Search Results

Ask a specific question about this device

The PRADO™ Lumbar Interbody Fusion System is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis and/or stenosis at the involved level(s). Additionally, the Prado™ Lumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion.

Additionally, the use of hyperlordotic devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.

PRADO™ Lumbar Interbody Fusion System consists of a series of implants and device specific instruments. PRADO™ Lumbar Interbody devices are manufactured from polyetheretherketone (PEEK) or Hydroxyapatite (HA) filled Polyetheretherketone (PEEK). The superior and inferior surfaces of the implants have ridges to interface with the vertebral endplates to resist rotation and migration. Additionally, the cephalad / caudal opening of each implant is maximized to facilitate bone through growth. Lateral fenestrations are provided to encourage bone ingrowth. Tantalum markers (per ASTM F560) or titanium (per ASTM F136), are configured as rods at the extremes of the PRADO™ Lumbar Interbody Devices to allow for radiological confirmation of the positioning. The proximal face of each interbody has a threaded thru hole which is to be used to interface with the inserter.

PRADO™ Lumbar Interbody Devices are available in four footprints to coincide with the surgical approach and patient need: PRADO™ P, PRADO™ T, PRADO™ L and PRADO™ A. The implants are available in a range of sizes to accommodate variations in patient anatomy.

The provided FDA 510(k) clearance letter for the PRADO™ Lumbar Interbody Fusion System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML-driven medical device.

The document describes a mechanical implant (intervertebral body fusion device) and discusses its physical characteristics, materials, and non-clinical mechanical testing (ASTM F2077-18 and ASTM F2267-04), which typically involve evaluating properties like static compression, dynamic compression, expulsion, and subsidence. The clearance is based on substantial equivalence to predicate devices for these mechanical properties.

The questions you've asked (regarding acceptance criteria, sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are highly relevant to the validation of AI/Machine Learning (ML) medical devices, particularly those that perform diagnostic or prognostic functions based on image analysis or other data.

Since the provided document is for a physical implant and not an AI/ML device, it naturally does not include the details pertinent to AI/ML validation studies. Therefore, I cannot extract the requested information from this text.

To answer your request, if this were an AI/ML device, the required information would typically be found in a separate section of the 510(k) submission, often within a "Performance Data" or "Clinical Performance Testing" section, specifically detailing the validation study for the AI algorithm.

If you intended to provide a document related to an AI/ML medical device, please provide that document, and I will be able to answer your questions.

Ask a specific question about this device

The TriMed Total Wrist fusion system is indicated for the following:

1. Wrist arthrodesis
2. Fractures of the wrist
3. Osteotomies of the wrist

The TriMed Total Wrist Fusion products are devices which are to be used as an aid to fixation of bone for treatment of certain fractures, osteotomies, or arthrodesis that lend themselves to the principle of plate and/or screw fixation.

The TriMed Total Wrist Fusion System implants are made from implant grade stainless steel.

The provided FDA 510(k) clearance letter is for a medical device (TriMed Total Wrist Fusion System) andではありません a software/AI product. Therefore, the questions related to acceptance criteria, study details, expert involvement, and ground truth establishment for AI performance are not directly applicable.

However, I can extract the information relevant to the device's testing and acceptance criteria as described in the document, which focuses on mechanical performance rather than AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria from these guidance documents are not detailed in the provided FDA letter. The letter only states that the device met them.

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

• Sample Size: Not explicitly stated. The document refers to "All test samples," indicating that a set of samples were tested, but the exact number is not provided.
• Data Provenance: Not applicable in the context of clinical data for AI. For mechanical testing, the data would originate from laboratory testing of manufactured devices.

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

• Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

4. Adjudication Method for the Test Set

• Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

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

• No. The document explicitly states: "Clinical studies were not conducted for the subject devices." MRMC studies are typically for evaluating the clinical effectiveness of diagnostic tools, often involving AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Not applicable. This refers to AI algorithm performance. The device is a physical fusion system.

7. The Type of Ground Truth Used

• For mechanical testing: The "ground truth" implicitly refers to the specified performance requirements and limits outlined in the FDA guidance documents (e.g., strength, fatigue life, stiffness). The device's performance is measured against these engineering standards.

8. The Sample Size for the Training Set

• Not applicable. This refers to AI model training data.

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

• Not applicable. This refers to AI model training data.

Summary specific to the provided document:

The TriMed Total Wrist Fusion System underwent non-clinical (mechanical) testing based on FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws/washers. The key finding is that all tested samples of the device met the specified acceptance criteria outlined in these guidance documents. No clinical studies were performed. The "ground truth" in this context refers to the engineering performance standards set by the FDA for such devices.

Ask a specific question about this device

The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy.

The provided FDA 510(k) clearance letter for the "panaSIa SI Fusion System" describes a medical device, specifically a smooth or threaded metallic bone fixation fastener, intended for sacroiliac (SI) joint fusion.

Based on the provided document, the acceptance criteria and the study proving the device meets these criteria are limited in detail. This is typical for a 510(k) clearance for this type of device, which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than extensive clinical studies or AI algorithm performance validation.

Here's an analysis of the provided information, addressing your points where possible, and noting where information is not present in the document.

Overview of Device and Clearance Type

The panaSIa SI Fusion System is a physical implant (a threaded, expandable device made of titanium grade alloy) used for sacroiliac joint fusion. The FDA clearance is a 510(k), which means the manufacturer demonstrated the device is substantially equivalent to legally marketed predicate devices. This type of clearance typically relies on non-clinical testing (e.g., mechanical performance) and comparison of design, materials, and indications for use, rather than extensive human clinical trials or complex AI performance metrics.

Acceptance Criteria and Study Details (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission (510(k) for a physical implant), the "acceptance criteria" are not explicitly quantifiable metrics like sensitivity/specificity for an AI algorithm. Instead, they are typically the successful fulfillment of recognized standards and comparative performance to predicates.

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

• Sample Size: The document mentions "cadaver testing," which refers to ex vivo testing of the device. However, it does not specify the sample size (i.e., number of cadavers or test specimens from cadavers) used for this testing.
• Data Provenance: The document does not specify the country of origin of the cadaver data or whether the testing was retrospective or prospective. Given it's cadaver testing, it's inherently a controlled, ex vivo experimental setup rather than a patient-based retrospective/prospective study.

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

• This information is not applicable/not provided in this type of 510(k) submission. The "ground truth" for a physical implant's mechanical performance is typically established by engineering standards (like ASTM F3574) and direct measurement, not by expert consensus on image interpretation or clinical outcomes.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical imaging studies or clinical trials where human interpretation or consensus is required. This information is not applicable/not provided for a mechanical device performance test.

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

• This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). This device is a physical implant; therefore, no MRMC study was done or is relevant for this submission.

6. Standalone (Algorithm Only) Performance Study

• This refers to the performance of an AI algorithm alone, without human intervention. Since this is a physical medical device and not an AI algorithm, a standalone algorithm performance study was not conducted or is not relevant.

7. Type of Ground Truth Used

• For the non-clinical performance testing:
  • Mechanical Standards: Adherence to established engineering standards (ASTM F3574 for static and dynamic vertical shear testing).
  • Comparative Performance: The performance of the device was directly compared against a predicate device in cadaver models. While not explicitly stated as "ground truth," the predicate device's known performance serves as the benchmark against which the new device is measured.
  • No clinical outcomes or pathology ground truth was used for this 510(k) clearance, as it is based on substantial equivalence through non-clinical testing.

8. Sample Size for the Training Set

• This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and prior device designs, but not through a formalized data training set as seen in AI development.

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

• As there is no AI "training set," this question is not applicable.

In summary, the provided FDA 510(k) clearance letter details a non-AI medical device (an SI joint fusion implant). The "acceptance criteria" and "study" proving these criteria are primarily based on:

• Substantial equivalence to legally marketed predicate devices in terms of intended use, principles of operation, design, and materials.
• Non-clinical performance testing, specifically:
  • Adherence to ASTM F3574 for static and dynamic vertical shear testing.
  • Comparative cadaver testing against an additional predicate device.

The document does not delve into the detailed quantitative results of these tests (e.g., exact maximum shear force sustained), sample sizes of cadavers, or the specific methods of ground truth establishment beyond relying on industry standards and direct comparison. This level of detail for non-clinical testing is typically found within the full 510(k) submission, not the public-facing clearance letter.

Ask a specific question about this device

The Rialto™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.

The provided FDA 510(k) clearance letter for the Rialto™ SI Fusion System does not contain information about the acceptance criteria and study proving a device meets those criteria in the context of an AI/Software as a Medical Device (SaMD).

The document describes a medical implant (Rialto™ SI Fusion System) and its mechanical and MRI safety performance, not an AI or software device. The studies mentioned (ASTM F2182-19e2, F2052-21, F2213-17, F2119-24, F2503-23) are for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment, which are standard non-clinical tests for physical medical devices.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/SaMD, as the provided input does not pertain to such a device.

If you have a document describing the clearance of an AI/SaMD, I would be happy to analyze it for the requested information.

Ask a specific question about this device

The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when ≤ 20° lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.

The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.

The OneLIF™ Interbody Fusion System includes interbody cages and retention plates designed for anterior or oblique insertion techniques. The purpose of this submission is to add additional implant sizes to the previously cleared system.

The provided text is a 510(k) clearance letter for a medical device called the OneLIF™ Interbody Fusion System. It does not contain information about acceptance criteria and a study proving device performance in the way typically observed for AI/ML-based devices.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is a common pathway for clearance of conventional medical devices like interbody fusion systems. The "performance data" mentioned refers to mechanical testing of the physical hardware, not a clinical performance study with human subjects, AI accuracy, or human-in-the-loop metrics.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown based on the given document:

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

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 mentioned. The "test set" here refers to physical implant designs and their mechanical properties, not a clinical dataset of patients or images.

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 mentioned. Ground truth in this context would be related to the mechanical properties and compliance with ASTM standards, typically assessed by engineers or testing laboratories, not clinical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not mentioned. Adjudication methods are typically used for clinical endpoints or image interpretation studies.

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

• No. This is a hardware device (interbody fusion system), not an AI-assisted diagnostic or treatment system.

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

• No. This is a hardware device.

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

• Not applicable / Not mentioned for clinical ground truth. For the mechanical testing, the "ground truth" would be established by the ASTM F2077 standard's specifications for mechanical behavior (e.g., strength, fatigue life) under specific loading conditions.

8. The sample size for the training set

• Not applicable / Not mentioned. This device does not use a training set in the context of AI/ML.

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

• Not applicable / Not mentioned. This device does not use a training set.

Ask a specific question about this device

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in five variations with one size per variation. The implant is manufactured from titanium alloy per ASTM F136.

The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.

The provided document is a 510(k) clearance letter for a medical device (SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System), not an AI/ML medical device. As such, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies, which are typical requirements for AI/ML device submissions.

The document is for a mechanical implant system and focuses on demonstrating substantial equivalence to a predicate device through:

• Identical indications for use.
• Identical technological design principles.
• Justifications and adoptions of existing performance testing (e.g., steam sterilization, FEA, pushout testing) from the predicate device (K241813), rather than new performance studies on clinical data or AI model outputs.

Therefore, I cannot extract the requested information to fill in the table or answer the questions related to AI/ML device validation.

Summary of why the requested information cannot be provided from the input:

• No AI/ML Component: The device is a physical implant (sacroiliac joint fusion system), not a software or AI-driven diagnostic/therapeutic device.
• Substantial Equivalence: The clearance is based on demonstrating substantial equivalence to a predicate device, meaning it relies on already established safety and efficacy data for a previous version or similar device, not de novo clinical trials or performance studies specific to an AI algorithm.
• Focus on Physical Properties: The "Performance Testing" section mentions engineering analyses (FEA, pushout testing) and sterilization, which are relevant to the physical characteristics and safety of an implant, not the diagnostic or analytical performance of an AI system.

Ask a specific question about this device

The Tera Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion.

The Tera Lumbar Interbody Fusion System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The Tera Lumbar Interbody Fusion System is intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

The Tera Lumbar Interbody Fusion System consists of intervertebral body fusion devices intended for lumbar interbody fusion using a transforaminal lumbar interbody fusion surgical approach (TLIF), an oblique transforaminal interbody fusion surgical approach (Oblique TLIF), or a posterior lumbar interbody fusion surgical approach (PLIF). The devices are intended to improve stability of the spine while supporting fusion. The Tera Lumbar Interbody Fusion System cages are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). The components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile.

Tera Lumbar Interbody Fusion System cages are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. All cages are manufactured using the L-PBF (laser powder bed fusion) additive manufacturing method. L-PBF allows for the formation of solid, non-porous cages with a layered porous lattice structure on the surfaces of the components, including the surfaces of the interior graft window. This intricate structure facilitates bone in-growth by providing a larger surface of implant/bone contact than a buffed surface. The cages are also titanium anodized to allow for identification of various heights by color.

Tera-T Ti Interbody cages, Tera-O Ti Interbody cages, and Tera-P Ti Interbody cages are also available with a Promimic HAnano Surface (hydroxyapatite (HA) coating). Cages are coated with a 20nm HA layer composed of crystalline hydroxyapatite particles that mimic human bone tissue through shape, composition, and structure. This surface treatment increases implant anchoring by facilitating osseointegration and enhancing early bone growth. All Tera Lumbar Interbody Fusion System implants are only available sterile packaged.

Non-sterile, reusable surgical instruments to support implantation of the system are provided for use with Tera Lumbar Interbody Fusion System devices are provided in steam sterilization trays.

The provided text describes a 510(k) clearance for a medical device called the "Tera Lumbar Interbody Fusion System." This document is a regulatory approval for a physical medical device (an implant used in spinal fusion surgery), not a software or AI-driven diagnostic device.

Therefore, the requested information about acceptance criteria for AI/software performance, such as MRMC studies, ground truth establishment, training set details, or expert adjudication, is not applicable to this document. The clearance is based on mechanical performance testing and substantial equivalence to a predicate device.

Here's a breakdown of the relevant information provided in the document regarding the device's acceptance and testing:

Acceptance Criteria and Device Performance for Tera Lumbar Interbody Fusion System

The Tera Lumbar Interbody Fusion System is a physical medical device. Its acceptance criteria and performance are based on mechanical testing to demonstrate substantial equivalence to previously cleared predicate devices, rather than AI or software performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and reported values. Instead, it states that the device was tested against recognized ASTM standards, and its performance met the acceptance criteria of these standards.

Note: The document states, "Performance equivalence demonstrated that the subject device met the acceptance criteria of the standards and is substantially equivalent to the predicate devices." This indicates that the established acceptance criteria were the thresholds defined by the respective ASTM standards for intervertebral body fusion devices.

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

The document refers to "mechanical performance testing" and "worst-case analysis and resulting worst-case configuration mechanical testing." It doesn't specify a precise numerical sample size for the physical devices tested (e.g., "N units were tested"). However, typically, mechanical performance testing of medical implants involves a statistically sufficient number of samples to ensure robust results, often following specific sample size recommendations within the testing standards.

• Test Set Sample Size: Not explicitly stated as a number of devices (e.g., "10 units"). However, "worst-case configuration mechanical testing" implies selected configurations representative of the most challenging conditions.
• Data Provenance: The data is generated from in-vitro (laboratory) mechanical testing of the manufactured device. It is not patient or clinical data. No country of origin for data or retrospective/prospective status is applicable as it's not a clinical study.

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

This question is not applicable for this type of device clearance. Ground truth, in the context of AI/software, refers to human expert annotations or pathological diagnoses. For mechanical devices, "ground truth" is defined by the performance requirements of the relevant engineering standards (e.g., ASTM F2077, ASTM F2267, ASTM F3001). The "experts" in this context would be the engineers and technicians performing the tests and validating the results against the standard requirements.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in human expert annotations for AI ground truth. For mechanical testing, the results are quantitative measurements against predefined thresholds in the standards.

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

No, a MRMC study was NOT done. MRMC studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable. This device is not an algorithm. The "standalone" performance here refers to the device's mechanical integrity on its own without human interaction during the test (other than setting up the test). The mechanical tests performed (static/dynamic compression, shear, subsidence) are essentially "standalone" evaluations of the device's physical properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is defined by the acceptance criteria specified in the relevant ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices and titanium alloys. These standards define the mechanical properties and performance thresholds that the device must meet.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical implant, not an AI model, so there is no "training set."

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

This question is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device

The FlareHawk Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

FlareHawk Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion.

The FlareHawk interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine.

The FlareHawk Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation.

The provided FDA 510(k) clearance letter for the FlareHawk Interbody Fusion System does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or diagnostic accuracy.

This document is for an Intervertebral Body Fusion Device (a spinal implant), which is a physical medical device, not a software-based diagnostic AI device. Therefore, the questions posed in the prompt related to AI performance, ground truth establishment, expert consensus, MRMC studies, and training/test set sizes are not applicable to the information provided in this 510(k) summary.

The "studies" mentioned in the document are non-clinical bench performance tests primarily related to MRI compatibility of the implant, such as:

• Measurement of magnetically induced displacement force
• Measurement of magnetically induced torque
• Evaluation of MR image artifacts
• Measurement of radio frequency induced heating

These tests confirm the physical properties and safety of the implant in an MRI environment, not the diagnostic or analytical performance of an AI algorithm.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and a study proving device performance in the context of an AI device, as the provided text pertains to a physical orthopedic implant.

Ask a specific question about this device

The AERO MIS Facet Fusion System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• Spondylolisthesis,
• Spondylolysis,
• Pseudoarthrosis or failed previous fusions which are symptomatic, or
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability.

The system is intended for use with bone graft material.

The AERO MIS Facet Fusion System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "AERO MIS Facet Fusion System." This document discusses the regulatory approval process and states that the device is "substantially equivalent" to a previously cleared predicate device based on its indications for use, design, function, materials, and performance.

However, the text does not contain any information about acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria, as the necessary information is not present in the provided document.

Ask a specific question about this device