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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• . Inflammatory joint disease including rheumatoid arthritis
• . Correction of functional deformity including congenital hip dysplasia
• . Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• . Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
  Signature Orthopaedics' Origin, Aria, Remedy, TSI, Pegasus, Spartan, World and Encore Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.
  Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Cemented Origin femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.
  Signature Orthopaedics' SignaSure Insert is indicated for use with a cementless Signature Orthopaedics' Logical Acetabular Cup to provide dual mobility articulation.
  Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
  Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:
• . Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• . Certain high subcapital and femoral neck fractures in the elderly
• . Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Encore Hip Stem is manufactured from forged titanium alloy (Ti6Al4V) as per ISO 5832-3 and ASTM F136. The Encore Stem is straight and tapered with a rectangular cross-section. The stem has a polished distal tip to reduce fixation leading to proximal stress shielding. It features a titanium and hydroxyapatite plasma spray proximal coating below its resection line.

The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Encore Hip Stem." It concerns the regulatory approval process for a new hip implant. The document does not contain information about software or AI-based devices; therefore, it does not include acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set information as requested in the prompt.

The document discusses the substantial equivalence of the Encore Hip Stem to previously cleared predicate devices based on non-clinical performance testing and engineering evaluations. These tests are related to the mechanical properties and design of the physical implant, not the performance of an AI algorithm.

Specifically, the "Performance Testing" section states:
"Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Encore Hip Stem is adequate for anticipated in-vivo use. No animal or clinical testing was required to support substantial equivalence. Non-clinical testing carried out included:

• Range of Motion Testing
• Stem and Neck Fatigue FEA
• Stem and Neck Fatigue Testing
• Rim Impingement Analysis"

Therefore, I cannot provide the requested information from the given text as it pertains to a physical medical device, not an AI or software device.

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The CoreHip® System is intended to replace a hip joint. The device is intended for:

· Patients suffering from severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur

• · Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
• · Patients suffering from disability due to previous fusion
• · Patients with acute femoral neck fractures

The CoreHip® System is available with two (2) types of femoral stem is manufactured from CoCrMo and is intended for cemented fixation and the other femoral stem is manufactured from Ti with Plasmapore® and is intended for uncemented (pressfit) fixation.

The CoreHip System includes cemented and uncemented (pressfit) stems. The CoreHip uncemented (pressfit) Stem is offered as CoreHip uncemented (pressfit) Primary and CoreHip uncemented (pressfit) Extended which are manufactured from Ti with a Ti plasma spray coating (Plasmapore®) proximally and rough-blasted distally. The Cemented Stem is offered as CoreHip Cemented Primary stem which is manufactured from CoCrMo. The CoreHip System includes stem variants of varus, neutral, valgus and dysplasia is offered in CoreHip uncemented (pressfit) Primary only), which have different medial curves in order to address different patient morphologies. The femoral stems will be offered in a 12/14 external taper in stem sizes 1 to 11 for the uncemented (pressfit) design (primary (except size 1 dysplasia) and extended) and sizes 1-11 for the cemented design.

This document is a 510(k) premarket notification for a hip implant system, not an AI/ML device study. Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML device is not present in this document.

The document discusses the substantial equivalence of the CoreHip® System to predicate devices. It focuses on the safety and effectiveness of the traditional medical device (hip implant) through:

• Indications for Use: Defining for which patient conditions the device is intended.
• Technological Characteristics Comparison: Comparing materials, fixation types, stem sizes, and geometry with predicate devices.
• Performance Data: This section details non-clinical performance testing, primarily mechanical endurance testing, to demonstrate the device's substantial equivalence to previously cleared devices.

Here's what can be extracted regarding performance, even though it's not related to AI:

Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific numerical targets and reported device performance values in the way you might expect for a diagnostic or AI device. Instead, the performance claims are based on compliance with established standards and comparison to predicate devices.

Key Performance Statements:

• "Endurance properties of the CoreHip cemented and uncemented (pressfit) stem, head and neck were evaluated in accordance to Guidance for Industry and FDA Staff Non-clinical Information for Femoral Prostheses, September 17, 2007; ASTM F2068-15; ISO 7206-4 and ISO 7206-6."
• "Additional Femoral head/Taper testing was completed."
• "Range of Motion (ROM) analysis to satisfy the requirements of ISO 21535 was completed."
• "Testing demonstrated that the subject device is substantially equivalent to the Primary and reference predicate devices."
• "PYROGEN TESTING: LAL testing was completed and met the pyrogen limit of 20 E.U./device."

Essentially, the acceptance criteria are implicitly met by:

1. Adherence to recognized industry standards: ASTM F2068-15, ISO 7206-4, ISO 7206-6, and ISO 21535.
2. Demonstrating substantial equivalence to legally marketed predicate devices in terms of performance and safety.
3. Meeting specific pyrogenicity limits: LAL testing confirmed meeting the pyrogen limit of 20 E.U./device.

As this is a 510(k) for a physical implant, specific "reported device performance" in terms of accuracy, sensitivity, or specificity (relevant to AI/ML) is not applicable. The performance is assessed on mechanical integrity, fatigue life, and biocompatibility, which are demonstrated through testing against relevant standards.

The remaining points of your request are not applicable to the provided document as it describes a non-AI medical device submission.

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The BIOLOX delta Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion: patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

The BIOLOX delta Ceramic Femoral Heads are fabricated from an alumina matrix composite and are available in diameters of 28, 32, 36, and 40 mm with a range of offsets to accommodate various patient anatomies. They serve as an alternative to both metal and alumina ceramic femoral heads for use in total hip arthroplasty.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BIOLOX delta Ceramic Femoral Heads:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device, its intended use, and a comparison to a predicate device. It does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific fatigue limits, wear rates, a certain number of cycles successfully passed). Instead, the performance is assessed against the substantial equivalence to a predicate device.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The document refers to "non-clinical testing" which implies mechanical and engineering tests, not patient data in the traditional sense of a "test set" for an AI or diagnostic device.
• Data Provenance: The "non-clinical testing" was likely conducted by Zimmer GmbH, which is located in Winterthur, Switzerland. However, the exact location of the testing facilities is not explicitly stated. The data is non-clinical/engineering (not patient data), so the concept of retrospective or prospective doesn't directly apply in the same way as clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. For this type of device (femoral head prosthesis), "ground truth" is established through engineering principles, material science, and mechanical testing standards, rather than expert consensus on medical images or clinical diagnoses.
• Qualifications of Experts: Not specified, but implied to be engineers, material scientists, and regulatory specialists involved in medical device design, testing, and regulatory submissions.

4. Adjudication Method:

• Adjudication Method: Not applicable. This document describes a 510(k) submission for a medical device (a ceramic femoral head), not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment is based on objective engineering test results and regulatory review.

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

• MRMC Study: No. This is a physical orthopedic implant, not a diagnostic or AI-assisted device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. There is no algorithm involved in this device. The performance is assessed through non-clinical (mechanical) testing of the physical implant.

7. Type of Ground Truth Used:

• Ground Truth: The "ground truth" in this context is established through engineering principles, material standards, mechanical testing results, and comparison to established performance characteristics of predicate devices. This includes:
  • Results from pull-off testing.
  • Results from range of motion analyses.
  • Results from fatigue strength analysis.
  • Adherence to material specifications (alumina matrix composite).
  • Compliance with relevant ASTM or ISO standards for orthopedic implants (though not explicitly listed, this is inherent in regulatory submissions).

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that uses a "training set." The development of the device relies on established engineering design principles, material science, and manufacturing processes, which are refined through iterative design and testing rather than a statistical training set.

9. How Ground Truth for Training Set was Established:

• Ground Truth for Training Set: Not applicable, as there is no training set in the context of an AI/ML model for this device. The "truth" for the device's design and manufacturing is derived from decades of knowledge in biomedical engineering, orthopedics, materials science, and testing standards for implantable medical devices.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.
   Porous coated components are intended for uncemented biological fixation.

The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Testing: 6 worst-case stems were used for both distal and proximal stem fatigue testing. The sample size for the Range of Motion analysis is not explicitly stated but implies at least one simulation.
• Data Provenance: The data is from non-clinical testing performed by Biomet Manufacturing Corp. The country of origin is not explicitly stated, but the company is based in Warsaw, IN, USA. The data is prospective in the sense that it was generated for the purpose of this 510(k) submission, not gathered retrospectively from existing patient data.

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

This section is not applicable as the studies described are non-clinical mechanical engineering tests, not studies requiring human expert assessment of medical images or patient outcomes. The "ground truth" for these tests is defined by the international standards (e.g., ISO, ASTM) and the specified load/cycle requirements.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. There were no human expert assessments requiring adjudication. The tests were objective mechanical measurements against predefined pass/fail criteria.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This device is a hip implant, and the testing described is mechanical, not related to AI-assisted human reading.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was based on internationally recognized engineering standards and specifications. Specifically:

• Distal Stem Fatigue: ISO 7206-4:2002, ASTM F2068-03
• Proximal Stem Fatigue: ISO 7206-6:1992
• Range of Motion Analysis: ISO 21535:2009
• PPS Plasma Sprayed Coating: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and 21 CFR 888.3358.

The "ground truth" is therefore adherence to these established mechanical performance and material characterization standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The number of samples for mechanical testing (6 worst-case stems) served as the test set.

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

This section is not applicable for the same reason as above. There is no training set mentioned or implied.

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