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The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.

• · 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 where sufficient bone stock is present

The Mpact Extension implants are a line extension to Medacta's Mpact (K103721) and Mpact Extensions (K122641, K132879, K183582 and K200391) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:

• Liners sizes 22/A and 28/A of each design type (flat, hooded, offset +4mm and face changing . +10°);
• Acetabular Shells size Ø44 of each design type (No-hole, Two-holes and Multi-holes); ●
• Acetabular Shells sizes from Ø42T to Ø58T of each design type (No-hole, Two-holes and Multi-● holes) allowing to be coupled with an increase size of liner.

The Mpact Extension implants are sterile implantable devices intended to be used during Total Hip Arthroplasty: the acetabular shells together with their respective liners are used to replace the acetabulum.

Analogously to the predicate devices, the subject acetabular shells are made of Ti6Al4V according to ASTM F136-13 and Ti coated according to ASTM F1580-18, while the subject liners are made of High-Cross ultra-high molecular weight polyethylene (UHMWPE).

The provided text does not describe an AI medical device, but rather an orthopedic implant (hip joint prosthesis). Therefore, the questions regarding acceptance criteria, study details, expert qualifications, adjudication methods, AI assistance, standalone performance, and training set information are not applicable to this submission.

The FDA 510(k) summary for the Medacta International S.A. Mpact Extension (K230011) outlines the device, its indications for use, comparison to predicate devices, and performance data for substantial equivalence.

Here's a summary of the information provided in relation to the device's performance, but not in the context of AI:

1. Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding device performance for an AI model. Instead, it lists the following non-clinical performance tests conducted to support substantial equivalence for the orthopedic implant:

   Acceptance Criteria (Implied by Test Type)	Reported Device Performance
   Acetabular cup fatigue assessment	Performed (Implicitly met industry standards for fatigue strength)
   Acetabular cup deformation assessment	Performed (Implicitly met industry standards for resistance to deformation)
   PE liners stability (Axial Disassembly Force) per ASTM F1820	Performed (Implicitly met ASTM F1820 standard)
   Evaluation of impingement risk	Performed (Rationale provided, implicitly acceptable risk)
   Evaluation of Range of Motion (ROM) per EN ISO 21535	Performed (Implicitly met EN ISO 21535 requirements)
   PE HC liner wear test	Rationale for wear test provided (This suggests either the wear characteristics were considered equivalent to predicates, or specific wear tests were deemed not necessary based on similarity to previously cleared devices, or a rationale was provided to explain why testing demonstrated acceptable wear. The document states "Rationale for wear test" which implies a justification was given, rather than a direct report of a wear rate.)
   Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14	Performed (Implicitly met pyrogenicity standards)
   Pyrogen test per USP chapter	Performed (Implicitly met pyrogenicity standards; note that the devices are not labeled as non-pyrogenic or pyrogen-free)
   Biocompatibility	Assessed (Implicitly met biocompatibility standards)
   Shelf-Life evaluation	Performed (Implicitly demonstrated acceptable shelf-life)

2. Sample Size for Test Set and Data Provenance: Not applicable as this is not an AI device. The performance tests for the orthopedic implant are laboratory-based mechanical and biological tests, not statistical analyses using a test set of medical data.

3. Number of Experts and Qualifications: Not applicable. Ground truth for an AI device involves expert annotations; for an orthopedic implant, it's about meeting engineering and biological standards.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No clinical studies were conducted, and this is not a device that would typically involve human-in-the-loop AI assistance.

6. Standalone Performance Study: Not applicable. This refers to AI algorithm performance without human interaction. The device is a physical implant.

7. Type of Ground Truth Used: Not applicable in the AI sense. For the orthopedic implant, "ground truth" would be defined by established engineering standards (e.g., ASTM, ISO) for material properties, mechanical performance, and biocompatibility.

8. Training Set Sample Size: Not applicable. This device is not an AI algorithm requiring a training set.

9. Ground Truth for Training Set Establishment: Not applicable.

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The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

Total 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, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.

Partial hip arthroplasty is indicated in the following cases:
· Acute traumatic fracture of the femoral head or neck

• · Non-union of femoral neck fracture
• · Avascular necrosis of the femoral head.
• · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The AMIS-K Long cemented stem is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.

The AMIS-K Long is a straight, double-tapered cemented stem whose primary stability is ensured by bone cement.

The AMIS-K Long implants in this submission are comprised of the following size: from #2 to #5 with 2 different stem body size for #2, #3 and #4, 1 different stem body size for #5. Stem length: 200 - 250 - 300 mm (for each size).

The AMIS-K Long implants are part of the Medacta Total Hip Prosthesis system.

The Medacta Total Hip Prosthesis system consists of femoral stemoral heads, and acetabular components.

The AMIS-K Long are cemented stems manufactured from high nitrogen stainless steel (ISO 5832-9) with a mirror polished surface.

The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high polyethylene (HXUHMWE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120531 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).

The AMIS-K Long implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

The provided text is a 510(k) summary for a medical device (Amis K Long hip prosthesis), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML performance. Specifically:

• No acceptance criteria for AI/ML performance are listed. The acceptance criteria mentioned refer to non-clinical performance tests for the physical hip prosthesis (e.g., pull-off strength, fatigue testing).
• No study proving AI/ML device performance is described. The document explicitly states "No clinical studies were conducted." and describes non-clinical mechanical tests.
• The requested elements (sample size, data provenance, expert qualifications, etc.) are not applicable in this context as the document is about a physical implant, not an AI/ML diagnostic or assistive device.

The study described in the document primarily focuses on non-clinical mechanical tests to validate the physical properties of the hip prosthesis, such as pull-off strength, range of motion, and fatigue. These tests adhere to established international standards (ASTM, EN ISO, ISO).

In summary, the provided text does not contain the information necessary to answer the questions about acceptance criteria and a study proving device performance as they relate to AI/ML or diagnostic accuracy.

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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 MPACT Extension implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthrodesis, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

The MPACT implants subject of this submission are comprised of the following products:

• 33 sizes of Offset +4mm PE liners; and
• 32 sizes of Face-changing +10° PE liners.

These liners are a component of a total hip joint prosthesis that is used to replace the acetabulum. The component is an inner liner made of High-Cross ultra-high molecular weight polyethylene (UHMWPE); which is inserted in the Acetabular shell.

They are all a line extension to Medacta's MPACT (K103721), and MPACT Extensions (K122641 and K132879) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. In detail, the Liners subject of the current submission are compatible with the MPACT No-Hole and Two-Hole (K132879), MPACT Multi-Hole and Rim-Hole (K132879); and the Mpact 3D Metal Acetabular Shells (K171966).

As regards to the femoral head components, the MPACT Extension Liners can be combined with the CoCr Ball Heads (K072857 and K080885), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).

The provided text describes the regulatory clearance for a medical device called "MPACT Extension" and details the non-clinical performance data used to demonstrate its substantial equivalence to predicate devices. It explicitly states that no clinical studies were conducted. Therefore, the acceptance criteria and study information related to human performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing was conducted according to written protocols with acceptance criteria based on standards. The specific numerical acceptance values or individual performance results are not explicitly listed in this summary, but the general statement "device passed the tests, supporting substantial equivalence" implies that the acceptance criteria were met for all listed non-clinical tests.

2. Sample size used for the test set and the data provenance
Not applicable. No human test set was used as this was a non-clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No human test set was used.

4. Adjudication method for the test set
Not applicable. No human test set was used.

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 performed. The document explicitly states: "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical implant (hip joint component), not an algorithm or AI software for which standalone performance would be relevant.

7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" was established by the specified industry standards (ASTM F1820-13, EN ISO 21535, European Pharmacopoeia §2.6.14, USP chapter , USP chapter ). These standards define the methodologies and acceptable performance limits for mechanical properties and biocompatibility.

8. The sample size for the training set
Not applicable. No human training set was used. "Training set" typically refers to data used to train AI models; this device is a physical implant.

9. How the ground truth for the training set was established
Not applicable. No human training set was used.

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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, 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.

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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.

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