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The SIMPLEX Cervical Fixation System is intended for anterior screw fixation of the cervical spine. Indications for use include:

• degenerative disc disease (ddd) defined as back 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 fordosis)
• tumor
• pseudoarthrosis
• failed previous fusion
  Warning: "This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."

The SIMPLEX Cervical Fixation System consists of plates and is used to build a spinal construct. The purpose of the SIMPLEX Cervical Fixation System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The screws are available in five lengths. The self-tapping thread of the screws eliminates the need for preliminary tapping.

This document describes the SIMPLEX Cervical Fixation System, a medical device used for spinal stabilization. The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the way you've outlined.

Therefore, many of the requested categories – particularly those related to a study proving performance against acceptance criteria for an AI or diagnostic device – are not applicable to this type of submission. This is a mechanical implant, and its "performance" is generally assessed through mechanical testing and comparison to similar devices, not through a clinical trial with human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is present and where it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary primarily focuses on demonstrating that the SIMPLEX system is "substantially equivalent" to the predicate device (Radix Cervical Plate - K033951). For mechanical implants, this often involves showing similar materials, design principles, indications for use, and performance in standardized mechanical tests. Specific numerical acceptance criteria and a detailed comparison against them are typically part of the engineering design file, not usually summarized in this public 510(k) document. The key performance statement is that its "results [are] comparable to other cervical plates."

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

• Sample Size: Not specified in the provided summary. Mechanical testing usually involves a defined number of test specimens (e.g., N plates or N screws) per test type.
• Data Provenance: Not specified, but generally, mechanical testing data comes from laboratory tests conducted by the manufacturer or a third-party testing facility. It's not clinical data (retrospective or prospective).

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 medical device, not an AI or diagnostic tool requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical performance is established by the physical properties of the materials and component designs, and validated through engineering tests.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing is against engineering specifications and industry standards, not subjective expert 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

• Not Applicable. This device is a surgical implant, not an AI-powered diagnostic or assistive tool. No human reader or AI interaction is involved in its direct function.

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

• Not Applicable. This device is a surgical implant, not an algorithm.

7. The type of ground truth used

• Not Applicable in the traditional sense. For mechanical devices, "ground truth" is typically derived from:
  • Engineering specifications: Material properties, dimensional tolerances.
  • Standardized test methods (e.g., ASTM 1717): These methods define how to measure performance (e.g., fatigue, static strength) and provide benchmarks or comparative data.
  • Benchmarking against predicate devices: Showing similar performance characteristics to already-approved devices.

8. The sample size for the training set

• Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable. See point 8.

Summary regarding "Study that proves the device meets the acceptance criteria":

The document states: "Testing was performed according to ASTM 1717 with results comparable to other cervical plates."

This single sentence is the "study" summary for this 510(k) submission. It indicates that the device underwent mechanical testing adhering to the ASTM F1717 standard, which is "Standard Test Methods for Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants." The key "proof" is the statement that the "results comparable to other cervical plates." This suggests that the SIMPLEX system met the expected mechanical performance profiles (e.g., static strength, fatigue life) typical for devices of its kind, as defined by industry standards and comparison to its predicate device. This comparison of performance to similar, legally marketed devices is the core of a 510(k) submission for this type of implant.

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Radix Cervical Plate is intended for anterior screw fixation of the cervical spine.

Indications for use include:

• degenerative disc disease (ddd) defined as back 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
• failed previous fusion

The Radix Cervical Plate is a one or two level plate that is secured to the anterior cervical vertebral bodies with unicortical bone screws. The plate is available in twelve lengths ranging from 38mm to 60mm in lengthe. It has six holes to receive the bone screws. The screw holes allow variable angulation of the screws.

Ease of intra-operative handling is enhanced by pre-contouring the plates in two directions to facilitate adaptation to the patient's anatomy and self-tapping uni-cortical screws, which shorten operating time. The acrews are 03.9mm and are available in five lengths, 10mm to 18mm. The self-tapping thread of the screws eliminates are ed or preliminary tapping.

The provided text describes a 510(k) summary for the "Radix Cervical Plate," a medical device for spinal fixation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-related aspects is not present in the document.

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

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to a previously legally marketed device (predicate device) in terms of intended use, technological characteristics, and safety/effectiveness. This is typically shown through non-clinical testing and comparison.
• Reported Device Performance: The document states: "Testing was performed according to ASTM 1717 with results comparable to other cervical plates." This is a general statement about performance, but no specific numerical results or benchmarks are provided. Also, the "performance" here refers to mechanical integrity, not clinical outcomes related to the indications.

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

• Not applicable / Not provided. This document describes a non-clinical (mechanical) testing scenario, not a clinical trial with a "test set" of patient data. ASTM 1717 is a standard for mechanical testing of spinal implant constructs, which would involve physical samples of the device, not a population of patients.

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

• Not applicable / Not provided. Ground truth definition by experts is relevant for clinical studies, especially those involving image analysis or diagnostic accuracy. This document details non-clinical mechanical testing.

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

• Not applicable / Not provided. Adjudication methods are used in clinical trials to resolve discrepancies in expert opinions on patient outcomes or diagnoses. This is a non-clinical submission.

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. This device is a physical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.

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

• No. As above, this is a physical medical device, not an algorithm or AI system.

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

• For the non-clinical testing (ASTM 1717), the "ground truth" would be established engineering principles and the mechanical properties/specifications defined by the ASTM standard. There's no biological "ground truth" in this context.

8. The sample size for the training set:

• Not applicable / Not provided. "Training set" is a concept for machine learning models. This document describes a physical medical device and its non-clinical testing.

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

• Not applicable / Not provided. See point 8.

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The UNIMAX Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Pisharodi Surgicals, Inc. UNIMAX Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine,

When used as a pedicle screw fixation system of the non-cervical spine in skeletally mature patients, the UNIMAX Pedicle Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The UNIMAX Pedicle Screw System 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 thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

As a pedicle screw system the UNMAX Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The UNIMAX Pedicle Screw System consists of pedicle screws (K014302) vertical, washers, nuts and horizontal plates. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The additional component that is the subject of this Special 510(k) submission is the Offset Horizontal Plate. Its purpose is to provide rigidity to the spinal construct similar to the horizontal plate cleared on K014302.

Here's a summary of the acceptance criteria and study information for the UNIMAX Pedicle Screw System, based on the provided 510(k) summary:

This submission (K024313) is for an additional component, the Offset Horizontal Plate, for the existing UNIMAX Pedicle Screw System (K014302). Therefore, the study focuses on demonstrating the substantial equivalence of this new component rather than a comprehensive study of the entire system.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail a "test set" in the context of clinical data or a large-scale algorithmic evaluation. The evaluation appears to be based on nonclinical (mechanical/bench) analysis. The sample size for this analysis is not stated explicitly but implies a sufficient number of tests to demonstrate equivalence.

Data provenance: Not applicable in the context of clinical data, as it's a nonclinical evaluation.

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

Not applicable. The ground truth for this nonclinical evaluation would be established by engineering principles and material science standards (e.g., ASTM F136 conformance for titanium alloy), not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable, as this was a nonclinical mechanical analysis.

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

No. This was a nonclinical evaluation of a mechanical component, not an AI or diagnostic device requiring MRMC studies.

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

No. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the nonclinical evaluation of the Offset Horizontal Plate's strength is based on engineering analysis and comparison to a predicate device's mechanical properties. The material conformance to ASTM F136 for titanium alloy (Ti-6Al-4V) also serves as a ground truth for material quality.

8. The Sample Size for the Training Set

Not applicable, as this is a mechanical device, not an AI or machine learning algorithm.

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

Not applicable.

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The Universal MultiAXis (UNIMAX™) Pedicle Screw System is intended to provide immobilization and stabilization of non-cervical posterior spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) Degenerative spondylolisthesis with objective neurological impairment; (2) Fracture; (3) Dislocation; (4) Scoliosis; (5) Kyphosis; (6) Spinal tumor, and (7) Failed previous fusion (pseudoarthrosis). " When used as a pedicle screw fixation system the UNIMAX Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The UNIMAX Pedicle Screw System consists of plates, bolts, screws and is used to build a spinal construct. The purpose of the UNIMAX System is to provide stabilization during the development of a solid spinal fusion. The system is available in a variety of sizes. The components and instruments needed for this system are described in the Surgical Technique Manual. The UNIMAX Pedicle Screw System components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM standard F-136. The UNIMAX components will be provided non-sterile.

The provided text describes a 510(k) pre-market notification for the UNIMAX Pedicle Screw System. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications) typically associated with AI/ML-based medical devices or diagnostic tools.

The document is for a traditional medical device (spinal implant) and focuses on demonstrating substantial equivalence to a predicate device based primarily on:

• Intended Use/Indications: Comparing the conditions the device is designed to treat.
• System Components and Materials: Verifying that the materials (titanium alloy, Ti-6Al-4V) conform to established ASTM standards.
• Biomechanical Test Results: These verify design specifications and support substantial equivalence in terms of safety and performance. However, specific acceptance criteria or detailed results of these biomechanical tests are not enumerated in the provided summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the specific questions about the study design, as that information is not present in the provided text. The questions posed ("What was the effect size of how much human readers improve with AI vs without AI assistance," "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done," etc.) are relevant for AI/ML devices, not for a pedicle screw system, which is a physical implant.

Based on the provided text, the following information can be extracted/inferred:

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

• Acceptance Criteria: Not explicitly stated in the summary. For a device like a pedicle screw system, acceptance criteria would typically relate to mechanical strength, fatigue life, torsional rigidity, pull-out strength, and material biocompatibility, often benchmarked against the predicate device. The summary generally states "Biomechanical test results verify the design specifications and support substantial equivalence."
• Reported Device Performance: The summary states: "Test results support the safety and performance of the UNIMAX System for its intended use." No specific performance metrics (e.g., specific load capacities, cycles to failure) are provided.

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

• Not applicable/Not provided. The "test set" here would refer to the samples used in biomechanical testing, not a dataset for an AI model. Details about the number of components or constructs tested are not in the summary.

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

• Not applicable/Not provided. This question is for AI/ML diagnostic devices, where "ground truth" often involves expert annotation of medical images or data. For a mechanical device, performance is typically measured through physical tests with objective outcomes, not expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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 not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• For the biomechanical studies, the "ground truth" would be objective physical measurements of strength, durability, and material properties, compared against pre-defined engineering specifications and/or performance of the predicate device.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/ML device.

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

• Not applicable/Not provided. This is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a traditional medical device (spinal implant) and therefore does not contain the type of information requested regarding AI/ML device evaluation criteria, study design, or performance metrics. It focuses on demonstrating substantial equivalence through comparison of intended use, materials, and generic mention of biomechanical test results.

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