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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 (1.3 and below); and
Who are having the device removed after the development of a solid fusion mass. d)

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 orioin 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 is comprised of titanium alloy (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 lateral offset addition will function as an offset rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods in an offset manner when building a construct.

The input provided describes a medical device, the Blackstone™ Spinal Fixation System - Lateral Offset, which is a modification to an existing system. The document is a 510(k) summary for premarket notification to the FDA.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document discusses:

• Device Description: The components and materials of the Blackstone™ Spinal Fixation System, specifically the lateral offset addition.
• Intended Use / Indications for Use: The clinical applications and patient populations for which the device is intended.
• Substantial Equivalence: The basis for claiming substantial equivalence to other legally marketed devices (Synthes, Interpore Cross, and Surgical Dynamics).
• FDA Communication: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Key elements missing from the provided text that would be necessary to answer the prompt are:

• Acceptance Criteria: Specific performance metrics (e.g., strength, durability, fatigue life, accuracy) with defined thresholds that the device must meet.
• Study Design and Results: Any testing (e.g., mechanical testing, clinical trials, bench testing) performed to evaluate the device's performance against defined criteria.
• Test Set Details: Sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods for any test data.
• Comparative Effectiveness Study: Information on MRMC studies or standalone algorithm performance.
• Training Set Details: Sample size and ground truth establishment for any training data.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about a study proving the device meets acceptance criteria based solely on the provided text. The document is a regulatory submission for substantial equivalence, which primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of design, materials, and intended use, rather than detailed performance study results against specific criteria in the way a clinical trial or algorithm validation study would present them.

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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 spondylolisthesis with objective evidence of neurologic impairment;
b) Fracture;
c) Dislocation;
d) Scoliosis;
e) Kyphosis;
f) Spinal tumor;
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) Spinal stenosis;
c) Spondylolisthesis;
d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) Pseudoarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation).
h) Failed previous fusion.

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (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) Pseudoarthrosis;
f) Tumor;
g) Trauma (i.e., fracture or dislocation);
h) Failed previous fusion.

The Blackstone Spinal Fixation System is a titanium alloy (6AL-4V ELI, per ASTM F136) device comprised of a variety of non-sterile, single use components. The Blackstone Spinal Fixation System Rigid Cross Connector is a modification to the Spinal Fixation System, which allows a 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, hooks, rods, and cross connectors that have received 510(k) clearance (K994217, K013558, K013885, K020674, K023498, K003537).

The provided document is a 510(k) Premarket Notification for a medical device: the Blackstone™ Spinal Fixation System - Rigid Cross Connector. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a new standalone clinical efficacy study with specific acceptance criteria and performance metrics described in typical AI/software device submissions.

Therefore, many of the requested data points (such as acceptance criteria, reported device performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of regulatory submission for a physical, mechanical medical device.

The study presented here to "prove the device meets acceptance criteria" is a demonstration of substantial equivalence to previously cleared devices, primarily through comparison of design, materials, and intended use.

Here's an attempt to address the points based on the available information, noting where information is not present or not applicable for this type of device:

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

• Acceptance Criteria: For a 510(k) for a mechanical device like this, the "acceptance criteria" are generally based on demonstrating that the modified device (Rigid Cross Connector) performs at least as well as and is as safe and effective as its predicate devices. This is typically achieved through engineering design verification, material testing, and a comparison of intended use, materials, and technological characteristics. The document explicitly states the "Basis of Substantial Equivalence" as the key criterion.
• Reported Device Performance: The document does not provide quantitative performance metrics in the way a software or diagnostic device would (e.g., sensitivity, specificity, accuracy). Instead, "performance" is implicitly demonstrated by the claim of substantial equivalence and by the successful mechanical design to fulfill its intended purpose within a spinal fixation system.

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 is a submission for a mechanical medical device (spinal implant). There is no "test set" of patient data or images in the context of an AI/software device. Compliance is based on engineering design, material specifications, and comparison to predicate devices, not on data analysis from a patient cohort.

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: There is no "ground truth" derived from expert consensus on patient data for this type of mechanical device submission. The "truth" is established by engineering principles, material standards, and clinical experience with similar predicate devices.

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

• Not Applicable: There is no "test set" or adjudication process in the context of diagnostic interpretation for this type of device.

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 spinal implant, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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)

• Not Applicable / Different Context: For this device, "ground truth" relates to validated engineering principles, material science, and the known clinical performance and safety profile of the predicate devices. It is not derived from patient-specific diagnostic "ground truth" as would be the case for an AI/diagnostic software.

8. The sample size for the training set

• Not Applicable: This is a mechanical device. There is no "training set" of data in the context of machine learning.

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

• Not Applicable: There is no "training set" for this type of device.

Ask a specific question about this device

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 is comprised of titanium alloy (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 domino addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods when extending a construct.

The provided text is a 510(k) summary for the Blackstone™ Spinal Fixation System, specifically the "domino" addition. It describes the device, its intended use, and states the basis for substantial equivalence. Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Instead, it asserts substantial equivalence to a predicate device (Danek device) that has already been cleared by the FDA. This means the device is considered safe and effective because it is sufficiently similar to a device already on the market, rather than through independent performance testing against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on equivalence, not performance against pre-defined metrics.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method 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 or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described in the context of performance testing.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set ground truth is described.

Summary of available information related to equivalence:

• Basis of Substantial Equivalence: The Blackstone™ Domino is considered substantially equivalent to the Danek device, which has been cleared by the FDA for certain anterior and pedicle fixation use indications.
• Device Description: The Blackstone™ Spinal Fixation System is comprised of titanium alloy (6AL-4V ELI, per ASTM F136) devices in a variety of non-sterile, single-use components intended to build a spinal implant construct. The "domino" addition functions as a rod connector for extending a construct.
• Intended Use/Indications for Use: The document details various indications for the Blackstone Spinal Fixation System, including:
  • Pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint, adjunct to fusion with autogenous bone graft, fixed to L3 and below, and removed after solid fusion.
  • Pedicle screw system for skeletally mature patients providing immobilization and stabilization as an adjunct to fusion for instabilities/deformities of the thoracic, lumbar, and sacral spine (e.g., degenerative spondylolistheses with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion).
  • Anterolateral non-pedicle screw fixation for non-cervical spine (e.g., degenerative disc disease, spondylolistheses, spinal stenosis, spinal deformities, tumor, pseudoarthrosis, previous failed fusion, trauma).
  • Posterior non-pedicle screw fixation system for non-cervical spine (same indications as anterolateral non-pedicle screw fixation).

Ask a specific question about this device

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 (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 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 4.5mm, 5.5mm, and 7.5mm Multi-Axial Screws are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are 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 noncervical spine.

The Blackstone Spinal Fixation System consists of an assortment of screws and rods which have received 510(k) clearance (#K994217, and #K020674).

This is a 510(k) premarket notification for a medical device (spinal fixation system), not an AI/ML device. Therefore, the concepts of acceptance criteria, study data, ground truth, expert adjudication, and training/test sets as they relate to AI/ML performance metrics are not applicable to this document.

The document describes the device, its intended use, and claims substantial equivalence to previously cleared devices based on its design and indications for use. The FDA's review confirms this substantial equivalence.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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 anterolateral screw/staple fixation of the T6-L5 spine, is intended for the following indications:

• a) Degenerative disc disease (ddd) this should be defined. Based on the 5/23/96 Panel meeting, ddd should be defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• b) Spondylolisthesis
• c) Trauma (i.e., fracture or dislocation)
• d) Spinal stenosis;
• e) Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• f) Tumor
• g) Pseudarthrosis
• h) Previous failed fusion.

The Blackstone™ Spinal Fixation System Staple & Washer (System Modification) are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components. These devices are an adjunct to the Spinal Fixation System, which allows a surgeon to build a spinal implant construct. The system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The devices added to the current Spinal Fixation System are listed below with a brief description.

Staple:
The Staple is available in one diameter and three thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Staple has a conical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components. Furthermore, the device has three prongs with a trocar tip which fix's the device to a vertebral body.

Washer:
The Washer is available in one diameter and three thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Washer has a conical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components.

I am sorry, but the provided text describes a 510(k) summary for a medical device (Blackstone™ Spinal Fixation System Staple & Washer) and does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The document is primarily focused on describing the device, its intended use, and establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the criteria.

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 Spacer (System Modification) is a titanium alloy (6AL-4V ELI, per ASTM F136) device, which is a non-sterile, single use component. This device is an adjunct to the Spinal Fixation System, which allows a surgeon to build a spinal implant construct. The system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The device added to the current Spinal Fixation System is listed below with a brief description.

Spacer:
The Spacer is available in one diameter and two thicknesses. This device may be required in various clinical applications, as determined by a qualified surgeon. The Spacer has a spherical recess feature, which allows the head of a pedicle screw to nest in it for congruent contact between components.

The provided document is a 510(k) summary for a medical device (Blackstone™ Spinal Fixation System Spacer Modification) and does not contain information about the performance or acceptance criteria of a study for this specific device modification. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study proving the device meets acceptance criteria, as such a study is not described in this document.

Here's why and what information is available (or explicitly not available) based on your request:

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

• Not Applicable / Not Available: The document does not describe performance acceptance criteria or a study with reported performance specific to the "Spacer" modification. This 510(k) relies on substantial equivalence to predicate devices, not on new performance data demonstrating the Spacer's efficacy against specific criteria.

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

• Not Available: No test set is described because no new performance study for the Spacer modification is presented. The substantial equivalence argument is based on the design, materials, and intended use being similar to already cleared predicate devices.

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

• Not Available: No ground truth establishment is described because no new performance study for the Spacer modification is presented.

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

• Not Available: No test set or adjudication method 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 Delineated (and likely Not Applicable): This device is a mechanical implant (spinal fixation system component), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.

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

• Not Delineated (and Not Applicable): As explained above, this is a mechanical medical device, not an algorithm. Standalone algorithm performance is not relevant.

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

• Not Available: No ground truth is described.

8. The sample size for the training set

• Not Available: There is no mention of a training set as this is not an AI/ML device requiring such data.

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

• Not Available: There is no mention of a training set or ground truth establishment.

Summary of the Document's Information:

The document serves as a 510(k) premarket notification for a modification to an existing spinal fixation system. Its primary purpose is to demonstrate substantial equivalence of the new "Spacer" component to legally marketed predicate devices.

• Device: Blackstone™ Spinal Fixation System Spacer (System Modification)
• Device Description: A titanium alloy (6AL-4V ELI) non-sterile, single-use component (Spacer) with a spherical recess feature, available in two thicknesses (3mm and 5mm). It is an adjunct to the existing Spinal Fixation System, designed to stabilize the spinal operative site during bone graft fusion.
• Premarket Pathway: 510(k) – Substantial Equivalence
• Predicate Devices:
  • Blackstone™ Spinal Fixation System (K994217)
  • Blackstone™ Spinal Fixation System Second-Gen Cross-Connector (K003735)
  • Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558)
  • Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674)
• Basis of Substantial Equivalence: The modification (Spacer) is an addition to an existing system, and its materials, design, and intended use are deemed similar enough to the cleared predicate devices such that new clinical performance data is not required to establish safety and effectiveness for a 510(k). The FDA's letter concurs with this finding of substantial equivalence.

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 (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.

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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 (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.

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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 (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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