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The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.

The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium allow described by such standards at ASTM F67 or ASTM F136 for ISO 5832-2/3.

This Pre-market Notification adds 5.5mm rods and associated polyaxial screws to the LTD Polyaxial System.

The provided text describes the 510(k) summary for the LTD Polyaxial Fixation System, a spinal fixation device. The study described focuses on biomechanical testing to demonstrate the device's mechanical integrity and performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study design elements for AI/diagnostic devices (e.g., sample size for test sets, ground truth establishment, MRMC studies) are not applicable here.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list numerical "acceptance criteria" for each performance metric in a table format, nor does it provide specific "reported device performance" values beyond a general statement of meeting acceptance criteria. This is common for predicate device submissions where the focus is on demonstrating equivalence to already marketed devices through similar testing.

However, the "Performance Data" section indicates the types of tests conducted and a general statement of their success:

Note: The specific numerical acceptance limits for these biomechanical tests are not provided in the summary. For spinal fixation devices, these limits are typically derived from standards (e.g., ASTM, ISO) or established by comparison to predicate devices, ensuring the device can withstand physiological loads without failure.

Study Details

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: Not applicable in the context of this biomechanical testing. The "test set" would refer to the number of device components or constructs tested. The specific number of samples tested for each biomechanical test (e.g., number of rods, screws, or constructs) is not specified in this summary.
• Data Provenance: Not applicable. Biomechanical tests are laboratory-based and do not involve human data.

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

• Not Applicable. This is a biomechanical study, not a study requiring expert interpretation or ground truth establishment based on human or biological data. The "ground truth" in this context would be the physical properties and performance characteristics of the materials and device constructs as measured by specialized testing equipment.

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

• Not Applicable. As this is biomechanical testing, no expert adjudication is involved.

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 a study involving human readers or AI assistance. It is a biomechanical performance study of a physical medical device.

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

• Not Applicable. There is no algorithm or AI involved in this device or its testing as described.

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

• Mechanical Performance Standards/Specifications: The "ground truth" or reference for passing these tests would be the established industry standards (e.g., ASTM F1717-96 for Spinal Implant Constructs, which often specifies testing methods and acceptance criteria) or the measured performance of legally marketed predicate devices. The device is expected to meet or exceed these established benchmarks for strength and durability.

8. The sample size for the training set

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

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

• Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device submission.

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The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spiral tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by bark nin of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) turnor resection, and/or (7) failed previous fusion.

The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2

The provided 510(k) summary describes the LTD Polyaxial Fixation System, a spinal implant system. It presents performance testing results without defining explicit acceptance criteria in a quantitative table. The primary method for demonstrating safety and effectiveness is through substantial equivalence to predicate devices, supported by mechanical testing.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Results demonstrate that the LTD Polyaxial Fixation System complies with the recognized, voluntary performance standards for spinal implant systems." and "test results indicate that the LTD Polyaxial Fixation System is substantially equivalent in static and fatigue strength to predicate devices previously cleared by FDA." However, specific numerical acceptance thresholds (e.g., minimum load values, ranges) or direct comparison data to the predicate devices are not provided in this summary.

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

• Sample Size: Not explicitly stated. The document refers to "testing" and "test results" without providing the number of units tested for each mechanical test.
• Data Provenance: The study is reported as laboratory mechanical testing. The origin of the device manufacturer (U.S. Spinal Technologies, Inc.) is Boca Raton, Florida, USA. As this is a 510(k) submission, the data is prospective for this submission, conducted to demonstrate equivalence.

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

• Not Applicable: This submission relies on mechanical laboratory testing of the device components, not on expert assessment of clinical data or images. Therefore, clinical ground truth establishment by experts is not relevant to this specific study as described.

4. Adjudication Method for the Test Set

• Not Applicable: As this involves mechanical testing following a standard protocol (ASTM F1717-01), there is no adjudication method in the sense of reconciling expert opinions. The validity of the test results would be determined by adherence to the standard and proper measurement techniques.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: No MRMC study or any clinical comparative effectiveness study involving human readers is mentioned. The submission focuses on mechanical performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable: The device is a physical spinal implant system, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Mechanical Performance Standards: The "ground truth" for this study is defined by adherence to a recognized, voluntary performance standard (ASTM F1717-01) for spinal implant constructs in a vertebrectomy model, and demonstrating substantial equivalence in static and fatigue strength to predicate devices. The properties of the materials (medical grade titanium or titanium alloy described by ASTM F67, ASTM F136, ISO 5832-3, or ISO 5832-2) also serve as part of the "ground truth" for material specifications.

8. The Sample Size for the Training Set

• Not Applicable: This is a mechanical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

• Not Applicable: As there is no training set for an AI model, this question is not relevant.

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