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The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery.

The SMS implants are comprised of the following products:

• SMS Cementless Solid Standard Stem (available in 11 sizes from size 3 to 13); and ●
• . SMS Cementless Solid Lateralized Stem (available in 11 sizes - from size 3 to 13).

Both are available on the US market via the clearance - K181693.

Concerning the new sizes of the solid version: 1V2, 2V2, size 14, and size 15; both STD and LAT versions have been introduced as a product range extension to the stems currently marketed as the SMS product line (K181693).

The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), MiniMAX (K170845), and SMS (K181693).

The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).

The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

This is a 510(k) premarket notification for the "SMS Cementless Stem" (K201673), a hip prosthesis. The document details the device, its intended use, and a comparison to predicate devices, along with performance data.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines various non-clinical performance tests conducted for the SMS Cementless Stem. However, it does not provide specific acceptance criteria values or the quantitative results of these tests in a table format. It only states that the testing was conducted "according to written protocols with acceptance criteria that were based on standards."

Here's what can be inferred for a table, but actual criteria values and results are missing in the document:

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

The document explicitly states: "No clinical studies were conducted." Therefore, there is no test set in the context of human clinical data or patient outcomes. The "performance data" refers to non-clinical mechanical and material tests. The sample sizes for these mechanical tests are not provided in this summary. Data provenance is not applicable here as no human data was used.

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

Not applicable as no clinical studies were conducted and no ground truth in the clinical sense was established. The "ground truth" for the non-clinical tests would be the specifications and requirements of the referenced ISO and ASTM standards.

4. Adjudication Method for the Test Set

Not applicable as no clinical studies were conducted which would require adjudication of expert opinions or outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC study was mentioned or performed, as "No clinical studies were conducted." This device is a mechanical implant, not an AI or diagnostic tool that would typically undergo MRMC studies.

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

Not applicable. This device is a hip implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical performance and coating tests, the "ground truth" implicitly refers to the
requirements and specifications outlined in the referenced international standards (ISO and ASTM) and the European Pharmacopoeia/USP chapters. The device is expected to meet these pre-defined engineering and material standards. This is a form of engineering/material specification compliance as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical implant, 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 medical device's approval.

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The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

· Avascular necrosis of the femoral head.

· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

MiniMax anatomical stems are coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.

The anatomical design of the MiniMax stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip has a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.

MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300um, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.

This submission seeks add Size 9 left and right anatomical stems to the currently marketed MiniMAX product line.

The provided text describes a 510(k) premarket notification for a medical device (MiniMAX hip prosthesis) and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document is a traditional medical device submission focused on substantial equivalence to a predicate device, primarily through mechanical testing and material characterization.

Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies for an AI/ML device is not present in the provided text.

However, I can extract the information that is present regarding the device's performance data and how it was evaluated.

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

The document does not provide a table of acceptance criteria with numerical targets and reported performance for an AI/ML device. Instead, it lists the types of performance tests conducted for a mechanical hip prosthesis and states that the "subject devices do not represent a new worst case when compared to the previously cleared devices."

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

The document mentions "worst-case device" testing for the predicate device, K170845. This typically implies a very small sample size, potentially N=1 or N=3, for each test as per engineering standards for mechanical devices. It's not a 'test set' in the sense of an AI/ML validation. There's no information on data provenance (country of origin, retrospective/prospective).

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 is a mechanical device submission, not an AI/ML study requiring expert ground truth for interpretation.

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

Not applicable.

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

Not applicable. This is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable.

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

For mechanical testing, the "ground truth" is defined by the passing criteria of the specified international standards (e.g., ISO, ASTM). For example, fatigue tests would have an endurance limit or cycles to failure requirement specified in the standard.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

Ask a specific question about this device

The hip prosthesis SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. Hip replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty.

The SMS femoral stem is a cementless bone preserving short stem designed for proximal fixation in total or partial hip arthroplasty for primary or revision surgery. The SMS implants subject of this submission are comprised of the following products:

• SMS Cementless Solid Standard Stem (available in 11 sizes); and ●
• SMS Cementless Solid Lateralized Stem (available in 11 sizes).

The SMS implants are line extensions to Medacta's Total Hip Prosthesis - AMIStem-H, Quadra-S and Quadra-H Femoral Stems (K093944), AMIStem and Quadra - Line Extension (K121011), AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794), Quadra-H and Quadra-R Femoral Stems (K082792), AMIStem-H Proximal Coating (K161635), and MiniMAX (K170845).

The SMS implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polvethylene (HXUHMWPE).

Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966) and Medacta Bipolar Head (K091967).

The SMS stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

This document describes the premarket notification (510(k)) for the SMS Femoral Stem, a cementless bone-preserving short stem designed for proximal fixation in total or partial hip arthroplasty.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, though it's important to note that this is a medical device submission, not an AI/ML device submission, so the questions regarding human readers, training sets, etc., are not directly applicable here. The document focuses on mechanical performance and biocompatibility for a physical implant.

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

The document lists performance tests and the standards they adhere to, implying that meeting these standards constitutes the acceptance criteria. However, it does not explicitly state numerical acceptance criteria and does not present specific performance data values in a table format. It merely states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." and that the studies "demonstrated substantial equivalence."

Here's a generalized representation based on the provided information:

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

The document lists various non-clinical mechanical and coating tests, which typically involve physical samples of the device components. It does not specify the sample sizes (number of stems tested for fatigue, etc.) for each test. The provenance of the data is implicit: it's generated from laboratory testing of the device components. There is no clinical data or patient-derived data mentioned.

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 to this type of medical device submission. Ground truth and expert adjudication are relevant for AI/ML diagnostic devices, not for physical implants that undergo mechanical and material testing. The "ground truth" for these tests are the established scientific principles and measurement techniques outlined in the specified ISO and ASTM standards.

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

This question is not applicable for the same reasons as #3. Mechanical testing results are typically objectively measured and evaluated against a standard, not subject to expert adjudication in the same way as diagnostic interpretations.

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 as this is not an AI/ML device. No MRMC study was conducted.

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

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

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

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges outlined in the referenced international (ISO) and American (ASTM) standards. For instance, a fatigue test determines if the device can withstand a certain number of cycles at a specific load without failure, as per the standard's requirements. Pyrogenicity is determined by established biological testing methods (LAL test, USP pyrogen test).

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical implant undergoing mechanical and material characterization.

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

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

Ask a specific question about this device

The hip prosthesis QUADRA-P is designed for cementless use in total or partial hip arthroplasty; for primary or revision surgery. Hip replacement is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty.

The Quadra-P implants are line extensions to Medacta's Total Hip Prosthesis – AMIStem-H, Quadra-S, and Quadra-H Femoral Stems (K093944); AMIStem and Quadra - Line Extension (K121011); AMIStem-P, AMIStem-P Collared, and AMIStem-H Proximal Coating Femoral Stems (K173794); Quadra-H and Quadra-R Femoral Stems (K082792); and AMIStem-H Proximal Coating (K161635).

The Quadra-P implants subject of this submission are comprised of the following products:

• . Quadra-P STD. Stem sizes 0 - 10;
• Quadra-P LAT, Stem sizes 0 - 10.
  The Quadra-P implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads, and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).

The Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

This document is a 510(k) premarket notification for the "Quadra-P" hip prosthesis, specifically describing the physical and mechanical testing performed to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information about the performance or acceptance criteria of an AI/Software device, nor does it describe a study involving humans or the establishment of ground truth for such a device.

Therefore, I cannot extract the information required to answer your questions about acceptance criteria and studies proving the device meets those criteria, as the provided document pertains to a physical medical device (hip prosthesis) and its mechanical engineering performance tests, not an AI or software-based medical device.

The document discusses:

• Device Name: Quadra-P (hip prosthesis)
• Regulation Number: 21 CFR 888.3353 (Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis)
• Performance Data (Non-Clinical Studies):
  • Range of Motion (ROM) testing (EN ISO 21535:2009)
  • Fatigue testing (ISO 7206-4 and ISO 7206-6)
  • Pull off force testing (ASTM F2009-00)
  • Pyrogenicity testing (European Pharmacopoeia §2.6.14/USP and USP )
• Clinical Studies: "No clinical studies were conducted."

Since the request is specifically about a device proving it meets acceptance criteria through a study involving a test set, expert ground truth, adjudication methods, and potentially human readers (which implies an AI/Software device or diagnostic device), the provided text is entirely irrelevant to those questions.

Ask a specific question about this device

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The BIOLOX® delta Option and Extra-long Heads include femoral heads and neck sleeves. The design features are summarized below:

• Femoral Heads
  • BIOLOX® delta Option:
    • Manufactured from alumina matrix composite
    • Head sizes: 28mm, 32mm, 36mm, 40mm, 44mm
    • Conical Bore: 16/18 Taper
  • BIOLOX® delta Extra-long:
    • Manufactured from alumina matrix composite
    • Head Sizes: 32mm, 36mm, 40mm
    • Conical Bore: 12/14 Taper
• Neck Sleeves
  • BIOLOX® delta Option:
    • Manufactured from titanium alloy
    • Neck Sleeve sizes: Short, Medium, Long, and Extra-long
    • Conical Bore: 16/18 External Taper, 12/14 Internal Taper

The provided document describes a 510(k) premarket notification for the BIOLOX® delta Option and Extra-long Heads, which are components of total hip arthroplasty systems. Per the document, the device did not undergo clinical testing, and therefore, no acceptance criteria based on clinical performance metrics are provided. The clearance is based on substantial equivalence to predicate devices and non-clinical testing.

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

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

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in error rate) are not stated in the document. The non-clinical tests assess the physical and mechanical properties of the device. The document states that the safety and effectiveness are "adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." The reported "performance" for these non-clinical tests would typically be within the expected range for such devices and comparable to predicate devices, but the specific numerical results or acceptance thresholds are not detailed in this summary.

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

The document primarily discusses non-clinical testing. For these mechanical tests, the sample sizes are not specified, nor is the country of origin of the data mentioned. The data provenance is non-clinical (laboratory testing). No human test set data is presented.

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. The document describes non-clinical testing of a hip implant device, not a diagnostic or AI-based device requiring expert ground truth for a test set.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 document pertains to the mechanical and biological safety of an orthopedic implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable. This device is not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is based on established engineering principles and material science standards for evaluating the performance and safety of medical devices. For instance, burst strength tests have defined failure points based on material properties and structural integrity. For biocompatibility, the ground truth is established through validated testing methods outlined in international standards (e.g., ISO 10993) or by referencing previously cleared devices with known biological responses.

8. The sample size for the training set

Not applicable. This 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, this is a physical medical device, not an AI model.

Ask a specific question about this device

The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Hip Replacement is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatoid polyarthritis, or congenital hip dysplasia.

· Avascular necrosis of the femoral head.

· Acute traumatic fracture of the femoral head or neck.

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

The purpose of this submission is to gain clearance for the new MiniMAX, which are anatomical HA coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.

The anatomical design of the MiniMAX stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip have a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.

MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300μm, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.

MiniMAX stems are similar to predicate devices Howmedica Osteonics' ABG III Monolithic Hip Stem (K123604) and Medacta's MasterLoc Stem (K151531).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not explicitly stated in the provided document. The document mentions "testing was conducted to written protocols," but does not detail the number of units tested for each mechanical or coating test.
• Data provenance:
  • Country of origin: Not specified beyond the manufacturer being Medacta International SA (Switzerland). The testing standards are international (ISO, ASTM, European Pharmacopoeia, USP).
  • Retrospective or Prospective: Not applicable in this context as these are laboratory-based non-clinical performance and material tests, not clinical data from patients.

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 non-clinical performance tests is established by adhering to widely recognized engineering and medical device standards (ISO, ASTM, EN, USP, European Pharmacopoeia) and internal protocols. These tests measure objective properties (e.g., fatigue strength, range of motion, coating characteristics) rather than requiring expert interpretation of clinical data as a "ground truth."

4. Adjudication method for the test set

• Not applicable. This concept typically applies to clinical studies where different readers or experts might have varying interpretations. For non-clinical, objective testing, results are measured against predefined acceptance criteria from established standards. There is no "adjudication" in the sense of reconciling differing expert opinions on the test outcomes.

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 is a medical device (hip prosthesis), not an AI-based diagnostic or assistive software. The submission focuses on the safety and effectiveness of the implant itself through material properties and mechanical performance.

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

• No, a standalone (algorithm only) performance study was not done. This is a hardware medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the performance data in this submission is based on established international and national standards (e.g., ISO 7206 series for hip prostheses, ASTM F2009 for taper connections, EN ISO 21535 for hip-joint implants, European Pharmacopoeia and USP for pyrogenicity). These standards define the acceptable performance parameters and testing methodologies for such devices.

8. The sample size for the training set

• Not applicable. This submission describes a physical medical device. There is no "training set" in the context of an algorithm or machine learning model. The relevant "data" for development would involve extensive engineering design, material science data, and prior knowledge from similar predicate devices.

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

• Not applicable. As there is no training set in the AI/ML sense, there is no ground truth established for a training set. The device design and manufacturing process would be informed by decades of biomechanical research, clinical outcomes with similar devices, and engineering principles. The "ground truth" for its design and manufacturing would be validated through the performance testing described.

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