself, but rather the performance of the modified instruments.

Given this, I will answer the questions based on the information provided regarding the modified instrumentation.

Here's an analysis of the provided text:

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

   The document does not explicitly state acceptance criteria in a numerical or pass/fail threshold format for the performance tests. Instead, it states that testing was performed to "ensure" or "demonstrate" certain outcomes. The reported performance is a conclusion that these aims were met.

   Acceptance Criteria Description (Implicit)	Reported Device Performance
   Ensure that the addition of a surface treatment to previously cleared instruments does not negatively impact biocompatibility of the instruments.	"Biocompatibility Testing was performed to ensure that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact biocompatibility of the instruments." (Implies successful demonstration, i.e., no negative impact found).
   Demonstrate that the coating provides additional wear resistance to the instruments.	"Additionally, ball on flat wear testing... was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration, i.e., coating provides additional wear resistance).
   Demonstrate that the coating provides additional corrosion resistance to the instruments.	"Additionally, ... corrosion resistance testing was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration, i.e., coating provides additional corrosion resistance).
   Demonstrate the effect of the surface treatment on the instruments' mechanical properties related to indentation.	"Additionally, ... instrumented indentation testing... was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments." (Implies successful demonstration regarding the mechanical properties under indentation, likely linking to wear resistance, as the primary stated purpose of the coating is scratch resistance and hydrophobicity, and the performance testing aims to show additional wear/corrosion resistance.) The document does not state specific acceptance criteria values (e.g., "indentation depth less than X µm") nor does it provide quantitative results. It only states the testing was performed to demonstrate the effect.

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 the sample sizes used for the biocompatibility, wear, indentation, or corrosion resistance testing. It also does not provide information about the provenance of data (e.g., country of origin, retrospective or prospective). These types of tests are typically in vitro or in vivo (for biocompatibility) and not based on patient data provenance.

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 type of information (number and qualifications of experts for ground truth) is relevant to clinical studies involving human interpretation or pathology. Since the described tests are device performance tests related to materials science (biocompatibility, wear, corrosion, indentation) for surgical instruments, the concept of "ground truth" established by clinical experts for a "test set" in the context of diagnostic or interpretive performance does not apply here. The "ground truth" for these tests would be derived from validated testing methodologies and their results.

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

   Similar to point 3, adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and a consensus or tie-breaking mechanism is needed to establish a "ground truth" for comparison with an AI system. This concept is not applicable to the material and mechanical performance testing described in this document.

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. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic devices, often involving AI assistance, by comparing the performance of multiple human readers on multiple cases. The submission K190565 is for changes to surgical instruments (not a diagnostic device, and no AI component is mentioned). Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with AI assistance is applicable or reported.

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

   This question relates to the performance of an AI algorithm in isolation. Since the device in question (modified surgical instruments) does not involve an AI algorithm, no standalone algorithm performance testing was done.

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

   For the material and mechanical tests (biocompatibility, wear, indentation, corrosion), the "ground truth" is established by the results of standardized and validated laboratory testing methods. This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather objective measurements and observations from controlled experiments. For biocompatibility, this usually involves in vitro (e.g., cytotoxicity) and/or in vivo (e.g., irritation, sensitization) tests against recognized standards (e.g., ISO 10993 series).

8. The sample size for the training set

   The concept of a "training set" and "test set" is central to machine learning and AI development. Since this submission is for physical surgical instruments and does not involve AI, there is no training set in this context. The "tests" described are physical performance tests, not AI model evaluations.

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

   As there is no training set for an AI model, this question is not applicable.

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The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:

• Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Fracture
• Spinal stenosis
• Tumors (primary and metastatic)
• Failed previous fusions
• Pseudoarthrosis
• Deformity (i.e. kyphosis, lordosis, and/or scoliosis).

The Cervical Plate spinal internal fixation device made from titanium alloy (all components are made from ASTM F-136). It is provided in a variety of sizes ranging from 20mm to 110mm in length, and accommodating fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. All plates, regardless of length have a nominal thickness of 1.85mm and width of 18mm. Screws are provided in 4:0mm and 4.5mm diameters and in fixed and variable angle styles. Screws are prevented from backing out of the plate by attaching a separate locking mechanism. The mechanism is either a lock washer, consisting of a set screw attached to a washer, or a lock cover, which is a solid screw whose head captures both bone screws at the level of application.

The provided text describes a medical device, the "Cervical Plate," and its 510(k) summary for FDA clearance. However, it does not contain details about a clinical study that would typically involve acceptance criteria related to a device's performance in a human context, nor does it discuss ground truth established by experts, an MRMC study, or standalone algorithm performance.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device to legally marketed predicate devices based on design and mechanical performance.
• Device Description: Material, sizes, and locking mechanisms.
• Indications for Use: The medical conditions for which the device is intended.
• Design Requirements: The need to stabilize the spine and maintain alignment.
• Risk Analysis Method: Qualitative summarization and quantitative analysis of in-vivo performance requirements, with test results meeting or exceeding design input.
• Performance Aspects: Testing according to ASTM F1717 for static axial compression, dynamic axial compression, and static torsion.
• Reliance on Standards: ASTM F1717 was used, but no specific performance standard exists for anterior cervical spinal plates.

Therefore, the requested information cannot be fully provided based on the input text. The "acceptance criteria" discussed are primarily mechanical performance benchmarks relative to design input and predicate devices, not clinical efficacy or diagnostic accuracy.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The testing was biomechanical/mechanical in a lab setting, not on patient data.
• Data Provenance: The tests were conducted according to ASTM F1717, which is a standard for in vitro mechanical testing of spinal implant constructs. This implies a controlled laboratory environment, not data from a specific country or retrospective/prospective patient data.

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

• Not applicable. Ground truth for a clinical or diagnostic study is not established in this context. The "truth" for this device's performance is its mechanical behavior under specified loads, measured in a lab.

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

• Not applicable. There's no clinical "adjudication" in a mechanical performance study. The tests follow standardized protocols (ASTM F1717).

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

• Not applicable. This is a physical medical device (cervical plate), not an AI/software device that assists human readers.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" for this device's performance is based on the objective mechanical measurements obtained through standardized laboratory testing (ASTM F1717). This compares the device's physical properties (strength, stability) against engineering specifications and the performance of predicate devices.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned, as this is a physical device and not an AI/machine learning application.

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

• Not applicable.

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The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with the following conditions:

• degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• tumor,
• pseudoarthrosis, and
• failed previous fusion.
  Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Cervical Plate system consists of multiple sized plates and screws. All components are fabricated from anodized titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the cervical spine.
The screws utilized in the Cervical Plate are of the self tapping cortical type and are available in 04.0mm and a variety of lengths.

The provided text describes a 510(k) submission for a medical device called "Cervical Plate." This submission details the device's design, intended use, and its substantial equivalence to a previously marketed device. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or in-vitro diagnostic study would.

Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device, which is a different kind of regulatory pathway. The "Summary Nonclinical Tests" section mentions "Testing was performed according to ASTM F1717," which refers to a standard for mechanical testing of spinal implant constructs. This typically involves biomechanical or material testing rather than assessing performance against clinical acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain this information. The documents are focused on regulatory approval via substantial equivalence based on design similarity and mechanical testing to an ASTM standard, not a clinical performance study with acceptance criteria.

To elaborate on why I cannot provide the requested information:

1. Acceptance Criteria Table & Reported Device Performance: This type of table would typically present metrics like sensitivity, specificity, accuracy, or other clinically relevant measures and compare them against predetermined thresholds. This information is absent.
2. Sample Size for Test Set & Data Provenance: This would refer to patient data used in a clinical study. The document does not describe such a study.
3. Number of Experts & Qualifications for Ground Truth: This is relevant for studies involving human interpretation or diagnosis. Not applicable here.
4. Adjudication Method: Also relevant for studies with human interpretation. Not applicable here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is for evaluating AI-assisted performance compared to human readers. Not applicable as this is a physical medical device, not an AI diagnostic tool.
6. Standalone Performance Study: This would describe the performance of an algorithm without human intervention. Not applicable.
7. Type of Ground Truth: This would be clinical outcomes, pathology, expert consensus, etc. Not applicable to the information provided.
8. Sample Size for Training Set: This is for machine learning models. Not applicable.
9. How Ground Truth for Training Set was Established: Again, for machine learning. Not applicable.

The provided text focuses on the device's physical and mechanical characteristics, its intended use, and its similarity to an existing device, along with adherence to a mechanical testing standard (ASTM F1717), which is a common approach for spinal implants to demonstrate safety and efficacy through mechanical performance rather than clinical performance against specific disease-related acceptance criteria.

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