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Eisertech, LLC Temporary Fixation Pins are indicated for the following:

• guide wire for osteosynthesis implants

• accessories for external fixation (Steinmann Pin)

• application as implant according to the principles of fracture management

The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:

The provided document is a 510(k) summary for a medical device (Temporary Fixation Pins), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the way you've described.

Therefore, most of the information you've requested regarding acceptance criteria, study design, sample sizes, ground truth, experts, and comparative effectiveness studies is not present in this type of document because such studies are generally not required for 510(k) clearances.

However, I can extract the relevant information and explain why other parts are missing based on the nature of a 510(k) submission.

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

Explanation: In a 510(k) submission like this, the "acceptance criteria" for the device's performance are implicitly met by demonstrating substantial equivalence to a predicate device that has already established safety and effectiveness. No new, specific performance acceptance criteria are defined for this particular submission.

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. No performance study was conducted.
• Data Provenance: Not applicable. No performance study was conducted.

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: Not applicable. No performance study was conducted.
• Qualifications of Experts: Not applicable. No performance study was conducted.

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

• Adjudication Method: Not applicable. No performance study was conducted.

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 is a physical medical device (fixation pins), not an AI/software device that would involve human readers or AI assistance.
• Effect Size: Not applicable.

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

• Standalone Study: No. This is not an algorithm or AI device.

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

• Type of Ground Truth: Not applicable. No performance study was conducted in this 510(k) submission. The "ground truth" here is the prior FDA clearance of the predicate device, which established its safety and effectiveness.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No AI/software device or training data set is involved.

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

• Ground Truth Establishment for Training Set: Not applicable. No AI/software device or training data set is involved.

Summary of Device and Rationale from the Document:

• Device: Eisertech, LLC Temporary Fixation Pins
• Indications for Use: Guide wire for osteosynthesis implants, accessories for external fixation (Steinmann Pin), application as implant according to the principles of fracture management.
• Predicate Device: aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire, Steinmann Pin (K131459)
• Primary Argument for Substantial Equivalence: The subject device is substantially equivalent because it uses the "same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device." It also notes that the surface treatment is identical to a reference device (K190565).
• Performance Testing: "Performance testing is not necessary and was not performed on the subject device" due to the substantial equivalence argument based on materials, geometry, dimensions, and intended use to the predicate.

In essence, this 510(k) submission is a regulatory filing arguing that the new device is sufficiently similar to an already-approved device that it does not raise new questions of safety or effectiveness, therefore eliminating the need for extensive new performance studies as would be required for a novel device or a PMA.

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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 Interbody Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Interbody Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK) or titanium alloy. The devices are intended to be implanted either one device per level when used in the ALIF, Banana, or Lateral styles, and one or two devices per level when used in the PLIF/TLIF style.

Tantalum pins are embedded in the PEEK versions of the implants to help allow for radiographic visualization.

This document is a 510(k) premarket notification for an Interbody Cage and does not contain the specific type of detailed acceptance criteria and study results typically found in performance studies for AI/ML-driven medical devices. The device is a physical implant, not a software algorithm.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission.

However, I can extract the relevant "performance data" that addresses the device's equivalence to predicates, which serves as the "acceptance criteria" and "study" in the context of this 510(k) submission.

Here's a summary of the information that can be extracted, adapting the request to the nature of the provided document:

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

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

• The document mentions "worst-case size testing submitted as part of K113478" and "Additional testing (compression) per ASTMF F2077." However, it does not specify the sample size for these tests for the current submission or the original K113478.
• Data Provenance: The tests are likely prospective mechanical tests conducted on the manufactured devices/materials, rather than clinical data from human subjects. The country of origin of the data is not specified but is implicitly tied to the manufacturer/testing labs involved in the 510(k) process.

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

• Not Applicable. This is a mechanical device submission. "Ground truth" in the sense of expert clinical annotation is not relevant here. Engineering standards and physical measurements are used.

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

• Not Applicable. Mechanical testing against industry standards (e.g., ASTM F2077) does not involve adjudication in this manner.

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 for a physical interbody fusion cage, not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This is for a physical interbody fusion cage.

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

• Based on engineering standards and physical properties: The "ground truth" for this device's performance evaluation lies in meeting established mechanical testing standards (e.g., ASTM F2077 for compression strength of intervertebral body fusion devices), material specifications (ASTM F2026, ASTM F560, ASTM F136), and demonstrating equivalence in design (geometry, footprint) to predicate devices. The goal is to show that the new variations (materials, sizes) do not introduce new safety or effectiveness concerns compared to already cleared devices.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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When used as a pedicle screw fixation system, the Eisertech Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

2. Degenerative spondylolisthesis with objective evidence of neurologic impairment

• 3. Fracture
• 4. Dislocation
• 5. Scoliosis
• 6. Kyphosis
• 7. Spinal tumor and/or
• 8. Failed previous fusion (pseudoarthrosis)

The Eisertech Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion. When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Eisertech Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies)

• 2. Spinal stenosis
• 3. Spondylolisthesis
• 4. Spinal deformities
• 5. Fracture
• 6. Pseudoarthrosis
• 7. Tumor resection and/or
• 8. Failed previous fusion

The Eisertech Spinal System consists of a variety of polyaxial screws, rods, hooks, locking nuts, and rod-to-rod connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. All components are made of titanium allow per ASTM F136.

This document is a 510(k) premarket notification decision letter from the FDA for the "Spinal System" device by Eisertech, LLC. It outlines the regulatory classification, indications for use, and a summary of non-clinical tests conducted to establish substantial equivalence to a predicate device.

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

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

The document does not explicitly present acceptance criteria in a tabular format as performance metrics for a diagnostic or AI device. Instead, it details mechanical testing performed on the Spinal System to demonstrate its safety and effectiveness relative to a legally marketed predicate device.

Acceptance Criteria (Implied from Mechanical Testing Standards):

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 refers to mechanical testing of a physical device, not a test set of data. Therefore, concepts like sample size for a test set of data, country of origin, or retrospective/prospective data provenance are not applicable in this context. Mechanical testing typically involves a number of physical samples (e.g., individual screws, rods, or assembled constructs) to ensure statistical validity of the results, but the exact number of samples used for each mechanical test is not specified in this summary.

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 question is not applicable. The "ground truth" for a mechanical implant like the Spinal System is established by engineering standards and physical measurements, not by expert consensus on clinical images or data. The "experts" involved would be mechanical engineers and quality control personnel following established test protocols.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving interpretation (e.g., image reading). For mechanical testing, the results are derived from objective measurements against defined pass/fail criteria, not subjective interpretations 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 question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Spinal System is a physical implant, not an AI diagnostic tool, so such a study would not be performed for this device.

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

This question is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention. The Spinal System is a physical medical device, not an algorithm, so this concept does not apply.

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

The "ground truth" for the mechanical performance of the Spinal System is based on:

• Established engineering standards: Specifically, ASTM F1717 for static and dynamic testing of spinal implant constructs.
• Physical measurements and defined tolerances: The device components and assembled constructs must meet specific strength, stiffness, and fatigue resistance criteria as outlined in the relevant ASTM standards or internal design specifications.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train an AI model. The Spinal System is a physical medical device, and its performance is evaluated through mechanical testing, not by training an algorithm.

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

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

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The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.

The provided 510(k) summary for the Eisertech, LLC Cervical Cage does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've described for an AI/ML device.

This 510(k) is for a medical device (an orthopedic implant), not an AI/ML diagnostic or therapeutic device. The submission is a Special 510(k), which focuses on a minor change to an already cleared device, specifically changing the material of the marker pins from titanium to tantalum.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of device and submission.

Here's a breakdown of why the requested information is absent and what is provided:

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

• Not Applicable. The submission states, "The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided." For this type of mechanical device, performance would typically relate to mechanical strength, biocompatibility, and radiographic visibility. The change to tantalum for marker pins aligns with existing material standards (ASTM F560) and is explicitly stated as not affecting overall performance. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) reported for this device in the context of diagnostic performance.

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

• Not Applicable. There was no "test set" in the context of evaluating diagnostic performance or algorithm output. The submission relies on the substantial equivalence principle, where the modified device is compared to a previously cleared device and a predicate device with similar material usage.

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 performed, as this is a medical implant, not a diagnostic tool requiring expert interpretation for validation.

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

• Not Applicable. No test set requiring adjudication was used.

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 implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an algorithm or software device.

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

• Not Applicable. As no performance study requiring ground truth was conducted for this specific submission, no ground truth types are mentioned. The substantial equivalence argument rests on material properties and device design.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. No training set, no ground truth establishment for a training set.

Summary of Relevant Information from the Document:

• Purpose of Submission: To change the material of marker pins from titanium to tantalum.
• Device Description: Cervical Cage manufactured from PEEK with tantalum marker pins for radiographic visualization.
• Justification for No Additional Testing: "The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided." This is based on:
  • The primary material (PEEK) and geometry are unchanged from the predicate K110915.
  • The new marker pin material (tantalum, ASTM F560) is identical to that used in another predicate device (Nexxt Spine Honour Spacer System, K120345).
• Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

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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 PLIF Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

PLIF Cage is a hollow, generally rectangular box made The of polyetheretherketone (PEEK) and having titanium x-ray markers. It is provided in a variety of shapes and sizes, and is intended to be filled with a bone graft material. The smallest footprint of the device is 8mm medial-lateral x 20mm anterior-posterior. The largest footprint is 12mm medial-lateral x 30mm anteriorposterior. Available heights range from 7mm to 16mm. The device is available either in a non-lordosed configuration, or with a built-in six degree lordotic angle.

The PLIF cage may be inserted via an open or minimally invasive approach. It may be placed singly or in pairs.

Bone graft volume of the device is variable depending on the device size; larger sizes have more volume for graft. The smallest graft volume, in the 20x8x7mm non-fordotic device is approximately 354.1mm² (0.4cc), while the largest in the 30x12x16 lordotic device is approximately 3,530mm3 (3.5cc).

The surface area of the device contacting the endplates ranges from 118mm² to 220mm2 for the smallest and largest footprint devices, respectively.

The PLIF cage may be made either from Zeniva PEEK (Solvav Advanced Polymers, Alpharetta, GA USA) or PEEK Optima (Invibio, Inc., West Conshohocken, PA USA). The particular grade of PEEK used is tracked via product lot numbering and is displayed on the package label.

The provided text does not describe acceptance criteria for a diagnostic device or a study validating its performance in the context of medical imaging or AI. Instead, it details the 510(k) summary for a medical device called "PLIF Cage," which is an intervertebral fusion device, and the FDA's decision regarding its substantial equivalence to predicate devices.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document focuses on the mechanical testing and material equivalence of a physical implant (PLIF Cage) rather than the performance metrics of a diagnostic tool or an AI algorithm.

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The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

The Cervical Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.

Cervical Cage Acceptance Criteria and Study Details

The provided document describes the Eisertech, LLC Cervical Cage, an intervertebral fusion device. The acceptance criteria and supporting study are focused on the device's mechanical performance and substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the mechanical testing of the Cervical Cage. The phrase "the Cervical Cage was tested" implies a singular or small number of devices were tested for each scenario.
• Data Provenance: The data is from prospective bench testing of the device prototypes, conducted by Eisertech, LLC. The "country of origin of the data" is not explicitly stated but can be inferred as the USA, where Eisertech, LLC is located.

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

• This information is not applicable to this type of device and study. The "ground truth" for the mechanical performance of an implant like the Cervical Cage is established through objective, standardized biomechanical testing against defined loads and established material properties, not through expert human interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set:

• This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints (e.g., radiology reads). For biomechanical testing, the results are typically quantitative and objective measurements.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images. The Cervical Cage is a surgical implant, and its evaluation focuses on its mechanical integrity and biocompatibility.

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

• Yes, the testing described is a standalone (algorithm only without human-in-the-loop performance). The "algorithm" in this context refers to the device itself and its inherent mechanical properties, which were tested objectively without human involvement in interpreting the results beyond reading the quantitative data.

7. The Type of Ground Truth Used:

• The ground truth used for this mechanical performance study is based on engineering design requirements and established biomechanical standards (ASTM F2077 and ASTM F2267). These standards define the parameters and methodologies for testing intervertebral body fusion devices, and the device's ability to "meet or exceed" these accepted engineering benchmarks serves as the "ground truth" for its mechanical fitness.

8. The Sample Size for the Training Set:

• This information is not applicable. The Cervical Cage is a physical medical device, not an AI or software algorithm that undergoes machine learning training. There is no concept of a "training set" in this context. The design of the device would have involved engineering principles and potentially iterative prototyping and testing, but not in the sense of a machine learning training set.

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

• This information is not applicable, as there is no "training set" for this type of device. The "ground truth" for the device's design and mechanical properties would be established through engineering calculations, material science, and the aforementioned ASTM standards.

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