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The Ghost Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Ghost Spacer System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The spacers have a basic rectangular shape, a hollow center for placement of autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, lateral or anterior approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the GHOST Spacer System components with components from any other system or manufacturer. The GHOST Spacer System components should never be reused under any circumstances.

This document describes the FDA's 510(k) clearance for the Life Spine Ghost Spacer System, an intervertebral body fusion device. While it establishes the device's substantial equivalence to predicate devices, it does not include a study describing acceptance criteria and demonstrating the device meets those criteria from an AI/algorithm perspective.

The provided text focuses on the device's physical and functional characteristics, material, and mechanical testing (e.g., Static and Dynamic Axial Compression & Compressive Shear Testing per ASTM F2077, and Static subsidence testing per ASTM F2267) to demonstrate substantial equivalence to previously cleared devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI-powered device, as the information is not present in the provided document. The device in question is a physical implant, not an AI/algorithm-driven diagnostic or therapeutic tool.

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The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or coricocancellous bone graft, and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

The TranS1 Interbody Fusion System is used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. The devices are designed to be used in conjunction with supplemental spinal fixation instrumentation. The subject devices are multiple component systems comprised of single-use implants designed to treat the lumbar spine.

The TranS1 Interbody Fusion System lumbar implants are fabricated from PEEK (ASTM F2026) with Tantalum (ASTM F560) x-ray markers. The TranS1 Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

I am sorry, but the provided text only discusses the FDA's 510(k) clearance for the TranS1 Interbody Fusion System, which is a medical device used for spinal fusion procedures. It specifies the intended use, material composition, and references performance testing conducted according to ASTM standards for static and dynamic mechanical properties, as well as subsidence and expulsion.

However, the text does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity), or any study details proving an AI/ML device meets such criteria.

Therefore, I cannot fulfill your request for information about:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes and data provenance for a test set for an AI/ML device.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC study for an AI/ML device.
6. Standalone performance for an AI/ML algorithm.
7. Type of ground truth used for an AI/ML device.
8. Sample size for the training set for an AI/ML device.
9. How ground truth was established for the training set for an AI/ML device.

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The RESOLUTE Threaded Cage System is intended to be used bilaterally for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment.

The Resolute Threaded Cage System intended to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Resolute Threaded Cage System implants are devices intended to serve as an intervertebral body fusion device. The implant is available in a range of diameters and lengths to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) described by ASTM F136. The implant is hollow to permit packing with autograft bone graft and/or allogeneic composed of cancellous and/or corticocancellous bone and a supplemental fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine to help promote intervertebral body fusion. The cylindrical surface has threads to assist in the interface with the vertebral endplates to prevent migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Resolute Threaded Cage System components with components from any other system or manufacturer. The Resolute Threaded Cage System components should never be reused under any circumstances

The provided document is a 510(k) premarket notification summary for the Life Spine Resolute™ Threaded Cage System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical performance data or acceptance criteria related to an AI/algorithm-based device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The "performance data" section refers to mechanical testing of the implant itself, not to the performance of any AI or algorithm.

To explicitly address the numbered points in the request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing of the physical implant (Static Axial Compression, Static Axial Compression Shear, Dynamic Compression Shear & Dynamic Axial Compression testing) to demonstrate substantial equivalence to predicate devices, not performance against specific AI/algorithm acceptance criteria.

2. Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI/algorithm is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI/algorithm test set is mentioned.

4. Adjudication method for the test set: Not applicable. No test set for an AI/algorithm is mentioned.

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 document is about a physical medical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document is about a physical medical implant.

7. The type of ground truth used: Not applicable. No ground truth for an AI/algorithm is mentioned.

8. The sample size for the training set: Not applicable. No training set for an AI/algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI/algorithm is mentioned.

In summary, the provided FDA 510(k) clearance letter and summary pertain to the physical characteristics and mechanical performance of an intervertebral body fusion device and do not involve an AI or algorithm. Therefore, the requested information about AI acceptance criteria and study details cannot be extracted from this document.

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The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental internal spine fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Plateau-V Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from either PEEK-OPTIMA LT1 or Zeniva PEEK ZA-500 with tantalum markers. The implant is hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

The provided text describes a medical device, the Life Spine Plateau Spacer System, and its clearance process with the FDA. However, it does not contain any information regarding acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification for an intervertebral body fusion device, which is a physical implant, not an AI device. The included "Performance Data" section solely refers to mechanical testing of the implant itself (e.g., static axial compression, expulsion, subsidence, and dynamic axial compression tests) to demonstrate its substantial equivalence to predicate devices, focusing on physical and material properties.

Therefore, I cannot fulfill your request for the following sections because the provided text does not contain this type of information:

1. A table of acceptance criteria and the reported device performance: No AI device is described, so no such criteria or performance data is available.
2. Sample size used for the test set and the data provenance: No AI device or test set for an AI device is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI device or ground truth for an AI device.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses substantial equivalence for a physical medical device (intervertebral body fusion device) based on its design, materials, indications for use, and mechanical performance relative to existing predicate devices.

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The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.

The Alamo T device is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. Supplemental fixation and autograft is required to facilitate fusion.

The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.

The provided document is a 510(k) premarket notification for a medical device called the "Alamo T Intervertebral Body Fusion Device." This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate. In such submissions, the acceptance criteria and study data are presented somewhat differently than for a novel device undergoing clinical trials.

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

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission asserting substantial equivalence (SE) for modifications to an existing device and new sizes, the "acceptance criteria" are intrinsically tied to demonstrating that the new device performs similarly to, or no worse than, the predicate device, especially concerning mechanical and biological integrity. The performance is assessed against the established safety and efficacy of the predicate, rather than novel clinical endpoints.

2. The device's ability to maintain structural stability at the fusion site following discectomy is preserved.
3. The risk of migration or back-out is not increased. | "Finite element analysis and engineering rationale were used to demonstrate that the modifications and new sizes did not present a new worst case and that no additional testing was necessary."

The FMEA (Failure Modes and Effects Analysis) would identify potential failure modes due to changes and assess their mitigation. The engineering rationale would involve comparing the mechanical characteristics of the new sizes/designs to the predicate, likely using established biomechanical principles and potentially referencing existing test data for the predicate.

Specific performance metrics (e.g., stiffness, compressive strength, torsional stability) against a target (e.g., "equal to or greater than predicate") are implied but not explicitly stated in this summary. |
| Biocompatibility & Material Safety | The materials used (PEEK Optima® LT1 and Tantalum markers) are biocompatible and safe for long-term implantation, consistent with established materials in the predicate devices and per relevant ASTM standards. | The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. These are the same materials as the predicate. This reliance on established materials compliant with ASTM standards implies biocompatibility and material safety are met. No new testing explicitly detailed, relying on existing material characterization. |
| Functional Equivalence (Graft Accommodation, Fixation) | 1. The hollow center accommodates bone graft effectively.
2. Inferior and superior surfaces with ridges ("pyramid pattern" and "teeth") improve fixation and stability and prevent back-out and migration.
3. Graft volume and window size are adequate and comparable to appropriate predicates. | "The device footprint has a hollow center to accommodate bone graft..." and "the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration."

The document states: "Sythes OPAL was used as a predicate for graft volume and Surgical Supplies-Biolign was used as a predicate for graft windows." This indicates comparison to established functional benchmarks in similar devices. New sizes were validated using Life Spine's PLATEAU system as a "dimensional predicate." The "Teeth" feature is also compared to the predicate Alamo T. |
| Indicated Use & Clinical Application | The device performs its intended function for spinal fusion in skeletally mature patients with DDD at L2-S1, requiring supplemental fixation and autograft, implanted via a transforaminal approach, without altering the fundamental scientific technology or increasing risks. | "The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology." The "Indications for Use" statement is identical to the predicate (K120401). This statement implicitly confirms that the device is expected to perform equivalently in a clinical setting based on its design and material similarity and validated mechanical properties. No clinical testing was required to demonstrate substantial equivalence, implying the modifications are considered minor enough not to necessitate new human studies. |
| Sterilization & Radiographic Visualization | 1. Sterilization method (steam by end user) is effective and validated.
2. Tantalum markers allow for adequate radiographic visualization. | Sterilization: "End User (Steam)" - stated to be the same as the predicate.
Radiographic Markers: "Yes" - stated to be the same as the predicate. The use of ASTM F560 compliant tantalum implies established radiographic visibility. |

Note: For 510(k) clearances, "acceptance criteria" are not always explicit performance thresholds like in a clinical trial. Instead, they are often about demonstrating that the modifications do not introduce new safety concerns or alter the fundamental technology such that the device is no longer substantially equivalent to a legally marketed predicate. The "study" described is primarily non-clinical: FMEA, FEA, and engineering rationale based on predicate comparisons.

Study Details from the Document:

Due to the nature of this 510(k) submission (a line extension with dimensional modifications), the "study" described is primarily non-clinical.

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

• Test Set Sample Size: Not applicable. No physical "test set" of devices was used for direct comparative bench testing in the provided summary for performance. The "test set" here refers to the new sizes and dimensional modifications themselves that were analyzed via FMEA, FEA, and engineering rationale.
• Data Provenance: The data provenance is internal engineering analysis and comparison to existing data/specifications of predicate devices. This is not external patient data (e.g., country of origin). The evaluation is based on component-level design and material properties. The analysis is prospective in the sense that it's evaluating the proposed changes before marketing, but it leverages retrospective data/knowledge from predicate devices.

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

• Number of Experts: Not specified. "Engineering rationale" implies input from qualified engineers or biomechanical experts within the manufacturer's team or consultants.
• Qualifications: "Quality and Regulatory Consultant" (Kellen Hills) and "Frank Morris (Alliance Partners, LLC)" are listed as contact persons. The FMEA and FEA would be conducted by engineers with relevant expertise (e.g., mechanical engineering, biomechanics). Specific qualifications are not detailed beyond their roles.

4. Adjudication Method for the Test Set:

• Not applicable as there was no independent clinical or expert review of a "test set" of cases. The assessment was internal through FMEA and FEA. This is a technical assessment rather than a clinical adjudication process.

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

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This type of study is for evaluating human performance influenced by a diagnostic aid (AI), which is not the nature of this interbody fusion device.

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

• Not applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI does not apply. The "standalone" performance here relates to the mechanical properties of the device itself, which were evaluated via FEA and engineering rationale, not algorithms.

7. The Type of Ground Truth Used:

• For the non-clinical assessment, the "ground truth" is a combination of:
  • Established mechanical properties and design specifications of the predicate devices.
  • Biomechanical principles and engineering calculations.
  • Regulatory standards (e.g., FDA's 2007 Special Controls guidance for Intervertebral Body Fusion Devices, ASTM F2026 for PEEK, ASTM F560 for Tantalum).
  • Clinical experience and safety profiles of the predicate devices (implied by their prior clearance and market use).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of an algorithm or AI system for a physical implant device submission like this. If we consider analogous concepts, the "training" for demonstrating substantial equivalence comes from the extensive historical data, design principles, and performance of existing predicate devices, which allows for leveraging FMEA/FEA rather than requiring de novo testing.

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

• Not applicable. As there is no training set as understood in AI/algorithm development, the concept of establishing ground truth for it doesn't apply. The device's "ground truth" (its safety and effectiveness claim) is based on its similarity to legally marketed devices whose safety and effectiveness have already been established through prior regulatory review and clinical use.

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