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The Medyssey Navigation System is indicated for use during the preparation and placement of Medyssey screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medyssey Navigation System is reusable and is specifically designed for use with the Medtronic Navigation StealthStation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Medyssey Navigation System is limited to use only with ILIAD™ Spinal Fixation System and Zenius™ Spinal Fixation System (including Hedjet and ARTeMIS pedicle screw systems).

Medyssey Navigation System is comprised of reusable instruments intended to be used in conjunction with the Medtronic StealthStation® Navigation System and its associated NavLock arrays to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Medyssey Navigation System is comprised of Bone Taps and Screw Drivers. These instruments are made of medical grade stainless steel. The Medyssey Navigation System is supplied clean and non-sterile, to be sterilized by the end user.

Here's an analysis of the provided FDA 510(k) clearance letter for the Medyssey Navigation System, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Note: This document is a 510(k) clearance letter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, and statistical analyses typically found in a full submission. Therefore, some information, especially regarding specific numerical performance metrics, sample sizes for test sets, and detailed adjudication methods, is not explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance

The provided document defines the acceptance criteria implicitly through "Performance Testing" which aims to demonstrate "substantial equivalence to the predicate instruments" and suitability for intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

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

• Sample Size: Not explicitly stated. The document mentions "comparative dimensional analysis" and "performance testing" of the Medyssey Navigation System instruments. The specific number of instruments tested, or cases/measurements included in the accuracy and functionality testing, is not provided.
• Data Provenance: Not explicitly stated. The nature of the testing ("comparative dimensional analysis," "functionality, accuracy and compatibility with the Medtronic StealthStation® System") suggests laboratory and/or bench testing. There is no indication of clinical data from patients or a specific country of origin for the data beyond Medyssey Co, Ltd. being based in Korea. It appears to be a prospective test conducted for the purpose of this submission, based on physical and functional evaluation of the device.

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

• This information is not provided in the document. The type of testing described (dimensional analysis, compatibility, reprocessing validations) typically relies on engineering and quality control measurements rather than expert human interpretation in the same way an AI diagnostic device would. If any expert evaluation was involved in assessing functionality or accuracy, it is not detailed.

4. Adjudication method for the test set

• This information is not provided in the document. Given the nature of the testing (dimensional analysis, compatibility, reprocessing), a formal adjudication method by multiple experts (like 2+1 or 3+1) is unlikely to be applicable in the same way it would for a clinical study involving subjective interpretations. The results would likely be based on objective measurement comparisons against specifications or predicate device data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The provided document describes engineering and performance testing to demonstrate substantial equivalence, not a clinical study involving multiple human readers assessing performance with or without AI assistance. The Medyssey Navigation System is an instrument; it's not an AI/software device that assists human interpretation of medical images or data.

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

• This question is not applicable as the Medyssey Navigation System is a surgical instrument. It is designed to be used with a human surgeon and the Medtronic StealthStation® Navigation System (which itself is a navigation tool, not an autonomous algorithm for diagnosis or treatment decision-making). The "algorithm only" concept does not apply here.

7. The type of ground truth used

• The "ground truth" for the performance testing appears to be based on:
  • Engineering Specifications/Standards: For dimensional analysis and compatibility with the Medtronic StealthStation.
  • Recognized Standards: For reprocessing validations (ANSI/AAMI ST98 and ISO 17665).
  • Predicate Device Data/Characteristics: For comparison to demonstrate substantial equivalence in terms of design, dimensions, materials, technology, and function.

8. The sample size for the training set

• This information is not applicable/not provided. The Medyssey Navigation System is a physical instrument, not a machine learning or AI model that requires a training set. The term "training set" is relevant for AI/ML algorithms.

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

• This information is not applicable/not provided for the same reasons as point 8.

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The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod. The Cobalt Chrome Rods are for use with the Zenius or Iliad System. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medyssey Cannulated Pedicle Screws and Cobalt Chrome Rods:

1. Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical (bench) testing for the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The acceptance criteria are implicitly defined by the chosen ASTM standard and the comparison to predicate devices, which means the new device must perform at least as well as the legally marketed predicates.

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

• Test Set Sample Size: The document does not specify the exact number of devices (screws/rods) tested for each non-clinical test (static compression, torsion, tension, dynamic compression). Standard test methodologies for medical devices like ASTM F1717-04 typically require a minimum number of samples for statistically valid results, but these specific numbers are not detailed in this summary.
• Data Provenance: The data is from non-clinical (bench) testing performed by Medyssey Co. Ltd. The country of origin of the testing data is not explicitly stated, but Medyssey is a Korean company with a US-based contact for regulatory purposes.

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

This information is not applicable as the study described is non-clinical (bench testing) of physical device properties, not a clinical study involving human patients or expert interpretation of medical data. The "ground truth" here is the measured mechanical performance of the device against established engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical (bench testing). Adjudication methods are typically employed in clinical studies or studies involving expert review of medical images/data to resolve discrepancies in interpretation.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (spinal pedicle screws and rods), not an AI/software device. Therefore, there is no mention of human readers or AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical study is:

• Engineering Standards and Specifications: Adherence to ASTM F1717-04.
• Predicate Device Performance: The mechanical performance of the new device was compared to that of legally marketed predicate devices. The implicit ground truth is that the predicate devices are safe and effective, and therefore, a device demonstrating equivalent or superior mechanical properties would also be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set

This information is not applicable as the study described is non-clinical (bench testing) of a physical device. There is no concept of a "training set" for this type of evaluation.

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

This information is not applicable as there is no training set for this non-clinical study.

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The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Medyssey C7 Anterior Cervical Interbody Fusion Cage system consists of a series of PEEK (polyetheretherketone) cervical interbody spacers of various footprints and thicknesses. The C7 ACIF cages have ridges on their superior and inferior surfaces to prevent migration, and graft windows to allow for bony fusion. Tantalum markers are incorporated into the devices to allow for radiographic visualization of the implants.

The provided document is a 510(k) summary for the Medyssey C7 Anterior Cervical Interbody Fusion Cage. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not involve studies evaluating the diagnostic accuracy or performance of an AI/ML powered medical device, which would typically involve human readers, ground truth establishment, or training/test sets.

Therefore, many of the requested elements are not applicable to this document. The information provided below reflects what is available in the document.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression
• Static Torsion
• Static Compressive Shear
• Dynamic Compression
• Subsidence
• Expulsion | Non-clinical tests were performed for:
• Static Compression
• Static Torsion
• Static Compressive Shear
• Dynamic Compression
• Subsidence
• Expulsion

Conclusion: Based on the testing and comparison analysis to the predicate devices, Medyssey believes that the subject Medyssey C7 Anterior Cervical Cage System is substantially equivalent to the predicate devices. The minor differences in design were evaluated through testing and do not affect the safety and efficacy of the device for its intended use. |

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

Not applicable. This is a non-clinical testing submission for a physical medical device (interbody fusion cage), not an AI/ML powered device using test sets of data. The "tests" refer to mechanical and material property assessments.

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. Ground truth as typically understood for diagnostic AI/ML models is not relevant here. The "ground truth" for a physical device would relate to engineering standards and mechanical properties, assessed by engineers and technicians.

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

Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies.

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 an interbody fusion cage, 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 device is an interbody fusion cage, not an AI algorithm.

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

Not applicable. For this device, "ground truth" would be defined by engineering specifications and material science standards.

8. The sample size for the training set

Not applicable. This device is an interbody fusion cage, not an AI algorithm requiring a training set of data.

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

Not applicable.

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The LT Cage System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Medyssey LT Cage System consists of cages of various widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Medyssey LT Cage System is to be used with supplemental fixation.

The device is offered in 64 sizes, with heights ranging from 8 - 15mm, lengths from 25 - 32mm and a width of 11mm. They are also available with 0°, 4° and 8° lordosis. The devices are manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and are supplied non-sterile.

The purpose of this submission is to provide a device that is manufactured from titanium alloy, which is similar to the PEEK device currently available from Medyssey Co. Ltd.

This 510(k) summary describes a medical device, the Medyssey LT Cage System, which is an intervertebral body fusion device. The submission focuses on demonstrating substantial equivalence to a predicate device, the Medyssey LP Cage.

Here's an analysis of the provided information against the requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression ASTM F2077-03
• Static Torsion ASTM F2077-03
• Static Compressive Shear F2077-03
• Dynamic Compression F2077-03
• Subsidence ASTM F2267-04
  The submission states, "No additional testing is required to support this submission" for the subject device due to the change only being material and the new material being stronger. This implies that the LT Cage is expected to meet or exceed these performance metrics. |
  | Substantial Equivalence to Predicate | The overarching acceptance criterion for this 510(k) is substantial equivalence to the Medyssey LP Cage. This was met, and the FDA provided a clearance letter. |

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

This submission is for a material change to an existing device (the Medyssey LP Cage). No new clinical test set or data was used for the Medyssey LT Cage System to prove its performance directly. The basis for acceptance is derived from the established performance of the predicate device and the recognized properties of the new material. Therefore, information regarding sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or provided in this context.

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

Not applicable. As this is not a study involving a clinical test set requiring expert ground-truthing, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring an adjudication method.

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

No. This submission is for a medical device (intervertebral cage) and not an AI or imaging diagnostic tool. Therefore, a MRMC comparative effectiveness study, human readers, or AI assistance is not relevant or described.

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

No. This is a physical medical implant device, not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" in this context is the established mechanical performance and biocompatibility of the titanium alloy (Ti-6Al-4V) and the mechanical performance data of the predicate Medyssey LP Cage, which was tested against ASTM standards.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device submission, as it does not involve machine learning or an algorithm.

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

Not applicable. As there is no training set, the establishment of its ground truth is not relevant.

In summary, this 510(k) submission successfully argued for substantial equivalence based on:

• Identical design and fundamental scientific technology between the subject and predicate devices.
• A change only in material (from PEEK to titanium alloy).
• The new material (titanium alloy) being stronger and having established biocompatibility for orthopedic implants.
• Reliance on existing non-clinical test data for the predicate device, which demonstrated compliance with relevant ASTM standards for mechanical performance.

The FDA's clearance (K121246) indicates agreement with the argument that "No additional testing is required to support this submission" for the subject device.

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The Novel III Spinal System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra 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.

In addition, the Novel Spinal System is 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 the thoracic lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Novel ///TM Spinal Fixation and Adjustable Bridge System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Novel /// ™ Spinal Fixation and Adjustable Bridge System implant components are fabricated from titanium allov (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Novel ////™ Spinal Fixation and Adjustable Bridge System implants.

This 510(k) summary does not contain information related to an AI/ML device. The submission is for a medical device (spinal fixation system) and its modified sterilization trays, not a software algorithm that performs diagnostic or prognostic functions.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth, MRMC studies) are not applicable to this document.

Here's an analysis based on the information provided in the 510(k) summary, focusing on the device modification mentioned:

Acceptance Criteria and Study for Novel III™ Spinal Fixation and Adjustable Bridge System (Modified Sterilization Trays)

This 510(k) submission primarily concerns a "Special 510(k): Device Modification" related to redesigning custom sterilization trays for the Novel III™ Spinal Fixation and Adjustable Bridge System. The core spinal fixation device itself has already been cleared (predicates K081153 and K103147).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are focused on the sterilization process for the redesigned trays, not on the clinical performance of the spinal system or an AI/ML algorithm.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • For the sterilization validation, the sample size is not explicitly stated in the summary, but it would typically involve a statistically relevant number of sterilization cycles and biological indicator tests. The summary just states it was "satisfactorily performed."
  • For mechanical testing of the implant, the sample size is not specified but would follow ASTM F 1717-04 guidelines.
• Data Provenance: The data provenance for the tests performed (sterilization validation, mechanical testing) is not specified beyond being generated by Medyssey Co. Ltd. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are relevant for clinical studies, not typically for device performance testing like sterilization or mechanical strength.

3. Number of Experts and Qualifications for Ground Truth Establishment

This item is not applicable as the submission does not involve an AI/ML algorithm or a diagnostic/prognostic device that requires expert ground truth establishment from clinical images or data. The ground truth for sterilization is a defined SAL, established through validated laboratory procedures.

4. Adjudication Method for the Test Set

This item is not applicable. The type of testing performed (sterilization validation, mechanical testing) does not involve human readers or adjudication processes.

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

This item is not applicable. No MRMC study was performed as this is not an AI/ML device, nor is it a diagnostic imaging device where human reader performance would be the primary endpoint. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system."

6. Standalone Performance (Algorithm Only)

This item is not applicable as there is no algorithm or software component for standalone performance evaluation in this 510(k) submission.

7. Type of Ground Truth Used

• For Sterilization Validation: The ground truth is the Sterility Assurance Level (SAL), which is a quantitative measure (1 x 10⁻⁶), established through specific, validated laboratory methods involving biological indicators and physical parameters of the sterilization cycle.
• For Mechanical Testing: The ground truth is the performance specifications defined by the ASTM F 1717-04 standard.
• For Substantial Equivalence: The ground truth is the characteristics and performance of the predicate devices and the regulatory standard for equivalence.

8. Sample Size for the Training Set

This item is 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

This item is not applicable as there is no training set.

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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Zenius 146 Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius "" Spinal System implants.

The provided text describes a 510(k) summary for a spinal system and its modification, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or even extensive non-clinical testing beyond basic mechanical and sterilization validation.

This document specifically states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system." The purpose of this submission was for the clearance of the redesign of the custom sterilization trays, not for assessing the clinical performance or efficacy of the spinal system itself beyond its substantial equivalence to the previously cleared predicate.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text, with clear limitations:

1. Table of acceptance criteria and the reported device performance:

Important Note: The document focuses on demonstrating substantial equivalence to a previously cleared device, particularly for a modification to sterilization trays. It does not present new performance data for the implant itself beyond the scope of that modification.

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

• Mechanical Testing: Not specified for this submission, as the mechanical tests (ASTM F 1717-04) were already performed for the predicate device, and the current submission primarily concerned sterilization trays. For the sterilization validation, the sample size and provenance are not detailed in this summary; it just states it was "satisfactorily performed."
• Clinical Data: No clinical tests were conducted for either the subject system or the predicate system (as stated in the document).

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

• Not applicable as no clinical tests were performed, and thus no expert ground truth was established from clinical data for this submission. The "ground truth" for mechanical testing would be the ASTM standards, and for sterilization, the AAMI guidelines.

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

• Not applicable as no clinical tests were performed and no human adjudication of results is mentioned for the non-clinical tests.

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

• No MRMC comparative effectiveness study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic system.

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

• Not applicable. This device is a mechanical spinal implant, not an algorithm.

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

• For mechanical properties: ASTM F 1717-04 standards.
• For material properties: ASTM F 136 standard for titanium alloy.
• For sterility: AAMI ST77 and AAMI ST79 guidelines.
• No clinical ground truth (expert consensus, pathology, outcomes data) was used or generated for this specific submission because no clinical studies were performed.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning algorithm.

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

• Not applicable. This is a mechanical device, not a machine learning algorithm.

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The LP Cage® is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The LP Cage is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. All implantable components are manufactured from PEEK Optima LT1 and medical grade titanium alloy (Ti6Al4V-ELI).

This document describes the pre-clinical performance testing of the Medyssey LP Cage, an intervertebral body fusion device.

1. Acceptance Criteria and Reported Device Performance:

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

The study refers to "pre-clinical testing" and the use of "recognized protocol" and ASTM standards for testing. However, the specific sample sizes (number of devices tested for each criterion) are not provided in the document. The data provenance is from Medyssey Co, LTD. in South Korea, and the testing appears to be prospective bench testing focused on the physical characteristics and performance of the device.

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

This document is for a medical device (LP Cage) and focuses on bench testing rather than diagnostic or observational studies. Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical readings. The "ground truth" for the device's performance is derived from its physical properties and mechanical behavior under standardized testing conditions against established engineering standards (ASTM).

4. Adjudication Method for the Test Set:

Given that this is bench testing of a physical device against engineering standards, an adjudication method is not applicable in the context of expert consensus or disagreement. The results are objective measurements against predefined criteria in the ASTM standards and the "recognized protocol" for expulsion testing.

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

No MRMC comparative effectiveness study was done. This document describes the pre-clinical bench testing of a physical medical device, not a diagnostic algorithm or a tool that assists human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical implant (LP Cage), not an algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this specific submission.

7. Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established physical performance benchmarks outlined in ASTM standards (F2077-03, F2267-04) and a "recognized protocol" for expulsion testing. The substantial equivalence claim is based on the device's ability to meet or exceed the performance of predicate devices according to these objective tests.

8. Sample Size for the Training Set:

Not applicable. This document describes the pre-market submission for a physical medical device. There is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are assessed through bench testing.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for such a set.

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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Zenius "M Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius™ Spinal System implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zenius™ Spinal System.

It's important to note that this document is a 510(k) Special Premarket Notification for a modification to an existing device. This type of submission often relies heavily on proving substantial equivalence to the predicate device, rather than entirely new, extensive studies.

Acceptance Criteria and Device Performance for Zenius™ Spinal System (K103272)

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Absence of Specific Information for AI-Related Questions:

It is crucial to understand that the provided text is for a spinal fixation system (a physical medical device), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the questions related to AI performance, sample sizes for test/training sets, experts for ground truth, adjudication methods, and MRMC studies are not applicable to this type of device submission. The study is mechanical/physical testing, not an algorithmic performance evaluation.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size in the context of device testing. Mechanical tests specified by ASTM F 1717-04 would involve a certain number of test units, but this detail is not provided.
• Data Provenance: The mechanical testing was performed by Medyssey Co., Ltd., which is a Korean company (Gyeonggi-do, Korea). The ASTM standards are international standards. This is lab-based physical testing, not a clinical data set.
• Retrospective/Prospective: Neither. This refers to laboratory mechanical testing, not clinical studies.

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

• Not Applicable. For a mechanical spinal implant, "ground truth" is established through engineering specifications, material properties, and adherence to validated testing standards (like ASTM F 1717-04). It does not involve expert consensus in the way an AI diagnostic tool would.

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

• Not Applicable. Since there's no diagnostic or interpretative output from the device being evaluated by human experts, there's no adjudication method in play.

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 hardware device; AI assistance for human readers is irrelevant.

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

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

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

• Engineering Specifications and Standardized Mechanical Test Results: The "ground truth" for this device revolves around its ability to meet the defined mechanical performance thresholds and material specifications outlined in standards like ASTM F 1717-04 and ASTM F 136. The predicate device's existing clearance (K093104) serves as the basis for substantial equivalence for similar material and design modifications.

8. The sample size for the training set:

• Not Applicable. This is not an AI device that requires a training set. The "training" for a physical device involves its design, manufacturing processes, and material selection, all adhering to established quality systems.

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

• Not Applicable. No training set in the AI sense. The "ground truth" for the device's design and manufacturing is established through adherence to engineering principles, material science, and quality management systems (21 CFR part 820, ISO 9001, ISO 13485).

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The Novel III Spinal System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra 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. In addition, the Novel Spinal System is 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 the thoracic lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Novel ///™ Spinal Fixation and Adjustable Bridge System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Novel III TM Spinal Fixation and Adjustable Bridge System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Novel ///™ Spinal Fixation and Adjustable Bridge System implants.

The provided text is a 510(k) summary for the Novel III™ Spinal Fixation and Adjustable Bridge System, which is a medical device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through mechanical testing and comparison of design and intended use.

Therefore, the document does not contain the information requested in points 1-9, as those details are typically associated with clinical trials or studies assessing diagnostic performance, which are not relevant for this type of device submission.

Here's a breakdown of why the information is not present:

• Acceptance Criteria and Device Performance (1): Not applicable for this type of device. The acceptance criteria here would be meeting the mechanical testing standards (ASTM F 1717-04 for the predicate, and implied substantial equivalence for the modified device). No specific reported "performance" in the sense of diagnostic accuracy or a clinical outcome study is provided or required for a device modification of this nature.
• Sample Size, Data Provenance (2): No clinical test set involving patients is described. The "test set" refers to the components tested in mechanical validation.
• Number of Experts, Qualifications (3): No expert ground truth establishment for a test set is described.
• Adjudication Method (4): Not applicable as there's no interpretation of clinical data by experts.
• MRMC Comparative Effectiveness Study (5): This is a mechanical device, not an AI or diagnostic tool where human readers would improve with AI assistance.
• Standalone Performance (6): "Algorithm only without human-in-the-loop performance" is not relevant for a spinal fixation system.
• Type of Ground Truth (7): Not applicable. The "ground truth" for this device is its mechanical integrity and ability to perform its intended structural support function, verified by engineering and material standards, not by clinical pathology or outcomes in a study for this submission.
• Sample Size for Training Set (8): No training set as this is not an AI/ML device requiring training data.
• Ground Truth for Training Set (9): Not applicable, as there's no training set.

Summary of what is present and relevant to the 510(k) in relation to 'testing':

The submission indicates that the predicate device (Novel™ Spinal System) underwent mechanical testing, including:

• Static Compression Bending
• Static Tension Bending
• Static Torsional
• Dynamic Compression Fatigue Testing

All these tests were performed per ASTM F 1717-04.

The subject device (Novel III™ Spinal Fixation and Adjustable Bridge System) "contains dimensionally modified components (not worst case) and therefore not subject to ASTM F 1717-04 additional testing." This implies that because the modifications were not considered "worst case" in terms of mechanical stress, the new device was deemed substantially equivalent to the predicate without needing to repeat all the same mechanical tests. The acceptance criteria for the subject device are therefore implicitly:

1. Substantial Equivalence: The modified components do not negatively impact the mechanical performance already established for the predicate device.
2. Compliance with ASTM F 1717-04 (by proxy via predicate): The predicate device met these standards, and the modifications to the subject device are not considered to compromise that compliance.

In essence, the "study" proving the device meets acceptance criteria is the mechanical testing of the predicate device against ASTM F 1717-04, and the subsequent engineering analysis that concluded the modifications in the Novel III™ system did not require new, full-scale mechanical testing due to their non-worst-case nature.

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The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Medyssey Co. Ltd., Zenius ™ Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd., Zenius ™ Spinal System implants.

This document describes a 510(k) premarket notification for a spinal fixation system, not an AI/ML powered medical device. Therefore much of the requested information, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, and MRMC studies, is not applicable to this submission type.

Here’s an analysis based on the provided text, focusing on the available information:

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

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

This information is not applicable. The device is a physical medical implant (spinal fixation system), and its performance was evaluated through mechanical testing, not clinical data or a test set in the context of AI/ML. The provenance of the data is the mechanical testing conducted according to ASTM standards.

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

This information is not applicable. Ground truth, in the AI/ML sense, is not relevant for this type of device submission. Performance was established through standardized mechanical tests.

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

This information is not applicable, as there was no test set requiring human adjudication for ground truth.

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

No MRMC study was done, nor would it be relevant for this type of physical implant device. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate systems."

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

This is not applicable. This is a mechanical device, not an algorithm.

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

For this device, the "ground truth" for proving performance was based on:

• Adherence to Material Standards: Conformance to ASTM F 136 for titanium alloy.
• Mechanical Testing Standards: Performance against established benchmarks and predicate devices in static and fatigue testing protocols as defined by ASTM F 1717-04.
• Predicated Device Equivalence: The performance of existing, legally marketed devices (U&I Corporation OPTIMA™ Spinal System and Medyssey's Co. Ltd., NOVEL™ Spinal System) served as the benchmark for "substantial equivalence."

8. The sample size for the training set

This information is not applicable, as there was no training set for an AI/ML algorithm.

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

This information is not applicable, as there was no training set for an AI/ML algorithm.

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