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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758).

Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.

The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

The provided text is an FDA 510(k) clearance letter and associated summary for a hip stem device. This type of document describes the device, its indications for use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria for a software device, specifically around AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment, training data, etc., is not contained within this FDA clearance document.

The document states under "Clinical Testing" (Page 7): "No clinical testing is required to establish the safety and effectiveness of Trivicta." This indicates that the clearance was based on non-clinical performance data (sterilization, shelf life, biocompatibility, mechanical testing) and comparison to predicate devices, not on a study involving AI performance or human-in-the-loop assessments as would be typical for medical AI devices.

Therefore, I cannot fulfill your request for the specific AI-related acceptance criteria and study details because the provided document is for a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device.

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• 1. Loss of joint configuration and joint function.
• 2. Osteoarthritis of the knee joint.
• 3. Rheumatoid arthritis of the knee joint.
• 4. Post-traumatic arthritis of the knee joint.
• 5. Valgus, varus, or flexion deformities of the knee joint.
• 6. Revision procedures where other treatments or devices have failed.

The BKS, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.

The BKS is indicated in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.

BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications requirements.

The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.

The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offiset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.

The purpose of this special 510(k) submission is to request clearance for BKS Revision Sleeve Junction Box of the BKS Revision System which is an extension of Ortho Development's previously cleared predicate BKS Revision Sleeves System (K181569).

The subject device incorporates the same locking taper interface for mating with the BKS Revision Sleeves and the same principle of operation for locking the A/P position relative to the BKS Revision Modular Femoral Component. The subject device is manufactured in the same manner from the same material. The subject device also employs the same packaging components and sterilization method.

Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.

This document describes Ortho Development's 510(k) submission for the BKS Revision System, specifically focusing on the BKS Revision Sleeve Junction Box. The submission is a "special 510(k)" which implies that the changes to the device are minor and do not alter its fundamental scientific technology or indications for use. Therefore, the acceptance criteria and the study proving the device meets them are based on demonstrating that the modified device performs equivalently to the predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification to an existing device (BKS Revision Sleeves System, K181569), the acceptance criteria are implicitly that the modified device (BKS Revision Sleeve Junction Box) performs comparably to the predicate device and meets established consensus standards for orthopedic implants.

• Geometric analysis: Confirms adjustments to envelope geometry, internal configuration, and driving feature are optimized for femoral sleeves.
• Axial fatigue strength per ASTM F1814: Demonstrated to meet requirements.
• Disassembly strength: Demonstrated to meet requirements.
• Assembly evaluation: Confirmed proper assembly and function. |
  | Material: Use of same materials as the predicate device. | The subject device is manufactured from the same material as the predicate. |
  | Principle of Operation: Maintain the same mechanism for connection and locking as the predicate. | The mechanics of the connection and locking mechanism are the same as the predicate device. |
  | Packaging and Sterilization: No change in packaging components or sterilization method. | The subject device employs the same packaging components and sterilization method as the predicate. Labeling, packaging, and sterilization do not change. |
  | Indications for Use: Maintain the same indications for use as the predicate device. | The Sleeve Junction Box is technologically the same as the already cleared Tapered Junction Box, including in terms of indications for use/intended use. |
  | Overall Design Inputs: Meet the original design inputs of the predicate device. | Performance data demonstrate that the original design inputs of the predicate are met. Verification and validation conducted according to design control procedures within a risk analysis framework to determine that the design outputs meet the design inputs using the same test criteria and methodology as the predicate K181569. |

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

The document does not explicitly state the sample size for mechanical testing (e.g., number of devices tested for fatigue or disassembly). The evaluation performed involved testing of the device itself rather than a clinical study with patient data. Therefore, there is no "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective collection as this is a physical device testing study.

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

Not applicable. This is not a study involving expert review of medical images or clinical data to establish ground truth. The "ground truth" here is the established performance characteristics and safety profile of the predicate device, against which the modified device's mechanical properties are compared using established engineering test methods.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of mechanical engineering study. The evaluation relies on standardized test methods (like ASTM F1814) and engineering analysis.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical implant (knee joint prosthesis components), not an AI-assisted diagnostic or prognostic device that would typically involve MRMC studiescomparing human readers with and without AI assistance. Therefore, there is no effect size of human readers improving with AI assistance.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this special 510(k) is the established performance and safety profile of the predicate device (BKS® Revision Sleeves System, K181569) as demonstrated through its initial clearance and compliance with recognized consensus standards. The modified device is tested against these established benchmarks using engineering principles and standardized tests to confirm equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical medical device.

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

Not applicable, for the same reason as point 8.

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This device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

• Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed hip surgery.
• Fractures of the femoral neck or head.
• Avascular necrosis of the femoral head.
• Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.

The Legend® Acetabular Shell is a one-piece, hemispherical shell prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit into a prepared acetabulum, which maximizes contact between the shell and bone.

The Legend® Acetabular Shell is manufactured from titanium alloy Ti-6A1-4V ELI per ASTM F136. The outer surface of the shells are coated with commercially pure titanium (CPT)(ASTM F1580) sintered porous coating. The inner surface of the shell is designed to lock together with the Escalade® and Legend® Acetabular Liners which are made from extensively cross-linked polyethylene. The Legend® Acetabular Shell is also designed to be used with cancellous bone screws and apical plugs.

The existing Legend® Acetabular Shell (K161080) is coated with commercially pure titanium (CPT) sintered bead coating. This submission allows a similar sintered coating to be applied by an additional supplier: Avalign Thortex (MAF-2607) in addition to the original supplier.

This document is a 510(k) premarket notification for a medical device called the "Legend® Acetabular Shell." It describes a submission to add an additional supplier for a porous titanium coating that is applied to an existing device.

Therefore, the submission does not involve the development or testing of an AI/ML device. The performance data section refers to mechanical testing of the coating material to ensure it meets established orthopedic implant standards, not the performance of an AI model.

As such, I cannot provide details regarding acceptance criteria and studies for an AI/ML device, as this documentation pertains to a traditional orthopedic implant. There are no mentions of AI, machine learning, deep learning, algorithms, or any related terms.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, ground truth, MRMC, etc.) are applicable to AI/ML device submissions, which are not present in this document.

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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Trivictal is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating. The stem has a variety of sizes to accommodate most patients encountered: lengths (101-119mm), horizontal offsets (38-53mm), vertical offsets (29-36mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar. Trivicta™ is compatible with the following Ortho Development devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

This looks like a 510(k) summary for a medical device (Trivicta Hip Stem), not an AI/ML powered device. Therefore, the questions related to AI/ML performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," training set information, and adjudication methods for ground truth, are not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, indications for use, and performance testing related to the physical characteristics and safety of the hip stem, not software performance.

Here's an analysis of the provided information, focusing on the available details:

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

The document does not present acceptance criteria in a structured, quantitative table with specific target values for performance attributes, as would be typical for an AI/ML device. Instead, it outlines the types of non-clinical mechanical tests performed and states that the device was found to be "safe for its intended use" and "performs as well as the legally marketed predicates" based on these tests.

However, based on the categories of testing performed, we can infer some general "acceptance criteria" and "reported performance":

• Range of Motion Test (ISO 21535:2023)
• Shear Fatigue Test (ASTM F1160-14)
• Neck Fatigue Test (ISO 7206-6:2013)
• Distal Stem Fatigue Test (ISO 7206-4:2010)
• Engineering analysis of impingement performance (ASTM F2582-20)"

The overall conclusion states: "The results of verification and validation activities demonstrate that Trivicta performs as well as the legally marketed predicates." This implies that the device met the performance requirements of these tests relative to the predicate devices and applicable standards. |

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

This document details tests on the physical medical device (hip stem), not a data-driven AI/ML model. Therefore, "sample size for the test set" typically refers to the number of physical device units or test specimens used in mechanical testing. The document does not specify the exact number of samples for each mechanical test, nor does it refer to "data provenance" in the context of patient data. The tests are in vitro (laboratory) tests on the device itself.

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)

This question is not applicable. "Ground truth" in the context of AI/ML refers to expert labels on data. For a physical medical device like a hip stem, ground truth is established by objective engineering and scientific measurements and adherence to established material and mechanical standards. There are no human "experts" establishing ground truth in the AI/ML sense for these in vitro physical tests.

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

This question is not applicable as it relates to expert review for AI/ML ground truth, which is not relevant to the physical testing of a hip stem.

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

This question is not applicable. MRMC studies are used to evaluate the diagnostic performance of AI-assisted systems compared to human readers. This document describes a physical medical device, not an AI system.

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

This question is not applicable as it pertains to AI/ML algorithm performance.

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

For the physical device, the "ground truth" for its performance is based on:

• Adherence to recognized international and national standards (e.g., ISO 11137 for sterilization, ISO 11607 for shelf life/packaging, ISO 10993-1 for biocompatibility, ISO 21535, ASTM F1160, ISO 7206-6, ISO 7206-4, ASTM F2582 for mechanical testing).
• Objective physical and chemical measurements obtained during laboratory testing.
• Comparison to predicate devices that have established safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

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The Balanced Knee System TriMax PS Plus Tibial Inset is in cemented total knee arthroplasty procedures with the following indications:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System (BKS) TriMax PS Plus Tibial Insert is a line extension of the TriMax PS Tibial Insert (K131337) that offers slightly more constraint than the original PS Insert. The PS post geometry is the only design difference between the previously cleared predicate device and the subject device. The change slightly modifies the post's shape to provide additional internal/external and varus/valgus constraint if the surgeon determines the need exists. The balance of the design is identical including the articulating surface, locking mechanism, as well as the PS post location and height. The PS Plus inserts are intended for use in primary and revision knee surgeries with the same indications for use as the predicate. This implant is used with existing BKS and BKS Revision (BKSR) tibial travs. TriMax femoral components and the BKSR modular femoral components. The material is identical as well as all manufacturing processes, cleaning, sterilization and packaging that were cleared under K131337.

This document describes a 510(k) premarket notification for a medical device called the "Balanced Knee® System TriMax PS Plus Tibial Insert." The submission is a "Special 510(k)" because it is a line extension of a previously cleared predicate device (K131337).

Since this is a Special 510(k) for a line extension of an existing device, and the primary change is a slight modification to the PS post geometry, the provided document does not contain information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device through engineering analysis and verification testing.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance (in the context of a clinical study or AI performance evaluation)
2. Sample size used for a test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method for a test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm-only) 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 describes the engineering and material performance evaluations conducted to demonstrate that the new device's design outputs meet the design inputs, similar to the predicate. The "performance data" section refers to:

• Sterilization: Stated adherence to ISO 11135-1 with a Sterilization Assurance Level (SAL) of 10-6.
• Shelf Life: Validation according to ASTM D4169:2016.
• Biocompatibility: Suitability for implantation verified per ISO 10993.

The comparison of technological characteristics mentions evaluations in the following areas, indicating what was assessed, but not specific acceptance criteria or performance numbers:

• Geometric Analysis
• Contact Area and Pressure
• Constraint
• Wear
• Range of Motion
• PS Post Fatigue

It concludes that "The results showed similar or identical performance indicating that the design outputs of the PS Plus Tibial Insert meet the design inputs." This is a general statement of engineering conformance, not a specific performance metric from a study as typically requested for AI/diagnostic device approvals.

In summary, this document is a 510(k) premarket notification for a mechanical orthopedic implant, not a software or AI-driven medical device. Therefore, the types of studies and acceptance criteria typically associated with AI/software performance evaluations (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to the content of this FDA letter.

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The Progen™ short trochanteric nail is indicated for fixation of various types of stable and unstable neck, intertrochanteric, and peritrochanteric fractures.

The Progen™ long trochanteric nail is intended for fixation of stable femoral fractures occurring from the base of the femoral neck extending distally to a point approximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, and revisions.

The Progen™ long trochanteric nail is intended for fixation of stable and unstable femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10cm proximal to the intercondylar notch including fractures of the basilar neck, intertrochanteric fractures, peritrochanteric fractures, subtrochanteric fracture, femoral shaft fractures, pathological fractures, impending pathological fractures, tumor resection, nonunion, malunion, and revisions.

The Progen™ Trochanteric Nail System consists of temporary fixation intramedullary nails and their accompanying instrumentation designed for fracture fixation and stabilization of the femur. The implants are available in various lengths and diameters to accommodate a range of patient anatomy. Each of the intramedullary nails is secured by a sequence of screws that transect through holes in the proximal and distal sections of each nail.

The Progen™ Trochanteric Nail System consists of single-use intramedullary nails for stable and unstable neck, intertrochanteric, pertrochanteric, and subtrochanteric fractures and combinations of these fractures. The system consists of Nail, Lag Screw, Secondary Screw, Lag Cap, Locking Screws, Set Screws, and Nail End Cap. The nails and accompanying components are manufactured from titanium alloy (Ti-6Al-4V ELI). Additionally, the Nails and Lag Screws have a Type II anodized surface treatments.

The provided text describes the Progen™ Trochanteric Nail System, an intramedullary fixation rod system, and its substantial equivalence with predicate devices. However, this document does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

The information provided relates to a traditional medical device (an intramedullary nail system), and the performance data section focuses on sterilization, shelf-life, biocompatibility, and mechanical testing in accordance with ISO and ASTM standards. There is no mention of an AI/ML component, clinical testing, or any metrics related to AI/ML device performance such as sensitivity, specificity, or accuracy.

Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, ground truth, expert qualifications, or MRMC studies based on the provided text.

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1. Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis
2. Traumatic arthritis
3. Previous tibial condyle or plateau fracture with loss of anatomy or function
4. Varus deformities
5. Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged.

The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.

The Balanced Knee® System (BKS®) Uni is a single compartment knee replacement. The BKS Uni is indicated for cemented use only.

Cobalt Chromium Femoral Component
The femoral components are cobalt chromium (Co-Cr-Mo). The femoral components are right and left specific and are intended for cemented use only.

Titanium Tibial Trays
The titanium tibial trays (Ti-6Al-4V ELI) are left and right specific and are for cemented use only.

Polyethylene Tibial Insert
The E-Vitalize tibial insert is manufactured from crosslinked Vitamin E Ultra High Molecular Weight Polyethylene. The inserts match the respective size of the tibial tray used.

The provided text describes a 510(k) premarket notification for a medical device called the Balanced Knee® System Uni. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than on a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested categories (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of regulatory submission, as it pertains to a physical medical implant (a knee prosthesis) and not an AI/ML diagnostic or prognostic device.

Here's a breakdown of the information that is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical implant and not an AI/ML device, the "acceptance criteria" are related to mechanical performance, sterilization, shelf life, and biocompatibility, as confirmed through validation against established ISO and CFR standards.

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

Not applicable. This is for a physical device, and the "test set" refers to mechanical and material tests, not a dataset for an AI/ML model.

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

Not applicable. The ground truth for a knee prosthesis is established through mechanical and biocompatibility testing against defined industry standards, not expert evaluation of data.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This device is not an AI/ML diagnostic or prognostic tool. No MRMC study was performed.

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

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

7. The type of ground truth used

The "ground truth" for this medical device is established by validated engineering and biological standards. This includes:

• Sterility Assurance Level (SAL) via ISO standards.
• Packaging integrity and shelf life via ISO standards.
• Biocompatibility via ISO standards.
• Mechanical performance metrics for range of motion, constraint, interlock strength, fatigue, contact area/stress, and wear.

8. The sample size for the training set

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

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

Not applicable.

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The Pisces Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, sacrum and iliac spine (T1-Sacrum/Ilium) for the following indications:

1. Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3. Trauma (fracture or dislocation)
4. Spinal tumor
5. Failed previous fusion (pseudarthrosis)
6. Spinal stenosis
7. Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis

The Pisces Spinal System is an implantable system intended to provide immobilization and stabilization of spine segments. The subject device is a modular pedicle screw assembly that consists of pedicle screws with solid and cannulated options, modular tulips in standard, reduction, and extended tab configurations, spinal rods, and set screws. All components are made of implantable-grade titanium.

The modular tulip is an assembly which consists of a tulip body, a saddle, and a locking ring. The top of the tulip body receives a locking set screw which secures the tulip body assembly to an ø5.5mm or ø6.0mm rod and pedicle screw when tightened.

The pedicle screw has a spherical head which the tulip assembly snaps onto either before or after surgical insertion. The 5.5mm or 6.0mm rod is inserted into the tulip assembly. After assembly of multiple pedicle screws, a set screw is inserted into the tulip and locked to a predetermined locking torque, immobilizing the construct. For the 20mm reduction and 90mm extended tab tulips, the guide tabs are removed from the construct following final lock. 20mm reduction tabs can be used to provide length for rod reduction while 90mm tab tulips facilitate minimally invasive surgeries (MIS). All implants are provided sterile for single use only.

This document describes the Pisces Spinal System and demonstrates its substantial equivalence to predicate devices, thus the acceptance criteria are based on mechanical and biological performance rather than diagnostic accuracy.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state sample sizes for each specific test (e.g., number of devices tested for mechanical performance, number of samples for bacterial endotoxin testing). However, it mentions "Validation results" for sterilization, shelf life, and biocompatibility, and "Mechanical testing" was performed on the device. All these tests are inherently prospective, meaning the data was generated specifically for the validation of this device. The provenance is internal to Ortho Development Corporation, as they conducted or commissioned these validation tests.

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

This information is not applicable. The acceptance criteria for this device are based on objective, quantifiable engineering and biological tests (e.g., sterility, mechanical strength, material compatibility), not on subjective expert consensus for establishing ground truth like in a diagnostic device.

4. Adjudication Method for the Test Set

Not applicable, as the acceptance criteria are based on objective physical and chemical testing, not expert interpretation requiring adjudication.

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

No MRMC study was done. This is a medical device for surgical implantation, not a diagnostic imaging device that would typically involve human readers or AI assistance in interpretation.

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

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

7. Type of Ground Truth Used

The ground truth is based on established engineering standards (ASTM and ISO), biological compatibility standards (ISO 10993-1, ANSI/AAMI ST72), and regulatory limits for sterility and endotoxins.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm requiring 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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The Gecko Spinal System is a temporary implant for use in orthopedic surgery. The 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:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. 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 and older, adult scollosis, kyphosis and spondylolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Gecko Spinal System may also be used in conjunction with other Ortho Development's spinal rod systems made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The Gecko Spinal System is an implantable device intended to provide immobilization and stabilization of spinal segments. The device consists of an implantable polyethylene terephthalate (PET) braided band with a stiffened guiding section at one end and a metal leader at the other (both removed before final implantation), an implantable grade titanium alloy clamp that mates with 5.5mm diameter rods, and an implantable grade titanium alloy nut that secures the band, clamp, and connecting rod together. All implants are provided sterile for single use only; the implant should not be re-used or re-sterilized under any circumstances.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "The Gecko Spinal System." It is a regulatory approval document and does NOT contain information about a study proving the device meets acceptance criteria derived from AI/machine learning performance.

The content focuses on:

• Regulatory approval: 510(k) clearance, substantial equivalence to predicate devices.
• Device description: Components, materials, intended use, indications for use.
• Performance data (non-clinical): Sterilization (gamma radiation), shelf life (packaging), biocompatibility, and mechanical testing (static and dynamic band tension, axial grip, torsional grip, axial compression). These are standard engineering and material science tests for implantable medical devices, not performance metrics for an AI/ML algorithm.
• Absence of clinical testing: "None provided for basis of substantial equivalence." This explicitly states that no clinical trials were conducted or submitted for this specific 510(k) clearance.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI-powered device, study details for AI performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI. This information is simply not present in the provided text.

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These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.
   The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions.
   The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.

The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone.

The provided text describes a 510(k) premarket notification for the "Balanced Knee Revision System Trabecular Tibial Cone Augments." This is a medical device (knee joint prosthesis component) and not an AI/ML-driven device or an imaging device.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document discusses the substantial equivalence of the device to existing predicate devices based on technological characteristics and non-clinical performance testing.

Here's an assessment of the provided information relative to the device type described:

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

The document lists the following non-clinical tests that were conducted and "successfully met the predetermined acceptance criteria." However, the specific numerical acceptance criteria and reported performance values are not detailed in this 510(k) summary. It only states that the tests met the criteria.

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

This information is not applicable as this is a physical medical device, not an AI/ML imaging device. The "test set" here refers to physical specimens subjected to biomechanical and material tests, not a dataset for AI model evaluation. No data provenance in terms of country of origin or retrospective/prospective collection is relevant in this context.

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):

This is not applicable. Ground truth establishment by experts in the context of radiology or clinical interpretation is not relevant for this physical device's mechanical and material testing. The "ground truth" for these tests are the established ASTM and ANSI/AAMI standards.

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

This is not applicable. Adjudication methods are relevant for ambiguous or challenging cases in AI/ML performance evaluation, usually involving human experts. For mechanical testing, the results are objectively measured against predefined standards.

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

This is not applicable. MRMC studies are specific to imaging devices and AI/ML aids that influence human reader performance. This device is a prosthetic component.

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

This is not applicable. Standalone performance refers to an algorithm's output without human intervention, which is not relevant for a physical implant.

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

The ground truth for this device's performance evaluation lies in the established industry standards (ASTM, ANSI/AAMI) for mechanical, material, and biocompatibility testing. There is no "pathology" or "outcomes data" specifically mentioned for establishing ground truth for the premarket clearance of this component.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. The requested information pertains to an AI/ML or imaging device, which is a different category of medical product. Therefore, most of the specific questions are not applicable to the content of this document. The device's acceptance criteria are based on meeting established national and international standards for mechanical properties and biocompatibility.

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