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TGM Biolox® delta Ceramic Heads are indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components of compatible TGM Medical systems in cases of:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-union of proximal femoral neck fractures.

F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valea, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

The Biolox® delta Ceramic Heads are modular femoral components used in hip arthroplasty. The head attaches to a femoral stem via a 12/14 Morse taper and articulates with a polyethylene acetabular component. The ceramic material is Transition-Toughened-Platelet Alumina (TTPA) consisting of 75% Alumina, 24% Zirconia and 1% Platelet. The heads are available in three diameters (28, 32 & 36mm) and a variety of offsets.

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves a device meets such criteria to address your detailed request about performance, sample size, ground truth, or expert involvement in a medical device study.

The document is a 510(k) premarket notification summary for "TGM Biolox® delta Ceramic Heads." It primarily focuses on demonstrating substantial equivalence to predicate devices for marketing authorization, not on providing detailed performance studies against specific acceptance criteria.

Specifically, under "Clinical testing," the document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification."

Therefore, I cannot extract the information required to populate a table of acceptance criteria, describe a study on device performance, or detail aspects like sample size, ground truth, or expert involvement, as these were not part of the submission described.

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• Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, A. collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, B. dysfunction, or prior patellectomy).
• Failed osteotomy or unicompartmental replacements. C.
• Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone D. stock exists.
• The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced E. and stabilized at the time of surgery.
• Moderate valgus, varus, or flexion deformities. F.

All MRKS femoral components and tibial baseplates are intended for cemented use only: All MRKS stems are intended uncemented use.

The MILESTONE Revision Knee System (MRKS) is a semi-constrained, cemented knee prosthesis designed for either primary or revision total knee arthroplasty. The MRKS contains left and right configurations of a femoral component and a fixed-bearing tibial component, in addition to accessory components including stems, augments, screws, pegs, a taper plug, and a baseplate plug. The femoral component and tibial baseplate employ modularity for stem and augment attachment.

The MRKS femoral component is manufactured from cast cobalt chrome alloy. It is offered in six sizes (1-6) and is designed to articulate with the MRKS ultracongruent tibial insert and the MILESTONE Knee System (MKS) all poly patellar component (K112285). The MRKS femoral component is not designed to articulate with the MKS posterior stabilizing (PS) tibial insert (K112285) or any condylar constrained tibial components. The MRKS box profile is thicker than the MKS femoral component to accommodate increased bone loss.

The MRKS tibial component consists of two parts to be assembled at the time of surgery: a tibial baseplate and an ultracongruent (PCL substituting) tibial insert. The baseplate is manufactured from cast cobalt chrome alloy and is designed with an identical locking mechanism as the MKS tibial baseplate (K112285). The baseplate is offered in seven sizes (0-6) and is designed to accommodate the MRKS ultracongruent insert when used with the MRKS femoral component or the MKS PS tibial insert (K112285) when used with the MKS PS femoral component (Ki 12285). The MRKS tibial baseplate is thicker than the MKS baseplate to accommodate increased bone loss. The MRKS insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is designed with an identical locking mechanism, thickness, and size range as the MKS PS insert.

The MRKS accessory components are manufactured from Titanium alloy. The stems are available in three lengths (80, 110, and 150mm) and seven diameters (10-22mm). They employ a male 12/14 Morse taper for attachment to the CRKS femoral component or tibial baseplate. The taper plug is available in one size and is intended for use when a stem is not desired. The taper plug employs an identical male taper as the stem. The augments are available in left and right configurations, and are offered in a range of sizes to accommodate all sizes of the MRKS femoral components and tibial baseplates. Femoral augments are split into distal and posterior segments, each available in 5mm thicknesses. Tibial augments are available in 5mm and 10mm thicknesses. The pegs are offered in three sizes (short, medium, and long). Screws are offered in two sizes (short and long). The baseplate plug is offered in one size. The pegs and screws are designed for mechanically attaching the augments to their respective implants. Pegs also aid in stabilizing the implant post-operatively and are designed to fill the distal augments holes of the femoral component and augment holes of the tibial baseplate when augments are not desired. The baseplate plug is designed to fill the baseplate augment holes when pegs and augments are not desired.

This document is a 510(k) summary for a medical device called the "MILESTONE Revision Knee System (MRKS)", a revision knee prosthesis. It details the device description, indications for use, and a claim of substantial equivalence to predicate devices. Crucially, the provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway taken for this type of medical implant.

Therefore, I cannot populate the requested table and answer the study-related questions as those details are not present in the provided text. The document states:

"Because the MRKS components employ identical geometry and material characteristics as those employed by their respective predicate CRKS and CKS components, non-clinical bench testing and analyses were provided for these predicate components to validate the safety and effectiveness of the MRKS. No further testing on MRKS components was necessary."

This indicates that instead of new performance studies with specific acceptance criteria, the device relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.

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The Treasure Bipolar Head is intended for use as follows:

• A. Fractures of the proximal femur;
• B. Nonunions of proximal femoral neck fractures;
• C. Aseptic necrosis of the femoral head;
• D. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum;
• E. Salvage of failed total hip arthroplasty.
  The Treasure Bipolar Head is intended for cementless use. The Treasure Bipolar Head is intended for use with the Helicon Hip System.

The TGM Medical, Inc. Treasure Bipolar Head consists of a bipolar femoral head component, locking ring, and a bipolar insert component. The Treasure Bipolar Head is available either fully preassembled, or with the bipolar femoral head and locking ring preassembled and the insert separate. The bipolar femoral head component is manufactured from cobalt chrome alloy (CoCrMo, ASTM F75, ASTM F799, or ASTM F1537). The bipolar head has a highly polished spherical outer surface with a cylindrical bored internal diameter which accepts the polyethylene bipolar insert. The bipolar insert component and locking ring are manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The bipolar insert and locking ring are designed for use with the appropriate size bipolar head component.

The provided text describes a 510(k) premarket notification for the "Treasure Bipolar Head." This is a medical device submission, and the focus of such submissions is typically demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria in the way a clinical trial might.

Based on the provided text, here is the information regarding acceptance criteria and the "study" (which in this context is the substantial equivalence claim):

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

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

The document explicitly states, "No new performance data was required for the Treasure Bipolar head." Therefore, there was no "test set" in the sense of a new study involving human subjects or laboratory testing specifically for this 510(k) application. The substantial equivalence claim relies on the existing clearances and data for the predicate devices.

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

Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission. The ground truth for the safety and effectiveness of the predicate devices would have been established during their original clearance processes.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was conducted for this 510(k) submission.

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 hip prosthesis, 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 hip prosthesis, not an algorithm.

7. The type of ground truth used

The "ground truth" for the substantial equivalence claim is the pre-existing FDA clearance of the predicate devices (Consensus Bipolar System K922560, Consensus TaperSet Hip System K102399, and Helicon Hip System K111472), implying that these devices were deemed safe and effective based on their original data and regulatory review. The current submission's argument is that the Treasure Bipolar Head is sufficiently similar to these predicate devices not to raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of this 510(k) submission, as no new performance data or clinical study was conducted.

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

Not applicable, as no training set was used.

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The ZENITH Hip System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System.

The indications for use are:

• A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

The ZENITH Hip System (ZHS) offers a proximally porous and nonporous femoral stem component each compatible with all femoral heads, acetabular components, and cancellous bone screws of the Helicon Hip System (HHS). The porous ZHS stems are manufactured from forged Titanium (Ti) alloy, and employ a porous-coating made from commercially pure Ti (CPTi) beads. The nonporous ZHS stems are manufactured from forged cobalt chrome (CoCr) alloy. The porous Ti stem is a straight, collarless design available in 6 sizes ranging from 10 to 15mm. The nonporous CoCr stem is a straight, collared design available in 8 sizes ranging from 8 to 15mm. Both stems feature a neck-shaft angle of 128°, a 12/14 Morse taper trunnion, neck relief, and a cylindrical fluted shaft. A distal centralizer manufactured from polymethylmethacrylate (PMMA) is available for cemented applications of the CoCr stem.

The ZHS also includes 36mm femoral heads and acetabular cups. The heads are manufactured from forged or wrought CoCr alloy. The 36mm inserts are manufactured from conventional UHMWPE. The heads are highly polished and are available in four neck offsets (-5mm, Neutral, +5mm, +10mm). The heads incorporate an identical female 12/14 Morse taper used on all predicate HHS CoCr heads. The 36mm inserts are compatible with predicate HHS acetabular shells ranging in size from 56 to 68mm. Refer to the compatibility table (new Attachment 1 of the September 12, 2012 Al response/Supplement 1 ). The 36mm inserts are offered in neutral or 10 degree hooded configurations. Hooded inserts include an X-ray marker manufactured from wrought Ti alloy. The 36mm heads and mating inserts are also compatible with the Helicon Hip System.

Here's a breakdown of the acceptance criteria and study information for the ZENITH Hip System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (hip implant), which focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study involving an AI algorithm or human-in-the-loop performance. The "acceptance criteria" here refer to meeting performance standards for mechanical integrity and design equivalence, not for diagnostic accuracy or human performance with AI.

The "study" in this context is a series of non-clinical bench tests and a comparative analysis of specifications to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in terms of a numerical sample size of devices tested. The testing involved "worst-case stem/head configurations," implying a selection of representative components that would experience the highest stresses or potential failure modes.
• Data Provenance: The testing was "nonclinical bench testing" and involved a "Failure Modes and Effects Analysis (FMEA)." This indicates laboratory testing, rather than human clinical data. The data provenance is from the manufacturer's (or its licensee's) internal testing. Country of origin for the data is not specified beyond being generated for a U.S. FDA submission. The data is retrospective in the sense that it evaluates manufactured components against predefined criteria; it is not a prospective clinical trial.

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

• This question is not applicable in the context of this device and documentation. "Ground truth" in this context refers to the defined engineering specifications and performance standards against which the device's mechanical properties were measured. These standards are established by engineering principles, regulatory guidelines (e.g., ISO standards for implants, not detailed here), and comparison to predicate devices, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to a process of resolving discrepancies among human readers in interpreting clinical data. For bench testing of mechanical properties, results are typically measured objectively against predefined engineering thresholds.

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, an MRMC comparative effectiveness study was not done. This document pertains to a hip implant (hardware), not an AI algorithm for diagnostic imaging or decision support. Therefore, there is no AI component or human reader performance to evaluate.

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

• No, a standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on:
  • Engineering Specifications and Performance Standards: Established mechanical testing methodologies (e.g., fatigue testing, bond strength, fretting corrosion, range of motion) used to ensure the device meets required functional and safety thresholds.
  • Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness of legally marketed predicate devices. The ZENITH Hip System is shown to perform "at least as safely and effectively" as these predicates.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of a physical hip implant. The principles of substantial equivalence and bench testing do not involve machine learning training sets.

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

• This question is not applicable for the reasons stated in point 8.

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The MILESTONE Knee System Primary Knee is designed as a system and is not intended for substitution of components from other systems.

• A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
• B. Failed osteotomy or unicompartmental replacements.
• C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
  All MILESTONE Knee components are intended for cemented use only.

The MILESTONE Knee System (MKS) is a primary, fixed-bearing, total knee system designed to replicate the natural anatomy of the knee in order to restore knee function. It was developed to preserve and utilize healthy ligamentous structures, and to restore stability to the knee.
The MKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The femoral and tibial components are provided in left and right configurations. The femoral component is made from CoCr and is offered in a posterior stabilizing (PS) configuration. The tibial component comprises an asymmetric tibial baseplate made from CoCr alloy and an asymmetric PS tibial insert made from UHMWPE. The baseplate is designed to maximize metaphyseal bone coverage on the tibia. The baseplate employs a cruciate type keel to enhance implant fixation and torsion resistance. The tibial insert attaches to the baseplate via a mechanical locking mechanism. All MKS metallic components are available in uncoated variants for cemented use. The patellar component is an all-poly round patella made from UHMWPE, also intended for cemented use.

The provided document describes the TGM Medical, Inc. MILESTONE Knee System (MKS) and its substantial equivalence to a legally marketed predicate device, the Consensus Knee System (CKS). It is a traditional 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail sense, but rather establishes equivalence through material, design, and prior testing of predicate devices.

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

• Test Set (for the MKS itself): Not applicable in the traditional sense of a clinical trial with a "test set" of patients.
• Data Provenance: The "testing" referred to is non-clinical bench testing and analyses performed on predicate CKS components. The document does not specify the sample size for these predicate tests, nor does it mention a specific country of origin or whether the data was retrospective or prospective.

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

• Not applicable. This submission is based on substantial equivalence to a predicate device, relying on prior regulatory clearances and non-clinical bench testing of the predicate. There is no mention of a human expert-based ground truth establishment for a "test set" in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable. As there is no clinical trial with a "test set" requiring expert ground truth or adjudication described.

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

• No. An MRMC study was not done. The submission relies on establishing substantial equivalence to a predicate device through non-clinical testing and material/design comparisons, not comparative effectiveness studies with human readers or AI.

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

• No. This device is a total knee prosthesis, a physical implant, not an algorithm or AI software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" for demonstrating the safety and effectiveness of the MKS is established through:
  • Prior Regulatory Clearance of Predicate Devices: The FDA's clearance of the predicate CKS components (K954818, K110950, K932837, K001456, K945589) serves as the primary "ground truth" for their safety and effectiveness.
  • Biomechanical Testing of Predicate Devices: The non-clinical bench testing performed on the predicate CKS components validates their safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device (knee prosthesis), not an AI algorithm that requires a "training set."

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

• Not applicable. As a training set is not relevant for this type of device submission.

Summary of Acceptance Criteria and Evidence from the Document:

The MILESTONE Knee System demonstrates meeting what could be interpreted as "acceptance criteria" by establishing substantial equivalence to existing, legally marketed predicate devices. The key argument is that the MKS components employ identical materials, geometry, and design features as corresponding components of the Consensus Knee System (CKS). Therefore, the non-clinical bench testing and analyses previously conducted for the CKS components are considered sufficient to validate the safety and effectiveness of the MKS. No new clinical or non-clinical testing unique to the MKS components was deemed necessary because of this identity with the predicate.

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The HELICON™ Hip System is designed for total hip arthroplasty.

The indications for use are:

• Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• Proximal femoral fractures.
• Avascular necrosis of the femoral head.
• Non-union of proximal femoral neck fractures.
• Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

The HELICON™ hip stem is indicated for cementless use. The HELICON™ acetabular shell component is indicated for cemented or cementless use.

The HELICON Hip System (HHS) is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The HHS includes a femoral stem, a CoCr femoral head, non-crosslinked UHMWPE insert, acetabular shell and bone screws.

The HHS stem is a monolithic, titanium alloy, tapered hip stem available with a proximal CPTi plasma porous coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes ranging from 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. HHS stems are compatible with the HHS CoCr femoral head and HHS acetabular insert. The HHS CoCr head is highly polished and available in multiple offsets and diameters (22, 28, and 32mm). The HHS acetabular components include a titanium alloy shell and a mating UHMWPE insert. The shell is a hemispherical design, is available with or without screw holes, and employs a CPTi beaded, porous coating. The UHMWPE insert is available in 20° hooded or nonhooded (neutral) configurations in inner diameters of 22, 28, and 32mm. Titanium alloy bone screws are available for additional fixation.

The provided text describes a Premarket Traditional 510(k) Notification for the HELICON Hip System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this type of submission. The submission explicitly states: "No additional nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials." and "All of the observed results for the predicate TaperSet Hip System had been found substantially equivalent prior to devices currently marketed. The subject Helicon Hip System is identical in material and design to that of the TaperSet Hip System."

Below is an attempt to address the request based on the information provided, highlighting where information is not applicable due to the nature of a 510(k) for substantial equivalence.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The HELICON Hip System (HHS) demonstrates acceptance by establishing substantial equivalence to legally marketed predicate devices. This means that its acceptance criteria are implicitly those that the predicate devices met, and the "study" proving this is a comparative analysis against the predicates across various technological characteristics and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on identical design and materials to predicates, the acceptance criteria are inferred to be the performance standards met by the predicate devices. The reported device performance for HHS is asserted to be identical to these predicates due to the "identical material, characterization data, geometry and mechanical testing."

• Distal and proximal stem fatigue testing (worst-case stem).
• Range of Motion analysis.
• CPTi plasma sprayed and CPTi beaded metallic coating characterization (per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement").
• CPTi plasma spray characterization (per "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants...").
• Polyethylene insert retention mechanism testing.
• Bone screw mechanical strength testing.
• Modular connection analyses (fretting and corrosion of metallic femoral heads).
• Pin-on-flat testing of non-crosslinked UHMWPE/CoCr material combination. | Met by Predicate Devices; Asserted for HHS: All predicate bench testing results, covering the items listed in the criteria, were found substantially equivalent and are directly applicable to HHS due to identical design and materials. "No additional nonclinical bench testing was deemed necessary." "Therefore, the subject device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." |
  | Porous Coating Definition: CPTi plasma sprayed coating and CPTi beaded coating characterizations meet regulatory definition of porous coating for hip construct per 21 CFR 888.3358. | Met by Predicate Devices; Asserted for HHS: Both the CPTi plasma sprayed coating and the CPTi beaded coating characterizations meet the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358. |
  | Indications for Use: Consistent with the indications for use of the predicate devices. | Consistent: The indications for use for the HHS are identical to those of the predicate devices. |

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

• Sample Size: Not applicable. There was no new "test set" in the traditional sense for the HELICON Hip System. The assessment relies on the existing performance data and characterizations of the predicate devices.
• Data Provenance: The data provenance is from the non-clinical bench testing conducted for the predicate devices, specifically those associated with Consensus Orthopedics, Inc. (COI) and U.S. Medical Products, Inc. This would be retrospective as the testing has already been completed and reviewed by the FDA for the predicate devices.

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

Not applicable. This submission does not involve a clinical study requiring expert ground truth for a test set. The "ground truth" for the performance of the HELICON Hip System is established by its direct identity in materials and design to the already cleared predicate devices, whose performance characteristics were previously vetted by the FDA through their own respective 510(k) clearances.

4. Adjudication Method for the Test Set

Not applicable. There was no new test set requiring adjudication in this 510(k) submission.

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 mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" is based on the non-clinical bench testing results and material/design characterization data from the predicate devices. This data was previously accepted by the FDA as sufficient to demonstrate the safe and effective performance of those predicate devices. For the HELICON Hip System, the ground truth is its identicality to these well-characterized predicates.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an orthopedic implant 510(k) submission based on substantial equivalence to predicates.

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

Not applicable. There is no "training set" for this type of device submission.

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