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The GMK knee cemented prosthesis is designed for cemented application in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components.

The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications.

The GMK 3D Metal Tibial Baseplate is indicated for cemented application if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and avascular necrosis of the femoral condyle
• Post traumatic loss of joint configuration
• Primary implantation failure

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semiconstrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal Tibial Baseplate.

Limitations for use for GMK Sphere/GMK SpheriKA used with kinematic alignment

GMK Sphere and GMK SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Moderate valgus, varus, or flexion deformities.

The GMK Sphere & GMK SpheriKA Cementless is a line extension to the GMK Total Knee System and includes the following devices:

• GMK Sphere Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
• GMK SpheriKA Cementless Femoral Components. Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
• GMK SpheriKA ST Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes).

The subject devices are marketed as individually packaged femoral components, designed for cementless use in total knee arthroplasty procedures where the surgeon considers the bone quality to be sufficient for cementless applications.

The GMK Sphere & GMK SpheriKA Cementless implants are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with double-layer coating composed of Titanium plasma spray according to ISO 13179-1 Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants -- Part 1: General requirements and Hydroxyapatite according to ISO 13779-2 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite on the internal surface pockets.

This document refers to the review of a 510(k) premarket notification for the "GMK Sphere & GMK SpheriKA Cementless" knee prosthesis. Based on the provided text, there is no acceptance criteria and study that proves the device meets the acceptance criteria in the traditional sense of evaluating an algorithm's performance against predefined metrics (e.g., sensitivity, specificity for diagnostic devices).

This submission is for a medical device (knee prosthesis), not an AI/ML powered device, and the "performance data" provided refers to engineering and biocompatibility testing, not clinical performance metrics or studies involving human readers or ground truth as would be relevant for AI.

Here's a breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes a comparison to predicate devices, not the setting of specific performance targets (like accuracy, precision, etc.) for an AI/ML algorithm. The "performance data" listed are non-clinical engineering tests (mechanical properties, microscopy, pyrogenicity, biocompatibility, shelf-life) which are not presented with acceptance criteria and results in the format requested.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's performance evaluation. The "tests" performed are on the physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to an independently verified correct answer for a given input. This concept is not relevant to the described premarket notification for a knee prosthesis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no adjudication process described as it pertains to medical image interpretation or similar tasks for an algorithm.

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 explicitly states: "No clinical studies were conducted." The device is a physical knee implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" as an expert-derived annotation or definitive diagnosis is not relevant to the evaluation of a physical knee implant.

8. The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML algorithm or training set.

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review for a physical orthopedic implant (a knee prosthesis), not an AI/ML-powered medical device. Therefore, the questions related to acceptance criteria and study design for AI/ML performance evaluation are not applicable to this document. The "Performance Data" section details non-clinical laboratory testing for material properties, sterility, and biocompatibility to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation from AI/ML performance studies.

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The Medacta DM Converter is designed to be used in combination with the Mpact and Versafitcup CC Trio family cementless cups in total hip arthroplasty in primary or revision surgery.

Total hip Arthroplasty 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 DM Converter - TiN coated is a component of a total hip joint prosthesis that is used to replace the acetabulum in both primary or revision surgery. It is a highly polished metal liner made of High Nitrogen Stainless Steel according to ISO 5832-9 with a TiN coating on the external surface.

The DM Converter - TiN coated is inserted into the acetabular shell and can be coupled with a mobile liner: Medacta Double Mobility UHMWPE (ISO 5834-2 Type 1) liners (K083116 and K131458) or HighCross (highly crosslinked UHMWPE) liners (K092265 and K131458).

The DM Converter – TiN coated is available in 6 six sizes with a nomenclature that identifies the cup liner size (first letter) and the double mobility liner size (final three letters): D/DMB, E/DME, G/DMF, J/DMH and K/DML.

The provided text is a 510(k) summary for the Medacta DM Converter - TiN coated, a component of a total hip joint prosthesis. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis of the acceptance criteria and study aspects based on the provided document:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it lists the types of performance tests conducted and implies that the device satisfied the requirements of these standard tests. The "reported device performance" is not quantified in the document, but rather stated that "design validation and performance testing were conducted to written protocols" and the results support substantial equivalence.

Implied Acceptance Criteria (based on tests performed):

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 does not specify the sample sizes used for any of the performance tests.
The data provenance (country of origin, retrospective/prospective) is not mentioned. All studies appear to be non-clinical (laboratory) studies rather than field data.

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 information is not applicable as the studies are entirely non-clinical performance and design validation tests for a medical device component. There is no "ground truth" in the clinical sense established by human experts for these types of tests.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not present in this non-clinical 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

No MRMC comparative effectiveness study was done. This is a submission for a mechanical implant component, not an AI-assisted diagnostic or treatment device. 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

This question is not applicable as the device is a physical medical implant (a component of a total hip joint prosthesis), not an algorithm or AI system.

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

For the non-clinical performance tests, the "ground truth" is typically defined by the standards themselves (e.g., ASTM, ISO specifications for material strength, wear rates, and stability). The device either meets the specified performance parameters outlined in these standards or it does not. There is no expert consensus, pathology, or outcomes data involved in establishing "ground truth" for these engineering tests.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device and not a machine learning model.

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

This is not applicable for the reasons stated above.

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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 DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced.

Indications for Use:

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;

5. dislocation risks;

6. treatment of non-union, femoral neck fractures of the proximal femur with head involvement which are unmanageable by other techniques

Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

The Dual Mobility (DM) Inserts and Liners are designed for use with compatible DYNASTY® acetabular shells, MicroPort Orthopedics non-skirted femoral heads and PROFEMUR® femoral stems, to create a system with two articulating interfaces in the acetabular joint space of the hip.

The E-CLASS® DUAL MOBILITY INSERTS are manufactured from Vitamin E cross linked polyethylene conforming to ASTM F2695 and are available with an inner diameter of 28 mm and outer diameters from 38 mm to 56 mm in 2 mm increments. The E-Class® DM Inserts are compatible with and provide a primary articulating surface for all 28 mm, non-skirted femoral heads.

DM CoCr Liners are manufactured from cobalt chrome (CoCr) alloy conforming to ASTM F1537 (Type 1) and are available with inner diameters from 38 mm in 2 mm increments. The DM CoCr Liners are designed to mate with all DYNASTY® acetabular shells via a taper locking mechanism and provide the secondary articulating surface for the E-Class® DM Inserts.

This document is a 510(k) Premarket Notification from MicroPort Orthopedics, Inc. to the FDA regarding their E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS. The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document describes mechanical testing to demonstrate substantial equivalence, rather than a clinical study evaluating human-in-the-loop performance of an AI device. Therefore, the "acceptance criteria" discussed are for the mechanical properties of the orthopedic implants, not for an AI algorithm's diagnostic performance.

Tabla de criterios de aceptación y rendimiento informado del dispositivo:

Study Information (Mechanical Testing)

This document describes a premarket notification for an orthopedic implant, not an AI/software device. Therefore, the questions related to AI device performance evaluation (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not directly applicable to the type of study described.

However, based on the provided text, we can infer some details about the mechanical testing study:

1. Sample size used for the test set and the data provenance:

   • The sample size for each mechanical test is not explicitly stated (e.g., "n="). Instead, it mentions "MicroPort has evaluated the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS and data demonstrates substantial equivalence..." This implies multiple samples were tested for each specified mechanical test to comply with the relevant ASTM/ISO standards.
   • Data Provenance: The testing was "performed for the subject E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS" by MicroPort. The location is implied to be within MicroPort's testing facilities, likely in the US (Arlington, Tennessee, is mentioned as their address). It is inherently a prospective execution of validated test methods on newly manufactured devices.

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

   • Not applicable in the context of mechanical testing. "Ground truth" here refers to the precise measurements and evaluations against established engineering standards (ASTM, ISO). The "expertise" involved would be mechanical engineers and technicians conducting the tests and interpreting the results according to the specified standards.

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

   • Not applicable. Mechanical testing involves objective measurements rather than subjective expert consensus. Results are compared directly to numerical acceptance criteria defined by the standards.

4. 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 not an AI device or a human-in-the-loop study.

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

   • Not applicable. This is not an AI algorithm. The performance evaluation is inherently "standalone" in the sense that it's testing the physical properties of the device itself, not an algorithm's output.

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

   • The "ground truth" for mechanical testing is defined by the acceptance criteria specified in the referenced ASTM and ISO international standards. These standards provide the validated methodologies and performance thresholds for assessing the safety and efficacy of orthopedic implants.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning study requiring a training set.

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

   • Not applicable, as there is no training set for mechanical testing.

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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 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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