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The Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (TI -L5). Hawkeye (VBR) Spacers are also intended for use in the cervical spine (C2-T1).

When used in the cervical spine (C2-T1), the HAWKEYE™ VBR devices are intended for use in the skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), the HAWKEYE ™ VBR Spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e.,posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The ChoiceSpine HAWKEYE™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or “teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements.

The provided document is a 510(k) premarket notification for the Choice Spine HAWKEYE™ Vertebral Body Replacement (VBR) System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding an AI/ML-driven device or study. Therefore, I cannot extract the acceptance criteria or study details related to AI/ML performance as requested. The "Performance Data" section discusses mechanical testing (static and dynamic compression and torsion, subsidence, and expulsion) in accordance with ASTM standards, which are physical tests for the implant device itself, not performance metrics for an AI/ML algorithm. Similarly, "Clinical Literature" refers to a review to support the safety profile of the physical device.

Without the requested information from the provided text, I cannot complete the table or answer the specific questions related to AI/ML device performance and testing.

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The Choice Spine Navigation reusable instruments are intended to be used during preparation and placement of Choice Spine Lancer™ and Thunderbolt™ system screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Choice Spine Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Choice Spine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. The Choice Spine Navigation instruments are for use with Choice Spine pedicle screw systems, specifically, the Lancer™ and Thunderbolt™ Pedicle Screw Systems. The instruments are manufactured from medical grade titanium and stainless steel.

The provided text describes a 510(k) premarket notification for the "Choice Spine Navigation System." This submission focuses on establishing substantial equivalence to a predicate device, rather than proving the device's absolute performance against a set of de novo acceptance criteria through extensive clinical studies, as might be required for a PMA or novel device.

The context of a 510(k) submission means the "device performance" and "acceptance criteria" are viewed through the lens of demonstrating equivalence to a legally marketed predicate. Therefore, the "study" proving it meets acceptance criteria is primarily an engineering and non-clinical performance assessment against a recognized standard (ASTM F2554-10).

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) is substantial equivalence to a predicate device. This is demonstrated by showing that the new device has "nearly identical technological characteristics" and that any minor differences "do not raise any new issues of safety and effectiveness."

The specific performance testing mentioned is for positional accuracy, as this is a critical function of a surgical navigation system.

Important Note: The provided text is a summarization for FDA submission. It generally does not include the detailed numerical results from performance tests; instead, it states the conclusion that the performance was "sufficient for its intended use" and "substantially equivalent." Full test reports would contain the exact measurements.

Additional Information on the Study (Based on 510(k) Context)

Given this is a 510(k) submission, the "study" proving the device meets acceptance criteria is primarily a non-clinical performance study and comparison to predicates.

1. Sample sizes used for the test set and the data provenance:

   • The document explicitly states "non-clinical testing" and references ASTM F2554-10. This standard typically involves laboratory-based measurements rather than human patient data.
   • Therefore, the "test set" would consist of physical test setups or mock anatomy used to measure positional accuracy according to the ASTM standard.
   • No specific sample size for "cases" is mentioned, as it's not a clinical study on patients. The "sample size" would relate to the number of measurements taken during the laboratory testing according to the standard.
   • Data Provenance: The testing was conducted by Choice Spine, LP., based in the USA. It's non-clinical/bench testing, not retrospective or prospective patient data from specific countries.

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

   • For non-clinical performance testing like positional accuracy per ASTM F2554-10, expert consensus in the form of physical measurement standards and calibrated equipment establishes the "ground truth." There are no human experts adjudicating clinical images or outcomes.
   • The "experts" involved would be engineers and technicians trained in metrology and the use of the specified testing equipment (e.g., optical tracking systems, coordinate measuring machines) to perform the measurements according to the standard. Their qualifications would be in engineering and quality assurance/testing.

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

   • Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of clinical data (e.g., medical images) to establish a consensus ground truth.
   • For non-clinical performance testing, the "ground truth" is derived from calibrated measurement devices and the precise execution of a standardized testing protocol (ASTM F2554-10). The results are quantitative measurements.

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:

   • No, an MRMC study was not conducted for this submission.
   • This device is a surgical navigation system, not an AI-assisted diagnostic imaging device. Its function is to guide physical instruments in real-time during surgery, not to interpret images or assist "human readers" in a diagnostic context.
   • Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device's intended use and assessment.

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

   • The device itself is standalone in its measurement capability, but its intended use is inherently human-in-the-loop, assisting a surgeon.
   • The "performance" tested (positional accuracy) reflects the algorithm's ability to track and display positions accurately. This test is a standalone assessment of the system's mechanical and computational accuracy, independent of a specific surgical procedure or patient.

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

   • The ground truth for the positional accuracy testing is based on metrological standards and precise physical measurements obtained from calibrated equipment according to ASTM F2554-10.
   • It is not expert consensus on clinical findings, pathology, or patient outcomes data.

7. The sample size for the training set:

   • Not applicable. This device is hardware and software for surgical navigation. It's not described as an AI/machine learning device that requires a "training set" of data in the typical sense (e.g., for image classification or prediction).
   • Its functionality is based on established engineering principles (e.g., optical tracking, coordinate systems) and algorithms, not data-driven machine learning models that learn from a "training set."

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

   • Not applicable, as there is no "training set" in the context of machine learning for this device.

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The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients 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 patient history and radiographic studies);

• · Pseudoarthrosis;
• · Spondylolysis;
• · Spondylolisthesis:
• · Spinal stenosis;
• Tumors;
• · Trauma (i.e. Fractures or Dislocation);
• · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
• Failed Previous Fusion

The Raven Lumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment 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.

Raven Lumbar Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). Raven Lumbar Plate System consists of plates and screws manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.

The provided text is a 510(k) summary for the Raven Lumbar Plate System, a spinal intervertebral body fixation orthosis. It primarily describes the device, its indications for use, and its substantial equivalence to predicate devices through a risk analysis and mechanical testing.

Crucially, this document does not contain information about the performance of a software algorithm or AI device. The acceptance criteria mentioned refer to mechanical testing of the physical implant (Static and dynamic compression testing per ASTM F1717-15, and Static torsion testing per ASTM F1717-15), not the performance of a device that uses data, ground truth, or human experts as described in your request.

Therefore, I cannot extract the information required in your prompt based on the provided text. The prompt asks for details pertaining to the rigorous evaluation of a software or AI device, including aspects like sample size for test and training sets, expert adjudication, MRMC studies, and ground truth establishment. None of these concepts are addressed in the provided FDA 510(k) letter for a physical orthopedic implant.

If you have a document describing the evaluation of a medical device that is a software or AI product, please provide that text, and I will do my best to answer your questions.

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The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with (4) bone screws provided and the accompanying anterior cover plate assembly. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6Al-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6Al-4V ELI plate and screws per ASTM F136.

The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

The provided text describes a medical device, the Choice Spine HARRIER-SA™ Lumbar Interbody System, and its FDA 510(k) clearance. This document is a premarket notification for a traditional medical device, not a software as a medical device (SaMD) or AI/ML device that would have performance criteria in terms of accuracy, sensitivity, or specificity. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic performance (as implied by questions about ground truth, expert adjudication, MRMC studies, etc.) is not applicable here.

Instead, the "acceptance criteria" and "study" for this type of device refer to its mechanical and material safety and performance, as demonstrated through non-clinical testing in comparison to predicate devices. The study proves the device meets these criteria by demonstrating substantial equivalence.

Here's an interpretation of the request based on the provided document:

Acceptance Criteria and Study for the Choice Spine HARRIER-SA™ Lumbar Interbody System

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

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

This information is not applicable as the clearance is based on non-clinical (mechanical) testing and comparison to existing predicate devices, not on a clinical trial with a "test set" of patient data. The "test set" here would refer to the mechanical test specimens.

• Sample Size: The document does not specify the exact number of samples used for each non-clinical test (e.g., how many constructs were tested for static compression). This information is typically detailed in the full test reports submitted to the FDA, but not usually summarized in the 510(k) summary.
• Data Provenance: Not applicable. These are laboratory tests, not clinical data from patients.

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

This is not applicable. "Ground truth" in this context would refer to the established standards and specifications for mechanical testing (e.g., ASTM standards F2077, F2267). The "experts" involved are those who designed and conducted the mechanical tests according to these standards, typically engineers and biomechanical scientists, not medical professionals establishing diagnostic ground truth.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish a consensus "ground truth" for diagnostic purposes. Mechanical testing relies on objective measurements against defined standards, not subjective expert adjudication.

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

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices, especially AI-assisted ones, where human readers interpret medical images. This device is an intervertebral body fusion system, not a diagnostic imaging or AI tool.

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

This is not applicable. This question pertains to AI/ML software performance. The device is a physical implant.

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

The "ground truth" for this device's performance is established by validated mechanical testing standards (e.g., ASTM F2077 for intervertebral body fusion devices, ASTM F2267 for subsidence) and material specifications (e.g., ASTM F3001, ASTM F560, ASTM F136). The "truth" is whether the device meets or exceeds the biomechanical requirements and material properties as defined by these industry standards and the performance of predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a physical medical device undergoing mechanical testing for 510(k) clearance.

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

This is not applicable. As there is no training set, there is no ground truth to be established for it.

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The Choice Spine TiGer Shark™ System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six (6) months of non-operative treatment. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. This device is designed for use with supplemental fixation that is cleared for use in the lumbar spine.

The Choice Spine TiGer Shark™ System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C). The spacers have a basic rectangular shape, a hollow center for placement of bone graft and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulation combinations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, or lateral approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.

This document is a 510(k) summary for the Choice Spine TiGer Shark™ System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, and standalone performance) is not available within the provided text.

The document discusses the following types of non-clinical testing performed:

• Static Compression - Per ASTM F2077
• Static Compression Shear - Per ASTM F2077
• Dynamic Compression - Per ASTM F2077
• Dynamic Compression Shear - Per ASTM F2077
• Expulsion - N/A
• Subsidence - per ASTM F2267

It states that "Mechanical testing was conducted to prove that the new worst-case design is stronger, and after including all other similarities, shown to be equivalent to the predicate devices in safety, effectiveness, and performance." However, it does not specify the acceptance criteria for "stronger" or "equivalent," nor does it present the numerical results of these tests.

In summary, the provided text does not contain the information necessary to complete the requested table and study details.

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The Choice Spine Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Choice Spine Laminoplasty Fixation System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.

The proposed Choice Spine Laminoplasty Fixation System is an implant system that consists of various plates and screw configurations. The proposed plates are available in various configurations to address surgeon and patient needs as necessary. The proposed plate devices come preformed with holes for bone screws. The plate offered can be affixed to allograft or autograft material and secured with a bone screw from the system. A hinge plate is provided when additional stabilization is necessary. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy. The system components are made from medical grade Titanium Alloy Ti-6AI-4V ELI (ASTM F136), 17-4 SS (ASTM F899), 465 SS (ASTM A564), and 6061 T6 Aluminum (ASTM B221 and B209).

The provided document is a 510(k) premarket notification for the Choice Spine Laminoplasty™ Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven device.

Instead, for a medical device like a spinal fixation system, "acceptance criteria" are generally met through a combination of:

• Design Specifications and Material Compliance: Ensuring the device is manufactured from medical-grade materials to specific dimensions and tolerances.
• Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
• Mechanical Performance Testing: Evaluating the device's strength, durability, and resistance to various forces it might experience in vivo.
• Sterilization Validation: Ensuring the device can be sterilized effectively without compromising its integrity.
• Clinical Performance (often through substantial equivalence): Demonstrating that the device performs as intended and is as safe and effective as legally marketed predicate devices.

The document primarily focuses on the Substantial Equivalence claim, which is the cornerstone for 510(k) clearance.

Here's an analysis based on the provided text, addressing your points where information is available or inferable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are derived from recognized standards and comparative performance to predicates, rather than a specific set of diagnostic metrics.

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

For a spinal fixation system seeking 510(k) clearance, the "test set" primarily refers to the physical devices (prototypes or production samples) subjected to mechanical and material testing, not a dataset of patient images or outcomes.

• Sample Size for Mechanical Testing: Not explicitly stated in the document. These tests (ASTM F2193, ASTM F543) typically require a specific number of samples (e.g., n=5 or n=6) to establish statistical significance for material properties and device performance.
• Data Provenance: The mechanical test data would be generated in a lab setting, typically by the manufacturer or a contract testing facility, specifically for this device design. It's not "retrospective or prospective" in the sense of clinical trials.

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

This concept is not applicable to this type of medical device submission. "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where subjective human interpretation is being evaluated or augmented. For a spinal implant, mechanical tests use objective physical measurements against established standards, and "ground truth" for clinical safety and effectiveness is largely inferred from substantial equivalence to devices with a known clinical history.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used in clinical studies or when interpreting diagnostic images to resolve discrepancies among expert readers and establish a reference standard. For mechanical testing, the results are quantitative measures from instruments.

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

No, an MRMC comparative effectiveness study was not conducted or is not detailed in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices or AI tools to assess reader performance with and without AI assistance. This device is a physical implant, not a diagnostic tool.

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

Not Applicable. This device is a physical spinal implant, not an algorithm or AI product. Its performance is evaluated through mechanical testing and comparison to predicate devices, not algorithm-only performance.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily established through:

• Recognized Standards: Specific ASTM standards (F2193, F543) define the methodologies and expected performance characteristics for spinal fixation devices. Compliance with these standards forms a "physical ground truth."
• Predicate Device Performance: The established safety and effectiveness of the identified predicate devices (DePuy Mountaineer, Synthes Arch Fixation System, Medtronic CENTERPIECE Plate Fixation System, Spectrum Spine Laminoplasty Plating System) serve as a de-facto "clinical ground truth" for substantial equivalence. The new device is accepted if it performs similarly or better in mechanical tests and has similar indications and materials.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for a hardware device, no ground truth needed to be established for it.

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The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetherethertone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582). The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants. The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

The provided document is a 510(k) premarket notification for the Acapella Cervical Spacer System, which is an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance in diagnosis or treatment.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
2. Sample size used for the test set or data provenance for such a study.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How the ground truth for the training set was established.

Instead, the performance data presented is focused on mechanical testing to demonstrate the structural integrity and equivalence of the device.

Here's the information that is available in the document regarding the device's technical performance:

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document states: "The results of this non-clinical testing show that the strength of the Cervical Spacer System is substantially equivalent to the legally marketed predicate devices." This implies that the acceptance criteria for these mechanical tests were that the device's performance should be comparable or equivalent to the predicate devices. Specific numerical acceptance criteria are not provided, nor are the specific numerical results of the tests.

Study Details (Mechanical Testing):

• Type of Study: Non-clinical mechanical testing.
• Tests Performed:
  • Static axial compression per ASTM F2077-11
  • Static compressive shear per ASTM F (standard number incomplete in document)
  • Static torsion per ASTM F2077-11
  • Static subsidence per ASTM F2267-04
  • Static expulsion per ASTM F-04.25.02.02 (draft)
  • Dynamic axial compression bending per ASTM F2077-11
  • Dynamic compressive shear per ASMT F2077-11
  • Dynamic torsion per ASTM F2077-11
  • Custom static tension testing
• Sample Size: Not specified for each test.
• Data Provenance: Not applicable in the context of mechanical testing.
• Ground Truth: The "ground truth" for mechanical testing is established by the specified ASTM standards, which define the testing methodology and expected performance characteristics for such devices.
• Training Set: Not applicable as this is not an AI/algorithm-based device and no training set would be used for mechanical testing.
• Adjudication/Multi-reader/Standalone: Not applicable for mechanical testing.

In summary, this document demonstrates substantial equivalence through mechanical testing according to recognized standards, rather than through clinical studies involving diagnostic accuracy or clinical outcomes.

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The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or "teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. This system includes implants made of PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly defining and meeting performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily framed as demonstrating equivalence through mechanical testing, especially for worst-case designs. There is no mention of a study involving human-in-the-loop performance, expert ground truth establishment for diagnostic accuracy, or multi-reader multi-case studies as typically seen for AI/diagnostic devices. The acceptance criteria and "study" are focused on the mechanical performance of the implant.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance (Mechanical Testing)

Important Note: This device is a physical implant, not an AI/diagnostic software. Therefore, the typical acceptance criteria and study methodologies for AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, human reader improvement) do not apply to this submission. The "study" here refers to non-clinical mechanical testing.

Study Details (Mechanical Testing)

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

• Sample Size: Not explicitly stated for each mechanical test, but typically, mechanical testing for medical implants involves a small number of samples (e.g., n=3 or n=5) per test condition to demonstrate compliance with standards and equivalence.
• Data Provenance: Not explicitly stated, but implies lab-based mechanical testing of manufactured implant samples. No country of origin for "data" in the sense of patient data, as this is a mechanical test. The testing is non-clinical/pre-clinical. It is not retrospective or prospective in the clinical sense.

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

• N/A. This is mechanical testing of a physical device against engineering standards, not a diagnostic or AI device requiring expert interpretation of medical images or data. Ground truth is established by the specifications of the device and the mechanical properties derived from experiments.

4. Adjudication method for the test set:

• N/A. Adjudication is not applicable as this is mechanical testing, not a diagnostic interpretation or clinical outcome assessment.

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:

• N/A. This is a physical implant device, not an AI or diagnostic software. Therefore, no MRMC study or human reader assistance is relevant.

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

• N/A. This is a physical implant device. The "standalone performance" is its mechanical integrity under various loads without human interaction.

7. The type of ground truth used:

• Engineering specifications and ASTM standards (e.g., ASTM F2077, ASTM F2267). The "ground truth" for this device's performance is its ability to meet the mechanical strength, durability, and subsidence requirements as defined by recognized engineering standards and to demonstrate similar or superior performance to its predicate devices.

8. The sample size for the training set:

• N/A. This is a physical implant, not a software or AI device that requires a "training set" in the machine learning sense.

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

• N/A. Not applicable for this type of device.

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The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior, non-cervical pedicle, and non-pedicle fixation, the Lancer™ Open Pedicle Screw System is indicated for the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Overall levels of fixation are T1 to the Sacrum/Ilium. When used for fixation to the ilium, the lateral offset connectors on the Lancer™ Open Pedicle Screw System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6Al-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements.

The components include: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes connector and hook components.

The provided text describes a medical device, the Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems, and its substantial equivalence submission to the FDA. It does not describe an AI/ML device or a study comparing its performance against acceptance criteria in the context of AI/ML.

Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving a device meets acceptance criteria in an AI/ML context. The document focuses on the mechanical and material equivalence of a surgical implant system to previously cleared predicate devices, as assessed through non-clinical (mechanical) testing.

Here's why the requested information cannot be found in the provided text:

• AI/ML Device: The "Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems" are physical surgical implants (pedicle screws, rods, connectors) used for spinal stabilization. They are not AI/ML devices that perform diagnostic, predictive, or assistive functions involving data analysis.
• Acceptance Criteria (for AI/ML): The document discusses "Substantial Equivalence" based on "intended use/indications for use, materials, design features, operational principles, and levels of attachment" and mentions non-clinical (mechanical) testing. These are not acceptance criteria for an AI/ML model's performance (e.g., sensitivity, specificity, AUC).
• Study Proving Device Meets Acceptance Criteria (for AI/ML): The "Non-Clinical Evaluation" describes mechanical testing (Static Compression-Bending, Dynamic Compression-Bending, and Static Torsion tests per ASTM F1717). This is a purely physical performance evaluation, not a study involving test sets, ground truth, expert readers, or sample sizes relevant to AI/ML performance.
• Other AI/ML related questions: All other points in your request (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set size, training ground truth) are specifically applicable to the evaluation of AI/ML algorithms and are therefore not present or relevant in this document.

In summary, the provided text describes a traditional medical device (spinal implants) and its regulatory clearance process, which relies on demonstrating substantial equivalence to already-cleared predicate devices through mechanical testing, not through AI/ML performance evaluation.

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The Proliant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

The ChoiceSpine Proliant Posterior Pedicle Screw and Hook Fixation System is a toploading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar, and sacral spine. Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and Cobalt Chrome (Co-28Cr-6Mo per ASTM F1537) in various sizes. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.

This document is a 510(k) premarket notification for a Class II medical device, the ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System. It explicitly states that the device is substantially equivalent to a legally marketed predicate device (Exactech, Inc.'s Proliant® Pedicle Screw System, K102870).

A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting de novo clinical performance studies or establishing new acceptance criteria based on human reading performance. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, human reader studies, or detailed AI/ML performance metrics.

The study described is a non-clinical mechanical and biomechanical performance test designed to show the physical properties of the new device are comparable to the predicate.

Here's a breakdown of why this document doesn't fit your prompt's scope and what it does provide:

Why the Document Does Not Contain the Requested Information:

• Device Type: This is a pedicle screw and hook fixation system, which is a physical implant, not an AI/ML diagnostic or image analysis device. Therefore, concepts like "multireader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth establishment based on expert consensus," or "effect size of human readers improving with AI assistance" are not applicable.
• Regulatory Pathway: A 510(k) typically relies on demonstrating substantial equivalence to an existing legally marketed device. This means the primary evidence revolves around comparing the new device's design, materials, indications for use, and non-clinical performance (e.g., mechanical testing) to a predicate, rather than generating new clinical performance data against specific acceptance criteria for a diagnostic task.
• Absence of AI/ML: There's no mention of any AI or machine learning component in this device.

What the Document Does Provide (Mapped to Closest Relevant Concepts where possible, but not a direct match to your prompt):

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

   • Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion is that the new device's mechanical and biomechanical performance must be comparable or superior to the predicate device to demonstrate substantial equivalence for its intended use. The document states: "The results of this non-clinical testing show the strength of the Proliant Posterior Pedicle Screw and Hook Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
   • Reported Device Performance (Test Modes):
     • Static axial compression bending per ASTM F1717-14
     • Static torsion per ASTM F1717-14
     • Dynamic axial bending per ASTM F1717-14
     • No specific numerical results are provided in this summary, only the types of tests performed and a general conclusion of sufficiency.

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

   • Sample Size: Not explicitly stated (for mechanical tests, this would refer to the number of test specimens).
   • Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical studies with patient data.

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 this context refers to the physical properties measured in a lab, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

   • Not applicable. This refers to mechanical testing, not a human reader study.

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, not done. This is not an AI/ML device.

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

   • No, not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used:

   • Physical measurement of material properties and mechanical integrity. The "ground truth" is established by adherence to recognized industry standards (e.g., ASTM F1717-14) for testing the strength and durability of spinal implants.

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/ML model that requires training data.

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

   • Not applicable. No training set is involved.

In summary, the provided document details a 510(k) submission for a physical medical device (spinal fixation system) and demonstrates substantial equivalence through non-clinical mechanical testing, rather than addressing AI/ML performance metrics, human reader studies, or associated acceptance criteria.

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