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The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

The subject SMR Reverse HP Shoulder System is a line extension to the predicate SMR Shoulder System (K223876) consisting of Reverse HP crosslinked UHMWPE glenospheres and Co-Cr-Mo liners. The components are available in one diameter with various options to accommodate varying patient anatomy.

Based on the provided FDA 510(k) clearance letter for the SMR Reverse HP Shoulder System, here's an analysis of the acceptance criteria and the study proving the device meets them:

It's important to note that this document is a 510(k) clearance, which is primarily a declaration of substantial equivalence to a previously cleared predicate device, rather than a full, de novo approval that would detail extensive clinical performance studies with specific statistical acceptance criteria for novel claims. The focus here is on demonstrating that the new device (SMR Reverse HP Shoulder System) is as safe and effective as existing legally marketed devices, rather than proving a new level of clinical efficacy.

Therefore, many of the specific details you've asked for, such as precise quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or effect size for AI assistance), adjudication methods, or detailed expert qualifications for ground truth establishment, are typically not found in a 510(k) summary, as they are not generally required for demonstrating substantial equivalence for an orthopedic implant.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device performs as intended and is as safe and effective as its predicate. This is primarily done through non-clinical (mechanical) testing and reference to the predicate's established clinical history.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SMR Reverse HP Shoulder System are implicit in the demonstration of substantial equivalence to its predicate devices. The performance testing aims to show that the new components function equivalently to, or better than, the predicate components within the intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is primarily a non-clinical performance study combined with a post-market clinical data review for demonstrating substantial equivalence.

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

• Test Set (Non-clinical): The document states "Mechanical testing was performed on worst case components or constructs." This implies a limited sample size based on engineering principles (e.g., statistical power calculations for specific test types or industry standards for mechanical testing). Specific numbers are not provided, as is typical for 510(k) engineering tests.
• Data Provenance (Clinical): "Post-market clinical data from outside the United States on the subject and predicate device were provided in this submission." This indicates a retrospective collection of data from clinical use, not a prospective, controlled clinical trial specifically designed for this submission. The exact country of origin within "outside the United States" is not specified, nor is the specific sample size, though it is described as "patient-level radiographs, outcome measures, and safety data."

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

• Non-clinical: Ground truth is established by engineering standards and specifications (e.g., ISO, ASTM). The "experts" would be the engineers and technicians performing and assessing the mechanical tests against these predefined standards. Their qualifications are implicit in their ability to conduct and interpret these tests, but not explicitly stated in terms terms like "mechanical engineer with 10 years experience."
• Clinical: For the post-market clinical data, the "ground truth" refers to patient outcomes and safety information. This data is observed in real-world clinical practice, typically by treating physicians. There is no mention of a separate panel of experts specifically adjudicating this post-market data for "ground truth" purposes in the context described.

4. Adjudication Method for the Test Set:

• Non-clinical: The "adjudication" is against the pre-defined engineering standards and performance specifications for each mechanical test. This is typically a pass/fail determination based on quantitative measurements. No human-expert consensus "adjudication method" (like 2+1, 3+1) is described or typically applicable to component mechanical testing.
• Clinical: For the post-market clinical data, there's no mention of an adjudication method by external experts. The data would have been collected as part of routine clinical care or existing registries, and then compiled and analyzed by the manufacturer for the 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 study was done. This device is an orthopedic implant, not a diagnostic imaging AI algorithm. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not applicable to the SMR Reverse HP Shoulder System.

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

• Not applicable. As stated above, this is an orthopedic implant, not an AI algorithm.

7. The Type of Ground Truth Used:

• Non-clinical: The ground truth for mechanical testing is based on established engineering principles and international standards (ISO, ASTM) for orthopedic implants. These standards define the expected performance and limits for various mechanical properties.
• Clinical: The "ground truth" for the clinical data is real-world patient outcomes, safety events, and radiographic assessments collected during post-market use of the predicate device and the subject device (where applicable) outside the US. These are actual clinical observations rather than expert consensus on a test set.

8. The Sample Size for the Training Set:

• Not applicable for a 510(k) orthopedic implant. Training sets are relevant for machine learning algorithms. The design and validation of this mechanical implant do not involve "training sets" in this context. The "training" for the device would be the iterative design and development process, informed by biomechanical principles and material science, leading up to the final testing.

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

• Not applicable. See point 8.

In summary, the FDA 510(k) clearance for the SMR Reverse HP Shoulder System relies heavily on demonstrating engineering equivalence and material compliance through non-clinical testing, supplemented by a review of existing post-market clinical data for the predicate and related devices. It is a process focused on showing that the new device is "substantially equivalent" to an already cleared device, rather than a de novo approval process that would require extensive novel clinical efficacy studies with sophisticated statistical methodologies often seen for new drug or AI algorithm approvals.

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General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• 1. Primary and secondary osteoarthritis
• 2. Rheumatoid arthritis
• 3. Correction of functional deformities
• 4. Avascular necrosis
• 5. Femoral neck fractures

6. Revision after implant loosening dependent on bone mass and quality

The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.

The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.

Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.

Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.

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

• Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.

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

• Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.

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

• Standalone Performance: Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

• Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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Mpact 3D Metal Implants
The Mpact 3D Metal Implants is designed to be used in total hip arthroplasty, for primary or revision surgery.
The patient should be skeletally mature.
Total hip arthroplasty is indicated in the following cases:
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis or psoriactic 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.

Augments 3D Metal
The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.
The Augments 3D Metal are indicated in cases of:
· Congenital dysplasia
· Acetabular fractures
· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.

The Mpact® 3D Metal™ Implants and Augments 3D Metal™ are a line extension to the Mpact Acetabular System (K103721) which offers different acetabular shells, liner options, a screw plug, and cancellous bone screws for primary to complex hip revision solutions. The subject devices are manufactured using an Electron Beam Melting (EBM) process with titanium alloy powder. The devices subject to this 510(k) consist of two-hole shells, multi-hole shells, and augments.
The Mpact® 3D Metal™ Acetabular Two-Hole Shells are hemispherical porous shells with multiple liner options and two screw holes to be used with previously 510(k) cleared cancellous bone screws for additional fixation.
The Mpact® 3D Metal™ Acetabular Multi-Hole Shells are hemispherical porous shells with multiple liner options with up to 17 screw holes to be used with previously 510(k) cleared cancellous bone screws for additional fixation. The Mpact® 3D Metal™ Acetabular Shells can be coupled with standard Highcross Ultra-High Molecular Weight Polyethylene (UHMWPE) liners.
The Augments 3D Metal™ are porous metal augments designed to act as a defect filling implant in cases of severe bone loss in the acetabulum to help increase the stability of the acetabular component. The Augments 3D Metal™ are intended to be used in conjunction with the Mpact® Multi-Hole Acetabular Shells and Mpact® 3D Metal™ Multi-Hole Acetabular Shells to aid with bone defects in complex acetabular surgeries and provide surgeons with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

This document is a 510(k) Premarket Notification from Medacta International SA for their Mpact® 3D Metal™ Implants and Augments 3D Metal™. It asserts substantial equivalence to predicate devices. It does not describe any studies involving AI or machine learning. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, or MRMC studies for an AI/ML device is not applicable here.

However, it does describe the non-clinical performance and safety testing conducted for the medical device itself (hip implants and augments), to demonstrate substantial equivalence to predicate devices based on design, materials, manufacturing process, and performance.

Here's a breakdown of the available information based on your request, with an emphasis that this is for a physical medical device, not an AI/ML system:

1. A table of acceptance criteria and the reported device performance
The document states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, the specific acceptance criteria values and the reported device performance values are not provided in this summary document. It only lists the tests performed and the standards they reference.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This question is typically for AI/ML performance evaluation. For a physical device like hip implants, "test set" usually refers to the number of physical samples subjected to mechanical testing. This information (specific sample sizes for each test) is not provided in the summary. Data provenance is not applicable here as it refers to physical testing, not patient 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 is not applicable as the "ground truth" for a physical implant's mechanical performance is defined by the established engineering standards (e.g., ASTM, ISO guidelines) against which its physical properties are tested. No human experts are used to "establish ground truth" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for physical device mechanical testing.

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 for AI/ML systems and human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI/ML systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance of the device, the "ground truth" is defined by adherence to established international and national standards for medical devices and materials, specifically:

• ASTM F1854-15 (Stereological Evaluation of Porous Coatings)
• ASTM F1160-14 (Fatigue Shear Testing)
• ASTM F1044-05 (Static Shear Testing)
• ASTM F1147-05 (Tensile Strength Testing)
• ISO 7206-2:1996 (Deformation Testing)
• ASTM F1820-13 (Locking Mechanism Strength)
• EN ISO 21535:2009 (Range of Motion Testing)
• European Pharmacopoeia §2.6.14 and USP chapter (Bacterial Endotoxin Test)
• USP chapter (Pyrogen Test)

8. The sample size for the training set
Not applicable. This is for AI/ML systems.

9. How the ground truth for the training set was established
Not applicable. This is for AI/ML systems.

Summary of what is provided for the physical device:

The study proving the device meets acceptance criteria consists of non-clinical performance tests conducted according to written protocols and established standards.

Performed Non-Clinical Tests:

• Coating Characterization and Testing:
  • Stereological evaluation of porous coatings (ASTM F1854-15)
  • Fatigue shear testing (ASTM F1160-14)
  • Static shear testing (ASTM F1044-05)
  • Tensile strength testing (ASTM F1147-05)
• Deformation Testing: (ISO 7206-2:1996)
• Locking Mechanism Strength: (push-out, lever-out, and torque-out tests, ASTM F1820-13)
• Range of Motion Testing: (EN ISO 21535:2009)
• Dynamic Compression Testing of acetabular shell and augment assembly
• Fatigue Testing of the acetabular shell
• Pyrogenicity:
  • Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter )
  • Pyrogen test according to USP chapter

The document concludes that "Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations." This implies that the device met the acceptance criteria defined by these standards, but the specific results and numeric criteria are not detailed in this summary.

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The hardware: The Aequalis Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans. Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.

The software: The BLUEPRINT 3D planning software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINT 3D planning software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT-Scan (Computed Tomography) images of the patient. Only CT-Scan modality can be loaded with BLUEPRINT 3D planning software. BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan. This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan. The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide. BLUEPRINT 3D planning software does not include any system to manufacture the guide. BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.

BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). BLUEPRINT™ Patient Specific Instrumentation which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of Tornier. Tornier is the legal manufacturer for the hardware and the software.

The hardware: The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use. The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.

The software: BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement). It is intended to help to plan an operation by allowing surgeons to: position and select the glenoid implant, design a patient specific pin guide.

This submission seeks clearance for: Hardware: a guide made of Titanium with an orientation hole which allows for controlling rotation of the commercially available implant, AequalisTM PerFORM. Software modified to: Integrate a guide made of titanium, Add a glenoid sphere radius measurement.

The BLUEPRINT Patient Specific Instrumentation device's acceptance criteria and the study proving it are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Sample Size: The document states that studies using cadaver specimens were used for non-clinical testing. However, the exact sample size (number of cadavers) is not specified.
• Data Provenance: The cadaver studies were used for testing, implying prospective data collection for this specific validation. The country of origin of the data is not specified.

3. Number and Qualifications of Experts for Ground Truth:

• The document primarily focuses on validating the device's accuracy in guiding surgical procedures and meeting dimensional specifications. It does not explicitly mention the use of experts to establish a "ground truth" for a test set in the traditional sense of diagnostic AI performance. The ground truth for the "Patient Specific Guiding Wire test" would likely be derived from precise measurements taken during the cadaver studies, ensuring compliance with the device's design specifications. No information about expert qualifications or numbers is provided for this.

4. Adjudication Method for the Test Set:

• No adjudication method is mentioned. The "Acceptable" results for the non-clinical tests suggest that the measurements taken during the studies met predetermined specifications without requiring an adjudication process by multiple reviewers.

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

• No information about a multi-reader multi-case (MRMC) comparative effectiveness study is provided. This device is primarily a surgical planning software and patient-specific instrumentation, not a diagnostic AI intended to assist human readers in image interpretation for improved diagnostic accuracy.

6. Standalone Performance Study:

• Yes, a standalone performance was done. The document outlines "Non-clinical testing" for BLUEPRINT™ Patient Specific Instrumentation to "assess that no new safety or effectiveness questions were raised." This testing includes a "Patient Specific Guiding Wire test" and a "Dimensional test of The titanium guide," both of which evaluate the device's performance based on predefined acceptance criteria without human-in-the-loop performance described. The software's ability to measure in preoperative planning and generate a guide matching patient anatomy was validated using cadaver specimens.

7. Type of Ground Truth Used:

• The ground truth for the "Patient Specific Guiding Wire test" and "Dimensional test of The titanium guide" appears to be based on device specifications and direct physical measurements taken during cadaver specimen studies. For example, for the guiding wire test, the ground truth would be the ideal or intended version angle, inclination angle, and entry point, against which the device's actual performance is measured. Similarly, for the dimensional test, the ground truth is the specified dimensions of the titanium guide.

8. Sample Size for the Training Set:

• No information about a separate training set or its sample size is provided. The document outlines validation studies to assess the device's performance, but it does not detail the development or training of any machine learning components that would typically require a training set. The software mentioned is for pre-operative planning, visualization, measurement, and annotation, and the generation of a 3D file, which might not rely on machine learning in the same way a diagnostic AI would.

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

• Since there is no mention of a training set, there is no information provided on how its ground truth was established.

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The Minima S System is indicated for use in partial or total hip arthroplasty and is intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Minima S Stems are intended for use with compatible femoral heads and acetabular components. When used in partial hip arthroplasty, the Minima S stems are intended for use with Lock Bipolar Heads. Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• rheumatoid arthritis;
• treatment of femoral head and neck fractures; .
• revisions in cases of good remaining femoral bone stock.

The Minima S System is intended for partial or total hip arthroplasty in cementless use. It is a monolithic collarless stem available in 9 sizes (#4-#12) in standard and lateralized versions.
When used in total hip arthroplasty Minima S stems are coupled to:

• Biolox Delta femoral heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Limacorporate Cemented Cups (K112158) or
• Biolox Delta heads (object of this submission) or Limacorporate Femoral Heads (K112158) articulating with Delta TT Acetabular System (K112898).
  When used in partial hip arthroplasty the Minima S femoral stem is coupled to Lock Bipolar Heads (Limacorporate K112158).
  The Minima S stem is made of Ti6Al4V and it has a plasma sprayed titanium coating in the proximal area (ASTM F1472 - ISO 5832-3). The stem is characterized by a 12/14 conical taper to be coupled to Limacorporate Femoral Heads, Biolox Delta femoral heads or Lock Bipolar Heads. In addition necks are lowered to reduce accidental contact between stem and acetabular cups and they are mirror-polished to reduce abrasion of the UHMWPE cups in case of abnormal contact. The stem has a rectangular section and is characterized by a "V" shaped A-P profile to improve adaptability to the most common bone morphologies and to facilitate insertion of the stem in the canal.
  The Minima S System stems is available in standard and lateralized versions with different CCD angles (131° and 134°), offsets and stem lengths.
  Biolox Delta Heads devices are used by surgeons to replace the head of the femur during total or partial hip surgery. They are characterized by a spherical shape and are coupled with the acetabular cup (K112158, K112898) inserted in the acetabulum, in total hip replacement, or with Lock Bipolar Heads (K112158) in partial hip replacement.
  Biolox Delta heads are coupled with the Minima S stems by means of a 12/14 Morse taper. Biolox Delta heads are made of Biolox Delta ceramic and are available with 28, 32 and 36 mm of diameters and in sizes (offsets) S, M, L and XL (XL size available only for head size 36).

This document is a 510(k) premarket notification for the Minima S System, a hip replacement device. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting the results of a primary clinical study for the Minima S System itself. As such, information regarding acceptance criteria, device performance, and study design elements typically found in a clinical trial report is not present in this document for the Minima S System.

However, the document does describe non-clinical testing performed to demonstrate substantial equivalence. Based on the provided text, here's an analysis of the relevant sections, acknowledging that many requested fields cannot be filled due to the nature of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the non-clinical tests demonstrated the devices' ability to perform under expected clinical conditions, implying that the acceptance criteria for these tests were met. However, the specific quantitative pass/fail criteria (e.g., maximum deflection, number of cycles survived, minimum pull-out force values, specific burst pressure) are not detailed in this summary.

Information Not Available or Not Applicable Based on the Provided Document:

The following information is specifically requested for "the study that proves the device meets the acceptance criteria." Since this document details a 510(k) submission based on substantial equivalence and non-clinical testing, and explicitly states "Clinical testing was not necessary," most of the requested fields related to clinical studies, human reader performance, and ground truth establishment from patient data are not applicable and are therefore left blank or marked as "N/A."

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

   • Sample Size: Not specified for the non-clinical tests. Non-clinical mechanical tests typically use a smaller number of physical samples (e.g., n=3 or n=6 per test condition) rather than a "test set" of patient data.
   • Data Provenance: N/A (Non-clinical mechanical testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical test set requiring expert ground truth in this document).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication in this document).

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 refers to a hip replacement system, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document refers to a hip replacement system, not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. For the non-clinical tests, the "ground truth" would be the engineering specifications and performance limits defined by the referenced ISO standards and FDA guidance documents.

8. The sample size for the training set: Not applicable. This document refers to non-clinical testing for a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable. This document refers to non-clinical testing for a physical medical device.

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