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The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis:
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) spondylolistheses;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
f) pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation).

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
b) spondylolistheses;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
f) pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation)

The Blackstone Spinal Fixation System (SFS) is comprised of titanium allov (Ti-6AL-4V ELI per ASTM F136) devices in a variety of non-sterile, single-use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.

The SFS Parallel Rod Connectors will function as rod connectors. They are fabricated of titanium alloy (Ti-6AL-4V) and are provided in both top-loading and front-loading configurations. Both configurations allow for rod components to be connected side-to-side, rather than end-to-end, as with the currently marketed Blackstone SFS Axial Domino (Connector) (K030241 SE 2-21-03).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone SFS Parallel Rod Connectors:

It's important to note that the provided text is a 510(k) summary for a medical device (spinal fixation system component), not a research paper detailing a study on an AI/ML device. Therefore, the questions about AI/ML specific aspects (like multi-reader multi-case studies, standalone algorithm performance, or ground truth for training) are not directly applicable to this document. This document describes the regulatory submission for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implied) acceptance criteria is a mechanical testing study.

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

• Sample Size for Test Set: Not explicitly stated in this 510(k) summary. For mechanical testing of medical devices, sample sizes are typically determined by relevant ISO standards (e.g., ISO 12189 for pedicle screw spinal systems, ISO 1584 for spinal implants) and statistical considerations to provide adequate confidence in the results. This information would be in the full engineering report, not the summary.
• Data Provenance: The studies are likely prospective mechanical tests performed in a laboratory setting, not on human or animal data. The country of origin for the data would typically be the location of the testing facility, which is not specified but would generally be linked to the manufacturer (Blackstone Medical, Inc., USA).

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

This question is not applicable to this type of device and study. "Ground truth" in the context of mechanical testing refers to the objective physical properties and performance characteristics of the materials and device components. Test protocols and acceptance criteria are established by engineers and regulatory experts based on national and international standards, not by clinical "experts" establishing ground truth in the diagnostic sense.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods are typically for clinical studies involving human interpretation or assessment. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) that do not require adjudication in the way clinical interpretations do. The results are compared directly against pre-defined acceptance criteria based on engineering principles and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This is a physical medical device, not an AI/ML diagnostic tool. Such studies are typically for evaluating the impact of AI algorithms on human reader performance in interpreting medical images.

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

No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device, in the context of its performance validation, is established through:

• Engineering specifications and material properties: The physical and chemical characteristics of titanium alloy (Ti-6AL-4V ELI per ASTM F136).
• Established mechanical testing standards: Compliance with relevant ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards for spinal implants, which dictate how tests are performed and what constitutes acceptable performance (e.g., fatigue life, static strength).
• Performance of predicate devices: The "known" performance of legally marketed equivalent devices (K994217, K030241) serves as a benchmark for equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. There is no "training set" in the context of a physical medical device's mechanical testing to demonstrate substantial equivalence.

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

This question is not applicable, as there is no training set for this type of device submission.

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Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

• a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
• b) Who are receiving fusion using autogenous bone graft only;
• c) Who are having the device fixed or attached to the lumbar and sacral spine (1.3 and below); and
• d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

• a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
• b) Fracture;
• c) Dislocation:
• d) Scoliosis;
• e) Kyphosis;
• Spinal turnor: and f)
• g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-podicle fixation, is intended for the following indications:

• a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
• b) Spinal stenosis;
• c) Spondylolisthesis;
• d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
• e) Pseudarthrosis:
• Tumor; 1)
• g) Trauma (i.e., fracture or dislocation);
• h) Previous failed fusion.

The Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw is a titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Blackstone™ Spinal Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217, K013558 & K003735). The 4.5mm Multi-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217, K013558 & K003735).

This document is a 510(k) premarket notification for a medical device (Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screw). It describes the device, its intended use, and claims substantial equivalence to previously cleared devices.

This document focuses on regulatory approval based on substantial equivalence to existing devices, not on a study proving the device meets specific acceptance criteria through performance metrics. There is no performance data, clinical study, or technical acceptance criteria defined within this document. The FDA's 510(k) clearance process often relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and therefore does not raise new questions of safety and effectiveness.

Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.

Here's an assessment based on the provided text:

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

• Not Applicable. This document does not define specific performance acceptance criteria (e.g., tensile strength, fatigue life,
  etc.) beyond ensuring the device is substantially equivalent to predicates. No device performance metrics are reported.

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

• Not Applicable. No test set or data provenance is mentioned. The submission is based on demonstrating substantial
  equivalence, not on new performance testing data.

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

• Not Applicable. No ground truth establishment for a test set is described.

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

• Not Applicable. No test set requiring adjudication is described.

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

• Not Applicable. This device is a spinal fixation system, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a spinal fixation system, not an algorithm.

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

• Not Applicable. The concept of "ground truth" as it applies to performance evaluation is not relevant here. The "truth" in this context is the safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm is mentioned or relevant to this device submission.

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

• Not Applicable. No training set for an algorithm is mentioned or relevant.

Summary of what can be extracted from the document related to the "study":

• Study Type: This is not a performance study in the traditional sense, but rather a Substantial Equivalence Demonstration as part of a 510(k) premarket notification.
• "Acceptance Criteria": The primary "acceptance criterion" for this submission is that the device is substantially equivalent to legally marketed predicate devices.
• "Device Performance": The document claims the device's performance is substantially equivalent to the predicates. Specific performance data (e.g., biomechanical testing results) are likely contained in other parts of the 510(k) submission, but not in this summary. The summary only asserts equivalency.
• Predicate Devices: DePuy Motech Moss Miami Spinal System (K980477, K982320).
• Basis of Substantial Equivalence: The Blackstone™ 4.5mm Multi-Axial Screw is stated to be "by its very nature" substantially equivalent to the predicate, implying similar materials, design principles, and intended use as described.

This document serves as a regulatory summary for a mechanical device, not a report on a clinical or AI performance study.

Ask a specific question about this device

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture:
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor; and
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

The Blackstone Spinal Fixation System, when used for posterior non-pedicle fixation, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

The Blackstone™ Spinal Fixation System Posterior Hooks are a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct.

The Blackstone™ Spinal Fixation System consists of an assortment of screws and rods, which have received 510k clearance (K994217 & 003735) (K013558 pending). The Posterior Hooks are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217 & 003735) (K013558 pending).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone™ Spinal Fixation System Posterior Hooks.

Important Note: The provided document is a 510(k) summary for a medical device (spinal fixation system posterior hooks) from 2002. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials or detailed performance studies as might be expected for an AI/software as a medical device (SaMD). Therefore, many of the typical elements requested in your prompt for validating an AI device (like sample size for test sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of filing.

The "acceptance criteria" here refer to the regulatory pathway for demonstrating that the new hooks are as safe and effective as a previously cleared device. The "study" isn't a traditional clinical trial but rather a comparison to an existing product.

Acceptance Criteria and Reported Device Performance

Study Details (as applicable to a 510(k) for a device addition)

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

   • N/A. This is a 510(k) for an addition to an existing spinal fixation system. Substantial equivalence is demonstrated by comparing the new components (posterior hooks) to a predicate device (Danek CD Horizon Spinal System, K981676) and to the previously cleared Blackstone Spinal Fixation System components (K994217, 003735, K013558). No "test set" in the sense of a patient cohort or image dataset (as for AI) was used or described. The "data" refers to the technical specifications and indications of the predicate and existing devices.

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

   • N/A. Ground truth establishment by experts for a specific test set is not part of this type of 510(k) submission. The evaluation is based on regulatory review of technical documentation, materials, and intended use comparison.

3. Adjudication method for the test set:

   • N/A. Not applicable, as there is no "test set" or adjudication process in this context.

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

   • N/A. This is a physical medical implant, not an AI or diagnostic device. MRMC studies are not applicable.

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

   • N/A. Not an AI or software device.

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

   • The "ground truth" in a 510(k) submission for a device like this is primarily the established safety and effectiveness of the identified predicate device as determined by its prior FDA clearance. The new device is then compared against this established benchmark. There isn't "pathology" or "outcomes data" specifically collected for the new hooks in this filing.

7. The sample size for the training set:

   • N/A. This is not an AI or machine learning device; therefore, there is no concept of a "training set."

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

   • N/A. Not applicable.

Summary of 510(k) Process for this Device:

This 510(k) submission for the Blackstone™ Spinal Fixation System Posterior Hooks relies on demonstrating that the new components are substantially equivalent to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as existing, cleared devices on the market. The "study" in this context is primarily a comparison of technical characteristics, materials, and intended uses rather than a clinical trial or a performance study on a specific data set. The acceptance criteria are met if the FDA agrees that the new hooks do not raise different questions of safety and effectiveness compared to the predicate device.

Ask a specific question about this device

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment:
b) Fracture;
c) Dislocation:
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor: and
g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spinal stenosis:
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
e) Pseudarthrosis;
f) Tumor:
g) Trauma (i.e., fracture or dislocation);
h) Previous failed fusion.

The Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screw is a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Blackstone™ Spinal Fixation System consists of an assortment of screws and rods which have received 510k clearance (K994217 & K003735). The 4.5mm Mono-Axial Screws are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217 & K003735).

This is a 510(k) summary for a medical device (Blackstone Spinal Fixation System - 4.5mm Mono-Axial Screw System Addition), which describes its intended use and claims substantial equivalence to previously cleared devices. It is not a study report that evaluates the performance of the device against specific acceptance criteria using a test set.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, and MRMC studies cannot be extracted because such a study is not part of this document.

Explanation:

• 510(k) Pre-Market Notification: This document is a 510(k) submission to the FDA. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, i.e., substantially equivalent, to a legally marketed predicate device that is not subject to premarket approval (PMA).
• Substantial Equivalence: The fundamental principle of a 510(k) is to demonstrate "substantial equivalence" to a predicate device. This often involves comparing device design, materials, intended use, and performance characteristics to those of the predicate device. It typically does not require clinical trials or extensive performance studies with acceptance criteria in the same way a novel high-risk device might.
• Device Description and Indications for Use: The document clearly describes the device and its intended uses, comparing it to the predicate devices (DePuy Motech Moss Miami Spinal System).
• No Performance Data: There is no mention of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical properties under stress) for the new 4.5mm Mono-Axial Screw, nor is there any data from a study directly evaluating its performance against pre-defined acceptance criteria. The claim of equivalence is based on its similarity to the predicate device.

In summary, there is no study described in this document that proves the device meets acceptance criteria. The document serves as a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a performance study report.

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