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The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical ExcelsiusGPS® Robotic Navigation Platform to aid in implantation of the Innovasis pedicle screw system (Vector Pedicle Screw System and Excella Spinal System) implants. The instruments are manufactured from medical grade stainless steels and plastic.

The provided FDA clearance letter concerns the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments). This letter primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and engineering analysis rather than a human reader study or AI performance evaluation.

Therefore, many of the requested details, such as those pertaining to AI model training, human reader studies (MRMC), or a comprehensive standalone algorithm performance, are not explicitly available within this document. The device in question is a set of surgical instruments, not an AI or imaging device requiring such detailed performance evaluation in the context of this 510(k) submission.

However, based on the provided text, we can extract information regarding the performance data used to demonstrate safety and effectiveness for these specific instruments.

Acceptance Criteria and Reported Device Performance

The letter states that the instruments were evaluated for their accuracy performance and their ability to register with the navigation system and fit within the guide tube of the end-effector.

Study Details (Based on available information)

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of a clinical study. The evaluation appears to be primarily an engineering analysis and verification testing on the instruments themselves.
   • Data Provenance: The study described is a technical evaluation of the instruments, not a clinical trial with patient data. It is an "engineering analysis and geometric comparison to predicate devices," and "pass/fail verification testing." The location of this engineering and testing work is not specified, but the applicant (Innovasis, Inc.) is based in Salt Lake City, Utah, and their regulatory consultant in Colorado Springs, Colorado, suggesting a U.S.-based context for the submission. The information implies a retrospective approach in terms of comparing to existing designs and prospective in terms of conducting new verification tests on the manufactured instruments.

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

   • Not Applicable. This submission does not describe a study involving expert readers or medical professionals establishing ground truth for diagnostic interpretation. The "ground truth" for this device relates to its physical and functional specifications (e.g., dimensions, fit, compatibility with the navigation system), established through engineering methods.

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

   • Not Applicable. Adjudication methods are typically used in studies where human experts are interpreting medical images or data and discrepancies need to be resolved. This study is an engineering and verification test.

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. This device is a surgical instrument set and the submission does not mention an MRMC study or any AI component that would assist human readers in image interpretation or diagnosis.

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

   • No. This device is not an algorithm. The "performance data" refers to the instrument's mechanical and functional compatibility.

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

   • Engineering Specifications and Functional Compatibility. The ground truth for this device's performance is based on established engineering principles, design specifications, and the functional requirements for compatibility with the predicate navigation system (Globus ExcelsiusGPS). This includes geometric tolerances, material properties, and successful registration/fit with the navigation platform.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not Applicable. As above, this is not an AI/machine learning device. The "ground truth" for the device's design and function would be based on engineering design principles and specifications, tested through verification.

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The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S7 and StealthStation System S8, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Innovasis Navigation Instruments are reusable instruments used for the preparation and insertion of Innovasis Pedicle Screw System implants, in either open or percutaneous procedures. These instruments are designed for navigated use with the Medtronic StealthStation. The Innovasis Navigation Instruments include the Vector M-S Navigation Instruments for use with the Vector Pedicle Screw System and the Excella Navigation Instruments for use with the Excella II, Excella 3, and Excella MIS pedicle screws. The Innovasis Navigation Instruments are manufactured from medical grade stainless steels. The purpose of this 510(k) is to add the Vector M-S Navigation Instruments to the system.

The provided text from the FDA 510(k) summary (K250182) for "Innovasis Navigation Instruments" contains information required to answer some of the questions. However, critically, this submission focuses on a medical device (navigational instruments) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical "acceptance criteria" and "study types" associated with AI/SaMD performance evaluation (such as sensitivity, specificity, MRMC studies, ground truth establishment for algorithms, training sets, etc.) are not applicable and not detailed in this document.

The study described here is primarily an engineering analysis and geometric comparison to predicate devices, along with a validation of navigation compatibility. It does not involve AI performance evaluation or clinical outcomes in the way an AI/SaMD submission would.

Here's an attempt to answer the questions based on the provided text, while explicitly noting what information is not present or applicable.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This device is not an AI/Software as a Medical Device (SaMD). The acceptance criteria and studies described are for physical surgical navigation instruments, not for an algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical instrument, the "acceptance criteria" are related to its design, materials, and compatibility, rather than performance metrics like sensitivity or specificity.

• Indications for Use are identical to predicate.
• Manufacturing and Biocompatibility are identical to predicate.
• Instrument Types and Sizes are identical to predicate.
• Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry) are identical to predicate.
• Sterility is identical to predicate. | "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: Principles of Operation, Indications for Use, Manufacturing and Biocompatibility, Instrument Types and Sizes, Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry), and Sterility." |
  | Navigation Compatibility | - Compatibility with Medtronic StealthStation™ System S7 and S8. | "A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System S7 and S8."
  "The results show that the subject device is substantially equivalent to cleared predicated." |
  | Mechanical Performance | - Overall mechanical performance is equivalent to predicate devices. | "The overall technology characteristics and mechanical performance data lead to the conclusion that the Innovasis Navigation Instruments are substantially equivalent to the predicate device." |

Note: The text explicitly states, "The Innovasis Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to the predicate devices." This implies that the 'performance' is largely demonstrated by meeting design specifications and showing equivalence to existing, cleared devices.

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

• Sample Size for Test Set: Not applicable or not specified in the context of an AI/SaMD test set. The evaluation was an "engineering analysis and geometric comparison" and "validation." This suggests testing of instrument prototypes or production samples, but there is no "test set" of patient data as would be used for AI/SaMD.
• Data Provenance: Not applicable in the context of patient data. The evaluation is on the manufactured instruments themselves.

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

• Number of Experts: Not applicable. Ground truth, in the AI/SaMD sense (e.g., image annotations, disease labels), is not established for this type of device submission. The "ground truth" here is the design specification and the functionality of the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation or labeling of data that would require 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

• MRMC Study: No. This is not an AI/SaMD and therefore an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

• Standalone Performance: No. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: For this device, the "ground truth" is primarily based on design specifications, engineering principles, and the established safety and effectiveness of the predicate devices. The "validation" would confirm that the instruments correctly interface and function with the Medtronic StealthStation System. There is no "disease ground truth" derived from expert consensus, pathology, or outcomes data in this submission.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/SaMD, so there is no training set for an algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided FDA 510(k) pertains to physical "Innovasis Navigation Instruments" for spinal surgery, which are Class II devices. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices through engineering analysis, geometric comparison, and compatibility validation, rather than the performance metrics and study designs typically associated with AI/Software as a Medical Device (SaMD) clearances.

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When used for posterior pedicle screw or posterior non-pedicle fixation, the Innovasis Vector™ Pedicle Screw System is intended to provide immobilization 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 discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture, dislocation, failed previous fusion (pseudoarthrosis), and/or tumor resection.

When used for posterior non-cervical screw fixation in pediatric patients, the Innovasis Vector Pedicle Screw System is indicated as an adjunct to freat adolescent idiopathic scoliosis (AIS). Additionally, the Innovasis Vector Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The Vector" Pedicle Screw System is a thoracolumbar system composed of polyaxial pedicle screws, rods, hooks, rod connectors, locking caps, lateral connectors, and transverse cross links. The system is designed with multiple options to address complex, multi-level deformity cases and accommodate various patient anatomies. The Vector Pedicle Screw System is also designed to facilitate percutaneous screw and rod placement via Minimally Invasive Surgery (MIS). The cannulated pedicle screws and extended reduction tabs allow for rod placement and minimal tissue disruption. The system was designed to minimize the number and complexity of procedural steps. Implants are manufactured from Titanium (Ti-6Al-4V ELI) per ASTM F136 or Cobalt Crome (CoCr) per ASTM F562.

This is a 510(k) summary for the Vector™ Pedicle Screw System. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does NOT describe a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Therefore, most of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can be extracted and a clear statement of what cannot:

Information that can be extracted:

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

   • Acceptance Criteria (Mechanical Performance): The document states that "All testing performed demonstrated substantially equivalent mechanical performance to legally marketed predicate devices." This implies the acceptance criteria were to be substantially equivalent to the predicates in the tested mechanical properties.
   • Reported Device Performance:
     • Static and Dynamic Compression Bending per ASTM F1717
     • Static Torsion per ASTM F1717
     • Static Axial and Torsional Grip per ASTM F1798
     • The performance for these tests was deemed "substantially equivalent" to predicate devices. Specific quantitative values are not provided in this summary.

2. Sample sized for the test set and the data provenance: Not applicable. This document refers to mechanical testing of components, not clinical data from a test set of patients. The provenance would be the test labs where the mechanical tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical or diagnostic accuracy studies, which were not conducted or reported here.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a pedicle screw system, not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical tests, the ground truth was the established standards and performance of the predicate devices.

8. The sample size for the training set: Not applicable. This refers to mechanical testing, not a training set for an AI model.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document addresses vs. what it does not:

This FDA 510(k) summary is for a physical medical device (pedicle screw system), not an AI/software device. The "study" referenced is a series of non-clinical (mechanical) tests to establish substantial equivalence with predicate devices, as opposed to a clinical study demonstrating diagnostic accuracy or clinical effectiveness in patients.

Therefore, the detailed questions about ground truth, expert adjudication, test set/training set sizes, and MRMC studies related to human reader performance with or without AI are not applicable to this document. The document explicitly states: "N/A - no clinical data were necessary."

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The Innovasis HAtetracell™-C Titanium Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

The HAtetracell™-C Titanium Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The HAtetracel™ -C Titanium Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical aproach. The HAtetracel™ - C implants are an additive mane from titanium alloy Ti-6Al-4V ELI per ASTM F3001 and are coated with a hydroxyapatite HAnano surface. The trabecular structures on the endplate contact surfaces , micro-, and nanofeatures that are designed to mimic cortical and cacellous bone to help facilitate intervertebral fusion. The HAtetracell™-C implant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and the open lattice structure is designed to radiographic signature. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Reusable instruments to support the surgery are provided with the implants in sterilization trays.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Summary of Mechanical Testing and Acceptance Criteria",
    "headers": [
      "Test Type",
      "Standard",
      "Acceptance Criteria",
      "Reported Device Performance"
    ],
    "rows": [
      [
        "Static and dynamic torsion testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static and dynamic axial compression testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static and dynamic compression shear testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static subsidence testing",
        "ASTM F2267",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Particulate analysis after dynamic testing",
        "ASTM F1877",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static expulsion testing",
        "FDA guidance special controls document",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Abrasive resistance testing",
        "ASTM F1978",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ]
    ]
  },
  "sample_size_test_set_provenance": "Not applicable as no clinical data or test set involving human subjects was used. All testing was non-clinical (mechanical).",
  "num_experts_ground_truth_qualifications": "Not applicable as no clinical data or ground truth established by experts was used.",
  "adjudication_method": "Not applicable as no clinical data or ground truth adjudication was performed.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.",
  "standalone_performance": "Not applicable, as this is a physical intervertebral body fusion device and not a software algorithm.",
  "type_of_ground_truth_used": "Not applicable. The 'ground truth' for the mechanical tests was established by adherence to industry standards (ASTM) and FDA guidance for performance criteria.",
  "sample_size_training_set": "Not applicable as no training set was used for this device's evaluation (no AI/machine learning component).",
  "how_ground_truth_for_training_set_established": "Not applicable as no training set was used."
}

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The Excella® Navigation Instruments are intended to be used during the preparation and placement of Excella II®, Excella 3® & Excella MIS® screws during spinal surgery to assist the surgeon in locating anatomical structures in either open or percutaneous spinal procedures. The Excella Navigation Instruments are specifically designed for use with the Medtronic® StealthStation® System S8 and associated tracking arrays, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra can be identified relative to an acquired image (CT, MR, 2D/3D fluoroscopic image reconstruction) and/or an image-based model of the anatomy.

The Innovasis® Excella® Navigation Instruments used for the preparation and insertion of Excella III , Excella 3° & Excella MIS® screws, in either open or percutaneous procedures. These instruments are with the Medtronic® StealthStation® System or as standalone, unnavigated instruments.

The FDA document concerns the Excella Navigation Instruments and its 510(k) premarket notification (K223511), which determined the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does NOT describe a study that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, accuracy, or any performance related to an AI/algorithm-driven diagnostic or assistive system.

Instead, the document details engineering and functional testing for a stereotaxic instrument (navigation instruments for spinal surgery). The acceptance criteria and "study" described are focused on the physical and functional performance of the navigation instruments themselves, not on an algorithm's diagnostic or predictive capabilities and their impact on human reader performance.

Therefore, I cannot fulfill the request as it pertains to an AI/algorithm-driven device performance study, because the provided document does not contain that information. The device in question is a physical instrument for navigation during surgery, and the "tests" described are for its mechanical and operational accuracy and compatibility.

Summary of Available Information (related to engineering/functional testing, not AI performance):

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (High-Level)	Reported Device Performance
   Positional Accuracy	All measurements were within specifications and comparable to the predicate product (ASTM F2554-18)
   Navigated Instrument Accuracy	Confirmed
   Navigation System Functionality	Confirmed under expected use conditions
   CAD Model Accuracy	Verified that CAD models are accurately reflected in the application software
   Implant/Instrument Mating	Verified that instruments can be assembled with appropriate devices according to intended use
   Spine Tools Package Functionality	Verified that the Spine Tools package has met the required interface needs of the spine application software

2. Sample size used for the test set and data provenance:
   This information is not provided in the document. The testing described (e.g., positional accuracy, simulated use) would likely involve a sample of the instruments themselves, but the exact number or data provenance (e.g., specific images or patient data) is not detailed.

3. Number of experts used to establish ground truth and qualifications:
   This information is not provided. The testing appears to be engineering-focused (e.g., comparing measurements to specifications or CAD models), not dependent on human expert interpretation of medical images.

4. Adjudication method for the test set:
   This information is not applicable/provided. The testing appears to be quantitative measurements and functional checks, not requiring adjudication of human interpretations.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size:
   No MRMC study was done or reported. The device is a navigation instrument, not an AI model assisting image interpretation, so such a study would not be the primary means of validation for this type of device.

6. Stand-alone (algorithm-only) performance:
   Not applicable. The device is a physical instrument, not a standalone algorithm. While it needs to interface with a navigation system (Medtronic StealthStation S8), the performance described is for the instrument itself.

7. Type of ground truth used:
   The "ground truth" for these tests appears to be engineering specifications, CAD model data, and predefined functional requirements. For positional accuracy, it would be the true physical position as measured by a highly accurate reference system.

8. Sample size for the training set:
   Not applicable. This is a hardware device undergoing functional and performance testing, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:
   Not applicable. See point 8.

In conclusion, the provided FDA document details the regulatory clearance for a medical instrument based on engineering and functional performance tests tied to physical accuracy and compatibility, not an AI-driven device requiring clinical performance metrics like sensitivity, specificity, or human reader studies.

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The Pore Matrix™ Matrix HA Fusion Porous Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The Matrix HA Fusion device is intended to be used with supplemental fixation, such as the Sapphire Medical Group Cervical Plate System. The Matrix HA Fusion device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

The Pore Matrix™ Matrix HA Fusion Porous Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical segment to promote fusion which restricts motion and decreases pain. The Matrix HA Fusion Porous Cervical IBF System is implanted via an Anterior Cervical Discectorny and Fusion (ACDF) surgical approach at one level from C2-T1 and is indicated for use in skeletally mature patients with degenerative disc disease (DDD).

The Matrix HA Fusion Porous Cervical IBF Implants are made from Invibio PEEK-OPTIMA® HA Enhanced and include Pore Matrix Technology. Hydroxyapatite (HA) is fully integrated throughout the porous layers. The Matrix HA Fusion Porous Cervical IBF Implant is made from PEEK which has a modulus of elasticity similar to human vertebral bone. The Porous Layers on the endplate contact surfaces and along the graft window utilize Pore Matrix Technology, a geometry that unlike smooth PEEK, is designed to mimic anatomical cancellous bone, with interconnected spherical pores. The surface to promote cell signaling, on-growth, and fusion. The Matrix HA Fusion Porous Cervical IBF Implant may provide an increased opportunity for bone ingrowth and for achieving early integration. The Matrix HA Fusion Porous Cervical IBF Implant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and is radiolucent allowing assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The implants come in 7 heights, 6-12mm in 1mm increments, 8 Footprints with an 8° lordotic angle.

The provided text is a 510(k) summary for the "Matrix HA Fusion Porous Cervical IBF System" and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document states that the device is identical to a predicate device (K220875 Innovasis HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System) in terms of design, materials, manufacturing process, packaging, sizes, and intended use. Therefore, the testing performed on the predicate device is considered fully transferable.

Because this is a substantial equivalence submission, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on providing detailed performance studies against specific acceptance criteria for the new device as if it were a novel technology.

Therefore, I cannot provide the requested information from the given text.

To reiterate, the provided document explicitly states the following:

• "The Pore Matrix™ Matrix HA Fusion Porous Cervical IBF System is identical to the predicate device, K220075 Innovasis HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System."
• "Therefore, the testing that was performed on the Innovasis device is fully transferable to the Pore Matrix device."

This means that no new studies were conducted for the Matrix HA Fusion Porous Cervical IBF System to demonstrate its performance against acceptance criteria. Its performance is inferred to be the same as the predicate device it is "identical" to.

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The Innovasis HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative weatment. The HAcancellous PEEK-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

The HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System is for Anterior Cervical Discectomy and Fusion (ACDF). The implant is available in multiple size options to match vertebral anatomy and is intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain.

The HAcancellous PEEK-C Implants are made from Invibio® PEEK-OPTIMA® HA Enhanced1 and include Pore Matrix™M Technology2. Hydroxyapatite (HA) is fully integrated throughout the implant, including the porous layers. The HAcancellous PEEK-C Implant is made from PEEK which has a modulus of elasticity similar to human vertebral bone. The Porous Layers on the endplate contact surfaces and along the vertical walls of the graft window utilize Pore Matrix Technology, a geometry that unlike smooth PEEK, is designed to mimic anatomical cancellous bone, with interconnected spherical pores. The surface porosity is designed to promote cell signaling, on-growth, in-growth, and fusion. The HAcancellous PEEK-C Implant may provide an increased opportunity for bone ingrowth and for achieving early integration3. In vitro performance or animal studies may not be representative of clinical performance. The HAcancellous PEEK-C lmplant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and is radiolucent allowing assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The implants come in 7 heights, 6-12mm in 1mm increments and 8 Footprints with an 8° lordotic angle. Reusable instruments to support ACDF surgeries are provided with the implants in sterilization sets. Innovasis implants are designed and validated for use with these instruments described in the Surgical Technique Guide. Usage of any instrumentation outside of the validated design intent is considered off-label use.

The provided text describes the regulatory clearance for the "HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System," an intervertebral body fusion device.

It's important to note that this document is a 510(k) summary for a medical device (an implantable hardware device), not an Artificial Intelligence (AI) or machine learning (ML) enabled diagnostic or interpretive device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML evaluation (like MRMC studies, ground truth establishment by experts, training/test set provenance, etc.) are not applicable to this type of device.

The "study" referenced in this document concerns the mechanical and material performance of the implant, not its diagnostic accuracy or the performance of an AI algorithm.

However, I can extract information related to the device's performance and how it was shown to meet regulatory requirements for its intended use, framed within the context of a non-AI medical device.

Here's an attempt to answer your request based on the provided text, while explicitly stating where AI/ML-specific criteria cannot be met:

Acceptance Criteria and Device Performance for HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System

This device is a physical, implantable medical device, not an AI/ML system. Therefore, the "acceptance criteria" and "study" are related to its mechanical performance, material properties, and biocompatibility, rather than diagnostic accuracy or human-AI reader performance.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/ML Specific Criteria:

As this is a physical implantable device, the following points are not applicable and therefore, no information is provided in the document for them:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices for mechanical testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI sense is established by experts for physical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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-assisted reading device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for a physical device is its adherence to mechanical performance standards and material specifications.
8. The sample size for the training set: Not applicable. This device does not use a "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical implant based on its substantial equivalence to previously cleared predicate devices, primarily demonstrating safety and effectiveness through mechanical testing, material characterization, and comparison to established standards for intervertebral body fusion devices. It does not involve AI or machine learning technology.

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The Innovasis AxTiHA Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.

The AxTiHA Stand-Alone ALIF System is for Anterior Lumbar Interbody Fusion (ALIF). The IBF implants are an additive manufactured device comprised of Ti-6Al-4V (ELI) per ASTM F3001 and Hydroxyapatite (HA) and are available in multiple size options to facilitate a more precise anatomical fit. The IBF implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell® Technology structure provide increased volume for autograft loading and bone throughgrowth. The IBF devices include integrated fixation by way of three converging bone screws and optional screw anti-backout locking clips manufactured from Ti-6AI-4V (ELI) per ASTM F136.

This document is an FDA 510(k) clearance letter for a medical device called the "AxTiHA® Stand-Alone ALIF System." It does not contain information about an AI/ML powered medical device, therefore, a detailed answer based on your request cannot be provided.

The document discusses a physical medical device used in spinal fusion surgery (intervertebral body fusion device), not a software or AI-based diagnostic/therapeutic tool. The performance data mentioned (ASTM F2077 for Dynamic Axial Compression and Dynamic Compression Shear, and bone screw pushout) are related to the mechanical properties and stability of the physical implant, not to the accuracy or performance of an AI model in interpreting medical images or data.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes, data provenance, ground truth establishment for AI model training or testing.
• Expert consensus, adjudication methods, or MRMC studies for AI model evaluation.

The document confirms the device's substantial equivalence to a predicate device based on mechanical testing, which is appropriate for a physical implant.

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The Innovasis® TxTiHA™ IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis® AxTiHA™ Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.

TxTiHA™ IBF System
The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.

AxTiHA™ Stand-Alone ALIF System
The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth.

The provided text is a 510(k) summary from the FDA for two intervertebral body fusion devices, the TxTiHA™ IBF System and the AxTiHA™ Stand-Alone ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than presenting a clinical study or acceptance criteria in the typical sense for a new AI/medical device.

Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (especially those related to clinical trials, AI, ground truth, and human reader performance) is not present in this document.

However, I can extract the information that is available:

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

The document does not provide a table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing:

The core "acceptance" for this type of device (a 510(k) submission) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Sample Size: Not applicable. The document describes non-clinical performance testing of the devices themselves (e.g., mechanical strength), not a clinical test set involving patient data or imaging. Therefore, concepts like sample size of patients, data provenance, retrospective/prospective studies, or country of origin are not mentioned.
• Data Provenance: The non-clinical tests likely occurred in a lab setting. The company is Innovasis, Inc. in Salt Lake City, Utah, USA.

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 document does not describe a clinical study requiring human experts for ground truth establishment.

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

Not applicable. There is no test set in the clinical sense described here.

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-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is not an AI device.

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

Not applicable. The "ground truth" for these physical devices is their compliance with specified ASTM standards and material properties, verified through non-clinical mechanical testing, rather than clinical outcomes or expert labels.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set described.

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The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.

The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.

The provided text describes the submission of a 510(k) premarket notification for a medical device called the "TruView Light Cable" and its variants. This document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Instead, it focuses on the substantial equivalence of a physical medical device (a fiber optic light cable) to existing predicate devices.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.

However, the document does contain information about performance testing for the physical device. Here's a breakdown of the relevant information provided:

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

The document states that the TruView Light Cable was subjected to three performance tests and "met the acceptance criteria for the testing performed." While specific numerical acceptance criteria and performance values are not explicitly detailed in a table, the document lists the types of tests and their purpose:

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

• Sample Size: Not specified. The document simply states "three (3) performance tests." It does not indicate the number of units tested for each performance test.
• Data Provenance: Not specified regarding "country of origin of the data" or "retrospective/prospective." This testing would typically be prospective, in-house laboratory testing of the manufactured devices.

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 is a physical device performance test, not a diagnostic algorithm requiring expert interpretation of medical images or data. Ground truth would be defined by engineering specifications and objective measurements (e.g., temperature, fit, light intensity).

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:

• Not Applicable. This is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• For a physical device like a light cable, the "ground truth" would be established by engineering specifications, regulatory standards, and objective measurements.
  • For the Fit Test: Successful mechanical coupling and operation.
  • For the Collateral Heating Test: Temperature measurements staying below defined safety thresholds for burns.
  • For the Intensity Test: Light intensity measurements meeting efficacy requirements while staying below defined thresholds to prevent patient injury.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML model that requires a training set.

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

• Not Applicable. See point 8.

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