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Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

• Sternotomy indications including the "rewiring" of osteomized sternums;
• Repair of long bone fractures due to trauma or reconstruction.

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
• Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

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

• For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
• The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

• Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

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

• No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
• The document explicitly states: "No clinical data were included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
• Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

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

• Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

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The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

The Arthrex Humeral Plating and Cerclage Button consist of straight humeral plates and a 3.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 90.5 - 309 mm and include suture holes for soft tissue refixation. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294) and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria, as typically found in submissions for AI/ML-based medical devices. The document describes a traditional 510(k) premarket notification for a Class II metallic bone fixation appliance (Arthrex Humeral Plating System and Cerclage Button).

The "Performance Data" section mentions mechanical testing (4-point bend, MRI compatibility) and bacterial endotoxin testing, which are standard for orthopedic implants to demonstrate engineering performance and biocompatibility compared to predicate devices. However, this is not a study proving an AI/ML device meets clinical acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you listed, such as sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device described in this document.

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Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
• · Repair of long bone fractures due to trauma or reconstruction
• · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
• · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.

The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:

Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.

• Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
• Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.

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

Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation requiring 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 device is a surgical suture, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
• Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP pyrogen limits) to ensure the device does not cause adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, no AI model or training set is applicable here.

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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 Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.

Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as requested. It's important to note that the document primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence, rather than a clinical effectiveness study with human subjects.

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes performance tests conducted and the general outcomes. The acceptance criteria can be inferred from the stated goals of the tests.

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 for Test Set: The document does not specify the exact number of devices or test samples used for the quasi-static load, dynamic resistance, pyrogenicity, or biocompatibility tests. It only mentions that the tests were conducted. For the Design Validation, it states "sawbone workshop," implying physical models were used, but the quantity of models or devices tested within the workshop is not detailed.
• Data Provenance: Not explicitly stated. The manufacturer, Medacta International SA, is located in Switzerland, but the location where the tests were performed or the origin of any raw data used in validation is not mentioned. Given these are non-clinical hardware tests, "retrospective or prospective" doesn't directly apply in the same way it would to clinical patient data. The tests are prospective in the sense that they were planned and executed to support the submission.

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 device is a bone fixation cable, and the performance data presented is from non-clinical mechanical, material, and sterilization tests. The "ground truth" for these types of tests is established by industry standards, engineering principles, and validated test methods, rather than expert consensus on medical images or patient outcomes. The "sawbone workshop" likely involved surgical or biomechanical experts, but their number and specific qualifications are not detailed.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret data to establish a ground truth or resolve discrepancies. These methods are not relevant for the non-clinical hardware validation tests described.

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

No. This is a medical device (bone fixation cable), not an AI/CAD system. Therefore, an MRMC study or AI assistance evaluation is not relevant or applicable.

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

Not applicable. This is a medical device, not a software algorithm.

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

For the non-clinical tests described:

• Mechanical Performance: Ground truth derived from established engineering and biomechanical principles, material science, and relevant ISO/ASTM standards (implied, though not explicitly cited beyond "written protocols"). The predicate device's performance often serves as a benchmark for comparison.
• Biocompatibility: Ground truth from established biocompatibility standards (e.g., ISO 10993 series, though not explicitly cited).
• Pyrogenicity/Sterilization: Ground truth from pharmacopoeial standards (European Pharmacopoeia §2.6.14, USP , USP ).

8. The sample size for the training set

Not applicable. This is a medical device for which non-clinical performance data is provided, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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DALL-MILES Cable System
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.

Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.

Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· rheumatoid arthritis;
· correction of functional deformity;
· revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
   The Exeter X3 RimFit Cup is intended for cemented use only.

Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.

This FDA 510(k) letter and summary (K240418) is for a "Stryker Orthopaedics Hip Systems Labeling Update." This submission is not for a new medical device or an AI/software device that requires performance evaluation. Instead, it is a "Change Being Effected" bundled submission to add a contraindication to the labeling of existing, already cleared Stryker Orthopaedics Hip Systems.

Therefore, the provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states under "Non-Clinical Testing" and "Clinical Testing" that these were not required as a basis for substantial equivalence because the technological characteristics of the subject devices are identical to those of the predicate devices.

In summary, the request for information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not applicable to this document, as it pertains to a labeling update for previously cleared devices, not a new device or a device requiring new performance data.

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The Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.

The ACCORD Cable System includes cables (with or without clamps), trochanteric grips, and plates. (K223762).
The Smith & Nephew ACCORD Cable System consists of Cobalt Chrome cables (without clamps) to be used with the ACCORD Titanium trochanteric grips or ACCORD Titanium plates and also Stainless Steel and Cobalt Chrome cables with clamps to be used alone. These materials are identical to the material that has been previously cleared in K223762, K031162, and K993106.
The implants within this system are single-use and are Gamma sterilized.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the Smith & Nephew ACCORD Cable System. It does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this submission is for labeling updates to an existing, previously cleared medical device (ACCORD Cable System). The core assertion is that there are no significant changes in design, technological characteristics, function, sterilization, or packaging as a result of these labeling updates. Therefore, no performance testing (bench, animal, clinical) was required for this specific 510(k) submission (K233949).

Consequently, I cannot extract the information required to answer your prompt, as the prompt is designed for a study demonstrating the performance of a new or significantly modified device, particularly one involving AI/ML and associated acceptance criteria. The document explicitly states:

• "There is no significant change in design, technological characteristics, function, sterilization or packaging of the devices as a result of this submission."
• "The subject Smith & Nephew ACCORD Cable System devices are identical in function, design features, materials, packaging, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared (K223762, K031162). These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled."
• "Therefore, since there are no changes to the design features, or manufacturing methods of the subject ACCORD Cable System devices, no performance testing (bench, animal, clinical) was required."

This 510(k) relies on the substantial equivalence to its predicate devices (K223762, K031162, K993106), which would have had their own studies to demonstrate safety and effectiveness at the time of their clearance. However, those studies are not detailed in this document.

Therefore, I cannot provide the requested information based on the provided text. The document describes a regulatory filing for a non-AI/ML device that did not require new performance studies due to the nature of the submission (labeling updates only).

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The VariTrax Sternal CircumFixation system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The VariTrax Sternal CircumFixation System consists of polyetheretherketone (PEEK) locking bands with a detachable stainless-steel needle and a PEEK buttress plate. They are single-use devices provided in a sterile kit. The VariTrax bands are placed in peristernal fashion through the intercostal space with the help of the detachable needle. Once inserted, the needle is removed and the VariTrax implants are attached and locked to the VariTrax buttress plate, then tightened and secured in place to provide stable fixation of the sternum.

The provided document is a 510(k) premarket notification for a medical device (VariTrax Sternal CircumFixation System), not a study report or a publication detailing acceptance criteria and study results for an AI/ML powered device. Therefore, it does not contain the information requested in the prompt.

The document discusses various tests for the device, such as biocompatibility and mechanical performance (lateral distraction, longitudinal shear, static tensile band, four-point bend, and needle pull out) to demonstrate substantial equivalence to predicate devices. However, this is for a physical medical device, not an AI/ML software.

The concepts of "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "type of ground truth" are typically relevant for the evaluation of AI/ML-powered medical devices. Since the VariTrax Sternal CircumFixation System is a physical bone fixation device, these specific metrics for AI/ML evaluation are not applicable and thus not present in the provided text.

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ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners
The indications for use for total hip arthroplasty include:

• 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• 2. Rheumatoid arthritis:
• 3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and.
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks
   MDM Liners are intended for cementless use only.

Universal Cement Restrictor, OmniFit Distal Cement Spacer
For cement spacers, mid-shaft restrictors and Cement Plugs:
· In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

Artisan Bone Plug
These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.

Trident® II Acetabular System (Trident II Cups (Clusterhold HA, Tritanium Clusterhole, Tritanium Multihole, Tritanium Solidback), 6.5mm Low Profile Hex Screw, Hex Dome Hole Plug
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liner:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.

Restoration® Modular Hip System
The Restoration® Modular Hip System is indicated for use in:
· Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• Rheumatoid arthritis
• · Correction of functional deformity;
• Revisions procedure where other treatments or devices have failed; and
  • Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
  Additional indications specific to the Restoration Modular Hip System
  The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Accolade II Femoral Stems, Anato Femoral Stem, Secur-Fit Advanced
The indications for use for total hip arthroplasty with stems include:

• · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:
  · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
  The Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

TRIDENT AND TRITANIUM® ACETABULAR COMPONENTS
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.

• · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  · Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
  The HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only. Dome hole plug is indicated for cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous

Acetabular Dome Hole Plug
The Dome Hole Plug is an optional device which is available to seal the Howmedica Osteonics Acetabular Shell components during cemented or cementless applications of the Howmedica Osteonics Done Hole Plug is threaded into the dome hole of the shell.
Indications
• In cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous.

DALL-MILES® SYSTEMS
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hig; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the greater trochanter due to extended trochanteric osteotomies.

Exeter® V40™ Hip System (includes Orthinox V40 Femoral heads)
The Exeter® V40™ Femoral Hip System is indicated for:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;

• correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  The Exeter® V40™ Femoral Stem Hip System is intended for use in total or hemi hip replacement. It is intended for cemented use only.

Exeter Centralizer, EXETER Intramedullary Plug

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• 2. rheumatoid arthritis;
• 3. correction of functional deformity;
• 4. revision procedures where other treatments or devices have failed: and,

5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   The Exeter Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal. The Exeter Centralizer is intended to be used with bone cement.
   The Exeter Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty. The Exeter Intramedullary Bone Plug is intended to be used with bone cement.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

1. Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.

Restoration GAP II Acetabular Shell
Painful, disabling joint disease of the hip resultive arthritis, rheumatoid arthritis, post- traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Segmental and/or cavitary acetabular defects which make it difficult to restore normal hip biomechanics or to reconstitute the normal structural continuity and integrity of the acetabulum, using standard total hip replacement acetabular components and procedures.

Gap Screws, Torx Screws, and Osteolock Bone Screws
HOWMEDICA OSTEONICS Torx Cancellous Bone Screws are intended for supplemental fixation of associated HOWMEDICA OSTEONICS cementless Acetabular Shells.
· HOWMEDICA OSTEONICS RESTORATION GAP Plate Screws are intended for fixation of the dome and illac plates of the associated HOWMEDICA OSTEONICS RESTORATION GAP Acetabular Shell, TRIDENT TRITANIUM Hemispherical Multihole Acetabular Shells, restoration Acetabular Augments, and Restoration Anatomic shells.

Insignia Hip Stem
Hip Arthroplasty Indications:
• Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
· Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
· Correction of functional deformity
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners: · When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components: • When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Omnifit HFX Femoral Stems
For use as a Bipolar Hip Replacement:

• Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  • Salvage of failed total hip arthroplasty.
  · Femoral neck fractures.
  For use as a Total Hip Replacement:
  • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
  · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  · Clinical circumstances which require an altered femoral resection level due to a proximal fracture, bone loss or calcar lysis.

Omnifit EON Cemented Femoral Stems
For use as a Bipolar Hip Replacement:
· Femoral head/neck fractures or non-unions.

• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  • Salvage of failed total hip arthroplasty.
• For use as a Total Hip Replacement:
  • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, post-traumatic arthritis or late stage avascular necrosis.
• · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  Indications for use as a Total Hip Replacement include:
  · noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Restoration Anatomic Shell
• Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liner:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Trident Constrained Acetabular Insert/ Constrained Acetabular Insert
The Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Trident X3, Trident Crossfire, and Trident X3/Crossfire Elevated Rim Acetabular Liners
· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

UHR Bipolar

• · Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
  · Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  Other Considerations:
  · Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty.

Unitrax V40 Head, V40 Adapter Sleeve and C-Taper Adapter Sleeve
The HOWMEDICA OSTEONICS Unitrax Endoprosthesis, and the V40 Modular Adaptor sleeves are used as a hemiarthroplasty device for the following indications: femoral neck fractures, idiopathic avascular necrosis, and nonunions. The C-taper sleeves are intended for use as a Hemi-Hip Replacement with the following indications: femoral head/neck fractures or nonunions, aseptic necrosis of the femoral head/neck and oster- and post traumatic arthritis. The patient's acetabular bone stock must be adequate to support articulation with the ad of the endoprosthesis.

BIOLOX Delta Ceramic Heads (V40, C-Taper and Universal and C-Taper to Universal Taper Adapter Sleeve)
The femoral heads are intended fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.

• · Revision of previous cup arthroplasty or other procedures
  · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
  · Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
  For Use as a Bipolar Hip Replacement
• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• · Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  The general intended use for these devices is "In general, these devices are intended for use in primary or revision hip arthroplasty."

Alumina C-Taper and V40 Ceramic Heads
For Use as a Total Hip Replacement:
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
Additional indications for the Alumina C-Taper Ceramic Heads
For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• · Aseptic necrosis of the femoral head.
• · Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
  · Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
  · Salvage of failed total hip arthroplasty

Co Cr Femoral Heads (C-Taper and V40 Taper, LFIT and non-LFIT)
· Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.
· Revision of previous cup arthroplasty or other procedures
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Accolade C Femoral Stems, Accolade HFx Femoral Stems
Indications for use as a Total Hip Replacement include:
· noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

• rheumatoid arthritis;
• · correction of functional deformity;
• · revision procedures where other treatments or devices have failed; and,
  · treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Accolade TMZF and Accolade TMZF Plus Femoral Stems
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40TM femoral heads that can be mated with a TMZF 5° 40'trunnion.
Indications:
· Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis.
avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
• Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Revision procedures where other treatments or devices have failed.

The devices covered by this submission are Stryker Total Hip components which include femoral stems, acetabular shells, liners, femoral heads, acetabular augments, acetabular bone screws, acetabular plugs, cables, trochanteric grips, cement restrictors, and distal femoral spacers. All devices are commercially available and have been cleared in prior 510(k) submissions.

All the subject devices have been cleared for MR conditional in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified.

This document is a 510(k) Premarket Notification from the FDA regarding a labeling update for Stryker Orthopaedics Hip Systems. It explicitly states that no changes have been made to the devices themselves, only to the MR conditional information in the instructions for use.

Therefore, the usual format for acceptance criteria and studies proving the device meets those criteria (which would typically involve performance metrics for an AI/software-based device) is not applicable here. This submission is about demonstrating that the updated MR Conditional labeling information is safe, not about a new or modified device's performance against clinical endpoints.

However, I can extract information related to the testing performed to support the updated labeling, which serves as the "study" in this context.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria (for MR Conditional Labeling Safety) and Reported Device Performance:

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

• Sample Size: Not specified in terms of number of devices or scenarios tested, but the document mentions that testing was "comprehensively" performed.
• Data Provenance: The testing was conducted by the manufacturer, Stryker Orthopaedics, to obtain data for updating the MR conditional information in the labeling. This is non-clinical testing.
• Retrospective or Prospective: This would be considered prospective testing, as new tests were conducted specifically to gather data for the labeling update.

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

• This concept is not applicable here. The "ground truth" for MR Conditional labeling is established through physical testing and engineering analysis according to regulatory standards and guidance documents, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. As the testing is non-clinical (device safety in an MR environment), there's no "adjudication" in the sense of clinician agreement on an outcome. The results are based on direct measurements from physical tests.

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

• No. This type of study is for evaluating the clinical effectiveness of AI/software in assisting human readers (e.g., radiologists, pathologists). This submission is for a labeling update of a physical medical device (hip implants) regarding its MR compatibility and does not involve AI or human readers.

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

• No. This is not an AI/algorithm-based device. It is a physical orthopedic implant.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is based on non-clinical testing results that demonstrate the safety of the device in an MR environment, specifically regarding RF-related heating effects. This is a combination of physical measurements and engineering analysis in accordance with FDA guidance documents. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. This product is a physical device, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable. See point 8.

In Summary:

This FDA 510(k) notification is for a labeling change related to MR compatibility of a hip implant system, not for a new or modified device's clinical performance or an AI/software device. The "study" referenced is non-clinical testing to ensure the safety parameters provided in the updated labeling are accurate and supported by data, specifically related to RF-induced heating. The acceptance criteria and "performance" are therefore framed around meeting the requirements of the FDA guidance document for MR safety testing.

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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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