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

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

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

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

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

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

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

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

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

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

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

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

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

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

Not applicable. No "ground truth" establishment by experts for a test set was required for this substantial equivalence submission.

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

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

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

Not applicable. This device is a physical intervertebral body fusion system, not an AI/software device.

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

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

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

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

8. The sample size for the training set

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

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

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

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

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

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

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

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The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System is indicated for interbody fusion procedures in skeletally mature patients with disc disease (DDD) in the lumbar spine at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). KMTI Tesera-k ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of nonoperative treatment. The Tesera-k ALIF System implants are available in standalone (Tesera-k SA) and non-standalone (Tesera-k A) configurations.

Tesera-k SA ALIF cages are intended to be implanted from a direct anterior surgical approach only. Tesera-k SA ALIF cages are intended to be used with the coverplate and screws provided. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles less than 20° and use all four screws are standalone and require no supplemental fixation. Tesera-k SA ALIF assemblies (cage, screws, coverplate) that contain cages with lordotic angles greater than or equal to 20° or if the surgeon chose to use fewer than four screws are considered non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

Tesera-k A ALIF cages are monolithic and do not interface or mate with any additional implants. Tesera-k A ALIF cages may be implanted from direct anterior or oblique insertion angle. Tesera-k A ALIF cages are non-standalone and require supplemental fixation cleared by the FDA for use in the lumbosacral spine.

The Kyocera Medical Technologies, Inc. (KMT) Tesera-k Anterior Lumbar Interbody Fusion (ALIF) System implants support foraminal height and decompression between lumbar or lumbosacral vertebral bodies during spinal correction and fusion as well as reusable instruments to assist in endplate preparation and implantation. The Tesera-k ALIF System implants are available as a monolith without integrated fixation (Tesera-k A) or as a standalone with integrated fixation (Tesera-k SA) and are additively manufactured from Ti-6Al-4Vper ASTM F2924. The Tesera-k SA constructs includes screws and a coverplate manufactured from Ti-6Al-4V per ASTM F136 from the Tesera SA ALIF System (K193320, K131122, K140106, and K180502). The Tesera-k ALIF implants are sterile packaged and inserted via a direct anterior or oblique anterior surgical approach. The Tesera-k ALIF implants are offered in a variety of sizes and lordosis options to meet patient anatomical needs.

I am sorry, but the provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that uses AI. The document is an FDA 510(k) clearance letter and summary for a spinal interbody fusion device (Tesera-k ALIF System), which is a physical implant, not an AI or software-based device.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (for AI).
2. Sample size and data provenance for a test set (for AI).
3. Number and qualifications of experts for ground truth (for AI).
4. Adjudication method (for AI).
5. Multi-reader multi-case (MRMC) comparative effectiveness study with AI.
6. Standalone AI performance.
7. Type of ground truth used (for AI).
8. Sample size for the training set (for AI).
9. How ground truth for the training set was established (for AI).

The document focuses on the mechanical performance data (static and dynamic axial compression, compression shear, and subsidence) for the physical implant as per ASTM standards, concluding that the Tesera-k ALIF System is substantially equivalent to predicate devices based on these non-clinical tests.

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The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.

The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices

This document describes the FDA's decision regarding the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System and focuses on its substantial equivalence to previously cleared devices rather than a study about AI performance. Therefore, many of the requested categories are not applicable.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific performance metrics for an AI device. Instead, it focuses on demonstrating substantial equivalence for a medical implant (ALIF System) by meeting established standards and performing tests relevant to its physical properties and function.

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

• Sample Size for Test Set: Not applicable. This document describes the substantial equivalence of a physical medical implant (ALIF System) based on engineering tests, not a software device or AI algorithm evaluated on a data test set. The "tests" mentioned (Dynamic Shear Compression, Expulsion) refer to physical testing of the device itself.
• Data Provenance: Not applicable for an AI or software study. The data is generated from physical material and mechanical testing of the device components.

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

• Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of device submission. The "ground truth" for the device's physical properties is established by adherence to ASTM standards and validated engineering test methods performed by qualified laboratories.

4. Adjudication method for the test set:

• Not applicable. There is no human expert adjudication of test results in the sense of consensus on medical images or diagnoses for this device. The physical tests are governed by standardized protocols.

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 submission is for a physical medical implant, not an AI or software device that would involve human readers or AI assistance.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The "ground truth" for this medical device's performance is based on established engineering standards and validated physical test methods. For example, ASTM F2077-14 for intervertebral body fusion devices sets the benchmark for acceptable mechanical performance. Material composition adherence to ASTM F136-13, F2026-17, F560-17, and A564/M564-13e1 provides the "ground truth" for material specifications. Sterilization validation using AAMI/ANSI/ISO standards establishes the "ground truth" for sterility.

8. The sample size for the training set:

• Not applicable. This is not an AI or machine learning device that requires a training set.

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

• Not applicable. No training set is involved for this type of device.

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The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.

The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).

The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is an Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device has a built-in fixation mechanism that is manually deployed into the vertebral bodies by the operating surgeon.

The provided text describes the Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion device and its clearance by the FDA. It includes a 510(k) summary and non-clinical performance testing information.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was tested against acceptance criteria defined by predicate device performance. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it makes a general statement about meeting them.

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

The document does not specify the sample size for any of the non-clinical tests (e.g., how many devices were tested for static compression). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical engineering tests, not clinical studies involving patient data.

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 evaluation involved non-clinical performance testing of a physical device, not interpretation of clinical data requiring expert human assessment for ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable as the evaluation involved non-clinical performance testing of a physical device, not interpretation of clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:

This information is not applicable. The document describes the clearance of an intervertebral body fusion device, which is a physical implant, not an AI or imaging diagnostic device.

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

This information is not applicable. See point 5.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests was the performance of legally marketed predicate devices as defined by the relevant ASTM standards (ASTM F2077-14 and F2267-04). This implies that "ground truth" was established based on established engineering benchmarks and typical performance of similar, already-cleared devices.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of non-clinical mechanical testing of a medical device. This term is relevant for machine learning algorithms.

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

This information is not applicable. See point 8.

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The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.

The Renovis Tesera SC ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly.

When used without the cover plate and three screws the Renovis Tesera SC ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.

The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes the Tesera Trabecular Titanium (T3) cages, bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System requires no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies, stabilize the vertebral body and reduce the likelihood of expulsion of the implant. The Tesera Trabecular Titanium (T3) cages have windows in the side for visualization of the bone graft. The accompanying cover plate is designed to resist screw back-out and must be used when the screws are implanted. When used without the cover plate and screws, the Tesera SC ACF cages require supplemental fixation.

The Renovis Tesera SC ACF System cages are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V). The bone screws are manufactured from Titanium alloy (Ti-6Al-4V) and the cover plate assembly is manufactured from Titanium alloy (Ti-6Al-4V) and Nitinol alloy. The implants are provided to the end user sterilized through gamma irradiation.

The system also consists of reusable instrumentation used to implant the cages, screws, and cover plate assembly.

This document describes the Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System, a medical device. The information provided focuses on its substantial equivalence to predicate devices rather than detailing specific acceptance criteria and study results for device performance against those criteria in a tabular format. The FDA 510(k) summary typically assesses substantial equivalence based on similar intended use, design, materials, and performance testing to legally marketed devices, rather than establishing new, specific performance acceptance criteria for each submission.

However, based on the provided text, I can infer the types of performance criteria addressed through mechanical testing and report the nature of these studies.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for a diagnostic AI algorithm. Instead, it lists the mechanical performance tests conducted and asserts that "Differences between the Renovis Tesera SC ACF System and the predicate devices do not raise new issues of safety or effectiveness." This implies that the device met the performance expectations established by the predicate devices and relevant ASTM standards.

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

The document describes bench testing, meaning the "test set" consists of physical devices subjected to mechanical and material property tests.

• Sample Size for Test Set: Not explicitly stated for each test, but standard ASTM methods typically define minimum sample sizes for such tests.
• Data Provenance: This is not applicable in the usual sense for clinical data, as this is mechanical bench testing of devices (not human data). The tests were conducted to evaluate the physical and mechanical properties of the device itself.

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

Not applicable. For mechanical bench testing, "ground truth" is established by the standardized test methods (e.g., ASTM standards) themselves, which define the conditions, measurements, and interpretation of results. Experts are involved in designing and conducting the tests according to these standards, but there isn't a "ground truth" established by expert consensus on, for example, an image reading.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or expert reviews where there's variability in interpretation (e.g., of medical images) that needs to be resolved to establish a robust ground truth. For mechanical tests, the results are quantitative measurements against predefined standards.

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

Not applicable. This is a medical device for surgical implantation, not a diagnostic AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

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

7. Type of Ground Truth Used

For the performance testing mentioned:

• Mechanical Performance: The "ground truth" is established by adherence to recognized ASTM (and ISO) standards for material properties and mechanical performance. These standards define acceptable ranges for strength, fatigue life, corrosion resistance, etc., for intervertebral body fusion devices.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning algorithms. The design and manufacturing process are refined through engineering principles, material science, and iterative testing, not through a "training set" of data.

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

Not applicable, as there is no training set for a physical device. The design and manufacturing are based on established engineering principles, material science, and adherence to relevant industry standards for safety and efficacy of medical implants.

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The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft.

Patients should be skeletally mature and have at least six months of non-operative treatment.

The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is cleared under K131122. The SI28 ALIF implants (cages) are to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes; see below) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and cover plate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum.

This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized S128 implants (PEEK cages; titanium cages, screws and cover plates).

This document is a 510(k) Special Premarket Notification for the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System, focusing on the addition of gamma sterilization for its implants. It primarily addresses the safety and effectiveness of the sterilization method and its impact on the device's materials, rather than a clinical study of the device's performance in patients.

Therefore, the requested information focusing on clinical performance metrics, sample sizes for test/training sets, expert ground truth, and comparative effectiveness with AI is not directly applicable to this specific regulatory submission. This is because the submission is about a manufacturing change (sterilization method) to an already cleared device (K131122), not a new device or a clinical outcome study.

However, I can extract the information relevant to the performance data for the sterilization process, which is the core of this submission.

Acceptance Criteria and Reported Device Performance (for Gamma Sterilization)

Regarding the other requested information:

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

   • This document does not describe a clinical test set with human subjects. The "test set" here refers to material samples (Titanium and PEEK) and packaging subjected to sterilization and aging simulations. The sample sizes for these material tests are not explicitly stated but are part of standard validation protocols for ISO 11137-1 and internal Renovis testing.
   • Data provenance is from internal testing and validation performed by Renovis Surgical Technologies, Inc. and its sterilization/packaging validation partners. No country of origin for clinical data is applicable.

2. 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 as this is not a clinical study involving human expert interpretation of medical images or outcomes. Ground truth for material testing is based on established materials science and engineering principles and validated sterilization/packaging standards by qualified engineers and scientists.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments (like image interpretation) where there might be disagreement among experts. Material and sterilization testing follows objective, quantifiable methods against pre-defined specifications.

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

   • Not applicable. This submission is about a medical device (surgical implant) and a manufacturing process change (sterilization), not an AI-powered diagnostic tool or image analysis software.

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

   • Not applicable for the same reason as above.

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

   • The "ground truth" for this submission is based on established international and national standards for medical device sterilization (ISO 11137-1, ANSI/AAMI/ISO 11137-2), packaging (ISO11607-2, ASTM F1980-07), and material specifications (ASTM F2026, ASTM F136, ASTM F 560-08). This is objective, measurable data comparing post-sterilization/aging material properties to baseline and specified requirements.

7. The sample size for the training set:

   • Not applicable. There is no machine learning or AI training set described in this document.

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

   • Not applicable.

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