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The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),

• trauma (i.e., fracture or dislocation),

• spinal stenosis, ·

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudarthosis, and/or

• failed previous fusion.
  The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

• spondylolisthesis,

• trauma (i.e., fracture or dislocation),

• spinal stenosis.

• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• tumor,

• pseudarthosis, and/or

• failed previous fusion.

The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.

The Malibu™ Spinal System with the Daytona™ Deformity System is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as ground truth, training set, test set, effect size, etc.) are not applicable.

This device is a Pedicle Screw Spinal System and a Spinal Interlaminal Fixation Orthosis, which are hardware components (spinal rods and pedicle screws) used in spinal fusion procedures. The submission is a "Special 510(k)" for line extensions.

Here's the information based on the provided document:

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

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

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. The performance testing was based on mechanical testing of the devices themselves, comparing them to predicate devices.
• Data Provenance: The testing was mechanical/bench testing according to ASTM standards (F1717 and F1798) comparing the new device designs to existing predicate devices. This is laboratory-based data, not human patient data in this context.

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 medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring expert consensus for image or clinical data.

4. Adjudication method for the test set:

• Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring adjudication of clinical or image data.

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 medical device (spinal hardware), not an AI/ML device.

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

• Not applicable. This is a medical device (spinal hardware), not an AI/ML algorithm.

7. The type of ground truth used:

• For mechanical performance, the "ground truth" is established by the performance characteristics of legally marketed predicate devices and the requirements of recognized industry standards (ASTM F1717 and F1798). The new devices are shown to be "equivalent" in these mechanical tests to their predicates.

8. The sample size for the training set:

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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

• Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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1. The intended use of the Malibu system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• spinal tumor,
• pseudoarthrosis, and/or
• failed previous fusion.

2. The intended use and indications of the Malibu system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System or Sublaminar Wire System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• tumor,
• pseudarthosis, and/or
• failed previous fusion.

The system contains titanium alloy and cobalt alloy implants. This submission is intended to address the line extensions including titanium and cobalt alloy spinal rods, cap, set screw, and a sublaminar wire. All devices are supplied non-sterile. These devices are not compatible with stainless steel implants.

The SeaSpine Malibu Spinal System line additions (titanium and cobalt alloy spinal rods, cap, set screw, and a sublaminar wire) do not have specific acceptance criteria or a detailed clinical study described in the provided document that proves the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the manufacturer demonstrates that the new line additions are as safe, as effective, and perform as well as or better than existing, legally marketed predicate devices.

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

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

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. No clinical test set or human study data is described. The performance data focuses on mechanical testing and comparison to predicates.
• Data Provenance: Not applicable. The data primarily stems from mechanical testing and a comparison of design, materials, and intended use to existing predicate devices.

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

• Number of Experts: Not applicable. No human expert "ground truth" or clinical efficacy/safety study requiring expert assessment is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical test set or human study data 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

• MRMC Study: No. This submission is for spinal implants and does not involve AI or diagnostic imaging interpretation.

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

• Standalone Performance: No. This submission is for physical spinal implants, not a software algorithm.

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

• Type of Ground Truth: For the purpose of establishing substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices. The mechanical testing data aims to demonstrate that the new devices perform comparably to these known predicates. No clinical outcomes data for the new device is presented.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No training set for an algorithm is described.

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

• Ground Truth Establishment for Training Set: Not applicable. No training set for an algorithm is described.

In summary: The provided document is a 510(k) summary for line additions to an existing spinal system. The primary method for demonstrating safety and effectiveness is through proving substantial equivalence to previously cleared predicate devices, supported by mechanical testing rather than clinical trials with human subjects. Therefore, many of the questions related to clinical study design, expert evaluation, and AI performance are not applicable to this type of submission.

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The intended use of the Malibu system is as a temporary or permanent posterior, noncervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu spinal system, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:

• . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• . severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
• spondylolisthesis. ●
• . trauma (i.e., fracture or dislocation),
• spinal stenosis.
• . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• . spinal tumor.
• . pseudoarthrosis, and/or
• failed previous fusion. .

The intended use and indications of the Malibu spinal system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis .
• trauma (i.e., fracture or dislocation),
• . spinal stenosis.
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ◆
• . tumor,
• pseudarthosis, and/or .
• . failed previous fusion.

The Malibu system will include cannulated polyaxial screws, closed lateral connectors, rod connectors, precontoured rods, and countoured crossbars. All products are fabricated from titanium alloy, with the exception of the screws which have a cobalt alloy component. All products are being offered in a wide variety of different sizes. The Malibu parts in this submission are being added to the current Malibu product line, but these items are also compatible with and work in conjunction with components in the UCR system. All product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also offer a wide variety of instruments that range from polyaxial screw drivers to bone probes. These instruments will be made from various grades of stainless steel with a few handles made from Radel and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.

The provided document describes the Malibu™ Spinal System, which consists of various components for spinal fixation. This submission (K061342) is an addition to an existing product line. The device is a traditional medical implant, not an AI/ML powered device. Due to this, many of the requested criteria, such as "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "sample size for the training set," are not applicable.

Here's an analysis of the provided information, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Malibu Spinal System are based on substantial equivalence to predicate devices. This means that the device is considered safe and effective if it shares the same intended use, technological characteristics, and principles of operation as a legally marketed device, and does not raise new questions of safety or effectiveness.

The document reports that the device meets these criteria as shown in the "Comparison Analysis" table (Table 1).

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

This is not applicable as the submission relates to a physical medical device (spinal fixation system) and not an AI/ML powered device or a study involving patient data. The "test set" in this context refers to mechanical testing according to established standards. The document states "All products passed testing per applicable standards," indicating that the devices were subjected to engineering integrity tests. Specific sample sizes for such mechanical tests are not detailed in this summary.

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

This is not applicable for a physical medical device. "Ground truth" for this type of device is established through engineering and material science standards, and the expertise would lie with engineers and metallurgists involved in the design, manufacturing, and testing of the components.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML powered device. For mechanical strength, compliance with standards usually involves predefined measurement criteria and acceptance limits, rather than a human adjudication process.

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. The Malibu Spinal System is a physical implant, not an AI/powered device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been conducted.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Malibu Spinal System is based on engineering and material science standards, and performance benchmarks as established by predicate devices. The claim of substantial equivalence is based on the device's ability to meet the same mechanical strength, material composition, and functional design as previously cleared spinal fixation systems.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

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

Not applicable, as there is no training set for a physical implant.

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The intended use of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis.
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• spinal tumor,
• pseudoarthrosis, and/or
• failed previous fusion.

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis
• trauma (i.e., fracture or dislocation),
• spinal stenosis.
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• tumor,
• pseudarthosis, and/or
• failed previous fusion.

The Malibu Spinal System includes titanium alloy polyaxial reduction screws with a cobalt alloy component. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of a screw body and housing assembly. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also include locking caps in two different sizes. These items are designed to be part of the stand alone Malibu Spinal System, but are compatible with and will work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will offer a wide variety of instruments that range from modular taps to angled in-situ benders. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, aluminum, and Radel. These items are supplied "NON-STERILE" and must be sterilized prior to use.

The provided document does not describe an AI/ML powered device. Instead, it concerns a medical device called the "Malibu Spinal System," which is a traditional orthopedic implant for spinal fusion.

Therefore, the requested information elements such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for the training set was established" are not applicable to this document. These items are specific to the evaluation of AI/ML diagnostic or assistive devices, not mechanical implants.

The document focuses on demonstrating substantial equivalence of the Malibu Spinal System to predicate devices already on the market, primarily through comparison of:

• Intended Use
• Indications for Use
• Design
• Materials
• Sterilization
• Mechanical Strength

The acceptance criteria for such a device are typically met by demonstrating that its materials, design, and mechanical performance are equivalent to, or better than, legally marketed predicate devices, and that it is safe and effective for its intended use. The "study" mentioned for mechanical strength would be mechanical testing (e.g., fatigue, static strength) to ensure the device can withstand physiological loads, not clinical studies in the AI/ML context. The document explicitly states "Mechanical Strength: See test results," indicating that such tests were performed.

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The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis.
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• spinal tumor,
• pseudoarthrosis, and/or
• failed previous fusion.

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
• tumor,
• pseudarthosis, and/or
• failed previous fusion.

The Malibu Spinal System includes titanium alloy iliac monaxial and monaxial screws. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of an integrated body and housing. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also include titanium alloy caps, rods, and hooks. The caps will come in one size, the rods in two diameters, and the four types of hooks in a variety of sizes. All of these devices are designed to be a part of the stand alone Malibu Spinal System, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will offer a wide variety of instruments that range from rod forks to hook pushers. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, Radel, and medical grade Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.

The acceptance criteria and study proving device performance are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The provided document is a 510(k) summary for a medical device (Malibu Spinal System). It focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new performance criteria. Therefore, most of the requested information regarding "study" parameters (like sample size, experts for ground truth, adjudication, MRMC, standalone performance, training set) is not directly applicable or explicitly stated in this type of regulatory submission. The "study" here is a comparison analysis to predicate devices.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The comparison is made against existing predicate devices, implying that their established performance and characteristics serve as the "test set" for equivalence.
• Data Provenance: Not explicitly stated. The comparison is to predicate devices (Synthes Click'X Monoaxial Screw System, DePuy Acromed's Moss Miami System, and SeaSpine Inc.'s UCR Spinal System), which are legally marketed devices. The data for these predicate devices would have been generated during their own regulatory submissions or clinical use. The Malibu Spinal System itself underwent "Mechanical Strength" testing, the details of which are not provided (e.g., number of units tested, conditions, etc.).

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable or explicitly stated. This is a comparison of technical characteristics and intended use to existing devices, not a study requiring expert readers to establish ground truth for a novel output.
• Qualifications of Experts: N/A

4. Adjudication Method:

• Adjudication Method: Not applicable. The process described is a regulatory review for substantial equivalence based on a comparison document and potentially internal test results, not a study involving human reader interpretation.

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

• MRMC Study: No. This type of study is typically used for assessing the performance of diagnostic devices where human interpretation is involved. The Malibu Spinal System is an implantable surgical device.

6. Standalone Performance Study:

• Standalone Study: Yes, in terms of mechanical strength. The document states "Mechanical Strength: See test results" for the Malibu Spinal System. While the full report is not included, this indicates that the device's mechanical properties were evaluated independently to demonstrate its performance, which was then compared to the predicate devices. The specific details of this testing (e.g., the exact criteria, methodology, and outcome beyond "similar") are not provided.

7. Type of Ground Truth Used:

• Ground Truth: The "ground truth" for this submission is the established characteristics and performance of the predicate devices, as determined during their own regulatory approvals and market history. For the Malibu Spinal System's mechanical strength, the ground truth would be the measured physical properties and performance under specific test conditions, compared against the expected performance of the predicate devices.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that would require a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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