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The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). The system is limited to use in skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

• 1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• 2. spondylolisthesis,
• 3. trauma (i.e., fracture or dislocation),
• spinal stenosis, 4)
• 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• 6. tumor,
• 7. pseudoarthrosis, and
• 8. failed previous fusion

When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.

The Firebird Spinal Fixation System components are used with certain components of the SFS system, including rod connectors and cross-connectors.

The additional, non-pedicle components presented in this premarket notification consist of Hooks and Iliac Connectors.

This document is a 510(k) Premarket Notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System Expansion. It indicates that the submission is for an expansion of a previously cleared system, focusing on adding new non-pedicle components (Hooks and Iliac Connectors). Therefore, the "device" in question refers to these additional components for the existing Firebird Spinal Fixation System.

It's important to note that this is a 510(k) submission, which typically demonstrates substantial equivalence to a predicate device rather than independent proof of safety and effectiveness through a clinical trial with specific performance criteria for AI/software-as-a-medical-device. The "performance data" here refers to mechanical testing for the new components.

Here's an analysis based on the provided text, recognizing the context of a spinal implant device and not an AI/software device:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

• Results were compared to the predicate Firebird systems when used for the same intended use of iliac fixation. |
  | No New Issues of Safety or Effectiveness | - The mechanical evaluations addressed technical differences.
• "These differences do not present any new issues of safety or effectiveness." |
  | Substantial Equivalence to Predicate Devices | - The expanded system has the "same intended use and similar indications, technological characteristics and principles of operation" as its predicate systems.
• The device was granted 510(k) clearance due to substantial equivalence (K093926). |

Explanation of "Acceptance Criteria" for this device:

For spinal fixation systems like this, acceptance criteria in a 510(k) context are typically demonstrated through:

• Mechanical Testing: Showing that the new components meet established standards for strength, durability, and resistance to wear, and perform comparably to legally marketed predicate devices. The document specifically mentions static compression bending, static torsion, and dynamic compression bending.
• Biocompatibility: (Though not explicitly detailed in this summary, it's an inherent requirement for implantable devices.)
• Design Rationale & Risk Analysis: Demonstrating that the design is appropriate for its intended use and that potential risks have been mitigated.
• Demonstration of Substantial Equivalence: The overarching goal of a 510(k) is to prove the device is as safe and effective as a legally marketed predicate device.

2. Sample Size for Test Set and Data Provenance

This document describes mechanical testing of physical implants, not a clinical study involving a "test set" of patients or data in the way an AI/software device would. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission. Mechanical tests would use a certain number of device components but this is not specified as a "sample size" in this document.

3. Number of Experts and Qualifications for Ground Truth

Again, this is a mechanical device submission, not an AI/software device. There were no experts used to establish "ground truth" in the clinical sense for a test set. The "ground truth" for mechanical testing is derived from established engineering standards and comparison to predicate device performance data (often from similar mechanical tests or published data).

4. Adjudication Method

Not applicable. There was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission is for a physical spinal implant, not an AI/software device that would assist human readers in diagnosis or analysis.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device; there is no algorithm or standalone software performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this device's performance demonstration relies on:

• Engineering Standards: Established international and national standards for spinal implant mechanical testing.
• Predicate Device Performance Data: Mechanical test results from the identified predicate devices (e.g., Firebird Spinal Fixation System Cobalt-Chrome Rods, Blackstone Pedicle Screw System, Synthes Universal Spine System, DePuy Acromed systems). The performance of the new components must demonstrate equivalence to these established predicate devices.

8. Sample Size for the Training Set

Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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The Hallmark™ Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis:
c) Fracture;
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery

The Hallmark Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (6AL-4V ELI, per ASTM F136) components that allow a surgeon to build an anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation.

The provided text is a 510(k) summary for a medical device modification, specifically the "Hallmark Anterior Cervical Plate System Modification - Five-Level Cervical Plates." This document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical evaluations, rather than reporting on a clinical study with an AI component or complex performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-powered device or a study with detailed performance metrics are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. This is demonstrated through mechanical evaluations. While the document doesn't explicitly state quantitative acceptance values for these mechanical tests, the underlying assumption is that the modified device's performance in these tests is comparable to or better than previously cleared devices.

• Reported Device Performance: The document states:

  "Mechanical evaluations were conducted to demonstrate that the Hallmark Anterior Cervical Plate System with the addition of the Five-Level Cervical Plates is substantially equivalent to predicate devices and systems that have been cleared by FDA for the purpose of building a spinal implant construct in the cervical spine."

  No specific numerical performance data from these mechanical evaluations (e.g., fatigue strength, pull-out strength, stiffness values) are provided in the summary. The "performance" is implicitly deemed acceptable because it met the substantial equivalence standard.

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. This device is a mechanical implant. The "test set" would refer to physical prototypes or manufactured units subjected to mechanical testing. The document does not specify the number of devices tested or the provenance of any data (as no human data is involved). These would typically be lab-based mechanical tests.

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. As a mechanical implant, there is no "ground truth" in the diagnostic sense or expert review of images. Mechanical testing results are objective measurements.

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

• Not applicable. No expert adjudication of data is mentioned or relevant for this type of submission.

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

• Not applicable. This is a mechanical device, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• For mechanical devices undergoing engineering testing, the "ground truth" would be the objective measurements from the tests themselves, compared against established standards (e.g., ASTM standards for material properties or biomechanical performance) and existing predicate device data. The document does not explicitly detail the specific standards or predicate data used for comparison.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

Summary of Study Type:

The "study" conducted for this 510(k) submission was a series of mechanical evaluations (laboratory tests) designed to demonstrate that the modified Hallmark Anterior Cervical Plate System (with Five-Level Cervical Plates) performs equivalently to predicate devices under specified conditions. The objective was to show substantial equivalence for regulatory clearance, not to evaluate clinical performance or an AI algorithm.

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The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis,
3. trauma (i.e., fracture or dislocation),
4. spinal stenosis.
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor,
7. pseudoarthrosis, and
8. failed previous fusion
   The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

The Firebird Spinal Fixation System is a temporary, 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 spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.

The document describes the K092624 premarket notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System with the addition of a Cobalt Chrome Rod. This is a medical device submission, and as such, the concept of "acceptance criteria" and "device performance" as it might apply to software or AI algorithms is not directly applicable in the same way. Instead, the "acceptance criteria" for a medical device like this is typically demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.

Here's a breakdown based on the provided text, adapted to the context of a medical hardware device:

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

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

• Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For medical devices, "sample size" in this context typically refers to the number of devices or components tested. ASTM standards for medical devices usually specify the required number of samples for each test type to achieve statistical significance.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that the submission is to the FDA (USA), it is reasonable to infer the testing was likely conducted in the US or by a lab adhering to US standards. Mechanical testing on medical devices is inherently prospective, as it involves newly produced components subjected to defined test protocols.

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 question is not applicable. For mechanical testing of a medical device, "ground truth" is established by the specifications of the ASTM standards themselves and the objective measurements obtained from standardized testing equipment, not by a panel of human experts. Expert clinical opinion would be relevant in the initial design and indication definition, but not in validating the mechanical performance.

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

This question is not applicable. Mechanical testing of physical medical devices does not involve human adjudication in the way clinical studies or image analysis might. The results are based on objective physical measurements and adherence to pre-defined test protocols.

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

This question is not applicable. The device is a spinal fixation system (hardware), not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant to this submission.

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 spinal fixation system, which is a physical implant, not an algorithm.

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

The "ground truth" for the mechanical testing of this device is established by objective physical measurements (e.g., force, displacement, cycles to failure) in accordance with recognized industry standards (ASTM standards). These standards define the criteria for acceptable performance (e.g., fatigue life, strength) for spinal fixation systems.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing for a medical device like a spinal fixation system. The device's performance is evaluated against engineering standards and comparison to a predicate device.

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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The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis.
3. trauma (i.e., fracture or dislocation).
4. spinal stenosis.
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor,
7. pseudoarthrosis, and
8. failed previous fusion
   The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

The Blackstone Pedicle Screw System 4.0 mm Diameter Screws consists of an assortment of multiaxial and monoaxial pedicle screws.

The provided text describes a 510(k) premarket notification for a modification to the Blackstone Pedicle Screw System, specifically introducing 4.0 mm diameter screws. The submission highlights mechanical testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study involving human subjects or AI-based performance metrics.

Therefore, many of the requested elements are not applicable to this type of submission, as they pertain to clinical studies or AI/software validation.

Here's an analysis based on the provided document:

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

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

The document primarily discusses mechanical testing, not clinical studies or data involving human subjects in a "test set" in the context of AI or diagnostic performance. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) as they relate to human data are not applicable here. The data provenance would be from manufacturing and testing facilities.

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

Not applicable. This is a submission for a mechanical medical device, not a diagnostic or AI device that requires expert-established ground truth from images or clinical assessments. Ground truth for mechanical testing would involve engineering standards, material properties, and physical measurements.

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

Not applicable. Adjudication methods are relevant for clinical assessments or expert reviews, not for mechanical device testing where results are quantifiable through engineering metrics.

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

Not applicable. This is a mechanical device submission. There is no AI component or human reader involvement described.

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

Not applicable. This is a mechanical device submission.

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

For mechanical testing, the "ground truth" would be established by:

• Engineering Standards: Adherence to established ASTM or ISO standards for spinal implants (e.g., fatigue strength, torsional rigidity, pull-out strength).
• Predicate Device Performance Data: The performance characteristics of the legally marketed predicate devices (K081684, K052123, K052151) serve as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of AI or machine learning for this mechanical device.

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

Not applicable. There is no "training set" for this mechanical device.

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The Blackstone Pedicle Screw System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications regardless of the intended use:

1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. spondylolisthesis,
3. trauma (i.e., fracture or dislocation),
4. spinal stenosis,
5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. tumor,
7. pseudoarthrosis, and
8. failed previous fusion
   The Blackstone Pedicle Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.

The Blackstone Pedicle Screw System consists of an assortment of multiaxial and monoaxial pedicle screws, set screws, and screw bodies.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Blackstone Pedicle Screw System

1. Table of Acceptance Criteria and Reported Device Performance

• Similar indications as predicate devices.
• Similar technological characteristics and principles of operation as predicate devices.
• Mechanical testing addressed technical differences, showing no new safety or effectiveness issues. |
  | Mechanical Performance | Mechanical performance (e.g., strength, durability) must be comparable to predicate devices to ensure safety and effectiveness. | Mechanical testing was conducted which demonstrates that the system is substantially equivalent to predicate devices. |

Explanation of Implicit Criteria: The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. Therefore, the explicit acceptance criteria are not stated in terms of specific performance metrics for the device itself but rather its ability to perform at least as well as and be as safe and effective as the predicate devices. The "performance data" section states that mechanical testing was conducted to prove this equivalence.

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

The provided summary does not specify a sample size for a "test set" in the context of clinical data or human evaluation. The performance data section refers to "mechanical testing," which implies laboratory-based tests on device components or finished products.

• Sample Size for Test Set: Not applicable/Not specified in the provided document, as the study described is mechanical testing, not a user-based or clinical study.
• Data Provenance: Not applicable/Not specified. The tests are laboratory-based mechanical tests.

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

Not applicable. This information would be relevant for studies involving human interpretation or clinical outcomes. The document discusses mechanical testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used to resolve discrepancies in human assessments, which is not relevant to mechanical testing.

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, an MRMC comparative effectiveness study was not done. The document describes mechanical testing for a medical device (pedicle screw system), not an AI-assisted diagnostic or interpretative system that would involve human readers.

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

Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the mechanical integrity and functionality of the physical pedicle screw system itself, which was assessed through mechanical testing.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing would be the performance characteristics of the predicate devices. The Blackstone Pedicle Screw System was deemed acceptable if its mechanical performance was "substantially equivalent" to these known and previously approved devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set."

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

Not applicable. As there is no training set mentioned for this device, there is no ground truth established for it.

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When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).
The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.

The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLAR™ AL spacer is used singly, and is implanted using an anterior approach.

The PILLAR™ XL spacer is used singly, and is implanted using a lateral approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLAR™ Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.c., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ Spacer System 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 of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

The PILLAR™ XL PEEK Spacers consist of a variety of implants manufactured from PEEK-OPTIMA® I.T (Polyetheretherketone), as described by ASTM F-2026, with Tantalum markers as described by ASTM F-560. The implants are available in a variety of footprint sizes. Additionally, they are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights, in one millimeter increments. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR XL PEEK Spacers are intended for intervertebral body fusion or partial vertebral body replacement to aid in the surgical correction and stabilization of the spine,

The PILLAR XL PEEK Spacer components are not intended to be used as stand-alone devices. The PILLAR XI. PEEK Spacers must be used with supplemental internal fixation and are provided non-sterile.

This 510(k) premarket notification for the Blackstone PILLAR Spacer System Modification Confidential does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is a standard 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on mechanical performance evaluations and equivalence in configuration, indications for use, and fundamental scientific technology. It does not describe performance acceptance criteria or a study that rigorously tests the device's performance against such criteria.

Therefore, I cannot populate the table or answer the specific questions based on the provided input.

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When used as an Intervertebral Body Fusion System: The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System. When used as a Partial Vertebral Body Replacement (VBR) System: The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ SA PEEK Spacer System 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 of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

The Blackstone Medical, Inc. PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1), as described by ASTM F-2026, with tantalum markers as described by ASTM F-560. The implants are available in multiple footprint sizes, and a variety of heights and angles of lordosis. The implants incorporate integrated anterior screw holes to allow for medial placement of titanium screws that anchor to the vertebrae, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.

The provided text describes a 510(k) premarket notification for the Blackstone PILLAR SA PEEK Spacer System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance in the context of an AI/ML medical device.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not applicable as this submission is for a physical medical implant device, not an AI/ML diagnostic or predictive system.

Here's a breakdown of what can be extracted from the provided text, and where the information is not present:

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

Not Applicable. This submission is for a physical medical implant, not an AI/ML device. The "performance" is demonstrated through substantial equivalence to predicate devices based on mechanical testing and similar design/materials, rather than meeting specific performance metrics against a defined ground truth as would be the case for an AI/ML algorithm.

The basis of substantial equivalence relies on:

• Mechanical performance data: This implies various engineering tests were conducted to ensure the device's structural integrity and functionality are comparable to predicate devices. Specific quantitative acceptance criteria and detailed performance results from these mechanical tests are not provided in this summary document.
• Equivalence in configuration and indications for use: The device's design, materials (PEEK-OPTIMA® LT1 with tantalum markers), and intended uses are similar to cleared predicate devices.

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. As this is a physical medical implant, there is no "test set" of patient data or images in the context of an AI/ML device. The "testing" involved mechanical performance evaluations on the physical device itself.

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

Not Applicable. There is no "ground truth" in the AI/ML sense. The substantial equivalence relies on engineering standards and comparison to previously cleared devices.

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

Not Applicable. No human adjudication of a "test set" is described for this physical device submission.

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

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

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

Not Applicable. This is not an AI algorithm.

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

Not Applicable. The "truth" for this device's safety and effectiveness is established through adherence to material standards (ASTM F-2026, ASTM F-560), mechanical testing results (implied, but not detailed), and a comparison of its design, materials, and intended use to legally marketed predicate devices already cleared by the FDA.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. See point 8.

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When used as an intervertebral body fusion device, the PILLAR™ Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous nonfusion surgery at the involved level(s).

The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation, e.g .: the Blackstone Medical ICON Modular Pedicle Screw System, or the Blackstone Medical Inc. SFS Spinal Fixation System.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLARTM Spacer System.

The PILLARTM PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLARTM AL spacer is used singly, and is implanted using an anterior approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARTM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLARTM Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ Spacer System 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 of time. The Partial VBR device is intended to be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. The supplemental internal fixation system that may be used with the PILLAR™ Spacer System is the Blackstone Medical Spinal Fixation System.

The PILLAR Spacer System components consist of:

1. A PEEK Spacer

2. Tantalum Markers

Here's an analysis of the provided text regarding the acceptance criteria and study for the Blackstone Medical, Inc. PILLAR™ Spacer System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K081177) is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. In the context of a 510(k), explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or reader agreement are typically not presented as they would be for a novel device. Instead, the primary "acceptance criterion" is that the device's technological characteristics and performance are sufficiently similar to predicate devices such that it does not raise new questions of safety or effectiveness.

Therefore, the table reflects this approach:

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

The document does not provide information regarding a specific "test set" in the way one might expect for a diagnostic or AI-driven device. As this is a 510(k) for an implantable medical device, the "test set" primarily refers to the samples used in the mechanical testing.

• Sample Size for Test Set: Not explicitly stated for mechanical testing, but the context implies sufficient samples were tested to demonstrate substantial equivalence.
• Data Provenance: Not applicable in the sense of patient data. The "study" here is mechanical testing of the device itself, likely conducted in a lab setting.

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

This information is not applicable to this 510(k) submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic devices that interpret images or other patient data. For an implantable device like the PILLAR™ Spacer System, the "ground truth" for mechanical testing is established by engineering standards and validated testing protocols, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

This is not applicable to this 510(k) submission. Adjudication methods like "2+1" or "3+1" are used to resolve discrepancies among multiple expert readers in diagnostic studies. Mechanical testing does not involve such an adjudication process.

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 relevant for evaluating the performance of diagnostic tools (especially those with human-in-the-loop components) and comparing reader performance with and without AI assistance. This document describes an implantable device, not a diagnostic algorithm.

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 document pertains to a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this 510(k) is based on engineering standards and established mechanical testing methodologies. The device's components (PEEK Spacer, Tantalum Markers) and overall system are subjected to tests that simulate the forces and conditions they would experience in vivo, and the results are compared against performance benchmarks established by predicate devices and relevant standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an implantable medical device like this. Training sets are used for machine learning algorithms.

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

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

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is mechanical testing of the Blackstone Medical, Inc. PILLAR™ Spacer System.

• Purpose: To demonstrate that the device is substantially equivalent to legally marketed predicate devices (DePuy Acromed Saber™ Lumbar I/F Cage®, Surgical Dynamics, Inc. Ray Threaded Fusion Cage, Synthes Spine Opal Spacer System) in terms of safety and effectiveness.
• Methodology: Mechanical testing was performed on the PILLAR™ Spacer System. The document states that "The only technological differences between the PILLAR Spacer System and its predicates are minor dimensional characteristics and have been addressed mechanical verification testing."
• Results: The mechanical testing demonstrated that the PILLAR™ Spacer System is substantially equivalent to the predicate devices. The minor technological differences do not present any new issues of safety or effectiveness.

In essence, the entire 510(k) process is the "study" by which the device's acceptance (i.e., substantial equivalence) is proven, primarily through comparison to established, safe, and effective predicate devices, supported by mechanical performance data.

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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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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies:
b) spondylolisthesis:
c) fracture/dislocation:
d) spinal stenosis:
e) atlanto-axial fracture with instability;
f) occipito-cervical dislocation:
g) tumors;
h) revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Blackstone Ascent POCT System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone Ascent POCT System can also be linked to the Blackstone Spinal Fixation System using the Blackstone Ascent Axial or Parallel Connector.

The Blackstone Ascent POCT System is a temporary, 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 Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables.

The provided 510(k) notification for the Blackstone™ Ascent POCT System (K080394) describes a spinal implant system, not a medical device that would have performance metrics like sensitivity, specificity, or image quality. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of an AI/imaging device is not applicable.

This submission is for a modification to an existing device (plate and rod modifications) and primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "performance" of such a device is typically assessed through mechanical testing to ensure it meets established standards for strength, durability, and biocompatibility, rather than diagnostic accuracy.

Here's an attempt to answer the questions based on the provided document, noting when information is not applicable or available:

Acceptance Criteria and Device Performance

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

Given that this is a spinal implant system and a modification, the "acceptance criteria" are generally related to mechanical properties, biocompatibility, and meeting design specifications. The document does not provide a table of quantitative acceptance criteria or detailed test results. Instead, it asserts substantial equivalence based on the device description and intended use aligning with predicate devices.

Not Applicable in the traditional sense for a diagnostic device. For a spinal implant, acceptance criteria would typically involve:

• Mechanical Integrity: Withstanding specified forces (e.g., bending, torsion) without fracture or permanent deformation.
• Dimensional Accuracy: Conforming to design specifications.
• Biocompatibility: No adverse tissue reaction, assessed through materials testing and history of use of similar materials.
• Sterilization: Ability to be sterilized without degradation (if applicable, though this device is described as non-sterile).

The document implicitly "reports performance" by claiming substantial equivalence, which means its performance is expected to be comparable to the predicate devices based on design and materials.

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. This type of information is generally for diagnostic devices or those involving clinical studies. Mechanical testing of implants does not involve "test sets" of patient 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. Ground truth in the context of this device would relate to engineering specifications and mechanical testing standards, not clinical diagnostic accuracy assessed by experts.

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

Not Applicable. This concept applies to expert review processes for diagnostic studies, not mechanical testing or design comparisons for implants.

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

Not Applicable. This is specific to AI-assisted diagnostic devices.

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

Not Applicable. This is specific to AI/diagnostic algorithms.

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

For a spinal implant modification, the "ground truth" for demonstrating substantial equivalence is typically:

• Engineering Standards: Conformance to established ASTM/ISO standards for spinal implants (strength, fatigue, etc.).
• Material Specifications: Compliance with material properties for titanium alloy.
• Predicate Device Performance: The known, clinically accepted performance and safety profile of the predicate devices.
• Design Intent: Whether the modified components still fulfill the same functional requirements as the original device.

The document states the basis of substantial equivalence is that the modified components "are substantially equivalent to the identified predicate systems, which have been cleared by FDA for the purpose of building a spinal implant construct in the occipito-cervico-thoracic spine." This implies the "ground truth" is adherence to the established safety and effectiveness of the predicates and relevant engineering principles.

8. The sample size for the training set

Not Applicable. This is relevant for machine learning models, not mechanical devices.

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

Not Applicable. This is relevant for machine learning models, not mechanical devices.

In summary, the K080394 document is a 510(k) for a device modification to a spinal implant system. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices. This involves showing that the modified device has the same intended use, technological characteristics, and performance (e.g., mechanical properties, biocompatibility) as a legally marketed device. The document does not describe a study involving diagnostic accuracy, expert review, or AI performance, as it is for a physical implant. The "proof" relies on engineering principles, materials science, and a comparison to previously cleared devices.

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