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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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