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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.

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Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are intended to fill a bony void or defect area in a patient's specific cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone).

Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI) are individually sized and shaped implantable prosthetic plates intended to fill a bony void or defect area in a specific patient's cranial and craniofacial skeleton, ranging from 2 mm to 10 mm thick (typically 4mm thick based on the patient CT Scan imaging data) x 25mm to 250 mm wide x 25 mm to 250 mm long.

A Fusion Skull Implant (FSI) is intended to fill a bony void or defect area in a specific patient's skull, whereas a Fusion Craniofacial Implant (FCI) is intended to fill a bony void or defect area in a specific patient's facial region of the skull, excluding the Maxilla (upper jaw area surrounding the teeth only) and Mandible, both considered load bearing areas of the facial region of the skull.

The size, asymmetrical shape, thickness, contour, and edge profile are design elements of the non-load bearing patient-specific base implant. These design elements are used to support the base implant in the bony void or defect area to provide a "Precise Fit."

The single-use alterable base implant (1) is fabricated from a billet block of implant grade Polyether ether ketone (PEEK) Thermoplastic Polymer formulated with biphasic calcium phosphate (BCP PEEK), using a patient's CT scan imaging data, (2) is provided clean (non-sterile) for steam sterilization prior to implantation at a hospital or surgical site, and (3) are attached to the native bone using commercially available cranioplasty hardware and fasteners.

The provided FDA 510(k) clearance letter (K250334) addresses the marketing of the Fusion Craniofacial Implant (FCI) and Fusion Skull Implant (FSI). However, this document does not describe a study involving an AI model or a human-in-the-loop system.

The device described is a physical implant (Preformed Alterable Cranioplasty Plate) intended to fill bony voids or defects in the cranial and craniofacial skeleton. The review focuses on the substantial equivalence of this implant to previously cleared predicate devices, primarily based on material composition (a new PEEK formulation: BCP PEEK) and manufacturing processes.

Therefore, the requested information regarding acceptance criteria and studies proving an AI-driven device's performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be extracted from the provided text.

The performance data section in the document describes:

• Biocompatibility testing: Performed on the new material (Evonik Vestakeep iC4800R® BCP PEEK) according to ISO 10993 standards.
• Performance Testing: Refers to raw material certification and acceptance.
• Cleaning Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Steam Sterilization Validation: Conducted according to ANSI/AAMI ST79.
• Mechanical Testing Validation: A protocol developed by Kelyniam was used as there's no industry-accepted standard for non-load-bearing plates. It states that "all samples passed the acceptance criteria" and "performed equivalent to the predicate devices during mechanical testing using a worst-case scenario."
• Ship Testing Validation: Conducted for previously cleared devices, and the process is identical for the subject devices.
• Summary on Clinical Testing: States "Clinical Testing was determined not applicable" for these devices.

In summary, the provided document does not contain any information about an AI/software-based device, nor does it detail acceptance criteria or studies related to AI performance.

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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.

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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.

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PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body 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 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The PathLoc Lumbar Interbody Fusion Cage System implants are interbody fusion devices intended for use as an aid in spinal fixation. They are made of Titanium 6AL-4V Alloy (ASTM F136). These hollow, rectangular implants are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The implants can be expanded in height after insertion in the unexpanded state using the system instrumentation. The implants have serrations on the superior and inferior surfaces designed for fixation.

• PathLoc – TM / BluEX-TM are to be implanted via transforaminal and posterior approach.

The provided FDA 510(k) clearance letter for the PathLoc Lumbar Interbody Fusion Cage System focuses on the mechanical testing and material composition of the device, rather than a clinical study evaluating its performance with human readers or AI assistance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, multi-reader multi-case (MRMC) studies, ground truth establishment for image datasets, and training/test set details for AI, are not applicable to this submission.

This document describes a medical device (an intervertebral body fusion cage) which is a hardware implant, not an AI/Software as a Medical Device (SaMD). The acceptance criteria and "study" described are focused on bench testing (mechanical performance) and material biocompatibility to prove substantial equivalence to existing predicate devices.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Mechanical Testing)

The "acceptance criteria" for this device are based on demonstrating mechanical performance that is either superior or equivalent to the predicate device and in compliance with specified ASTM standards. The "study" proving this involves a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number of devices or units. For mechanical bench testing, sample sizes are typically defined by the ASTM standards (e.g., n=5, n=6, etc.) but are not detailed in this summary. It would be a sample of the manufactured devices.
• Data Provenance: The "data" here refers to the mechanical test results from manufactured devices. This is not "data" in the sense of patient images or clinical outcomes. The device is manufactured in South Korea. The testing would have been conducted in a lab environment. The provenance is internal bench testing, not patient-derived data, and is not retrospective or prospective in the clinical sense.

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

• Not applicable. This is a hardware device; its performance is measured by mechanical properties according to engineering standards, not by human interpretation of images or clinical outcomes requiring expert consensus. The "ground truth" is established by the specified ASTM test methods.

4. Adjudication Method for the Test Set:

• Not applicable. As the "test set" is physical devices undergoing mechanical tests, there is no human adjudication process involved as there would be for, e.g., image interpretation. The machines measure and report data directly.

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

• No. An MRMC study is relevant for evaluating the performance of AI (or human readers) in interpreting medical images. This device is a physical implant, not an imaging or diagnostic AI tool.

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

• Not applicable. This is a hardware device, not an algorithm or software. "Standalone performance" here is interpreted as the device's mechanical performance in isolation, which is precisely what the bench tests measure.

7. The Type of Ground Truth Used:

• Engineering/Material Standards and Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet predefined mechanical specifications outlined in ASTM standards and to demonstrate substantial equivalence (i.e., not inferior performance) to the predicate device. It's about physical properties, not clinical "truth" from patients.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this traditional hardware device clearance. This term (training set) relates to machine learning models.

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

• Not applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.

In summary: The FDA 510(k) clearance for the PathLoc Lumbar Interbody Fusion Cage System relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device in terms of design, materials, and mechanical performance. The framework of questions about AI algorithm performance, clinical ground truth establishment, and training/test datasets is not applicable to this type of medical device submission.

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The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® transforaminal lumbar interbody fusion devices are to be filled with auto graft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or corticocancellous bone and is to be used with supplemental fixation cleared for use in the lumbar spine. The device may be implanted via an open or minimally invasive approach.

The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis, kyphosis, or sagittal), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20° of lordosis. At more than two levels or with implants greater than 20° of lordosis, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended to be used with the screws that accompany the implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with the screws that accompany the implant and with supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine. These patients should be skeletally mature and have had at least six months of non-operative treatment. The device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® TLIF-C Articulating System is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® TLIF-C Articulating System is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® TLIF-C Articulating System is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. aprevo® TLIF-C Articulating System devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). These implants may be implanted via a variety of open or minimally invasive approaches.

The aprevo® Cervical ACDF lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. The aprevo® Cervical ACDF lnterbody System must be used with supplemental fixation systems. For hyperlordotic corrections (≥20° lordosis), the system must be used with at least an anterior cervical plate as supplemental fixation.

The aprevo® Cervical ACDF-X lnterbody System are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with the following degenerative cervical conditions: cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as discogenic 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) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone. When used as a standalone system, the aprevo® Cervical ACDF-X lnterbody implant with integrated screw fixation is intended for use at multiple contiguous levels, or up to two levels when used in trauma, deformity or failed previous fusions. Deformity procedures to correct coronal angulation or any use of hyperlordotic correction (≥20°) must include supplemental fixation such as posterior cervical screw fixation or anterior plating.

The aprevo® Lumbar Intervertebral Body Fusion Devices include ALIF, LLIF, TLIF, ALIF-X and TLIF-CA interbodies. The aprevo® lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws that accompany ALIF-X are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instruments are provided as single use, sterile-packed product to the end user.

The aprevo® Cervical Intervertebral Body Fusion Devices include ACDF, ACDF-X and ACDF-X no cams. The aprevo® Cervical ACDF System, which includes the aprevo® Cervical ACDF Interbody, aprevo® Cervical ACDF-X Interbody, and the aprevo® Cervical ACDF-X (NO CAM) Interbody are designed to stabilize the cervical spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient-specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture for the packing of bone graft. The aprevo® Cervical ACDF System interbodies are additively manufactured from Ti-6Al-4V ELI titanium alloy per F3001, while the screws are machined from Ti alloy per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and the instruments are provided to the end-user as single use, sterile-packed products.

The purpose of this 510(k) is to extend the expiration of imaging used to create 3D surgical plans. There have been no changes made to the software used in the surgical planning process.

The provided FDA 510(k) clearance letter (K250827) for Carlsmed, Inc.'s "aprevo®" interbody fusion devices primarily concerns the renewal of previously cleared devices and the extension of the imaging expiration dating used for 3D surgical planning. Therefore, the document does not contain details of a clinical study assessing the performance of an AI-based device meeting acceptance criteria in the way one might expect for a novel AI/ML medical device submission.

Instead, the performance testing summary indicates that "Clinical data was used to evaluate imaging expiration. Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts." This suggests that the "device" being evaluated for performance in this context is likely related to the software's ability to accurately segment or generate 3D models from imaging data over time, rather than the interbody fusion implants themselves. The clearance is for the physical implants, which are considered substantially equivalent to previously cleared predicates. The "performance testing" here seems to be an update or validation related to the software component of the surgical planning.

Given this context, I will extract information relevant to the software's performance, as that is the only "acceptance criteria" and "study" mentioned, even if it's not a typical AI model performance study against clinical outcomes.

Here's an interpretation based on the limited information provided, assuming the "device performance" refers to the imaging processing capabilities of the aprevo® system's software, specifically regarding the "expiration" of imaging data for 3D surgical plans:

Acceptance Criteria and Device Performance Study for Imaging Expiration

The context of this FDA 510(k) submission (K250827) indicates that the performance study was specifically undertaken to extend the expiration of imaging used to create 3D surgical plans. This suggests the "device performance" being assessed relates to the consistency and accuracy of the software's ability to process imaging data for surgical planning over time, implying that "aging" of the input imaging data does not degrade the software's output beyond an acceptable threshold.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only specifies the acceptance criterion. The specific numerical performance result (e.g., the exact DICE score achieved) is not provided in this public clearance letter. However, the clearance implies that the criterion was met.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: "Clinical data was used." No details on the country of origin or whether the data was retrospective or prospective are provided.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none).

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

• MRMC Study Done?: No, an MRMC study comparing human readers with and without AI assistance is not mentioned or implied by the description of this performance evaluation, which focuses on "imaging expiration" and DICE score.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done?: Yes, the use of a "DICE score" for "imaging expiration" strongly suggests an algorithm-only performance evaluation, likely comparing the software's segmentation or 3D reconstruction output against a form of ground truth derived from the clinical data. The phrase "There have been no changes made to the software used in the surgical planning process" further indicates an assessment of the software's intrinsic capabilities.

7. Type of Ground Truth Used

• Type of Ground Truth: The use of "DICE score" typically implies that the ground truth involves expert-annotated segmentations or regions of interest within the medical images. The DICE score measures the spatial overlap between the algorithm's output and the ground truth. While not explicitly stated, it's highly probable that this ground truth was derived from expert consensus or manual annotation of anatomical structures on the clinical imaging data.

8. Sample Size for the Training Set

• Training Set Sample Size: Not mentioned. This submission is for an extension/validation of existing software, not the initial clearance of a newly developed AI model, so details on original training are not typically included here.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not mentioned. As above, this document focuses on a validation study for imaging expiration, not the initial development or training of the AI algorithm.

Summary of Limitations Based on Provided Text:

The provided 510(k) summary (specifically the "Performance Testing Summary") is extremely concise regarding details of the study. It states that "Clinical data was used to evaluate imaging expiration" and that "Expiration dating was validated using statistical analysis (DICE score) with an acceptance criterion of >0.80. Additionally, the performance was evaluated across key cohorts."

Therefore, many typical details requested for robust AI/ML performance studies, such as specific sample sizes, expert qualifications, and adjudication methods, are not present in this public clearance letter. This is common for 510(k) summaries, which are often condensed versions of the full submission. The key takeaway is that the "performance testing" here addresses a specific aspect ("imaging expiration" for 3D surgical planning) of the software rather than a direct clinical efficacy study of the implant or a broad AI diagnostic/prognostic model.

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The aprevo® posterior/transforaminal lumbar interbody fusion device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal lumbar interbody fusion device is indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems). The device may be implanted via an open or minimally invasive approach.

The aprevo® posterior/transforaminal intervertebral body fusion device is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.

The aprevo® posterior/transforaminal lumbar interbody fusion device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody device, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single use.

This FDA 510(k) clearance letter pertains to a physical medical device, specifically an intervertebral body fusion device, not a software-based AI device. Therefore, much of the information typically sought for AI/ML device acceptance criteria (e.g., ground truth establishment, training set details, multi-reader multi-case studies) is not applicable or present in this document.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them based on the provided text.

Acceptance Criteria and Device Performance Study for aprevo® posterior/transforaminal lumbar interbody fusion device

This device is a physical implant designed for spinal fusion, and its acceptance criteria primarily revolve around mechanical performance and substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific "test set" sample sizes in the context of clinical or evaluation studies as would be seen for AI/ML. For a physical device, testing is primarily non-clinical.

• Sample Sized for "Test Set": Not explicitly stated in terms of a population size. Non-clinical testing typically involves a sufficient number of device samples or test configurations to demonstrate mechanical performance according to the specified ASTM standards.
• Data Provenance: The mechanical testing references ASTM standards (e.g., ASTM F2077, ASTM F2267), indicating laboratory setting for mechanical performance evaluation. A "cadaveric validation" was also performed. Details on the number of cadavers are not provided. The data is thus derived from non-clinical (laboratory/engineering) studies and a cadaveric study.

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

This information is not applicable as the clearance is for a physical medical device, not a diagnostic or prognostic AI/ML device requiring expert ground truth for interpretation. Mechanical testing and cadaveric validation do not typically involve human experts establishing a "ground truth" in the same way an AI model's output would be compared to a consensus reading.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic devices to assess the impact of AI on human reader performance. This device is a physical implant.

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

This information is not applicable. This device is a physical implant and does not involve an "algorithm only" performance. Its performance is assessed through its mechanical properties and successful fusion in conjunction with human surgical intervention and bone graft.

7. The Type of Ground Truth Used

For the mechanical performance, the "ground truth" is established by adherence to engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of predicate devices against which the new device is compared for substantial equivalence. For the cadaveric validation, the "ground truth" would be the observed physical behavior and performance within the cadaveric model. There is no clinical ground truth (like pathology or outcomes data from human patients) presented in this 510(k) summary, as "Clinical Testing" is explicitly stated as "Not applicable."

8. The Sample Size for the Training Set

This information is not applicable. This refers to a training set for an AI/ML model, which is not relevant to this physical medical device.

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

This information is not applicable for the same reasons as point 8.

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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.

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The Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.

The screws are not intended for interference or soft tissue fixation.

The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver.

The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.

The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel.

The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.

The provided text is an FDA 510(k) clearance letter for the "Eleganz Fusion Screw System." This document primarily focuses on the regulatory clearance process for a bone fixation device, asserting its substantial equivalence to previously cleared predicate devices based on design, materials, and intended use.

Crucially, the document explicitly states under "Non-Clinical and/or Clinical Tests Summary & Conclusions":

"No clinical tests were submitted, referenced or relied for the 510(k)."

This means that the clearance was not based on studies demonstrating the device meets acceptance criteria related to its performance in a clinical setting, such as the accuracy of an AI algorithm or the improvement of human readers with AI assistance. Instead, it relies on non-clinical testing (e.g., mechanical properties) and comparison to predicate devices.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study findings, sample sizes, expert ground truth establishment, or MRMC studies, as this information is not present in the provided FDA 510(k) clearance letter. The questions you've asked are typically relevant to the clearance of AI/ML-enabled medical devices, where performance metrics and human-in-the-loop studies are often critical for demonstrating safety and effectiveness. The Eleganz Fusion Screw System is a physical orthopedic implant, and its clearance pathway did not necessitate the types of studies you are inquiring about.

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