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1. Non-inflammatory degenerative joint disease Including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

This device is a single use implant and intended for cementless use only.

Resolve Modular Revision Hip Stem is a modular stem optimized for femoral primary or revision surgery. It consists of three main components:
(1) Resolve Proximal Component (two types: With Hole or No Hole, each available with HA/Ti plasma spray or Ti plasma spray coating)
(2) Resolve Distal Stem (four types: Taper Stem, Clothespin Stem, Clothespin With Hole Stem, and Interlocking Stems. Taper Stem is uncoated; others are available with HA/Ti plasma spray or Ti plasma spray coating. Clothespin With Hole Stem and Interlocking stem provide holes for additional Distal Interlocking Screw fixation.)
(3) Resolve Distal Interlocking Screw (used with Resolve Clothespin With Hole Stem and Interlocking stem)

Resolve Modular Revision Hip Stem can be used with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

All components are manufactured from Ti-6Al-4V alloy (ASTM F136). The coatings (HA/Ti plasma spray and Ti plasma spray) comply with ASTM F1580 and ASTM F1185, ISO 13779-6. Proximal components have standard and high offset designs.

Based on the provided FDA 510(k) Clearance Letter for the "Resolve Modular Revision Hip Stem," it's crucial to understand that this document pertains to a physical medical device (an orthopedic implant), not a software-based medical device or AI/ML algorithm.

Therefore, the concepts of "acceptance criteria for an AI/ML algorithm," "test set," "ground truth establishment," "expert adjudication," "MRMC studies," and "standalone performance" do not apply to the information contained within this 510(k) filing.

The 510(k) process for a physical device like this hip stem primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through:

• Indications for Use Comparison: Showing the device is intended for the same medical purposes.
• Technological Comparison: Demonstrating similar fundamental scientific principles, materials, design, and operating conditions.
• Non-Clinical (Bench) Testing: Conducting a series of engineering and materials tests to ensure the device meets specified mechanical and material performance standards, and that it is as safe and effective as the predicate devices.
• No Clinical Studies (unless specifically required): The letter explicitly states "No clinical studies were required or provided," which is common for devices demonstrating substantial equivalence through bench testing.

There is no "AI/ML algorithm" or "software performance" to describe acceptance criteria or study results for in this context.

Instead, I can extract and present the relevant information about the acceptance of this physical medical device based on the given 510(k) letter.

Acceptance Criteria and Study for the Resolve Modular Revision Hip Stem (Physical Device)

The "acceptance criteria" for a physical device in a 510(k) submission are not typically presented as a table of accuracy metrics. Instead, they are demonstrated by meeting various engineering and material standards, and by showing that the device performs similarly (or better) than the predicate devices in specified non-clinical tests. The "study" refers to the non-clinical (bench) testing performed.

1. Table of "Acceptance Criteria" (represented by tests aligned with regulatory standards) and "Reported Device Performance" (implied compliance or successful test outcomes):

Explanation of "Reported Device Performance": The document states: "Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that this device is safe and effective." This implies that the device successfully met the requirements and specifications of each listed test and standard, thus demonstrating its safety and effectiveness. Specific numerical performance values are not typically included in the summary letter itself but would be detailed in the full submission.

2. Sample Size and Data Provenance:

• Sample Size: Not explicitly stated for each test (e.g., number of stems tested for fatigue). These are typically engineering bench tests on a representative sample of device components or full devices.
• Data Provenance: The tests are non-clinical (bench tests), meaning they were conducted in a laboratory setting, not with human patient data. The manufacturer, United Orthopedic Corporation, is based in Taiwan.

3. Number of Experts and Qualifications for Ground Truth:

• This concept is not applicable as this is a physical device clearance based on non-clinical bench testing, not an AI/ML algorithm requiring expert review for ground truth establishment.

4. Adjudication Method:

• Not applicable for a physical device and non-clinical bench testing.

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

• Not applicable. This is a clearance for a physical orthopedic implant. The letter explicitly states: "No clinical studies were required or provided." MRMC studies are typically performed for imaging-based AI/ML devices to assess human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only):

• Not applicable as there is no algorithm. The performance documented is the standalone mechanical and material performance of the physical implant itself through a series of bench tests.

7. Type of Ground Truth Used:

• For the physical device, the "ground truth" for acceptance is based on established engineering standards (e.g., ISO, ASTM) and regulatory guidance (FDA guidance documents) for mechanical, material, and biological compatibility properties of orthopedic implants. Compliance with these predetermined, objective standards serves as the "ground truth" for safe and effective performance.

8. Sample Size for Training Set:

• Not applicable. This is not a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed based on extensive engineering principles, materials science, and prior knowledge from predicate devices.

9. How Ground Truth for Training Set was Established:

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's design and material selection would be established through decades of orthopedic research, biomechanical principles, and clinical experience with similar implants.

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The COREPASS FLEX/CONTROL microcatheters are indicated for:
· supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature).
· exchanging guidewires in the coronary and peripheral vasculature.
· the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

The provided text is a summary of a 510(k) premarket notification for a medical device (COREPASS Modular Microcatheter) and does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic tool. The document focuses on the regulatory clearance process for a physical medical catheter device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance (in the context of an AI device)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The "Performance Data" section in the document lists various physical and material-related tests conducted on the microcatheter (e.g., Sterilization, Shelf-Life Performance, Particulate Evaluation, Dimension Inspection, Media Flow Rate, Shaft Burst Pressure, Guidewire Compatibility, Coating Integrity, Flexibility and Kinking, Corrosion Resistance, Torque Strength, Tensile Strength, Radiopacity, and a range of Biocompatibility tests). It simply states:

"The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use."

This confirms that acceptance criteria exist for these physical properties and that the device met them, but the document does not elaborate on what those specific criteria are nor does it describe a study design in the way one would for an AI/software as a medical device (SaMD).

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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The provided text is an FDA 510(k) clearance letter for a medical device called the "MASADA Modular Spinal Fixation System." This document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML system.

The "Non-clinical Test Summary" explicitly states: "An engineering analysis determined that no new worst case conditions have been introduced since the previously cleared submission (K231694)." and the "Clinical Test Summary" explicitly states: "No clinical studies were performed."

This means the clearance was based on substantial equivalence to predicate devices through design, materials, and engineering analysis, rather than new performance data from a clinical or AI/ML-specific study.

Therefore, I cannot provide the requested table and details about acceptance criteria and study findings for an AI/ML device based on the given input.

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The HAnano InterFuse® Modular Interbody is intended to be used for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The HAnano InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous nonfusion surgery at the involved spinal level(s). The HAnano InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

The HA™" InterFuse® Modular Interbody is a modular lumbar intervertebral body fusion device with an implantable portion composed of polyetheretherketone (PEEK), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. This device is designed to be implanted via a PLIF approach utilizing a minimally invasive surgical technique to restore collapsed/afflicted disc space. The device construct consists of an initial A module, any number of middle B modules to appropriately fill the interbody space, and a final C module in which each module interlocks with the adjacent module(s). These modules are inserted via a rail system in which a PEEK and stainless steel tail attached to each module extends beyond the disc space and allows the modules to be inserted in a sequential fashion. The PEEK portion of the tail can be detaches the entire rail and allows the modules to be progressed laterally in the disc space and repeated to construct the implant in an in situ fashion. The modules will be manufactured in several different size/lordotic options to appropriately accommodate patient pathologies.

I am sorry, but the provided text does not contain the information required to fulfill your request. The document describes a 510(k) submission for a medical device (Intervertebral Body Fusion Device) and focuses on demonstrating substantial equivalence to a predicate device. It discusses the device's description, indications for use, modifications, and a summary of technological characteristics.

Crucially, it explicitly states:

• "Performance Testing - Clinical: Clinical testing was not applicable to support a substantial equivalence determination for the subject device."

This indicates that no clinical study (which would typically involve defining acceptance criteria, using a test set, establishing ground truth, and potentially MRMC studies) was conducted or presented in this submission. Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily relies on non-clinical performance testing related to material strength and surface coating (adhesion testing) to support the substantial equivalence claim.

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The Modular Medical MODD1 Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

The Modular Medical MODD1 Insulin Delivery System (i.e., MODD1 System) consists of the following:

• A reusable, software-controlled programmable Pump,
• A single-use, disposable 3.0mL (300 unit) Insulin Cartridge with an integrated battery to supply power to the Pump, infusion tubing, and Tubing Cap for attaching to the Infusion Set.
• . A single-use, disposable Adhesive Pad for affixing the MODD1 System to the user's body and allowing for temporary removal of the MODD1 System,
• A single-use, disposable Infusion Set inserted into the patient's subcutaneous tissue, and
• The MMI App, a smartphone application used to program the basal delivery schedule on the Pump.

Accessories to the MODD1 System are FDA-cleared and include the following:

• A single-use disposable syringe (K110771) and needle (K021475) used to fill the Insulin Cartridge reservoir, and
• A reusable Inserter (K163400), optionally used to insert the Infusion Set into the patient's subcutaneous tissue.

The MODD1 System has been demonstrated to be compatible with Humalog U-100 insulin.

The MODD1 System can deliver insulin at basal rates between 0.5 - 4 units per hour (programmable in 0.1-unit increments) and user-selected bolus doses of between 2 and 20 units (in 2-unit increments). Basal insulin delivery may also be suspended for a set period of 30 minutes when required by the user.

The delivery of insulin is achieved by gear motor rotation of a single fixed-position camshaft (components of the Pump controlled by software) that interfaces with the Insulin Cartridge pistons to control the movement of insulin from the insulin reservoir, into an interim chamber, and into the infusion tubing towards the Infusion Set inserted into the patient's subcutaneous tissue. Software monitors dispense output via feedback provided by multiple sensors, providing an alarm when issues with delivery (e.g., malfunctions, low reservoir volume, occlusions) are detected.

The Pump serves as the primary user interface of the MODD1 System. A Control Button is used to prime the fluid path, program bolus deliveries, check system status, and to temporarily suspend insulin delivery. The multi-color LED and piezo buzzer of the Pump provide audio-visual feedback to the user during the set-up process, programming of a bolus delivery, and changing of delivery modes (e.g., bolus, basal, suspend). Audio-visual feedback is also used to inform the user of system alarms (automatically generated) and system status (when requested by the user).

The MMI App is downloaded directly onto an Apple® iPhone 12 Pro Max running iOS version 16. The MMI App allows for the configuration of a basal delivery schedule on the Pump, consisting of up to two basal rates in a 24-hour period. The MMI App and Pump communicate using Bluetooth® Low Energy (BLE) and Near Field Communication (NFC). After the basal delivery schedule has been programmed on the Pump, all insulin delivery functions are controlled using the Pump user interface. Optional features of the MMI App include a dashboard display of current and historical Pump information and delivery history.

The provided text is a 510(k) Summary for the Modular Medical MODD1 Insulin Delivery System. It details the device, its indications for use, comparison to a predicate device, and a summary of non-clinical performance data.

However, the document does not provide information on an AI-driven medical device, nor does it conduct a study involving human readers or expert ground truth. It describes the regulatory submission for an insulin pump.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details from the provided text.

The text describes compliance with various medical device standards (e.g., ISO 14971, IEC 62366-1, ISO 10993-1, IEC 60601-1, IEC 62304) and includes bench testing for infusion delivery accuracy and occlusion detection, but these are part of standard medical device validation, not specific to AI performance as requested in the prompt.

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The Stryker Global Modular Replacement System, Modular Replacement System and Modular Rotating Hinge Knee Component are sterile, single-use devices intended for use in situations where there is a need for replacement of bone due to radical bone loss. This loss can be related to oncology, trauma or failed previous prosthesis. Specific Indications for Use are listed below.

Indications for the MRS Stems and Intercalary Stems (presented in K952970):

• This device is intended for use in patients requiring extensive reconstruction of the femur . and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.
• The Intercalary System is intended for use in situations arising from femoral mid-shaft tumor resection, or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

• Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581):

• Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217):
Proximal femoral reconstruction secondary to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Replacement System Cemented Stems (presented in K040749):
Femoral and/or proximal tibial replacement due to:
o Trauma
o Failed previous prosthesis
o Tumor resection

Indications for the Modular Rotating Hinge Knee System (presented in K002552):

• The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where there is destruction of the joint surfaces, with or without significant bone deformity; the cruciate and/or collateral ligaments do not stabilize the knee joint; the ligaments are inadequate and/or the musculature is weak; and revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

The Global Modular Replacement System (GMRS) is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System (MRS) or the Modular Rotating Hinge Knee System (MRH). The Modular Rotating Hinge Knee System is a tricompartmental knee system. The system consists of a stemmed femoral component and a stemmed tibial bearing component connected by a set of bushings and an axle. The MRH Tibial Rotating component is a part of the MRH system and mates with the GMRS Standard Proximal Tibia. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis.

The provided FDA 510(k) clearance letter and summary for the Stryker Orthopaedics Global Modular Replacement System, Modular Replacement System, and Modular Rotating Hinge Knee Component does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria.

This document is a clearance letter indicating a determination of "substantial equivalence" to previously marketed predicate devices. It does not present novel performance data or studies against pre-defined acceptance criteria.

The key statements from the document that confirm this are:

• "Non-Clinical Testing: Non-Clinical testing was not required as a basis for substantial equivalence." (Page 8)
• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence." (Page 8)

The submission focuses on adding a contraindication to the labeling, updating MRI Safety information, and making clerical updates to the Instructions for Use (IFUs). These changes do not necessitate new performance studies for substantial equivalence.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and studies because the provided document explicitly states that such testing was not required for this particular 510(k) submission.

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The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterlizations for the worst-case CrossRoads Modular Tray System included surgical instruments such as inserters, reamers, and ratcheting handles. The CrossRoads Modular Tray System is validated for a maximum load of 18.7 lbs (tray + instruments).

Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Drying time: 20 minutes

Dimensions do not exceed: 20.546" length x 10.022" width x 3.978" depth

The CrossRoads Modular Tray System is a reusable sterilization case with organizing trays intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects instruments during sterilization. All components are perforated for steam penetration. The tray can hold CrossRoads surgical instruments.

This document is a 510(k) Premarket Notification from the FDA for a medical device. It describes a sterilization wrap/case called the "CrossRoads Modular Tray System." The information pertains to the device's functional performance related to sterilization and handling, not to an AI/ML-driven diagnostic or image analysis system.

Therefore, the requested information elements such as "sample size for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable to this type of device and its regulatory review process. These questions are typically relevant for AI/ML-based diagnostic devices.

The document focuses on engineering and performance testing for mechanical and sterilization efficacy, not AI algorithm performance.

However, I can provide the acceptance criteria and reported device performance from the document based on the provided tables.

Acceptance Criteria and Reported Device Performance for CrossRoads Modular Tray System (K241050)

The device is a reusable sterilization case. The tests performed are standard engineering and sterilization validation tests, not AI/ML performance evaluations.

Table of Acceptance Criteria and Reported Device Performance

Dry Time Validation: The dry time validation is successful if the weight differential of the wrapped case after sterilization does not increase by 0.2% of the pre-sterilization weight, and there is no evidence of moisture on or within the sterilized package, wrap, and instruments. | Pass |
| Cleaning Validation | AAMI TIR30:2011, ISO19227, AAMI TIR12:2020, AAMI ST98:2022, ASTM F2459 (2018), ASTM D4839-03 (2017) | Acceptance Criteria 1 (Visual Inspection): Visibly clean without evidence of discoloration, residue or particulate to the unaided eye without magnification under normal task lighting.

Acceptance Criteria 2 (Protein): ≤ 6.4 µg/cm²

Acceptance Criteria 3 (Hemoglobin): ≤ 2.2 µg/cm²

Acceptance Criteria 4 (TOC): ≤ 1000 mg/device (or 100 mg/cm² for devices larger than 50cm²) | Pass |
| Biocompatibility | ISO 10993-1:2018 | The materials are biocompatible. | Pass |
| Handle Strength Assessment | Shear and Tensile Strength Analysis - 501913762 | The lowest failure force determined in the assessment of handle assembly components must be greater than the maximum load of 18.7 lbs. | Pass |

Based on the provided document, the following requested information is not applicable or not provided, as the device is a sterilization tray and not an AI/ML diagnostic system:

2. Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/ML model. The tests conducted (sterilization, cleaning, biocompatibility, handle strength) would involve specific numbers of units or samples as per the relevant standards, but this is not a "test set" for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of physical device testing.
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 these tests is defined by physical/chemical measurements and standardized biological indicator responses, not expert human 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.
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.): Ground truth for these tests is based on the results of validated physical and chemical tests (e.g., microbial growth/no growth, weight change, protein/hemoglobin/TOC levels, force measurements). Not based on expert consensus or pathology in a diagnostic sense.
8. The sample size for the training set: Not applicable (no training set for a traditional engineering device).
9. How the ground truth for the training set was established: Not applicable.

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The EVOLUTION® Hinge Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Hinge Knee System implants are for cemented use only.

GUARDIAN™ Limb Salvage Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/ or total femur is required with the following conditions: 1) patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The GUARDIANTM Limb Salvage Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment: 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications. 3) metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The DCW Modular Distal Femoral System is primarily indicated for procedures in which a variable resection length prosthesis is necessary to accommodate the condition of the femur, e.g. bone loss/removal in disease-related knee arthroplasty or a distally fractured femur. It is also indicated for revious total knee replacement where the femoral prosthesis has loosened, broken, or requires surgical removal for another medical reason. These indications are intended to provide relief of pain and restoration of knee function in skeletally mature patients.

Limb salvage surgery is indicated for cemented procedures where radical resection and replacement of the distal femur and/or proximal tibia is required with the following conditions: 1. patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2. surgical intervention for severe trauma. revision knee arthroplasties, and/or oncology indications. 3. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors)

The EVOLUTION® MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. inflammatory degenerative joint disease including rheumatoid arthritis; 3. correction of functional deformity: 4. revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Total Knee System nonporous components are for cemented use only. The EVOLUTION® Total Knee System porous components are for use without bone cement.

The ADVANCE® Total Knee System components are indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity: 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Total Knee System is for single use. The Advance Total Knee System porous components are for use without bone cement. The Advance Total Knee System non-porous components are for use with bone cement.

The Whiteside Condylar II™ Total Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis or traumatic arthritis, with or without moderate valgus, varus, or flexion deformities. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only.

The Whiteside ORTHOLOC™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. The prosthesis is also indicated for revision of a failed prosthesis where the cruciate ligaments are absent ligaments are intact. The device is intended for cemented use only.

The Whiteside ORTHOLOC® M.A. Total Knee System is indicated for use in conjunction with the metal tibial base of the Whiteside ORTHOLOC® II Total Knee System for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental or tricompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The prosthesis is also indicated for revision of a failed prosthesis where the posterior cruciate and collateral ligaments are intact. The device is intended for cemented use only.

The AXIOM ACL Retaining Tibial Tray and Tibial Insert are used in total knee arthroplasty for replacement of the tibial plateau of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. AXIOM ACL Retaining Tibial Tray and Tibial Insert are for cemented use only.

The A/P Curved Tibial Insert is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The A/P Curved Tibial Insert is intended for cemented application only.

The Second Generation Knee System is used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. The Second Generation Knee System is intended for cemented application only.

The Whiteside ORTHOLOC® Modular Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities, where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis. where the cruciate ligaments are absent. This device is intended for cemented use only.

The Modular Femoral Component and Constrained Tibial insert are used in total knee arthroplasty for replacement of the femoral condyles, tibial plateau and patella articulating surface of the knee joint due to degenerative bone disease, trauma, moderate deformity, or complications from failed prostheses. Additional indications specific to the Modular Femoral Component and Constrained Tibial Insert include use in patients with anterior/posterior, varus/valgus, and rotational joint instability resulting from inadequate or absent cruciate and collateral ligaments, or who's knee can not be stabilized by usual soft tissue management. This device is intended for single use in a cemented application only.

The ORTHOLOC® Tibial Plastic Insert, as part the ORTHOLOC® Total Knee System, is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis, traumatic arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate and collateral ligaments are intact. The system is also indicated for revision of failed prosthesis where the posterior cruciate and collateral ligaments are intended for cemented use only.

Total knee arthroplasty has been proved effective in reducing pain and in restoring functional knee motion. Such surgical procedures have been used in the management of: painful disabling bicompartmental joint disease secondary to osteoarthritis, theumatic arthritis; posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities. The device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cemented use only.

The ORTHOLOC® ADVANTIM™ Posterior Stabilized Knee System is indicated for relief of pain and restoration of knee function in skeletally mature patients with bicompartmental joint disease secondary to osteoarthritis, inflammatory arthritis or rheumatoid arthritis, with or without valgus, varus, or flexion deformities where the posterior cruciate ligaments are inadequate, absent or unable to be preserved intraoperatively. This prosthesis is also indicated for revision of a failed prosthesis, where the cruciate ligaments are absent.

The ULTRACK™ Total Knee System is intended for bicompartmental replacement of the knee joint for reduction of pain or increased function for the following conditions: 1) Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis; 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity: 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of fractures that are unmanageable using other techniques. This device is intended for cemented use only.

The subject devices include the following affected components: Tibial spacers manufactured from UHMWPE; Tibial hinge base with stop pins manufactured from UHMWPE, titanium alloy, and cobalt chromium alloys; Hinge bushings manufactured from UHMWPE; Tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy, cobalt chromium tungsten allov, and cobalt chromium molybdenum alloy; Femoral axial pins manufactured from combination UHMWPE and cobalt chromium molybdenum alloy and combination high density polyethylene (HDPE) and cobalt chromium alloy; Yoke extension stops manufactured from UHMWPE; Patellae manufactured from UHMWPE and cobalt chromium tungsten alloy. The subject materials conform to the following standards: GUR 1050 UHMWPE conforming to ASTM F648; GUR 1020 UHMWPE conforming to ASTM F648; High-density polyethylene; Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy conforming to ASTM F136; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F75; Cobalt-28 Chromium-6 Molybdenum Alloy conforming to ASTM F799; GUR 1020 5 MRad Cross-linked Polyethylene conforming to ASTM F648; Cobalt-20Chromium-15Tungsten-10Nickel Alloy conforming to ASTM F90.

The provided text is a compilation of FDA 510(k) clearance letters and summaries for various knee and limb salvage systems manufactured by MicroPort Orthopedics Inc. These documents primarily address administrative changes related to sterilization suppliers and parameters and assert substantial equivalence to previously cleared devices.

Crucially, the documents explicitly state that "No bench testing, animal testing, or clinical testing was performed to support this submission" ([28]D, [37]D) and "Clinical data were not submitted or relied on for a determination of substantial equivalence" ([29]E, [37]E).

Therefore, based solely on the provided text, it's not possible to describe acceptance criteria or a study that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a newly designed medical device.

The "study" referenced in these documents is limited to:

• Validation of sterilization parameters (Ethylene Oxide Sterilization Validation Report) according to ISO standards (ISO 11135:2014, ISO/TS 21387, and ISO 10993-7:2008) to demonstrate the new supplier can achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
• Biocompatibility assessment of the materials, concluding no impact on biological safety due to the change in sterilization supplier/parameters.

The acceptance criteria here are related to the maintenance of sterility and biocompatibility following a change in the manufacturing process (specifically, the sterilization supplier and parameters) for devices that have already established substantial equivalence through previous 510(k) submissions.

Given this context, I will address the questions to the best of my ability based on the information provided, explicitly stating where information is "Not Applicable" or "Not Provided" due to the nature of this particular 510(k) submission (change in sterilization process for already cleared devices, not a new device performance study).

Acceptance Criteria and Study for Sterilization Process Change (based on the provided document)

The core "study" described in the provided text is the validation of a change in Ethylene Oxide (EO) sterilization supplier and parameters for a range of existing knee and limb salvage system implants. The device performance being "proven" here is the continued sterility and biocompatibility of these devices after this change, asserting they remain as safe and effective as their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of devices) used for the sterilization validation or biocompatibility assessment. It states that the "subject sterilization process underwent sterilization" and that "biocompatibility assessment... was assessed" ([28]D, [37]D). Regulatory requirements for sterilization validation (e.g., ISO 11135) dictate specific sample sizes for sterility testing (e.g., bioburden, sterility tests). However, these specific numbers are not provided in this summary.
• Data Provenance: The data comes from internal validation studies conducted by MicroPort Orthopedics Inc. (or their contracted sterilization supplier) to support the change. The country of origin for the data is not explicitly stated, but MicroPort Orthopedics Inc. is based in Arlington, Tennessee, USA ([24] Submitted by, [30] Submitted by). The studies are prospective in the sense that they were conducted specifically to validate the new sterilization process before seeking 510(k) clearance for the change.

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

• Not Applicable in this context. This 510(k) submission is about validating a manufacturing process change (sterilization), not evaluating clinical performance or diagnostic accuracy. Therefore, there is no "ground truth" established by clinical experts for a test set in the sense of image interpretation or medical diagnosis. The "ground truth" for sterilization is defined by established international standards (ISO series) for achieving a specific SAL, and for biocompatibility, by biological safety assessments.

4. Adjudication Method for the Test Set

• Not Applicable. As no clinical or diagnostic test set requiring expert interpretation or consensus was performed, no adjudication method was used. The assessment relied on adherence to scientific and engineering standards for sterilization and material biocompatibility.

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 MRMC study was done. The device type (knee and limb salvage system implants) is a physical implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. The devices are physical implants, not algorithms.

7. The Type of Ground Truth Used

• The "ground truth" for this submission revolves around compliance with established international standards for sterilization and biocompatibility:
  • Sterilization: The ground truth is the achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ as defined by ISO 11135:2014 and ISO/TS 21387.
  • Biocompatibility: The ground truth is the absence of adverse biological reactions as demonstrated by assessment against ISO 10993-7:2008 and other relevant biocompatibility standards, ensuring material properties and device characteristics are unaffected.

8. The Sample Size for the Training Set

• Not Applicable. This submission is not for a new device development involving a "training set" for an algorithm. The "training" in this context refers to manufacturing process validation.

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

• Not Applicable. As above, no training set for an algorithm exists here. The "ground truth" for the overall device's safety and effectiveness was previously established by the predicate devices which had undergone their own respective regulatory clearances, covering aspects like design, materials, and clinical performance (if applicable). This 510(k) only addresses the impact of a change in sterilization supplier on these already established devices.

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Indications for the MRS Stems and Intercalary Stems (presented in K952970):

· This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement.

· The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection. or for prosthetic knee fusion.

Indications for the Global Modular Replacement System (presented in K023087):

· Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications.

Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581)

· Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement.

Indications for the Modular Replacement System Cemented Stems (cleared in K040749):

· Femoral and/or proximal tibial replacement due to:
- Trauma
- Failed previous prosthesis
- Tumor resection

The Global Modular Replacement System is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of the Modular Replacement System or the Modular Rotating Hinge Knee System. These devices are intended to be used in clinical situations where there is radical bone loss of the femur and/or proximal tibia. This radical bone loss can be related to oncology (tumor), trauma or failed previous prosthesis. The subject Global Modular Replacement System components are unchanged since the last premarket notification for the devices in K222056.

This document is entirely focused on a 510(k) premarket notification for a medical device called the "Global Modular Replacement System." It is a request for approval to market the device, and the content details its intended use, a comparison to legally marketed predicate devices, and a summary of its technological characteristics.

Crucially, this document does not contain any information about acceptance criteria, device performance testing results, ground truth establishment, sample sizes for training or test sets, expert qualifications, or MRMC studies for an AI/software device. The request is specifically for a physical medical device (hip and knee prostheses) and its purpose is to update labeling, including adding a contraindication and updating MRI safety information.

The sections you've requested (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, MRMC studies) are typically relevant for AI/Software as a Medical Device (SaMD) submissions where software algorithms are being evaluated for diagnostic or prognostic purposes.

Therefore, I cannot fulfill your request as the provided text does not contain the information you are asking for. It explicitly states:

"No additional testing was conducted for this submission, as the only changes being made are to modify the labeling to add a contraindication and an update to the MRI safety information to align with an FDA guidance document. Testing performed in the previously cleared premarket notifications is applicable to this submission." (Page 10)

This confirms that no new performance studies, as would be required for an AI/Software component, were performed or are detailed in this 510(k) submission.

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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( 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), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediative patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolessent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions.
  The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

This document is an FDA 510(k) clearance letter for the MASADA Modular Spinal Fixation System. It does not describe an AI medical device or any study proving a device meets acceptance criteria related to AI performance. Therefore, I cannot provide the requested information.

The document primarily focuses on:

• Device name: MASADA Modular Spinal Fixation System
• Regulatory classification: Class II, Thoracolumbosacral Pedicle Screw System, Spinal Interlaminar Fixation Orthosis, Bone Fixation Cerclage, Orthopedic Stereotaxic Instrument.
• Intended Use/Indications for Use: Immobilization and stabilization of the posterior, non-cervical spine, including an articulated "Navigated Instrument System" for guiding surgical placement using imaging (CT, MR, fluoroscopy). Also includes a Sublaminar Band System.
• Substantial Equivalence: Comparison to predicate devices (OLYMPIC Posterior Spinal Fixation System, OLYMPIC Navigated Instruments, OLYMPIC Deformity Band System, Globus CREO Stabilization System).
• Non-clinical testing: Static Compression Bending, Dynamic Compression Bending, Static Torsion, Tulip Dissociation (all mechanical tests according to ASTM standards).
• Clinical testing: Explicitly states "No clinical studies were performed."

The request asks for details specific to an AI/ML powered device, including:

1. Table of acceptance criteria and device performance (AI metrics).
2. Sample size and data provenance for a "test set" (implying data used for AI evaluation).
3. Number and qualification of experts for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (human reader improvement with AI).
6. Standalone (algorithm only) performance.
7. Type of ground truth (e.g., pathology, outcomes data).
8. Training set sample size and ground truth establishment for training.

None of this information is present in the provided text because the MASADA Modular Spinal Fixation System is a physical surgical implant and instrument system, not an AI/ML-driven diagnostic or therapeutic device. The "Navigated Instrument System" component uses existing imaging modalities (CT, MR) and a Medtronic StealthStation® System for anatomical localization, which is a computer-assisted surgical navigation system, but not an AI-powered device that processes medical images for diagnostic or prognostic purposes to which AI-specific acceptance criteria and studies would apply.

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