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Expandable Lumbar Fusion Cage (Type I , Type II ) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine(L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Expandable Lumbar Fusion Cage (Type II) are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Posterior Spinal Fixation System.

The Expandable Lumbar Fusion Cage system is a kind of fusion device for thoracolumbar and spinal stability. The main indication of this product is spinal fusion for spinal operation. The components of system are made of titanium alloy. The Expandable Lumbar Fusion Cage system is used by trained orthopaedic surgeons and/or neurosurgeons in a standard operating environment. The Expandable Lumbar Fusion Cage system provides a wide range of implants, including different widths, heights, lengths and angles to choose from.

The provided text does not describe a study involving AI or software for diagnostic or prognostic purposes. The device in question is an "Expandable Lumbar Fusion Cage (Type I, Type II)", which is an intervertebral body fusion device used in spinal surgery.

Therefore, the requested information regarding acceptance criteria, performance data from an AI study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not applicable to this submission.

The "Performance Data" section (Page 4, Section 7) clearly states:

"Mechanical testing (static and dynamic compression, static and dynamic compressionshear per ASTM F2077 and subsidence per ASTM F2267) was conducted to demonstrate substantial equivalence to the predicate device."

This indicates that the device's performance was evaluated through physical mechanical testing to confirm its structural integrity and safety, not through a study involving AI or software analysis of medical images or data.

In summary, none of the requested information regarding AI device acceptance criteria and study details can be extracted from the provided FDA submission document because the device is a physical implant, not an AI-powered diagnostic or prognostic tool.

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The Sterile Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Sterile Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided sterile. The Sterile Posterior Spinal Fixation System includes the following sets: RS8 LEGEND (designed for open surgery) and RS8 LONG (designed for minimally invasive surgery). Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Surgical instruments are provided with the subject device and predicate device. The subject of this submission is a design change to Posterior Spinal Fixation System(K201737). The Posterior Spinal Fixation System(K201737) is provided non-sterile and the subject device is provided sterile.

The provided text is a 510(k) summary for a medical device called "Sterile Posterior Spinal Fixation System." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/ML algorithm performance, nor does it describe an AI/ML device.

The document discusses the substantial equivalence of a physical medical device (spinal fixation system) to a legally marketed predicate device. The only change described is the sterilization method of the implants.

Therefore, I cannot extract the requested information about AI/ML algorithm performance, acceptance criteria, ground truth establishment, sample sizes for test/training sets, expert qualifications, or MRMC studies from this document. The document explicitly states:

"No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this change." (Page 5, "Performance data" section)

This indicates that extensive performance studies, as would be expected for an AI/ML device, were not conducted or required for this particular change to a physical implant.

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The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided non-sterile.

The Posterior Spinal Fixation System includes the following sets:
RS8 LEGEND (designed for open surgery) RS8 LONG (designed for minimally invasive surgery)

Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option.

The provided text describes a 510(k) premarket notification for a Posterior Spinal Fixation System, which is a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, and training/test set sample sizes for an AI/ML model are not applicable here.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, Medtronic Sofamor Danek USA, Inc.'s CD HORIZON® Spinal System (K130646). The acceptance criteria are implicit in the comparison to the predicate device and relevant standards.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable for a medical device):

The acceptance criteria are generally that the subject device performs comparably to the predicate device and meets applicable industry standards. The performance is assessed through bench testing and material characterization.

• Dynamic Compression: Experienced more fractures than predicate.
• Static Tensile: Tensile bending ultimate load lower than predicate.
• Static Torsion: Yield torque and torsional stiffness lower than predicate.
  (Note: Despite some lower values, the conclusion states these differences do not raise new questions of safety and effectiveness, implying overall equivalence or acceptable performance within design limits.) |
  | Sterilization | Provided non-sterile with validated cleaning and sterilization instructions. | Provided non-sterile; validated manual cleaning and steam sterilization instructions provided. (Same as predicate.) |
  | Surgical Instrument Materials | Acceptable materials for surgical use. | Stainless steel (17-4 PH), Silica gel, Polyformaldehyde (POM), Aluminum alloy. (Predicate materials unknown for comparison). |
  | Physical Dimensions (e.g., rods, screws) | Dimensions comparable to predicate device to ensure interchangeability or functional equivalence where applicable. | Rods: Subject: 5.5-6.0mm diameter. Predicate: 3.5-6.0mm diameter.
  Set Screws: Subject: 9.5-10mm diameter. Predicate: 6.0-10mm diameter.
  Crosslinks: Subject: 5.0-6.0mm diameter, 23-80mm length. Predicate: 3.5-6.0mm diameter, 13-120mm length.
  Polyaxial Reduction Screws: Subject: 4.5-7.5mm diameter, 25-90mm length. Predicate: 4.0-8.5mm diameter, 20-115mm length.
  MISS Polyaxial Reduction Screws: Subject: 4.5-10mm diameter, 25-110mm length. Predicate: 4.0-8.5mm diameter, 20-115mm length. |
  | MR Safety and Compatibility | Not explicitly stated as a criterion for the subject device. | Not evaluated for the subject device. Predicate is MR conditional. |

Study Proving Acceptance Criteria:

The device's acceptance is proven through non-clinical bench testing and adherence to recognized consensus standards for material characterization and biocompatibility, as compared to a legally marketed predicate device. The study aims to demonstrate substantial equivalence, not superior or absolute performance against new criteria.

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device, and the testing involved bench studies rather than testing on human or animal data sets for AI/ML performance evaluation. The provenance would be the test conditions and materials used in the lab.

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. "Ground truth" in the context of an AI/ML device for diagnostic or prognostic purposes is not relevant here. The "truth" for this device is its mechanical properties, material composition, and biocompatibility as determined by standardized physical and chemical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for bench testing of a physical medical device. The results are quantitative measurements against predefined standards or comparative measurements against the predicate device.

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 an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is established through:

• Physical and Chemical Standards: ASTM, ISO, and GB/T standards for material properties, mechanical strength, and biocompatibility.
• Predicate Device Comparison: The performance and characteristics of the legally marketed predicate device (CD HORIZON® Spinal System) serve as a de facto "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set: Not applicable. This is not an AI/ML device. The device itself is manufactured, and its properties are tested.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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