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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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The ChoiceSpine TigerShark™ M, Modular Interbody System is an intervertebral body fusion device 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 six (6) months of non-operative treatment. The device system is designed for use with autograft bone and/or allogenic bone grafts composed of cancellous bone grafts, and with supplemental internal fixation systems (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) cleared for use in the lumbosacral spine.

The ChoiceSpine TigerShark™ M, Modular Interbody System, consists of implants with components that are both additively and traditionally manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C and Ti-6Al-4V ELI per ASTM F136 respectively). The device is provided in lengths of 24-32mm and final heights of 9-17mm with 6° and 12° lordotic options and contains a hollow core to receive autogenous and / or allogenous bone graft.

The provided text is a 510(k) summary for a medical device (ChoiceSpine TigerShark™ M, Modular Interbody System). Such summaries primarily focus on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., mechanical, material, biocompatibility) rather than clinical studies evaluating AI-driven performance.

Therefore, the document does not contain the information required to answer the questions regarding acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-based device.

The questions you've asked (about sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance, training data, etc.) are highly relevant for the FDA's review of artificial intelligence and machine learning (AI/ML)-enabled medical devices. This document, however, describes a traditional orthopedic implant, an intervertebral body fusion device.

Without information specific to an AI/ML component, I cannot fulfill the request.

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The ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine system implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic StealthStation S7 (V2.1.0) and S8 (V1.2.0) systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The ChoiceSpine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use. The ChoiceSpine Navigation instruments are for use with any ChoiceSpine systems equipped with the appropriate and necessary features and geometry. These features and geometry have been tested for compatibility with the Medtronic® StealthStation®.

The provided text is a 510(k) summary for the ChoiceSpine Navigation System. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by performance testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance testing described. The study aimed to demonstrate substantial equivalence to the predicate devices. The key performance characteristic assessed was "dimensional analysis and positional accuracy" per ASTM F2554.

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

The document does not explicitly state a numerical sample size for the test set. It mentions "side-by-side testing," which implies that the ChoiceSpine Navigation instruments were tested alongside the Medtronic® StealthStation® system and a predicate device.

• Sample Size: Not explicitly stated as a number of unique cases. It refers to testing of the "ChoiceSpine Navigation system" itself against the predicate system. This suggests a physical testing setup rather than a dataset of patient cases.
• Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory-based performance validation of the instrument's compatibility and accuracy, rather than a clinical study with patient data. It is a "performance data" section, not a "clinical data" section. The document states it was a "side-by-side testing" with a "predicate device".
• Retrospective/Prospective: Not applicable, as it's a device performance validation, not a clinical data study.

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

The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for this type of device (surgical navigation instruments) is typically established through engineering measurements and comparisons to known standards or predicate device performance, not through expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. The study appears to be an engineering performance validation, not one requiring adjudication of clinical interpretations.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a technical performance validation of a medical device's accuracy and compatibility, not a study assessing the impact of AI assistance on human reader performance.

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

This question is not directly applicable in the context of this device. The "ChoiceSpine Navigation System" is a set of instruments designed to work with an existing navigation system (Medtronic StealthStation). It is not an AI algorithm in the traditional sense that would operate "standalone" to produce an interpretation or diagnosis. Its performance is intrinsically linked to its use with the Medtronic system. The performance data focuses on the accuracy and compatibility of the instruments when integrated with the navigation system.

7. The Type of Ground Truth Used

The ground truth used appears to be engineering measurements and direct comparison to a predicate device's performance, specifically for dimensional analysis and positional accuracy as defined by ASTM F2554. This is a technical validation against established engineering standards and existing device performance, not clinical outcomes, pathology, or expert consensus on a clinical condition.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments, not an AI/ML algorithm that requires a training set of data.

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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The Triton™ Sacroiliac Joint Fixation system is intended for fixation of sacroiliac joint distruptions, and intended for sacroiliac joint fusion for conditions including;
-sacroiliac joint disruptions,
-degenerative sacroiliitis
-to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
-Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint

The Triton™ Sacroiliac Joint Fixation System is a multiple component system consisting of non-sterile instruments and sterile, cannulated Ø8mm, Ø12mm and Ø14mm Screws offered in multiple lengths. The Triton SI Screws are manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, Class C. The implants feature 3 fluted channels for bone collection and a tapered proximal tip. The Ø12mm and Ø14mm Screws feature multiple open and porous-filled windows for packing and disbursement of autograft and allograft materials.

This FDA 510(k) summary is for a medical device called the Triton™ Sacroiliac Joint Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of AI/ML device performance or clinical outcomes.

The provided document primarily focuses on non-clinical testing for mechanical properties (e.g., static pull-out, torsion, cantilever) to demonstrate the safety and effectiveness of the physical implant by comparing its mechanical characteristics to existing predicate devices.

Therefore, many of the requested categories related to AI/ML device performance, human expert involvement, ground truth, and training data cannot be extracted from this document, as they are not applicable to the type of 510(k) submission described.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists non-clinical mechanical tests, but doesn't explicitly state acceptance criteria as pass/fail thresholds against specific numerical values. Instead, it implies that the device's performance in these tests was comparable to that of predicate devices, leading to a conclusion of substantial equivalence.

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

Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset for AI/ML. The provenance would be the materials used in manufacturing the device components for these tests.

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

Not applicable. This is not AI/ML performance testing requiring expert ground truth for classification or prediction. The "ground truth" for mechanical testing is established by standard engineering principles and test methods, often performed by engineers or technicians.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication in the context of mechanical testing as described here. Results are objectively measured according to the ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/ML device that assists human readers.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing is based on established engineering standards and measurements of mechanical properties (e.g., force, torque, displacement) as defined by ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

Summary of the Study Proving Device Acceptance Criteria (based on the provided document):

The Triton™ Sacroiliac Joint Fixation System underwent a series of non-clinical mechanical tests to demonstrate its performance and substantial equivalence to legally marketed predicate devices. These tests were conducted according to established ASTM standards:

• Static Pull Out (ASTM F543)
• Static Torsion (ASTM F543)
• Static Cantilever (ASTM F2193)
• Dynamic Cantilever (ASTM F2193)

The document concludes that the "differences in geometry are not significant and would not adversely affect the use of the product. The Triton™ System is substantially equivalent in material, size offerings, classification, anatomical location, manufacturing and sterilization methods, surgical approach, principle of operation, indications for use, and mechanical testing plan." This statement implies that the device successfully met the performance expectations by demonstrating comparable mechanical characteristics to the predicate devices, thereby establishing its safety and effectiveness for its intended use. The "ground truth" for these tests was the objective measurements obtained through adherence to the specified ASTM testing protocols.

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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 ChoiceSpine Navigation reusable instruments are intended to be used during preparation and placement of ChoiceSpine Lancer", Thunderbolt", and Blackbird™ system during spinal surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The ChoiceSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System (V2.1.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The ChoiceSpine Navigation instruments are non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System and SureTrak® II System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use. The ChoiceSpine Navigation instruments are for use with ChoiceSpine screw systems, specifically, Lancer™, Thunderbolt™, and Blackbird™ Spinal Systems.

The provided text is a 510(k) Summary for the ChoiceSpine Navigation System. It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it explicitly states that no new testing was performed for this specific submission to add Blackbird instruments. Instead, it relies on the previous testing of the predicate device.

Therefore, the following information cannot be fully extracted based on the provided text for the current submission:

• A table of acceptance criteria and reported device performance (for the current submission).
• Sample size used for the current test set.
• Data provenance for the current test set.
• Number of experts used to establish ground truth for the current test set and their qualifications.
• Adjudication method for the current test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done for the current submission.
• Whether a standalone performance study was done for the current submission.
• The type of ground truth used for the current test.
• Sample size for the current training set.
• How ground truth for the current training set was established.

Based on the provided text, here is what can be inferred about the original testing that established "substantial equivalence" for the predicate device, which this submission leverages:

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

The text does not explicitly state acceptance criteria in a table format. It only mentions that the "Navigation System has been tested per ASTM F2554-10, 'Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems'." It concludes that "The results of this non-clinical testing show that performance of the Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Without the actual report of the ASTM F2554-10 testing, specific numerical acceptance criteria and reported performance values cannot be provided here.

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

This information is not provided in the text for either the predicate device's testing or the current submission.

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

This information is not provided in the text. The testing mentioned (ASTM F2554-10) is a standard for positional accuracy of computer-assisted surgical systems, which is typically an engineering performance test and may not involve expert review in the same way clinical studies do.

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

This information is not provided in the text.

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

An MRMC study was not performed for this submission, as no new testing was conducted. The text describes an engineering performance test (ASTM F2554-10) for positional accuracy, not a comparative effectiveness study with human readers.

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

The submission states that the "ChoiceSpine Navigation System" was tested per ASTM F2554-10. This is a standard for evaluating the accuracy of computer-assisted surgical systems. This would be considered a standalone performance test of the device's accuracy, as it measures the system's ability to precisely locate anatomical structures. However, it's not an "algorithm only" test in the sense of an AI/ML algorithm being evaluated in isolation, but rather the integrated navigation system's performance.

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

The ground truth for the ASTM F2554-10 test would likely be based on physical measurements and precise anatomical models used to assess the positional accuracy of the surgical system. It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense of clinical ground truth.

8. The sample size for the training set

This information is not provided as the submission refers to an engineering performance test, not a machine learning model that would require a training set.

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

This information is not provided as no machine learning training set is relevant to the described testing.

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

The ChoiceSpine Harrier-SATM Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used.

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

The provided text focuses on the FDA 510(k) clearance of the ChoiceSpine Harrier-SA™ Lumbar Interbody System, specifically for a modification to make the use of anterior components optional. This document is a regulatory submission, not a clinical study report or a detailed performance and acceptance criteria document for AI/software-based medical devices.

Therefore, the information required to answer your request (acceptance criteria, study details of AI algorithms, sample sizes, expert ground truthing, MRMC studies, standalone performance, etc.) is not present in the provided text.

The document describes a mechanical testing comparison to predicate devices, not a study involving AI or human reader performance.

To reiterate, the provided text does not contain any of the following:

• A table of acceptance criteria and reported device performance related to an AI/software.
• Sample sizes for a test set or data provenance for AI/software.
• Number of experts for ground truth establish for AI/software, nor their qualifications.
• Adjudication method for a test set of AI/software.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
• Standalone performance of an AI algorithm.
• Type of ground truth used for AI data (expert consensus, pathology, outcomes).
• Sample size for training set for an AI algorithm.
• How ground truth for a training set for an AI algorithm was established.

This document pertains to a physical medical device (spinal interbody system) and its mechanical equivalence to existing predicate devices, not an AI/software medical device.

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