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The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. 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 Pro-Link® Ti Barbs Cervical Spacer System is to be used with autogenous bone graft and implanted via an anterior approach.

The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an interbody fusion device intended to be used with two (2) titanium bone barbs. The Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screw).

The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is offered in various device configurations based on surgical approach and patient anatomy. The Pro-Link® Ti Barbs Cervical Spacer System includes an interbody, containing a titanium alloy locking mechanism, which is implanted with two (2) titanium bone barbs. The interbody is offered in either PEEK (Polyetheretherketone) or in titanium alloy (Ti 6Al-4V ELI). The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screws).

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System components with components from any other system or manufacturer. The Pro-Link® Ti Barbs Cervical Spacer System components should never be reused under any circumstances.

I apologize, but the provided text from the FDA 510(k) clearance letter and related documents for the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System does not contain information about acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based medical devices (such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies).

The document is a clearance letter for a traditional orthopedic implant (intervertebral body fusion device), not a software or AI-driven device. Therefore, it focuses on demonstrating substantial equivalence to predicate physical devices based on design, materials, indications for use, and performance, primarily through a comparison of physical and mechanical properties, not through clinical or reader studies that would generate the types of data you are asking for.

The relevant sections of your request (2 through 9) are specific to the evaluation of AI/ML software devices, which are not applicable to the information provided in this document.

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The Blackhawk Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disease (DDD) with accompanying radicular symptoms at one level from C2-T1. 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. Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion.

The Blackhawk™ Ti Cervical Spacer System is a stand-alone anterior cervical interbody device consisting of a titanium alloy (Ti-6Al-4V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al-4V ELI) anchors per ASTM F136, and a titanium alloy (Ti-6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and are offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal bladed anchors that lock on deployment and provide additional fixation.

The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., an anterior plate, posterior pedicle screws) may be needed.

This document describes the ChoiceSpine Blackhawk™ Ti Cervical Spacer System, an intervertebral body fusion device. The focus is on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA. Therefore, the "acceptance criteria" and "device performance" are primarily related to biomechanical testing and material properties, rather than diagnostic accuracy as would be found in an AI/ML device submission.

Here's the information as requested, interpreted in the context of this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Biomechanical Testing (Implants): Not explicitly stated how many individual implants were tested for each biomechanical test (Static Subsidence, Dynamic Axial Compression, etc.). However, these tests are generally conducted on a sufficient number of samples (e.g., 5-10 per test condition) to establish statistical significance according to the ASTM standards.
• Sample Size for Cadaveric Testing: Not explicitly stated how many cadaveric spines were used.
• Data Provenance: The tests are non-clinical (laboratory and cadaveric studies). This is retrospective data collected for the purpose of this submission.
  • Country of Origin: Not specified, but generally, such testing is conducted in accredited labs, often within the US or by international labs recognized by the FDA.

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

This is not applicable in the context of an orthopedic implant biomechanical study. "Ground truth" in this scenario is established by the standardized methods outlined in ASTM specifications and accepted engineering principles, rather than expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" (i.e., test results meeting predefined criteria) is determined directly by the physical measurements from standardized biomechanical tests, not by expert consensus or adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/ML diagnostic devices to assess how the AI assists human readers. This submission is for an orthopedic implant.

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

This question is not applicable. The device is a physical implant, not an algorithm. The "standalone" performance here refers to the biomechanical performance of the implant itself, which is what the non-clinical testing evaluates (without human intervention in the device's function).

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Standardized Biomechanical Test Results: Adherence to established ASTM standards (F2267-04, F2077-18) defines the "ground truth" for mechanical properties (e.g., strength, fatigue resistance).
• Cadaveric Biomechanical Measurements: Measurements of range of motion and stability in a cadaveric model serve as "ground truth" for the device's functional performance in a relevant anatomical context.
• Sterilization Validation: Meeting a pre-defined Sterility Assurance Level (SAL) of 10^-6 is the "ground truth" for sterility.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device. The device's design and materials are based on established engineering principles and prior predicate device data, not machine learning.

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

Not applicable, as there is no training set for this type of device.

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HEDRON C® Spacers and HEDRON IC® Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

HEDRON C® Spacers and HEDRON IC® Spacers are intended to be used with supplemental fixation, such as an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When the HEDRON IC® Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC® Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-TI) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON® Lumbar Spacers (HEDRON A™, HEDRON P®, HEDRON T™, and HEDRON RT™) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T -T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) months of non-operative treatment. HEDRON® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

HEDRON IA® Integrated Lumbar Spacers are integrated lumbar interbody fusion devices indicated for use at one or more levels of the lumbosacral spine (L1-S1), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. These devices are intended to be used with or without three screws and or anchors which accompany the implants. These devices are with supplemental fixation (e.g. facet screws or posterior fixation). In addition, these devices are intended for stand-alone use in patients with DDD at one or two levels only when

HEDRON® Cervical Spacers (HEDRON C® and HEDRON IC®) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRONIC® Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON IC® Plate-Spacer, a standalone cervical interbody fusion device. HEDRON® Spacers are additively manufactured from titanium allov. as specified in ASTM F3001.

HEDRON® Lumbar Spacers are lumbar interbody fusion devices used to provide structural stability following discectomy. Each HEDRON® spacer has a different shape to accommodate various surgical approaches to the spine, including anterior, anterolateral, lateral, posterior or transforaminal approaches. All approaches are used in the lumbar spine; only anterolateral, or lateral approaches are used in the thoracic spine.

HEDRON® Integrated Lumbar Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability following discectomy. They are used with or without screws and/or anchors.

All HEDRON® Lumbar Spacers are additively manufactured from titanium powder. The mating screws and anchors are manufactured from titanium alloy and/or cobalt chrome alloy. Titanium screws and anchors are available with or without hydroxyapatite (HA) coating.

The SABLE® Expandable Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The device is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients.

SABLE® Spacers are manufactured from titanium alloy. The endplates are additively manufactured from titanium alloy powder and an internal component is manufactured from radiolucent PEEK polymer. The drive screw is manufactured from cobalt chromium alloy.

ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with ExcelsiusGPS® and may be used for a freehand navigated surgical procedure.

The provided text describes a 510(k) premarket notification for several spinal implant devices (HEDRON® Cervical Spacers, HEDRON® Lumbar Spacers, SABLE® Expandable Spacer, and ExcelsiusGPS® Instruments). However, it does not contain information about an AI/ML-based device.

Therefore, I cannot provide the detailed information requested regarding machine learning acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on the substantial equivalence of the new devices to existing predicate devices based on:

• Mechanical testing: Dynamic compression-shear testing was conducted in accordance with "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, and ASTM F2077.
• Technological Characteristics: The subject implants are stated to have the same technological characteristics as the predicate devices, including design, intended use, material composition, and range of sizes.
• Basis of Substantial Equivalence: The information provided within the premarket notification supports substantial equivalence of the subject spacers to the predicate devices with respect to technical characteristics, performance, and intended use.

In summary, the document addresses the regulatory requirements for hardware medical devices and does not involve AI/ML components or related performance studies.

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The Blackhawk™ Ti 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 Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Blackhawk™ Ti Cervical Spacer System is an anterior cervical interbody device consisting of a titanium alloy (Ti-4Al-6V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al- 4V ELI) anchors per ASTM F136, and a titanium alloy (Ti- 6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal anchors that lock on deployment and provide additional fixation.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML algorithm or software.

The document is a 510(k) premarket notification approval letter for the ChoiceSpine Blackhawk™ Ti Cervical Spacer System, which is a medical device for anterior cervical interbody fusion procedures. The content focuses on:

• Regulatory clearance: FDA clearance based on substantial equivalence to predicate devices.
• Device description: Materials (titanium alloy, nitinol), components (implant cage, internal locking components, anchors, locking cam), and sizes.
• Intended use/indications: Anterior cervical interbody fusion for degenerative disc disease at one disc level (C2-T1) with autogenous/allogenic bone graft and supplemental fixation.
• Predicate devices: Comparison to previously cleared ChoiceSpine and Exactech cervical spacer systems.
• Non-clinical testing: Mechanical tests (static subsidence, expulsion, dynamic axial compression, dynamic compression-shear, dynamic torsion) to demonstrate equivalence to predicates. These are engineering performance tests of the physical implant, not studies involving human readers or AI performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are related to studies evaluating AI/ML-driven medical devices, which is not the subject of this document.

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The GPS™ Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.

The basic shape of the GPS™ Cervical Spacers is a structural column having upper and lower implant openings and a central cavity for autograft bone. The devices have a have a "B" shaped cross-section. Surface teeth assist in the seating the implant between the vertebral bodies. Devices are available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "GPS™ Cervical Spacers". This document does not describe or include a study proving that the device meets specific performance acceptance criteria.

Instead, the document details:

• The FDA's determination of substantial equivalence (K210890) to a legally marketed predicate device (K142456).
• The device's indications for use: treating cervical disc degeneration and/or cervical spinal instability at multiple contiguous levels (C2-T1) in skeletally mature patients who have had non-operative treatment, to be used with autogenous and/or allogeneic bone graft and supplemental fixation.
• The device's description, materials (PEEK and tantalum), and technological characteristics (hollow structural frame, material, basic design, sizes).
• The fact that no new mechanical testing was performed for the current submission (K210890) because the change to a non-sterile condition does not create a mechanical worst-case scenario. It states: "Performance data remains unchanged for the subject devices as compared to the predicate versions of the device."

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and a study proving the device meets those criteria, a sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states that performance data remains unchanged from "the predicate versions of the device," implying that any such performance studies would have been associated with the original predicate device (K142456), not the current submission (K210890).

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The Tiger Shark Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TiGER SHARK Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/ or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

The ChoiceSpine Tiger Shark™ Cervical Spacer System consists of intervertebral body fusion devices comprised of titanium alloy (Ti-6AI-4V ELI per ASTM F3001, Class C). The spacers have a basic oval shape that coincides with the shape of vertebral bodies and a hollow center for placement of bone graft. They are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.

The provided text describes a 510(k) premarket notification for a medical device cleared by the FDA, the ChoiceSpine Tiger Shark™ Cervical Spacer System. This type of submission focuses on proving substantial equivalence to a predicate device, rather than extensive de novo clinical studies with acceptance criteria for AI performance. Therefore, the requested information about acceptance criteria, study design for AI models, expert adjudication, MRMC studies, and ground truth establishment for AI performance is not applicable to this document.

The document primarily details:

• Device Name: ChoiceSpine Tiger Shark™ Cervical Spacer System
• Regulation Number/Name: 21 CFR 888.3080, Intervertebral Body Fusion Device (Class II)
• Product Code: ODP
• Indications for Use: Anterior cervical spine intervertebral body fusion for degenerative disc disease (DDD) at one level (C2-C3 to C7-T1), in skeletally mature patients after 6 weeks of non-operative treatment, used with supplemental fixation and autogenous/allogenic bone graft.
• Device Description: Intervertebral body fusion devices made of titanium alloy, available in various heights and lordosis angles, manufactured using Electron Beam Melting (EBM) additive manufacturing.
• Predicate Devices: Genesys Spine Apache Cervical Interbody Fusion System (K150812) and ChoiceSpine Tiger Shark Cervical Spacer System (K183397).
• Purpose of Submission: To gain clearance for an additional titanium implant footprint (18x15mm) and instruments.
• Substantial Equivalence Conclusion: The device is similar to predicate devices in principle of operation, indications for use, stabilization method, anatomic location, approach, product code, classification, and biocompatibility. Minor differences (e.g., allogenic bone graft use, sterile provision) do not alter intended use or create a new worst case. Sterilization validation was performed.

To directly answer the prompt's request for acceptance criteria and study proving device meets them, based solely on the provided text, the information is not present as this is a traditional medical device clearance, not an AI/ML software clearance.

Therefore, the table and detailed points regarding AI/ML performance acceptance criteria cannot be fulfilled from this document.

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The SureMAX™ Family of Cervical Spacers is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The SureMAX™ Family of Cervical Spacers is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The SureMAX™ Family of Cervical Spacers is to be used with supplemental fixation; the hyperlordotic implants (≥10°) are required to be used with an anterior cervical plate. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.

The SureMAX™ Family of Cervical Spacers is an additively manufactured interbody system. These cervical implants have basic keystone shape and an open architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The SureMAX™ Family of Cervical Spacers is provided sterile.

The provided text is a 510(k) Summary for a medical device (SureMAX™ Family of Cervical Spacers) and does not describe an AI/ML-based medical device. Therefore, it does not contain the information needed to answer the questions about acceptance criteria and study proving device performance for an AI/ML device.

The document discusses:

• Device: SureMAX™ Family of Cervical Spacers, an additively manufactured interbody system used for anterior intervertebral body fusion.
• Indication: Treatment of cervical disc degeneration and/or cervical spinal instability.
• Performance Data: Mechanical testing per ASTM F2077 (static and dynamic compression and torsion), ASTM F2267 (subsidence), and expulsion studies.
• Conclusion: The device's performance is substantially equivalent to a predicate device based on these mechanical tests.

The information requested in the prompt, such as acceptance criteria based on accuracy metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document as it pertains to AI/ML device evaluation.

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The LEGEND Spine CORNICE Cervical Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one or two contiguous levels from C2 to T1. These patients should have had six weeks of non-operative treatment. The LEGEND Spine CORNICE Cervical Spacer System is also to be used with supplemental fixation system that have been cleared for use in the cervical spine. The LEGEND Spine CORNICE Cervical Spacer System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The LEGEND Spine CORNICE Cervical Spacer System is an Anterior Cervical Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. The Legend Spine CORNICE Spacers are made from either PEEK (VESTAKEEP i4 R per ASTM F2026) radiolucent material with embedded tantalum (ASTM F560) x-ray markers or Titanium Alloy conforming to ASTM F136.

The provided document is a 510(k) premarket notification letter and summary for the LEGEND Spine CORNICE Cervical Spacer System. This document describes a medical device, which is a physical implant, not an AI/ML powered device. As such, it does not include information typically sought for AI/ML devices regarding acceptance criteria, performance studies involving AI, human experts, and ground truth establishment in the way an AI/ML product would.

The performance testing described is mechanical testing for the physical implant to ensure its structural integrity and safety. Therefore, I cannot extract the information required for an AI/ML device from this document.

For completeness, I can describe the type of acceptance criteria and performance testing that were included for this physical device:

Acceptance Criteria and Reported Device Performance (Physical Device - Mechanical Testing)

Missing Information (as this is not an AI/ML device):

• Sample size used for the test set (no test set in the AI/ML sense)
• Data provenance (not applicable for mechanical testing)
• Number of experts used to establish ground truth (not applicable)
• Qualifications of those experts (not applicable)
• Adjudication method (not applicable)
• Multi-reader multi-case (MRMC) comparative effectiveness study (not applicable)
• Effect size (not applicable)
• Standalone performance (not applicable)
• Type of ground truth (not applicable)
• Sample size for the training set (not applicable)
• How ground truth for the training set was established (not applicable)

The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, which is standard for intervertebral body fusion devices. It does not involve any AI/ML components where ground truth and human-in-the-loop performance would be relevant.

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HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When the HEDRON IC™ Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.

HEDRON™ Cervical Spacers (HEDRON CTM and HEDRON ICT™) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRON ICT™ Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON ICT™ Plate-Spacer, a stand-alone cervical interbody fusion device. HEDRON™ Spacers are additively manufactured from titanium alloy, as specified in ASTM F3001.

The provided document is a 510(k) summary for a medical device (HEDRON™ Cervical Spacers), which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data. It does not describe an AI medical device or a clinical study that establishes acceptance criteria and proves the device meets those criteria from an AI performance perspective.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance for an AI model, as this document is not about an AI medical device.

The document discusses:

• Device Name: HEDRON™ Cervical Spacers
• Intended Use: Interbody fusion devices for cervical spine
• Mechanical Testing: Static and dynamic compression, torsion, compression-shear, subsidence, and expulsion in accordance with specific ASTM standards and FDA guidance.
• Basis of Substantial Equivalence: Similar technological characteristics (design, intended use, material composition, sizes) to predicate devices.

However, none of this relates to AI performance metrics, ground truth establishment, expert adjudication, or MRMC studies for AI devices.

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When used as a vertebral body replacement:

The ChoiceSpine Octane-A/T/P Spinal Implant is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Octane device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation to facilitate fusion.

When used as an intervertebral body fusion device:

The Octane-A/T/P Spinal Implant is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD), with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device may be used with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The Ascendant PC 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 Ascendant PC Cervical Spacer System is to be used autogenous and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Ascendant 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 Ascendant Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The BLACKHAWK™ 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 BLACKHAWK™ Cervical Spacer System is to be used autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plated via an open, anterior approach.

The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The Octane Straight PC Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be sketally mature and have had at least 6 months of non-operative treatment. The device system is designed for use with autogenous bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

The VEO™ Lateral Access & Interbody Fusion 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 at the involved level(s). These patients should have had six months of non-operative treatment. The VEO™ Lateral Access & Interbody Fusion System is designed to be used with autogenous and/or allogenic bone graft composed of cancellous and / or corticocancellous bone graft, and supplemental spinal fixation that is cleared for use in the lumbar spine.

This submission includes 7 subject devices. The device descriptions for each are listed below:

The ChoiceSpine Octane Straight Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The Octane Straight Intervertebral Fusion Device is provided sterile for single use.

The ChoiceSpine Octane Straight PC Intervertebral Fusion Device is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plane to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The device is plasma coated with commercial pure titanium (CPTi) per ASTM F1580. The Octane Straight PC Intervertebral Fusion Device is provided sterile for single use.

The BLACKHAWK™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK implant cage per ASTM F2026 with tantalum radiographic markers per ASTM F560, nitinol internal locking components per ASTM F2063 and two internal titanium alloy anchors (Ti-6Al-4V ELI) per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The devices feature a chamber intended to be filled with autogenous bone and or/allogenic bone graft material. They are used with two internal anchors that lock on deployment and provide additional fixation. The BLACKHAWK™ Cervical Spacer System is to be used with autogenous bone and or/allogenic bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Ascendant® Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with tantalum radiographic markers. 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 device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material. The Ascendant® Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).

The Ascendant™ PC Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. 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 device features an enclosed chamber intended to be filled with autogenous and or/allogenic bone graft material.

The VEO® Lateral Access & Interbody Fusion System is a multi-component system including instrumentation made of biocompatible materials such as Stainless Steel, Aluminum, and Radel R and implants made of Tantalum (ASTM F560) and PEEK (ASTM F2026) or Ti-6AI-4V ELI (ASTM F136).

The ChoiceSpine Octane®-A/T/P Spinal Implant is an implant constructed of medical grade Polyetheretherketone, (PEEK-OPTIMA® LT1) as described by ASTM F2026. The implant incorporates ridges on the superior and inferior surfaces to resist expulsion. The device is open in the transverse plain to allow insertion of bone graft prior to placement, and fenestrated along the sides. The radiolucent PEEK-OPTIMA® material allows visualization of the defect site on radiography to assess bone growth, and incorporates tantalum markers conforming to ASTM F560 to permit verification of position. The ChoiceSpine Octane Spinal Implant is provided sterile in three (3) styles:

. The Octane-T Spinal Implant, available heights of 7mm to 17mm, in 2mm increments;
. The Octane-P Spinal Implant, available in heights of 7mm to 17mm, in 2mm increments; and
. The Octane-A Spinal Implant, available in heights of 9mm to 19mm, in 2mm increments, and with a convex superior and inferior surface, angled at either 6° or 12° and in Small, Medium, or Large transverse profile.

This FDA 510(k) summary does not contain information regarding the acceptance criteria or a study proving the device meets acceptance criteria. The document is a premarket notification for multiple spinal implant systems seeking clearance for a change in indications for use, specifically to allow the use of autogenous bone and/or allogenic bone graft.

As such, the information typically found in an acceptance criteria and study report for a new medical device (such as those involving performance metrics, clinical trials, sample sizes, expert adjudication, or AI analysis) is not present here.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their devices are as safe and effective as existing, legally marketed devices, rather than introducing a novel technology that requires extensive new performance data.

Here's a breakdown of why the requested information is absent and what is covered:

1. A table of acceptance criteria and the reported device performance: Not provided. Substantial equivalence is based on comparing the subject device to predicates, not against specific performance criteria in a new study.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no new test set/clinical study described. The submission relies on the existing safety and effectiveness established for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment is described.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is more common for diagnostic imaging AI devices, not for spinal implants demonstrating substantial equivalence for a change in bone graft material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. There is no AI/algorithm component to train.

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

What the document does state about "testing" and "equivalence":

• Non-Clinical Testing: "All subject components have been cleared and therefore do not present a new mechanical worst-case and no non-clinical testing is needed." (Page 13) This indicates that previous testing on the components was deemed sufficient for the initial clearances, and the change in indications for use (specifically related to the type of bone graft) doesn't warrant new mechanical testing.
• Substantial Equivalence Conclusion: The document concludes that the subject devices are substantially equivalent to the predicates in various aspects including "principle of operation, materials, indications for use, biocompatibility, manufacturing and post processing steps, stabilization methods, sterilizations method, anatomic location and approach, product classification and product codes." The only noted difference is the specific wording around bone graft material. (Page 14)

In summary, this document is a 510(k) submission for spinal implants relying on substantial equivalence to existing devices for a minor change in intended use regarding bone graft material. It does not describe new performance studies or acceptance criteria in the manner requested.

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