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510(k) Data Aggregation
(74 days)
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 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 with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
I am sorry, but the provided text does not contain information about the acceptance criteria and the results of a study to prove a device meets those criteria. The document is a 510(k) summary for a spinal system (MOSS Miami Spinal System) and primarily discusses its description, intended use, and substantial equivalence to previously cleared devices. It also outlines the FDA's decision regarding its marketing, including specific limitations and warnings related to pedicle screw fixation.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.
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(56 days)
The MOSS Miami Spinal System is intended for non-cervical use in the spine.
When used with ante ior 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 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 with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the US-S1 vertebral joint, having fusions with antogenous 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 System is available in cither Stainless Steel or Titanium. The screws, polygial corect are available in Stainless Steel or Titanum. The screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial conrectors, staple washers and sacral extenders. The following screws, books, transwice organium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The resign, intended use, and material of these components have been cleared in previous 51 3(k) submissions.
The line extension covered in this submission are additional screw components to the existing 5mm Stainless Steel and 5.5mm Titanium alloy versions of the MOSS Miami Spinal System. The additional screws consist of Stainless Steel and Titanium 5-7mm diameter polyaxial and monoaxial screws in 5mm increments to provide screws lengths from 25mm to 90mm The additional screws also consist of Titanium 8mm diameter monoaxial screws in imm increments to provide screws lengths from 25mm to 90mm, and the addition of Stainless Steel 8mm monoaxial and polyaxial and of Titanium 8mm polyaxial screws in 1-1 lengths from 25mm to 90mm in 5mm increments. Additionally, the intended uses of the 7mm monoaxial and polyaxial screws, which were previously cleared as part of the 5mm stainless steel version of this system, were expanded to include anterior use.
The provided text does not contain information about acceptance criteria, device performance, or a study specifically designed for the DePuy Motech MOSS Miami Spinal System. The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested table and study details.
Here's why and what information is available:
- Nature of the Document: This is a regulatory submission for premarket notification (510(k)), not a clinical trial report or a detailed engineering performance study. The 510(k) process in the US allows a manufacturer to market a device by demonstrating that it is "substantially equivalent" to a legally marketed predicate device, without requiring extensive new clinical studies if the equivalence is clear.
- Focus on Substantial Equivalence: The document explicitly states, "Based on the information provided, DePuy believes that the subject additional screws in the MOSS Miami Spinal Systems and the additional indication of non-cervical anterior use of the Stainless Striel 7mm monoaxial and polyaxial screws are substantially equivalent to other currently legally marketed spinal systems' screws."
- Device Description: The "DEVICE DESCRIPTION AND INTENDED USE" sections detail the components, materials (Stainless Steel or Titanium), available sizes (diameters 5-8mm, lengths 25-90mm), and indications for use.
- Predicate Devices: The document lists several "SUBSTANTIALLY EQUIVALENT DEVICES" (e.g., DePuy Motech MOSS Miami Spinal Systems K933881, K950697, etc., and AcroMed VSP & ISOLA). The equivalence is largely based on similar design, intended use, and materials to these cleared devices, as well as the addition of different screw lengths and diameter.
- FDA Response: The FDA letter confirms the substantial equivalence with specific limitations and warnings regarding pedicle screw use, particularly for severe spondylolisthesis at L5-S1 and the requirement for device removal after fusion. This indicates that while the device was cleared, the FDA imposed strict conditions based on the existing evidence and regulatory framework for pedicle screws at the time.
In summary, the document serves to establish regulatory clearance by demonstrating equivalence, not to present novel performance data against specific acceptance criteria for a new device.
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(59 days)
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 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 with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in 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 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.
The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
The provided text is a 510(k) summary for the DePuy Motech MOSS Miami Spinal System and a clearance letter from the FDA. It does not describe any specific acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures typically associated with modern medical device studies, particularly for AI/software devices.
Instead, the document focuses on the regulatory acceptance of the device based on its substantial equivalence to previously cleared predicate devices. The "acceptance criteria" here are essentially the FDA's requirements for demonstrating substantial equivalence for marketing.
Here is a breakdown of the requested information based on the provided text, noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA Clearance) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| General Use (anterior screw fixation or posterior hook, non-pedicle screw fixation): | 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). |
| Pedicle Screw Fixation Use (Specific Limitations): | Intended for use in 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 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass. |
| Substantial Equivalence: | Components are identical to components of other MOSS Miami Spinal Systems previously cleared by FDA for anterior, posterior, and pedicle fixation uses. An insertion tool has been included for ease of implantation. |
| Regulatory Compliance: | - Required annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration (General Controls).- All labeling must state explicit limitations for pedicle screw use as described in the letter.- No labeling or promotion for pedicular screw fixation/attachment other than severe spondylolisthesis (Grades 3 and 4 L5-S1).- Specific warnings must be included in the package insert about pedicle screw use limitations and potential risks.- Use for pedicular screw fixation for other indications is considered investigational and requires IDE regulations compliance.- Compliance with Quality System Regulation (21 CFR Part 820). |
| Warning Statements: | Previous warning statements about components not approved for screw fixation into pedicles must be replaced by the specific warnings defined in the clearance letter. |
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 / Not provided. The summary for this orthopedic implant device focuses on substantial equivalence based on design and material similarity to previously cleared devices, not on a clinical performance study with a "test set" in the context of a software or diagnostic device. No patient data or clinical study population is mentioned for performance evaluation in this document.
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 / Not provided. Ground truth establishment by experts is not described, as this is neither an AI device nor a diagnostic device that requires such evaluation in the context of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not provided. Adjudication methods are not relevant to this type of device submission as 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 / Not provided. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not provided. This is an orthopedic implant, not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not provided. The "ground truth" here is regulatory acceptance based on substantial equivalence to predicate devices, not clinical truth derived from patient data.
8. The sample size for the training set
- Not Applicable / Not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not provided. This is not an AI/ML device that requires ground truth for a training set.
Summary of the Document's Focus:
This 510(k) submission exemplifies a pre-AI era device clearance for an orthopedic implant. The "acceptance criteria" discussed are primarily regulatory in nature, focusing on:
- Demonstrating that the device (MOSS Miami Spinal System components) is "substantially equivalent" to predicate devices (other MOSS Miami Spinal Systems).
- Defining the specific "Indications for Use," particularly the stringent limitations for pedicle screw fixation.
- Ensuring appropriate labeling and warnings are in place to mitigate risks associated with the device, especially concerning pedicle screw use.
There is no mention of performance metrics (sensitivity, specificity, accuracy), clinical study results, or data analyses typical of AI/software medical devices. The "study" here is the submission itself, demonstrating compliance with regulatory standards for substantial equivalence, rather than a clinical trial proving a specific performance metric.
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(68 days)
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 tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. discogenic back pain with degeneration of the disc confirmed by patient 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 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 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: 4 and 5mm diameter longitudinal rods. 5-7 mm diameter monoaxial screws. 5-7 mm diameter polyaxial screws, hooks, transverse connectors, axial connectors and staple washers. The following components are currently available in Titanium: 5.5 mm diameter longitudinal rods, 5-8 mm diameter monoaxial screws, 5-7 mm diameter polyaxial screws, hooks, tranverse connectors, axial connectors, washers and staple washers.
The products in this submission are additional components to the existing MOSS Miami Spinal System. The MOSS Miami 6 mm Sub-System consists of: 6 mm diameter longitudinal rods in lengths of 12, 30 and 48cm; axial and transverse connectors for joining longitudinal rods; 6mm and 7mm diameter mono- and polyaxial screws in various lengths, which are attached to the longitudinal rods with inner screws and outer nuts; and various hooks and other accessories. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.
The provided text describes the DePuy Motech MOSS Miami Spinal System and its 6mm Sub-System, focusing on the basis of substantial equivalence for FDA clearance. However, it does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or most of the requested study design elements (sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).
The primary claim for equivalence is based on mechanical testing, indicating similar biomechanical performance to previously cleared MOSS Miami systems and competitive spinal systems.
Here's a breakdown of the available information and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria are provided in the document. The document states that "Mechanical testing shows that the biomechanical performance of the components and subconstructs of the MOSS Miami 6 mm Spinal System is expected to be similar to the performance of the other MOSS Miami Spinal Systems and competitive spinal systems." This implies a qualitative comparison rather than a detailed, measurable acceptance criterion.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biomechanical Performance | Not explicitly stated | Expected to be "similar" to other Moss Miami Spinal Systems and competitive spinal systems. |
| Material | Match predicate devices | Identical to predicate devices |
| Design | Match predicate devices | Similar to predicate devices (with diameter being the only difference) |
| Intended Use | Match predicate devices | Matched, with specific limitations for pedicle screw fixation. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "mechanical testing," which typically involves material and device component testing, not clinical patient data.
- Data Provenance: Not specified. As it's mechanical testing, it would likely be laboratory-generated data, not from human subjects directly.
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/Not specified. Mechanical testing does not typically involve human experts establishing ground truth in the way clinical studies do. The "ground truth" would be the measured physical properties and performance characteristics.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This is not a clinical study involving human perception or diagnosis.
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 document pertains to a spinal implant system undergoing mechanical testing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For mechanical testing, the "ground truth" would be the objective physical measurements (e.g., tensile strength, fatigue life, torsional resistance, stiffness) obtained from standardized biomechanical test methods. These are compared against established engineering and regulatory benchmarks for similar devices or predicate devices.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not applicable.
Summary of what the document does state about the study/testing:
- Study Type: Mechanical testing.
- Purpose: To demonstrate that the biomechanical performance of the MOSS Miami 6 mm Spinal System is "similar to the performance of the other MOSS Miami Spinal Systems and competitive spinal systems."
- Basis of Equivalence: The primary basis relies on:
- Identical components (except for rod diameter) to previously cleared MOSS Miami systems.
- Mechanical testing results showing similar biomechanical performance.
- Key Difference: The only difference between the submitted device and predicate MOSS Miami systems is the 6mm diameter of the longitudinal rods, as opposed to the 5mm diameter of the predicate.
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(80 days)
The MOSS Miami Spinal System, with either the existing smooth rods or the subject ratcher rods, is intended for non-cervical use in the spine. When used with anterior screw fixation or posterior hook, nonpedicle screw fixation the MOSS Miam Spinal System is intended to treat scobosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed back surgery or degenerative disc disease (i.e. 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 fration 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.
This submission describes the addition of 5mm x 12cm, 5mm x 48cm longitudinal ratchet rods to the Stainless Steel MOSS Miami Spinal System. The ratcher rods are similar to the MOSS Miami 5.0mm smooth longitudinal rods that have been previously cleared for anterior, posterior non-pedicle use and posterior pedicle fixation (Grades III or IV spondylolisthesis at LS-S1). The ratchet rods are manufactured from the same material and have the same lengths as the previously cleared, smooth, longitudinal rods. The only difference in design between the subject ratchet rods and the previously cleared, smooth, longitudinal rods is that the ratchet rods are cold-worked, creating a ringed outer suface.
The ratcher rod system was designed to make interoperative adjustments easier and quicker than with the smooth rod system When the ratchet rods are used, hooks and screws can be initially positioned on the rod and held in place with a loose connection, then ratcheted into final position and tightened. With the smooth rods, components are tightened onto then must be repeatedly loosened, moved and re-tightened until final positioning is accomplished.
The 5mm ratchet rods described in this submission are intended to be used with the existing MOSS Miami Stainless Steel hooks, screws, inner screw and outer locking nut which have previously been cleared for marketing.
The provided text is a 510(k) summary for a medical device (DePuy Motech MOSS Miami Spinal System) and does not describe acceptance criteria, performance studies, or ground truth establishment in the context of an AI/ML device. It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical properties. Therefore, I cannot extract the requested information.
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