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The Curiteva Lumbar Interbody Fusion 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 back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Implants are intended to be used with autograft and/or allograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the lumbar spine. Patients should receive at least six (6) months of non-operative treatment prior to treatment with the device.

The Curiteva Lumbar Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate surgical approach, and the individual pathology and anatomical conditions of the patient.

The implants are generally rectangle-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

The Curiteva Lumbar Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.

Here's an analysis of the provided text regarding acceptance criteria and study information for the Curiteva Lumbar Interbody Fusion System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the acceptance criteria and performance data are entirely focused on mechanical testing, as this is a 510(k) submission for an intervertebral body fusion device, which typically relies on demonstrating substantial equivalence to predicates through physical and mechanical properties.

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

This document describes non-clinical mechanical testing of the device prototypes. Therefore:

• Sample size used for the test set: Not explicitly stated numerically for each test, but it would involve multiple samples of the device undergoing the specified mechanical tests. For medical device mechanical testing, typically a sufficient number of samples (e.g., n=5 or more per test condition) are used to ensure statistical validity and representativeness, but no specific numbers are given here.
• Data provenance: As this is non-clinical testing, the data provenance is from laboratory testing performed by the manufacturer (Curiteva, LLC) or a contracted testing facility. It is not patient-derived data (e.g., no country of origin or retrospective/prospective clinical study applies here).

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

This question is not applicable to the data presented. Ground truth and expert consensus are concepts relevant to clinical studies involving human interpretation or pathology. The study described here is purely mechanical testing of a physical device. The "ground truth" for these tests are the established ASTM standards and the physics of material behavior.

4. Adjudication Method for the Test Set

This question is not applicable as there is no "adjudication" in the context of mechanical testing. The results are quantitative measurements against predefined standards (ASTM F2077, F2267, F1877).

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

No, an MRMC comparative effectiveness study was not done. This type of study evaluates human reader performance, typically with medical images, both with and without AI assistance. The provided document describes mechanical testing of a physical implant.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this submission is derived from established engineering and material science standards (ASTM) and the objective measurements obtained from laboratory mechanical testing. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of mechanical testing of a physical device. Training sets are relevant to machine learning algorithms.

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

This question is not applicable for the same reason as above; there is no training set mentioned or implied in this document.

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The Curiteva Midline Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.

The Curiteva Midline Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 and are provided non-sterile.

The provided text is a 510(k) summary for the Curiteva Midline Anterior Cervical Plate System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, particular performance metrics, details of a study that proves the device meets those criteria, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot fulfill the request as the essential information is not present in the provided document.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through mechanical testing for implantable devices like the one described. It typically does not involve clinical studies with human readers or AI algorithms in the way the prompt's questions suggest.

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The Curiteva Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-T1) as an adjunct to fusion. The system is intended to provide temporary stabilization during the development of cervical spinal fusion in patients with the following: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformity (e.g., kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, and/or failed previous fusion.

The Curiteva Anterior Cervical Plate System consists of screws and plates. These implants are available in different sizes so that adaptations can be made to take into account pathology and individual patient anatomy. All implants are manufactured from Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Curiteva Anterior Cervical Plate System." It confirms that the device is substantially equivalent to legally marketed predicate devices.

Let's break down the information provided in the context of acceptance criteria and a study proving the device meets them:

Critique of the Provided Document Regarding Acceptance Criteria and Study:

The provided document is an FDA 510(k) clearance letter and a 510(k) Summary. It does NOT contain the detailed information typically found in a clinical study report or a pre-defined set of acceptance criteria for algorithm performance.

This document is for a mechanical medical device (spinal plate system), not an AI/ML software or diagnostic device. Therefore, the "acceptance criteria" and "study" described in the prompt are referring to mechanical and material performance testing, not AI performance metrics like sensitivity, specificity, or AUC, nor are they clinical trials with human readers.

The prompt's questions are geared towards the evaluation of an AI/ML-based medical device. My response will highlight how the provided document addresses, or doesn't address, these questions in the context of a mechanical device clearance.

Here's an attempt to answer your questions based solely on the provided text, interpreting "acceptance criteria" and "study" within the context of mechanical device testing:

Based on the provided FDA 510(k) clearance letter and summary for the Curiteva Anterior Cervical Plate System, the "acceptance criteria" and "study" refer to the mechanical and material performance testing required for this type of implantable device, rather than the AI/ML performance metrics that your questions typically relate to.

Acceptance Criteria and Device Performance (Mechanical Device Context)

Study Details (Interpreted for a Mechanical Device)

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

   • Test Set Sample Size: Not explicitly stated in terms of number of plates/screws tested. For mechanical testing, samples are usually a representative number of units per size/configuration tested to ISO/ASTM standards.
   • Data Provenance: The testing was "non-clinical testing," implying it was conducted in a laboratory setting (e.g., in vitro mechanical testing), not on human subjects. The location (country) of the testing is not specified, but it would have been conducted by the manufacturer or a certified testing lab. This would be considered "prospective" for the purpose of demonstrating device performance against pre-defined test protocols.

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

   • Not applicable in the context of mechanical device testing. "Ground truth" for mechanical testing is established by adhering to widely accepted international standards (e.g., ASTM F1717) and engineering principles. The "experts" would be the engineers and technicians performing and interpreting the mechanical tests according to these standards.

3. Adjudication Method for the Test Set:

   • Not applicable. Mechanical testing results are objectively measured (e.g., force, displacement, cycles to failure). There is no "adjudication" in the sense of reconciling human interpretations.

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

   • No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and their performance might be enhanced by an AI tool. This device is a surgical implant, not a diagnostic tool requiring human interpretation for its function.

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

   • Yes, in a way relevant to a mechanical device. The "performance data" presented is effectively "standalone" performance of the device itself under specified mechanical stress conditions, without human interaction during the test. There is no algorithm here; it's a physical product.

6. The Type of Ground Truth Used:

   • For mechanical testing, the "ground truth" is defined by established engineering standards (e.g., ASTM F1717) and the physical properties and failure points of the materials and designs under controlled loads. The comparison to predicate devices also serves as a benchmark for acceptable performance.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML product that undergoes a "training set" process. It's a manufactured medical device.

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

   • Not applicable. As above, there is no "training set" or "ground truth" establishment in the AI/ML sense for this mechanical device. Design validation and verification are based on engineering principles and compliance with standards.

Summary in relation to your prompt's original intent (AI/ML):

This document pertains to a traditional Class II mechanical implantable medical device. Therefore, the specific questions regarding AI/ML performance metrics (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI) are not directly addressed or applicable in the context of this 510(k) submission. The "study" described is entirely focused on demonstrating the physical and mechanical equivalence and safety of the implant compared to existing cleared devices through bench testing.

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The Curiteva Cervical Interbody Fusion is 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 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. Implants are intended to be used with autograft bone (comprised of cancellous and/or corticocancellous bone graft) and supplemental spinal fixation systems that have been cleared for use in the cervical spine. Patients should receive at least six (6) weeks of non-operative treatment with the device.

The Curiteva Cervical Interbody Fusion System implants are available in a variety of different footprints, styles and sizes to accommodate the individual pathology and anatomical conditions of the patient. The implants are generally box-shaped with an open central chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Curiteva Cervical Interbody Fusion System implants are manufactured from PEEK (per ASTM F2026) with Tantalum markers (per ASTM F560), or Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. The PEEK implants are available with or without a medical grade commercially pure titanium (CpTi) plasma coating (per ASTM F1580) on the superior and inferior surfaces.

The provided text describes a 510(k) premarket notification for the Curiteva Cervical Interbody Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving independent performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Cannot be provided directly. The document states that the device was "mechanically tested in the following test modes: static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, expulsion, and wear debris characterization per ASTM F1877." It then concludes that "the strength and performance... is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
• However, the specific acceptance criteria (e.g., minimum compression strength, maximum subsidence) and the reported numerical performance values for the Curiteva device or the predicate devices are not detailed in this document. It only states that the device met the requirements for substantial equivalence.

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

• Not applicable/Not mentioned. This was a non-clinical mechanical testing study, not a clinical study involving human patient data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply. The "sample size" would refer to the number of devices tested, which is not specified but implicitly sufficient to meet 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):

• Not applicable. This was mechanical testing, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging context.

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

• Not applicable. See point 3.

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

• No. An MRMC study is a clinical study typically used for diagnostic devices involving human interpretation of medical images, often with AI assistance. This document describes mechanical testing of an interbody fusion device, which is an implant, not an AI diagnostic tool.

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

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

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

• Not applicable. For mechanical testing, the "ground truth" is typically defined by the test standards (e.g., ASTM F2077, F2267, F1877) and the physical properties of the materials and device design. The results are quantitative measurements against these standards.

8. The sample size for the training set:

• Not applicable. This refers to a dataset for training machine learning models, which is irrelevant for this mechanical testing submission.

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

• Not applicable. See point 8.

Summary of available information related to performance:

The device's performance was evaluated through non-clinical mechanical testing based on established ASTM standards:

• Test Modes:
  • Static and dynamic compression (per ASTM F2077)
  • Static and dynamic torsion (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Expulsion
  • Wear debris characterization (per ASTM F1877)
• Conclusion: The results showed that the "strength and performance of the Curiteva Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The document focuses on establishing substantial equivalence, meaning the device performs as safely and effectively as a legally marketed predicate device, rather than defining novel acceptance criteria and demonstrating unique performance against them in a clinical study.

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