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The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis. Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

This document describes the validation study for the Iconix® HA+TM Anchor, a medical device used for soft-tissue to bone fixation. This is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and established performance benchmarks for such devices, rather than a clinical accuracy study for AI/software.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, not an AI/software device, the "acceptance criteria" and "reported device performance" are primarily based on meeting established standards and demonstrating comparable mechanical properties to a predicate device.

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

The provided document describes non-clinical performance testing and an animal study. It does not describe a clinical study with a human-derived test set in the way an AI/software device would.

• Non-clinical Mechanical Testing: The sample sizes for insertion, cyclic, and pullout testing are not specified. The studies were performed to compare against the predicate device.
• Animal Study: The sample size for the animal study is not specified. The purpose was to evaluate biological safety and in vivo performance.
• Data Provenance: The document implies these were prospective laboratory and animal studies conducted by the manufacturer, Riverpoint Medical, LLC. There's no mention of country of origin for the data or whether it was retrospective.

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

This question is not applicable in the context of this device and study type.

• For non-clinical mechanical testing, the "ground truth" is typically defined by engineering specifications and objective measurements (e.g., force, displacement), not expert interpretation.
• For the animal study, "ground truth" would be established through histological analysis, observation of biological responses, and potentially pathological evaluation, conducted by veterinary pathologists or researchers, but this is not explicitly detailed as "experts establishing ground truth" in the sense of a diagnostic interpretation task.

4. Adjudication Method for the Test Set

This is not applicable. There was no human "test set" requiring adjudication in the context of an AI/software performance study. Mechanical and biological test results are typically objectively measured against defined criteria.

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

This is not applicable. This device is a physical bone anchor, not an AI/software diagnostic tool. There were no human "readers" involved in interpreting findings from the device itself.

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

This is not applicable. This device is a physical bone anchor, not an algorithm or software. The mechanical and biological tests assess the device's inherent function, which is a "standalone" evaluation of its physical properties.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth was based on objective engineering measurements (e.g., load-to-failure, displacement) and comparison to the predicate device's established performance and industry standards for bone anchors.
• Biocompatibility/Animal Study: Ground truth was based on biological responses and safety profiles observed in the animal model, likely through histological analysis, gross observations, and clinical pathology, evaluated against established safety benchmarks for implantable materials.
• Suture Testing: Ground truth was based on United States Pharmacopeia (USP) requirements for tensile strength.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device, not an AI/software model that requires a training set.

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

This is not applicable, as there was no training set.

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The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;

• sacroiliac joint disruptions
• degenerative sacroiliitis
• to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
• acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX™ 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The T-FIX™ 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The T-FIX™ screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. T-FIX™ is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The T-FIX™ screws are made from a titanium alloy Ti-6Al-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment when packaged sterile.

This 510(k) summary does not contain information regarding software or AI/ML components, and therefore does not include acceptance criteria or a study proving device performance in that context. The device described, the T-FIX™ 3DSI Joint Fusion System, is a physical medical device (implants and instruments) for sacroiliac joint fusion, not a software-based diagnostic or therapeutic tool.

The "Non-Clinical and Clinical Performance Testing" section (VIII) refers to "Additional testing was performed to determine that Steam as a sterilization method will not impact the safety or efficacy of this implant," but it does not provide details on specific acceptance criteria or study results for this testing, beyond concluding that it "does not raise any new concerns of safety or efficacy."

Therefore, I cannot provide a table of acceptance criteria and reported device performance (Point 1) or any of the detailed information related to studies proving device performance, as requested in points 2 through 9, because this information is not present in the provided text for this specific device.

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The T-FIX® 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacrolliac joint fusion for conditions including;

• sacroiliac joint disruptions
• degenerative sacroiliitis
• to augment immobilization and stabilization of the sacrolliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
• acute, non-acute and non-traumatic fractures involving the sacroiliac joint

The T-FIX® 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The subject T-FIX® 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The subject T-FIX® screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. The subject T-FIX® is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The subject T-FIX® screws are made from a titanium alloy Ti-6A1-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment.

This document is a 510(k) summary for a medical device called the T-FIX® 3DSI Joint Fusion System. It details the device's indications for use and compares its technological characteristics and performance to predicate devices to establish substantial equivalence.

Based on the provided text, the device is a smooth or threaded metallic bone fixation fastener (product code OUR) and the approval process is for a Class II device. The device is intended for fixation of sacroiliac joint disruptions and fusion for conditions including degenerative sacroiliitis, augmentation of sacropelvic fixation in lumbar/thoracolumbar fusion, and acute/non-acute/non-traumatic fractures involving the sacroiliac joint.

The provided text does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance, nor does it define such acceptance criteria. The "performance testing" described is mechanical testing of the physical device and non-pyrogenicity endotoxin testing.

Therefore, I cannot provide a response fulfilling the request for acceptance criteria and study details related to AI/ML device performance. This document pertains to the regulatory clearance of a physical implantable medical device, not a software or AI/ML-driven diagnostic or assistive device.

To directly address the specific points of your request based on the available document:

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

   • Acceptance Criteria (Mechanical): The device must demonstrate "substantial equivalent performance" to identified predicates based on specific mechanical tests.
     • ASTM F543 (Static cantilever bending, Axial Pullout, Torque to Failure, and Dynamic cantilever bending)
     • ASTM F2193
   • Reported Performance (Mechanical): "In all, the biomechanical testing results demonstrate that the T-FIX® 3DSI Joint Fusion System is substantially equivalent to the predicate device."
   • Acceptance Criteria (Non-Pyrogenicity): The implants must meet the 20 endotoxin units (EU)/device pyrogen limit specification.
     • ANSI/AAMI ST72
     • USP <161>
   • Reported Performance (Non-Pyrogenicity): "the worst case subject EVOL® -SI Joint Fusion System implants verify that the subject implants (line extension T-FIX® 3DSI) meet the 20 endotoxin units (EU)/device pyrogen limit specification..."

2. Sample size used for the test set and the data provenance: Not applicable/not stated. The performance evaluation is based on mechanical properties of the device, not a data-driven test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and test results.

4. Adjudication method 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, as this is not an AI/ML device.

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

7. The type of ground truth used: Not applicable in the context of diagnostic performance. For mechanical testing, the ground truth is the specified performance thresholds per ASTM and ANSI/AAMI standards.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle:

post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for uncemented applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Porous Femur with HA"™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.

The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.

This document, K210308, is a 510(k) Premarket Notification for a medical device. It describes a new iteration of a total knee implant, the EMPOWR POROUS FEMUR with HAnano Surface™. The document focuses on demonstrating substantial equivalence to a predicate device, as clinical testing was not required for this submission. Therefore, the information provided primarily concerns non-clinical testing and comparisons, rather than a detailed study proving the device meets an extensive set of acceptance criteria through clinical trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through non-clinical testing, rather than explicit performance metrics derived from a clinical trial with pre-defined success/failure thresholds. The reported performance is framed in terms of meeting these comparison points.

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

• Sample Size for Test Set: Not applicable in the context of human clinical data for this 510(k) submission. The "test set" here refers to non-clinical laboratory tests on device components or full devices. The document does not specify the number of samples used for each non-clinical test (e.g., how many devices were subjected to abrasion testing).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, DJO Surgical (Legal Name: Encore Medical, L.P.). The document does not specify the country of origin for these lab tests, but it is implied to be internal testing or contracted testing performed under the manufacturer's oversight. The testing is not retrospective or prospective clinical data, but rather bench and material testing.

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

• This question is not applicable as there was no "ground truth" derived from human experts for a clinical test set. The ground truth in this context would be the results of the non-clinical tests (e.g., passing or failing a fatigue test, measured wear rates). These results are obtained through standardized testing protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable. There was no human "test set" in need of adjudication. The non-clinical tests have objective outcomes based on established methods and criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance

• Not applicable. This device is a medical implant (total knee prosthesis), not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described in the provided text.

6. If a Standalone (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

• As discussed, "ground truth" here refers to the outcomes of the non-clinical tests. The types of "ground truth" used are:
  • Engineering Test Results: Measurements from abrasion testing, pin-on-disk wear testing, fatigue testing, contact area testing.
  • Biocompatibility/Safety Testing: Bacterial endotoxin assessment results compared against pre-defined specifications (20 EU/device).
  • Material and Geometric Specifications: Confirmation that the new device's substrate material, geometry, and porous coating are identical to the predicate.
  • Predicate Device Performance: Reliance on the previously cleared predicate's mechanical testing results for identical geometries.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission as it does not involve machine learning or AI.

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

• Not applicable. See point 8.

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The Innovasis® TxTiHA™ IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis® AxTiHA™ Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.

TxTiHA™ IBF System
The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.

AxTiHA™ Stand-Alone ALIF System
The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth.

The provided text is a 510(k) summary from the FDA for two intervertebral body fusion devices, the TxTiHA™ IBF System and the AxTiHA™ Stand-Alone ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than presenting a clinical study or acceptance criteria in the typical sense for a new AI/medical device.

Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (especially those related to clinical trials, AI, ground truth, and human reader performance) is not present in this document.

However, I can extract the information that is available:

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

The document does not provide a table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing:

The core "acceptance" for this type of device (a 510(k) submission) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Sample Size: Not applicable. The document describes non-clinical performance testing of the devices themselves (e.g., mechanical strength), not a clinical test set involving patient data or imaging. Therefore, concepts like sample size of patients, data provenance, retrospective/prospective studies, or country of origin are not mentioned.
• Data Provenance: The non-clinical tests likely occurred in a lab setting. The company is Innovasis, Inc. in Salt Lake City, Utah, USA.

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 document does not describe a clinical study requiring human experts for ground truth establishment.

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

Not applicable. There is no test set in the clinical sense described here.

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-assisted device, nor does the document describe 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 device.

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

Not applicable. The "ground truth" for these physical devices is their compliance with specified ASTM standards and material properties, verified through non-clinical mechanical testing, rather than clinical outcomes or expert labels.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set described.

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