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The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.

The VERTEX Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The VERTEX bone staples are made from superelastic nitinol that does not require cold storage or heating.

This document is a 510(k) summary for the VERTEX Nitinol Staple System. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. This type of document refers to the regulatory clearance process for medical devices and does not typically include information about clinical studies or AI-related performance.

Here's a breakdown based on your request, highlighting what's not available in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states, "No FDA performance standards have been established for the VERTEX Nitinol Staple System." Therefore, the acceptance criteria are based on recognized consensus standards and current industry practice for demonstrating safety and substantial equivalence to predicate devices. The document only states that the device "meets" these criteria in a general sense, not providing specific pass/fail thresholds or quantitative results of the tests.

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

This document describes non-clinical bench testing rather than a clinical study with a "test set" of patients.

• Sample size for test set: Not applicable (non-clinical bench testing). The sample size would refer to the number of physical staples tested for each benchmark. This specific detail is not provided in the summary.
• Data provenance: Not applicable. The data is generated from laboratory bench tests.

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

Not applicable. Ground truth, in the context of clinical or AI studies, typically refers to expert labels or diagnoses. This document concerns a physical medical device and its mechanical/material properties, evaluated through non-clinical testing.

4. Adjudication method for the test set

Not applicable, as this is non-clinical bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This document does not mention any MRMC comparative effectiveness study. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to the non-clinical testing described for this device.

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

Not applicable. This document is for a physical medical device (nitinol staples), not an algorithm or AI system.

7. The type of ground truth used

For the non-clinical testing described, the "ground truth" would be established by:

• Physical measurements and material properties: Conforming to the specifications outlined in the respective ASTM standards (F564, F2129, F2082).
• Engineering analysis: Comparing the design, dimensions, and materials to the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm study that involves a training set.

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

Not applicable.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The VECTOR Hammertoe Correction System is a medical device designed for the fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The provided text describes the regulatory filing for this device, not a study evaluating its performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the "SUMMARY OF NON-CLINICAL TESTING" section, we can infer the types of tests performed to demonstrate safety and equivalence to predicate devices, which serve as the implicit acceptance criteria for this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for individual tests (e.g., number of implants tested for torsion, pullout, etc.). It describes non-clinical laboratory testing. The data provenance is from laboratory testing conducted by the manufacturer, Nvision Biomedical Technologies, LLC. Since these are non-clinical (mechanical and biological) tests, "country of origin of the data" and "retrospective or prospective" are not directly applicable in the same way they would be for clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical study involving mechanical and biocompatibility testing, not human expert evaluation of clinical images or diagnoses. The "ground truth" here is established by the specifications of the ASTM standards and regulatory limits (e.g., endotoxin levels).

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process as this was non-clinical laboratory testing.

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 document describes the regulatory filing for a medical fixation device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and recognized consensus standards: Specifically ASTM F543, which outlines standard test methods for metallic medical bone screws.
• Regulatory limits for biocompatibility: Recommended Bacterial Endotoxins limits (20 EU/device).
• Comparison to predicate devices: The "substantially equivalent" determination implies that the test results met or exceeded the performance characteristics of the predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

The Healix Compression Screw (HCS) System consists of 2.0mm to 8.5mm cannulated, solid titanium alloy, headless, headed screws and specialized instrumentation. The screw system has multiple lengths depending on diameter of the screws.

The provided text is related to a 510(k) premarket notification for the "Healix™ Compression Screw System." It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing.

However, the document does not contain information about:

• Acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.
• A study that proves the device meets specific acceptance criteria in terms of clinical performance because this device is a bone fixation fastener, not an AI or diagnostic tool.
• Sample sizes used for test sets or training sets in the context of AI or diagnostic algorithms.
• Data provenance, expert qualifications, or adjudication methods for ground truth, which are relevant for AI/diagnostic studies.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used for AI/diagnostic algorithms.
• How ground truth for a training set was established.

Instead, the document focuses on non-clinical testing to demonstrate the safety and effectiveness of the bone fixation screw system, establishing its substantial equivalence to previously cleared predicate devices.

Here's what can be extracted and what is missing relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail values for specific performances, but implied as meeting industry standards and being comparable to predicate devices. The tests performed are described.
• Reported Device Performance:
  • Torsion, driving torque, and axial pullout (per ASTM F543)
  • Static and dynamic bending (per ASTM F1264)

The "results of these tests, as well as engineering analysis of device characteristics, indicate that the HEALIX Compression Screw System is substantially equivalent to the predicate devices." This implies that the device met the performance expected for these tests and was found to be comparable to or better than the predicate devices, thereby satisfying the implicit acceptance criteria of substantial equivalence.

2. Sample Size for Test Set and Data Provenance: Not applicable in the context of this device and testing. The testing described is mechanical (physical properties of the screws), not clinical data-based.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in this context, refers to the reference standard for clinical performance in AI/diagnostic studies. Here, the "ground truth" is adherence to established mechanical testing standards and comparison to predicate devices, assessed by engineers and regulatory bodies.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is a mechanical device, not an AI or diagnostic reading system.

6. Standalone (Algorithm Only) Performance Study: No.

7. Type of Ground Truth Used: The ground truth for this device's evaluation is primarily based on engineering standards (ASTM F543, ASTM F1264) and comparison to the established performance of legally marketed predicate devices.

8. Sample Size for the Training Set: Not applicable. This document does not describe an AI/diagnostic device with a training set.

9. How the Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided document describes a mechanical device (bone fixation fastener) and its regulatory clearance based on non-clinical physical testing and comparison to predicate devices, rather than a diagnostic or AI device and its clinical performance evaluation. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets acceptance criteria for AI/diagnostic devices is not present.

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The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) 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: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

The FOCUS Pedicle Screw System is a spinal system used as an adjunct to fusion, to provide immobilization and stabilization of spinal segments in the non-cervical posterior spine (T1 to S1) of skeletally mature patients. The system consists in pedicle screws implanted into the bones, and capturing spinal rods. The system is stabilized by cross connectors. The device is implanted via a posterior approach.

This document is a 510(k) premarket notification for the "FOCUS Pedicle Screw System" and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The provided text pertains to a traditional medical device (a pedicle screw system for spinal fixation) and its substantial equivalence determination by the FDA. The evaluation of this device is based on non-clinical mechanical testing and comparison to predicate devices, not on AI/ML performance metrics.

Therefore, the requested information cannot be extracted from the provided input, as it describes a different type of device and regulatory review process.

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The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Boundary Anterior Lumbar Buttress Plate is a fixation system used as a buttress of the interbody, to stabilize the allograft or autograft at one level during the development of a spinal fusion. The device consists in a plate shaped to conform to the anatomy of the anterior lumbar and lumbosacral spine (L1-S1). A screw fixates the system to the anterior surface of the vertebral body, allowing the plate to extend onto the adjacent intervertebral space. The buttress end of the plate may be oriented either caudal or cephalad. The Boundary Anterior Lumbar Buttress Plate may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.

This document is a 510(k) premarket notification for a medical device called the "Boundary Anterior Lumbar Buttress Plate". It is not a study report for an AI/ML powered device, therefore, much of the requested information regarding AI acceptance criteria, training data, and expert review is not applicable.

However, I can extract the information relevant to the non-clinical testing performed and the substantial equivalence argument.

Here's a breakdown of the requested information where applicable:

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 provided in the document. For non-clinical mechanical testing, "sample size" typically refers to the number of devices tested. The document only states that "the following tests were performed," but does not detail the number of units tested. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of mechanical testing.

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 and expert review are concepts relevant to diagnostic or AI-powered devices, not mechanical fixation devices undergoing non-clinical bench testing. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under controlled conditions, measured against established engineering standards like ASTM F1717-13.

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

Not applicable. Adjudication methods are relevant for human interpretation or AI output, not for mechanical testing.

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

Not applicable. This is not an AI-powered device and no MRMC study was conducted.

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

Not applicable. This is not an AI-powered device.

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

For mechanical testing, the "ground truth" is established by the specified test methods and acceptance criteria defined within standards like ASTM F1717-13. The performance of the device is measured directly against these objective, quantitative standards.

8. The sample size for the training set

Not applicable. This is not an AI-powered device, so there is no "training set."

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

Not applicable. There is no training set for this device.

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The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment with an intervertebral body fusion device. The nv 'devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "nv". It is not a study report or technical documentation that describes the acceptance criteria or device performance. Therefore, I cannot extract the requested information from the provided text.

The provided text only states that the FDA has reviewed the premarket notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. It lists the indications for use of the device but does not include any information on studies conducted to prove the device meets acceptance criteria.

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The ny', nv", and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, or transforaminal approach.

The nv3, nvP, and nv1 are an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The purpose of this submission is to make changes to the number and design of the tantalum markers.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via a variety of approaches including anterior, posterior, or transforaminal. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

Here's an analysis of the provided text regarding the acceptance criteria and study for the nv³, nvº, and nv¹ intervertebral body fusion devices:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "No FDA performance standards have been established for the nvª, nvº, and nv*. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards." Therefore, the acceptance criteria are implicitly meeting the current industry standards as defined by ASTM F2077 and ASTM F2267 for static/dynamic compression and subsidence, respectively, and passing an "expulsion" test. The device's reported performance is that it met these criteria and was found to be "substantially equivalent to the predicate devices."

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

• Sample Size for Test Set: This information is not provided in the document. The document only lists the types of non-clinical tests performed (static/dynamic compression, subsidence, expulsion) but does not specify the number of devices or test conditions used for each.
• Data Provenance: The data is "non-clinical testing" conducted by the manufacturer, Nvision Biomedical Technologies, LLC. The provenance (e.g., country of origin, retrospective/prospective) of the data itself isn't explicitly stated beyond being lab-based mechanical testing.

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

• This information is not applicable/provided. The study described is non-clinical bench testing of a physical device's mechanical properties, not a clinical study involving human patients or expert review of medical images/data. Therefore, there's no concept of "ground truth" established by medical experts in this context.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. As above, this was non-clinical bench testing, so there was no adjudication process involving experts comparing results. The "adjudication" would be a comparison of measured mechanical properties against pre-defined engineering acceptance limits for the standards.

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

• This information is not applicable/provided. The document describes the marketing clearance for an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant here.

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

• This information is not applicable/provided. As explained in point 5, this is not an AI/SaMD product.

7. The Type of Ground Truth Used

• The "ground truth" for this non-clinical testing is the pre-defined mechanical performance specifications set by relevant ASTM standards (ASTM F2077 for static/dynamic compression and ASTM F2267 for subsidence), and an unspecified internal expulsion test criteria. The device's performance was compared against these established engineering and material standards.

8. The Sample Size for the Training Set

• This information is not applicable/provided. This is a physical, implantable medical device, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

• This information is not applicable/provided. As explained in point 8, there is no concept of a "training set" for this type of device.

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The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors,
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudarthrosis,
• failed previous fusion,
• spinal stenosis

The Tangis Anterior Cervical Plate is intended for anterior screw fixation of the plate to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-drilling and self-tapping bone screws using an anterior approach. Plates are available in a variety of lengths (20 mm – 92 mm), addressing multiple levels of fixation (one to four). The plate incorporates graft visualization holes on the longitudinal center line for intraoperative visualization. Bone screws are available in three diameters (3.75 mm, 4.25 mm, and 4.75 mm) and a variety of lengths (10 mm - 20 mm). All components are made from titanium alloy per ASTM F136.

The provided document describes a 510(k) premarket notification for the Tangis Anterior Cervical Plate, a medical device used for spinal fixation. It establishes substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "No FDA performance standards have been established for the Tangis Anterior Cervical Plate. The following tests were performed to demonstrate safety based on current industry standards." This indicates that the device was tested against recognized industry standards (ASTM F1717), and its performance was found to be comparable to accepted predicate devices, implying it met the unstated performance expectations within those standards. Without specific numerical thresholds from the report or the ASTM standard itself, exact quantitative acceptance criteria cannot be listed here.

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

This is an in-vitro non-clinical study involving mechanical testing of the device itself. Therefore, the concept of a "test set" in terms of patient data or clinical samples does not apply. The "sample size" would refer to the number of devices or constructs tested for each mechanical test. This information (e.g., how many plates were subjected to static compression) is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is not applicable as this is a non-clinical mechanical testing study.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. Ground truth for clinical outcomes or diagnoses is not established in this non-clinical mechanical testing study. The "ground truth" here is the physical measurement of mechanical properties, which is objective and does not require expert interpretation in the way clinical data would.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of expert review or clinical adjudication for this non-clinical mechanical study.

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

No. This is a non-clinical mechanical testing study. MRMC studies are relevant for evaluating the performance of diagnostic or screening devices typically involving human readers interpreting images or data.

6. Standalone Performance Study

Yes, in a sense. The mechanical tests (static and dynamic compression, static torsion) were performed on the device itself (algorithm only, without human-in-the-loop performance) to evaluate its structural integrity and performance against industry standards. This is the standalone performance of the physical device.

7. Type of Ground Truth Used

For this non-clinical study, the "ground truth" is established by the physical measurements and mechanical properties of the device under specific test conditions as defined by ASTM F1717. This is an objective, quantitative measurement of material and structural performance, not a subjective interpretation of clinical data.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/ML algorithm or clinical data for this non-clinical mechanical testing study.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment with an intervertebral body fusion device. The ny' devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

The nv is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow centre to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.

The provided document is a 510(k) premarket notification for a medical device called "nvC," an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating "substantial equivalence" to a predicate device, rather than conducting a full clinical study with specific acceptance criteria as might be seen for novel technologies or PMA applications. As such, the document details mechanical testing to support substantial equivalence rather than a study against a pre-defined performance acceptance criteria for a diagnostic or AI-driven device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets acceptance criteria (as would be typical for an AI/diagnostic device) are not directly applicable or available in this submission. This 510(k) primarily demonstrates the device's mechanical performance is comparable to an existing device, implying it meets the safety and effectiveness standards already established for such devices.

Here's an attempt to address your request based on the available information, noting where information is not present in the document.

Description of Acceptance Criteria and Proving Study for the nvC Intervertebral Body Fusion Device

The nvC device, a PEEK Optima® LT1 intervertebral body fusion device, established its substantial equivalence to predicate devices through a series of mechanical performance tests, rather than a clinical study with traditional acceptance criteria for diagnostic accuracy or clinical outcomes. The "acceptance criteria" here are implicitly the performance levels demonstrated by the predicate devices in the same standardized mechanical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of test samples (e.g., individual device units) used for each mechanical test. Mechanical testing typically uses a specific number of samples (e.g., n=5 or n=6) per test condition.
• Data Provenance: The tests were conducted internally or by a testing laboratory as part of the regulatory submission process. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are not applicable to material mechanical testing.

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

• This information is not applicable to mechanical testing of an intervertebral body fusion device. Ground truth and expert consensus are relevant for diagnostic devices or those involving interpretation of medical images/data. The "ground truth" for mechanical testing is established by the test standards themselves and measured physical properties.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, not in standardized mechanical testing.

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

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, and an AI's impact on their performance is evaluated. The nvC is a physical implant, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• No standalone performance study of an algorithm was done. This device does not involve an algorithm or AI. The tests performed are for the physical properties of the implant itself.

7. Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily based on engineering and material science standards, specifically the mechanical performance requirements outlined in ASTM F2077 and ASTM F2267, as well as general expectations for expulsion resistance. The performance of the predicate devices in these tests serves as the benchmark for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the context of data-driven models. The device's design is likely based on engineering principles and prior experience with similar implants.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.

Summary of the Study:

The study conducted for the nvC device was a series of non-clinical mechanical performance tests. These tests were performed in accordance with recognized ASTM standards (F2077 for axial compression and torsion; F2267 for subsidence) and also included an expulsion test. The purpose of these tests was to demonstrate that the mechanical properties and performance of the nvC device were substantially equivalent to those of its predicate devices: X-Spine Calix™ Cervical Interbody Spacer (K083637) and Genesys Spine Apache™ Cervical Interbody System (K103034). The conclusion of the submission is that the device's technological characteristics and performance are comparable to the predicate devices, thereby supporting its substantial equivalence for the stated indications for use.

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The nvª, nvº, and nv are intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

The nv4, nv9, and nvb are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.

The nv4 and nv2 devices have multiple footprints to adapt to the general shape of the vertebral endplates. The nv , nv , and nv are available in multiple heights to accommodate patient variability and have a hollow centre to accommodate bone graft. The devices are implanted via a variety of surgical approaches which include anterior, and transforaminal. There are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

This document is a 510(k) summary for medical devices (nvª, nvP, and nv*) from Nvision Biomedical Technologies, LLC. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner requested (i.e., performance metrics like sensitivity, specificity, accuracy, etc., typically associated with AI/ML devices).

The document focuses on:

• Device Description: Intervertebral body fusion devices made from PEEK Optima® LT1 with tantalum markers.
• Intended Use: Lumbar spinal fusion for degenerative disc disease (DDD) in conjunction with supplemental fixation and autograft.
• Substantial Equivalence: Claims substantial equivalence to listed predicate devices (Genesys Spine ApacheTM System and SeaSpine Spacer System – PacificaTM) in terms of intended use, materials, design, technological characteristics, mechanical safety, and performance.
• Mechanical Testing: Mentions performance testing was conducted according to standardized tests (Static and Dynamic Axial Compression per ASTM F2077, Subsidence per ASTM F2267, Expulsion) and that these results "demonstrate substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving device performance against those criteria, as this document does not contain that type of data. The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, focusing on design, materials, and mechanical safety, rather than a clinical performance study with specific acceptance criteria that would be relevant for devices like AI/ML products.

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