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The F3D Lateral Lumbar Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). F3D Lateral Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the Oro Lateral plate for fixation. If using the 1-hole CoreLink Oro Lateral Plate System, additional supplemental fixation is required (e.g. posterior fixation).

The CL5 Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). CL5 Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CoreLink Oro Lateral Plate System (LPS), in two and four-hole configurations, is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink Oro Lateral Plate System is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Alternatively, the CoreLink Oro Lateral Plate System may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink Oro LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The CoreLink Oro LPS, one-hole configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The one-hole plate is not intended for use in load-bearing applications.

Hyperlordotic interbody devices (≥20° lordosis) must be used in conjunction with the CoreLink Oro Lateral Plate System (LPS) for fixation.

The F3D Lateral Lumbar Interbody System, additively manufactured Ti-6A1-4V ELI per ASTM F3001 implants, and the CL5 Lateral Lumbar Interbody System, PEEK implants per ASTM F2026 with Tantalum per ASTM F560, are lumbar interbody spacers designed to provide mechanical support to the lumbar spine while arthrodesis occurs. The lateral lumbar spacers with hollow footprints for placement of graft material feature a wide variety of footprint, height, and lordosis options to accommodate patient anatomical needs. The F3D spacers are designed with a porous surface to optimize bone in-growth. The CL5 spacers are designed with ridges on the superior and inferior surfaces to improve grip against the end-plates and prevent expulsion. The Oro Lateral Plate System consists of plates and screws intended for use as a laterally placed supplemental fixation device via the lateral or anterior lateral surgical approach above the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Oro Plate System implants are manufactured from Ti-6AI-4V ELI per ASTM F136 with Nitinol springs per ASTM F2063 in the plate's screw anti-backout plates. The plates are offered in 1-Screw, or 4-Screw configurations and in multiple lengths for single level fixation. The 1-Screw plate configuration is designed to maintain the relative position of interbody spacers during spinal fusion and is non-load bearing. The 2-Screw and 4-Screw plate configurations are designed as supplemental fixation for lumbar fusion. The plate screws are available in a variety of size options.

All Oro plates may be permanently attached to the F3D or CL5 spacers and assume the indications for use of the spacers.

The spacer and plate systems have been previously cleared (K183239, K150847, and K190016). This 510(K) submission offers additional implants to the previously cleared sets.

The provided text describes medical devices (spinal implants) and their indications for use, characteristics, and comparison to predicate devices for FDA clearance. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or MRMC studies.

The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a detailed clinical study with performance metrics against pre-defined acceptance criteria for diagnostic AI/software.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because this type of information is not present in the provided text. The document primarily discusses mechanical testing results to demonstrate that the strength of the devices is "sufficient for their intended use and are substantially equivalent to legally marketed predicate devices."

The requested information points cannot be extracted from the given text as it pertains to AI/software performance validation, while the document describes physical medical devices and their mechanical testing.

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F3 provides image guidance by overlaying a previously constructed preoperative vessel anatomy, from a previously acquired contrast-enhanced, diagnostic CT scan, onto live fluoroscopic images in order to assist in the positioning of guidewires, catheters and other endovascular devices.

F3 is intended to assist fluoroscopy-guided endovascular procedures in the thorax. Suitable procedures include endovascular aortic aneurysm repair (AAA and mid-distal TAA) and angioplasty.

F3 i not intended for use in the X-Ray guided procedures in the liver, kidneys or pelvic organs.

The purpose of F3 is to assist the user with the visual evaluation, comparison, and merging of information between anatomical and functional images from a single patient. The user needs to take into consideration the product's limitations and accuracy when integrating the information from the registration results for final interpretation. F3 does not replace the usual procedures for visual comparison of datasets by a user. Fusion images are intended to provide additional information to a user's existing workflow for patient evaluation.

F3 offers:

• Visualization of multi-modality image data
• Automatic registration
• Import of DICOM data
• Capture of fluoroscopic image frames

Based on the provided text, the document describes the non-clinical performance testing of the F3 device, focusing on its registration accuracy and qualitative performance.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 20 clinical cases.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the context implies it's likely a US-based study given the FDA submission.
  • Retrospective or Prospective: Retrospective. The cases were collected "retrospectively over a 2 year period."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: "a group of board certified radiologists." The exact number is not specified beyond "a group."
• Qualifications of Experts: Board certified radiologists. No further details on their experience (e.g., years of experience) are provided.

4. Adjudication method for the test set:

• Not explicitly mentioned for establishing ground truth or for the qualitative preference assessment beyond "a group of board certified radiologists" preferring the results. The phrasing "expert identified results" for the training set suggests expert consensus, but details for the test set ground truth are limited.

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, a multi-reader multi-case (MRMC) comparative effectiveness study assisting human readers was not conducted. The study evaluated the device's standalone accuracy (technical performance) and qualitative preference by radiologists for the device's output. There's no mention of a study comparing human reader performance with and without F3 assistance.

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

• Yes, standalone performance was evaluated. The primary focus of the non-clinical testing was on the algorithm's registration accuracy (TRE) and its output's qualitative preference, without human interaction as part of the performance metric. The statement "Our registration engines differ... In this work we tested it on hundreds of image pairs to demonstrate its accuracy relative to expert identified results" confirms an algorithm-only evaluation for accuracy.

7. The type of ground truth used:

• For accuracy assessment (TRE):
  • Phantom data: For the thoracic phantom, the ground truth would be precise, known measurements or landmarks within the phantom.
  • Clinical data: For "clinically acceptable accuracy," the ground truth was defined by the predicate device's acceptable TRE of 3mm. This implies a reference or established method for measuring TRE on clinical images. The text also mentions "accuracy relative to expert identified results" when discussing the intensity-based registration engine more generally.
• For qualitative preference: Expert consensus/opinion from "a group of board certified radiologists."

8. The sample size for the training set:

• The training set size is not explicitly stated. However, for the intensity-based registration engine, it mentions, "In this work we tested it on hundreds of image pairs to demonstrate its accuracy relative to expert identified results." This "hundreds of image pairs" likely refers to the development/testing of the engine, which could encompass training, validation, and internal testing. But a specific "training set" size distinct from the "test set" (20 cases) is not provided.

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

• For the intensity-based registration engine, the ground truth was "expert identified results." This implies human experts (likely radiologists or other medical imaging specialists) manually established accurate registrations or measurements that the algorithm was trained and/or validated against. Details on the number of experts or their qualifications for the training set ground truth are not provided.

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The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). When used in the cervical spine (C2-T1), F3D Corpectomy devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. When used in the thoracolumbar spine (T1-L5). F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The F3D Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment. The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.

The CoreLink® M3™ Stand-Alone ALIF System is a standalone interbody fusion system 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation. Hyperlordotic implants (≥20° lordosis) are intended for use with supplemental fixation (e.g. posterior fixation) that are cleared for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, or none of the provided screws, then the additional supplemental fixation in the lumbar spine must be used to augment fixation.

Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as disco genic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Foundation 3D lumbar implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The Foundation™ 3D Interbody Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation™ 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Foundation™ 3D Interbody Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The CoreLink, F3D Interbody System is a collection of additively manufactured, machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical and lumbar spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti- 6A1-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft. The F3D Interbody System has open macroscopic 3D pores with a microscopic, roughened surface and nano scale features.

This is a 510(k) summary for the F3D Interbody System, which is a collection of spinal implants. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel AI/software device.

Therefore, many of the requested points regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies (especially MRMC, standalone AI performance) are not applicable or not provided in this type of regulatory submission for a physical medical device.

However, I can extract information related to the device's performance evaluation as described.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for a study in the sense of predefined thresholds for clinical performance. Instead, it describes performance testing conducted to characterize the material and its biological interactions, with the implicit acceptance criterion being that the device performs at least as well as or better than the predicate devices for comparable properties, and demonstrates favorable osteoblast functions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in terms of number of human subjects or distinct physical devices for each test. The performance data section describes types of tests performed (e.g., Scanning Electron Microscopy, Osteoblast Adhesion and Proliferation) but does not provide details on the number of samples or replicates for these tests. This is typical for pre-market submissions focusing on material characterization and in vitro biological response rather than clinical trials.
• Data Provenance: Not specified. It's an in vitro and material characterization study, so concepts like "country of origin" or "retrospective/prospective" in a clinical sense are not directly applicable.

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. This is not a study involving expert review of medical images or clinical data to establish a ground truth. The "ground truth" for the material characterization and in vitro biological studies would be the results obtained from the analytical techniques themselves (e.g., SEM images, quantitative assays for collagen, ALP, calcium).

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

Not applicable. There was no expert adjudication process for this type of performance data.

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 describes a physical medical device (spinal implants) and material science/biological response testing, not an AI/software device that would involve human readers or an MRMC study.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for the reported performance data is derived from direct measurements and analytical results from laboratory studies quantifying material characteristics and cellular responses. Examples include:

• Microscopic imagery (SEM, AFM) for nano-scale features.
• Spectroscopic analysis (EDS) for chemical composition.
• Quantitative assays for osteoblast adhesion, proliferation, collagen content, alkaline phosphatase activity, and extracellular calcium deposition.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The studies are for characterizing the material and its biological interactions.

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

Not applicable. This is not an AI/machine learning device.

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The F3D-C2 Cervical Stand-Alone System is a Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels depending on the assembly. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D-C2 Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) depending on the assembly. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone marrow aspirate as an adjunct to fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D-C2 Cervical Stand-Alone System is an interbody fusion device intended to be used with two titanium alloy screws and/or anchors which accompany the implants. When used with screws, the F3D-C2 Cervical Stand-Alone System is intended for use at one or two levels of the cervical spine (C2-T1) and requires no additional fixation. When used with one or more anchors, the F3D-C2 Cervical Stand-Alone System is intended for use at one level of the cervical spine (C2-T1) and requires additional supplemental fixation such as posterior cervical screw fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively manufactured and machined implants and associated instruments for surgical site preparation and implantation to provide mechanical support to the cervical spine while arthrodesis occurs. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. Integration consists of additive Ti-6Al-4V (ASTM F3001) anchors (also referred to as nails) or machined Ti-6A-4V (ASTM F136 and ISO 5832-3) screws. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The provided text describes a medical device, the F3D-C2 Cervical Stand-Alone System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria, device performance in terms of metrics like sensitivity, specificity, or accuracy, or any study involving human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because such details are not present in the provided document.

The document discusses the regulatory clearance process for a spinal implant and focuses on:

• Device Description: What the F3D-C2 Cervical Stand-Alone System is made of and its components.
• Indications for Use: The medical conditions and patient population for which the device is intended.
• Technological Characteristics: How it compares to predicate devices.
• Non-Clinical Performance Data: A list of mechanical tests performed to demonstrate its safety and effectiveness compared to predicate devices. These tests are physical and mechanical, not related to AI or diagnostic accuracy.

The performance data mentioned are for mechanical tests such as static axial compression, dynamic axial compression, subsidence, and pullout, all referencing ASTM standards. These are physical properties of the implant, not performance metrics for a diagnostic or AI-driven medical device.

To directly answer your numbered points based only on the provided text, I would have to state that the information is not present for most of them:

1. A table of acceptance criteria and the reported device performance: Not provided. The text lists types of mechanical tests (e.g., Static axial compression per ASTM F2077) but does not provide specific acceptance criteria values or reported performance values for these tests.
2. Sample sized used for the test set and the data provenance: Not provided. The mechanical tests typically involve testing multiple units of the device but the sample size is not stated. Data provenance refers to the origin of clinical data, which is not applicable here as these are non-clinical mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are mechanical tests, not clinical studies involving expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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. This document is about a physical medical implant, not an AI or diagnostic device.
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 (expert consensus, pathology, outcomes data, etc): Not applicable in the context you're asking. For mechanical tests, the "ground truth" would be the engineering specifications and established test methods, but not expert consensus or pathology in a clinical sense.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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The F3D Corpectomy devices are vertebral body replacement devices intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5).

When used in the cervical spine (C2-T1), F3D Corpectomy devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

When used in the thoracolumbar spine (T1-L5), F3D Corpectomy devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion.

These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

The F3D Corpectomy Cage is a spinal vertebral body replacement device which is available in a variety of different heights, footprints, and lordotic options to suit the individual pathology and anatomical conditions of the patient. The F3D Corpectomy cage consists of a static, single-piece vertebral body replacement cage. The F3D Corpectomy devices are intended for use in the cervical (C2-T1) and thoracolumbar spine (T1-L5). They are designed to provide mechanical support to the spine while arthrodesis occurs. The F3D Corpectomy System is made from titanium alloy (Ti-6Al-4V) per ASTM F3001.

The FDA 510(k) summary for the F3D Corpectomy System (K202637) focuses on establishing substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, rather than an AI/ML context. Therefore, many typical AI/ML study components (like expert ground truth, adjudication, MRMC studies, training set details) are not applicable or mentioned.

Here's an analysis of the provided text, outlining the acceptance criteria and the study performed, along with the information that is not available given the nature of this medical device clearance (spinal implant, not an AI/ML device):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a table with specific thresholds. Instead, it refers to industry standards (ASTM F2077 and ASTM F2267) and concludes that the device's strength is "sufficient for its intended use" and "substantially equivalent to legally marketed predicate devices."

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

• Sample Size: Not explicitly stated as a number of devices. The tests are typically performed on a statistically relevant number of physical device samples as required by the ASTM standards, but the exact count is not disclosed in the summary.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting ("Performance Data" section). There is no mention of patient data (retrospective or prospective) or country of origin for such data, as this is a mechanical safety and performance study for a physical implant.

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

• This information is not applicable as the evaluation is based on mechanical laboratory testing against industry standards, not on interpretation of medical images or patient outcomes requiring expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable as there is no human interpretation or decision-making process for the mechanical test results that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• This information is not applicable. The F3D Corpectomy System is a physical spinal implant, not an AI/ML-driven diagnostic or assistive device that would involve human readers.

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

• This information is not applicable. The device is a physical implant and does not involve an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device, in a mechanical testing context, is adherence to established industry-wide performance standards (ASTM F2077 for static/dynamic compression and torsion, ASTM F2267 for subsidence) and demonstrating equivalency to already-cleared predicate devices. These standards represent scientifically validated methodologies for assessing the mechanical robustness and safety of spinal implants.

8. The Sample Size for the Training Set

• This information is not applicable as the device is not an AI/ML product and does not involve a training set.

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

• This information is not applicable as the device is not an AI/ML product and does not involve a training set.

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The F3D Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The F3D Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment.

The F3D Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The CoreLink F3D Cervical Stand-Alone Interbody Fusion System is a collection of additively and subtractively manufactured implants and associated instruments for surgical site preparation and implantation. The subject cages are additively manufactured from Ti-6Al-4V per ASTM F3001. The subject screws are machined from Ti-6Al-4V per ASTM F136. The F3D Cervical Stand-Alone Interbody Fusion System includes additively manufactured interbody spacers. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer is a trapezoidal column to provide surgical stabilization of the spine. The inferior/superior aspects of the spacer incorporate a vertical cavity which can be packed with bone graft.

The acceptance criteria and study proving the device meets these criteria can be inferred from the provided FDA 510(k) summary for the F3D Cervical Stand-Alone Interbody Fusion System.

It's important to note that this document is a 510(k) summary for a medical device (interbody fusion system), not an AI/ML software device. Therefore, the questions related to AI/ML specific performance metrics (like human reader improvement with AI, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, etc.) are not applicable to this submission. The "device" in question here is a physical implant, and its performance is assessed via mechanical testing, not clinical imaging or diagnostic accuracy.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" and "reported device performance" are based on a series of non-clinical mechanical tests, demonstrating structural integrity and functional suitability. The specific quantitative acceptance criteria (e.g., minimum load bearing capacity, maximum displacement) are not explicitly stated with numerical values in this summary. Instead, the document states that the testing shows the device is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

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

• Sample Size for Test Set: This refers to the number of physical devices or components tested. The summary does not specify the sample size (number of units tested) for the mechanical tests.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. For a physical device, the "data" comes from engineering testing conducted under controlled laboratory conditions, likely at a testing facility. The document implicitly indicates this by listing "Empirical Testing Corp." as the contact for the submitter.

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

Not applicable. Ground truth in this context is established by engineering standards (ASTM standards) and physical measurements from mechanical testing, not by expert human interpretation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" in the sense of reconciling multiple human interpretations for ground truth. Testing follows defined ASTM protocols.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML software device.

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

Not applicable. This is not an AI/ML software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

• Established ASTM (American Society for Testing and Materials) standards: F2077 (for static/dynamic axial compression, compression-shear, torsion), F2267 (for subsidence). These are widely accepted engineering standards for testing spinal implant devices.
• Physical measurements and material properties: Conformance to material standards (ASTM F3001, ISO 5832-3, ASTM F136 for Ti-6Al-4V).
• Benchmarking against predicate devices: Performance is compared to "legally marketed predicate devices" to demonstrate substantial equivalence, implying that the predicates' performance serves as a comparative "truth" for acceptable safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device using a training set. The device is designed and manufactured based on engineering principles and materials science, then tested.

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

Not applicable. There is no AI/ML training set for this physical implant.

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The intended use of the F3 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The intended use of the F3 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

F3 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F3 is powered by two 12VDC 60Ah or tow 12VDC 73Ah. Group M34 batteries or Group M24. approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive wheels with drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.

This is a 510(k) premarket notification for a powered wheelchair (Permobil F3) and does not involve a diagnostic AI/ML device. Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Permobil M300 & M400) by comparing intended use, technological characteristics, and conformance to recognized standards.

However, I can extract information related to the device's performance based on the non-clinical testing:

1. Table of acceptance criteria and the reported device performance:

The document states that "The F3 complies to the below standards." This implies that the device met the requirements outlined in each standard, which serve as the acceptance criteria for those specific performance aspects. The document does not explicitly list numerical acceptance criteria or reported device performance values for each standard but asserts compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For non-clinical performance testing of a physical device like a wheelchair, the "sample size" would typically refer to the number of units tested, and the "data provenance" would relate to the testing facility and methodology. These details are not elaborated upon beyond stating compliance with international standards.

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. This is not an AI/ML device requiring expert ground truth for classification. The "ground truth" for a physical device is derived from the objective physical and functional measurements performed according to the specified test methods in the ISO standards.

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

Not applicable. This is not an AI/ML device involving human interpretation needing adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI/ML diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For this type of device, the "ground truth" is established by adherence to the objective measurements and protocols defined within the referenced international standards (e.g., ISO 7176 series). It relies on physical testing and measurement rather than expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The F3 Fractured Finger Fixator is indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers in which external skeletal fixation as provided by the F3 Fractured Finger Fixator alone is sufficient to obtain and maintain concentric reduction of the fracture-dislocation during bone and soft tissue healing.

The F3 Fractured Finger Fixator is an external skeletal fixator designed to obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint. This device exerts a volarly translating force on the middle phalanx while simultaneously lifting the distal end of the proximal phalanx to restore joint alignment. With the dorsal dislocation of the middle phalanx reduced, the fractured fragments of the joint surface are reopposed. The effect of the F3 is present throughout the complete range of finger motion allowing full active flexion and extension during healing of the bone and soft tissues.

Included with the F3 is a custom designed Pin Placement Guide that allows for a Transverse Bone Pin to be accurately placed through the axis of PIP joint rotation. The Dorsal Bone Pin inserted vertically into the middle phalanx. The F3 device is installed on the Dorsal Bone Pin and is linked to the Transverse Bone Pin with Elastic Bands. These bands provide the translating force that holds the joint concentrically reduced. A Tension Adjust Screw on the F3 allows the surgeon to "fine frune" the amount of tension in the Elastic Bands so they exert the least amount of tension necessary to me ' tain joint alignment.

The F3 Fractured Finger Fixator is manufactured using metal and plastic. The bone pins are fabricated from 316L stainless steel per ASTM F138. Both latex and non-latex elastic bands are supplied with the device. All components are designed for single use only.

The provided document is a 510(k) summary for the F3 Fractured Finger Fixator. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) submission for novel devices.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information on a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of available information related to performance and testing (though not presented as acceptance criteria or a formal study):

The document mentions that the F3 Fractured Finger Fixator is designed to "obtain and maintain concentric reduction of an unstable dorsal fracture-dislocation of the proximal interphalangeal (PIP) joint." It also states that the device allows "full active flexion and extension during healing of the bone and soft tissues."

The comparison to the predicate device (Compass PIP Joint Hinge) indicates that "The F3 is comparable to the predicate device with respect to function and application technique." However, this is a statement of design and intended use equivalence, not a direct measurement against predefined performance acceptance criteria from a clinical study. The FDA's 510(k) review determines "substantial equivalence" based on similar intended use, technological characteristics, and safety and effectiveness, rather than requiring new clinical data demonstrating performance against specific quantitative criteria if substantial equivalence can be shown otherwise.

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