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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 – S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 – S1), and for whom the device system is intended to be removed after solid fusion is attained.

Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.

The provided text describes the Moss Miami Spinal System Pin Nut (K023804), a spinal fixation device. However, it does not contain specific acceptance criteria or the details of a study that proves the device meets such criteria.

The document is a 510(k) summary and an FDA clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed studies.

Here's a breakdown of what can be extracted and what is missing from the provided text, relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical or qualitative acceptance criteria (e.g., tensile strength, fatigue life, torque strength, biocompatibility standards).
• Detailed performance results against those criteria. The document only states that "Data were submitted to characterize" the device.

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

Missing Information. The document mentions "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" but does not provide details about any specific test sets, their sample sizes, or the provenance of any data (e.g., country of origin, retrospective/prospective). This likely refers to mechanical testing data, which typically is conducted in a lab setting, not on patient data.

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

Missing Information. This type of information (expert review, ground truth establishment) is typically relevant for diagnostic or AI-driven devices. As this is a spinal implant, the "ground truth" would be established through mechanical testing standards, rather than expert review of images or clinical cases.

4. Adjudication Method for the Test Set:

Missing Information. Not applicable for a mechanical implant's performance testing.

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

Missing Information. Not applicable. The device is a spinal implant, not a diagnostic imaging or AI assistance tool that would involve human readers.

6. Standalone Performance Study:

Present (Implied): The statement "Data were submitted to characterize the Moss Miami Spinal System Pin Nut" implies that some form of standalone performance (mechanical testing) was conducted on the device itself.

Missing Information:

• Details of the standalone performance studies (e.g., type of tests, parameters measured, results).
• Any comparison to a "human-in-the-loop" scenario, as the device is an implant.

7. Type of Ground Truth Used:

Implied: The "ground truth" for a device like this would be established by mechanical testing standards (e.g., ASTM or ISO standards for spinal implants) and material specifications (ASTM F-136, ASTM F-138). The device's materials are explicitly stated: "Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel." This indicates that material properties conforming to these standards would be part of the "ground truth."

Missing Information: Specific details of these mechanical tests and their corresponding "ground truth" (e.g., required fatigue cycles, pull-out strength).

8. Sample Size for the Training Set:

Missing Information. Not applicable. This device is a passive implant; there is no "training set" in the context of machine learning or algorithms.

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

Missing Information. Not applicable, as there is no training set.

Summary of what the document does provide:

• Device Name: Moss Miami Spinal System Pin Nut
• Manufacturer: DePuy AcroMed, Inc.
• Date Prepared: August 2, 2002
• Predicate Device: Moss Miami Spinal System Titanium Pin Nut (K010742)
• Intended Use/Indications: Detailed for various spinal conditions, including scoliosis, kyphosis, lordosis, fracture, tumor, spinal stenosis, spondylolisthesis, previously failed fusions, and degenerative disc disease. Specific indications for pedicle screw fixation in skeletally mature patients and severe spondylolisthesis (Grades 3 and 4) at L5-S1.
• Materials: ASTM F-136 implant grade titanium alloy and ASTM F-138 implant grade stainless steel.
• FDA Clearance: K023804 granted on January 23, 2003, based on substantial equivalence to predicate devices.

In conclusion, the provided text is an FDA 510(k) summary and clearance letter, designed to demonstrate substantial equivalence for market clearance. It does not contain the detailed studies or acceptance criteria that would typically be found in a detailed device performance report or scientific publication for a new technology, especially not in the context of AI or advanced diagnostic algorithms. The "performance data" mentioned likely refers to mechanical and material data submitted to the FDA but not elaborated upon in this public summary.

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The Moss Miami Spine System is a pedicle screw system intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.

The Moss Miami Spine System is also a hook and sacral/illiac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.

The provided 510(k) summary for the Moss Miami Spinal System does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically found for AI/ML-driven devices (e.g., performance metrics against a clinical standard).

Instead, the documentation describes a traditional medical device submission for a spinal implant system. The "performance data" mentioned refers to engineering tests to characterize the physical properties and functionality of the device components, rather than clinical efficacy measured against specific performance metrics like sensitivity or specificity.

Therefore, many of the requested bullet points, particularly those related to clinical performance, ground truth, expert review, and sample sizes for AI/ML models, are not applicable to this type of submission.

Here's a breakdown of the information that is available, and why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format requested for AI/ML devices.

For this device (a spinal implant):

• Acceptance Criteria (Implied): The device (CrossOver Cross Connector) would need to meet biomechanical performance standards and demonstrate equivalence in design and materials to its predicate devices (MOSS MIAMI Spinal System Transverse Connector and EZ-Link Transverse Connector). This would involve tests for strength, fatigue, torsional forces, and material compatibility. These specific numerical criteria are not detailed in the summary.
• Reported Device Performance: The summary states: "Performance data were submitted to characterize the CrossOver Cross Connector." However, the actual results of these characterization tests (e.g., specific load capacities, fatigue cycles, torque resistance) are not reported in this summary document. The summary only confirms that such data "were submitted."

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

• Not Applicable in the traditional sense for a clinical performance study. For a mechanical device, "test set" refers to physical samples of the manufactured device components. The specific number of physical units tested is not mentioned in this summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "performance data" would have been generated in engineering labs, likely within the manufacturer's facilities or accredited testing labs, characterizing the mechanical properties of device components.

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

• Not Applicable. "Ground truth" in this context refers to clinical diagnoses or outcomes, which is relevant for AI/ML devices analyzing medical images or data. For a spinal implant, "ground truth" might relate to established engineering standards or material science properties, which would be validated by engineers and metallurgists rather than clinical experts.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for AI/ML performance studies. This is not relevant for the mechanical testing of a physical implant.

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 type of study specifically for AI/ML diagnostic or assistive devices, comparing human performance with and without AI aid. The Moss Miami Spinal System is a physical implant, not an AI/ML diagnostic tool.

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

• Not Applicable. This refers to the performance of an AI/ML algorithm independently. The Moss Miami Spinal System is a physical implant, not an algorithm.

7. The type of ground truth used

• Not Applicable in the clinical sense. For this device, "ground truth" would derive from established engineering principles, material science specifications (e.g., ASTM F-136 for titanium alloy), and biomechanical testing standards. This would not be "expert consensus, pathology, or outcomes data" in the clinical AI/ML context.

8. The sample size for the training set

• Not Applicable. There is no "training set" for a physical spinal implant device in the AI/ML context. The device design is based on engineering principles, predicate device designs, and material science, not machine learning from a dataset.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of what can be gleaned from the document regarding "performance":

• The submission included "Performance data... to characterize the CrossOver Cross Connector." This implies a series of mechanical and material tests.
• The device is "Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy," indicating adherence to a recognized standard for implant materials.
• The FDA's 510(k) clearance (K013296) indicates that the device was found "substantially equivalent" to predicate devices (K983583, K001372, K001470). This substantial equivalence is based on similar intended use, technological characteristics, and safety and effectiveness, which includes evaluation of the submitted performance data.

In conclusion, the provided document describes a much earlier and different type of device submission than one for an AI/ML medical device, and therefore the requested information categories are largely not applicable.

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The MOSS Miami Spinal System is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis, and lordosis, fracture, loss of stability due to turnor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

When used with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS MIAMI Spinal System is available in either Stainless Steel or Titanium. The following components are currently available in Stainless Steel: 5mm diameter longitudinal rods, 5-7mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5mm diameter longitudinal rods, 5-8mm diameter monoaxial screws, 5-7mm diameter polyaxial screws, hooks, transverse connectors, axial connectors, washers and staple washers.

The products covered in this submission are additional components to the existing MOSS Miami Spinal System and consist of: 4mm x 48cm longitudinal rods and 6mm monoaxial screws available in lengths from 25mm-55mm. All of these components are manufactured from Stainless Steel. The 6mm monoaxial screws are identical to those cleared in previous 510(k) submissions except the slot in the head is narrowed to accommodate a 4mm rod. The inner screws and outer locking nuts used to fix the monoaxial screws to the 4mm rod have also been cleared in previous 510(k) submissions.

Aside from the screws and outer locking nuts, the 4mm components described in this submission cannot be used interchangeably with the MOSS Miami 5mm rods, screws and hooks designed for use with that system.

The provided text only contains information about the device description and intended use of the DePuy Motech MOSS Miami Spinal System. There is no information present regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot answer your request based on the provided input.

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Ask a specific question about this device