Search Results

Intended Use The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.

Indications

• · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis.
• · Fracture or avascular necrosis of the femoral head.
• · Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• · All forms of osteoarthritis.
• · Patients with hips at risk of dislocation.
• · Femoral neck fracture or proximal hip joint fracture.

The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated for use without bone cement.

The OR30 Hip System is a modular dual mobility implant system consists of diffusion hardened oxidized zirconium (OXINIUM DH) alloy liners with a highly polished zirconium oxide inner surface and a machined locking taper and backside of Zr2.5Nb alloy (F2384-10R16). The locking taper and outside profile is designed to mate with a dedicated Ti6Al4V R3 acetabular shell with OD sizes 44mm to 74mm or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 liner and R3 shell size from 44mm to 74mm and REDAPT Modular shell size from 48mm to 74mm, a dedicated insert is available. Inserts are made of highly crosslinked ultra-high-molecularweight polyethylene (ISO 5834-2/ASTM F648) that is irradiated with a 10 Mrad dose and remelted . These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22 mm (for Size 44mm-52mm) and 28 mm (for size 50mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell (with optional screws and optional screw hole covers), an OXINIUM DH Liner, a cross linked polyethylene (XLPE) Insert and a femoral head.

The purpose of this Traditional 510(k) submission is to add additional components, namely additional sizes of the OR3O Dual Mobility OXINIUM DH Liners and OR3O Dual Mobility XLPE Inserts to the existing OR30 Dual Mobility System.

This line extension will consist of two smaller size OXINIUM DH Liners and four additional XLPE inserts to allow for a wider range of implant options for physicians to choose from. The materials and manufacturing processes will be the same, with the exception of accounting for different sized implants.

This document is a 510(k) Premarket Notification from the FDA regarding the "OR30 Dual Mobility System," a hip joint prosthesis. The provided text primarily focuses on establishing substantial equivalence to existing predicate devices based on design, materials, indications for use, and performance data, including biocompatibility and mechanical testing.

However, the document does NOT contain information about any study involving AI, human readers, or the establishment of ground truth for evaluating such a system. The "acceptance criteria" and "device performance" described in the document relate to the physical and biological characteristics of the orthopedic implant and its components, not to the performance of an AI or diagnostic system.

Therefore, I cannot extract the information required by your prompt, as it pertains to AI/diagnostic system evaluation, which is absent from this regulatory submission for a hip joint prosthesis.

The document covers:

• Device Description: What the OR30 Dual Mobility System is, its components (liners, inserts, shells, femoral heads), and the materials used (OXINIUM DH, XLPE). It highlights that the current submission is for a line extension – adding smaller sizes of existing components.
• Indications for Use: The medical conditions for which the hip system is intended (e.g., hip degeneration, fracture, failed previous hip surgery, osteoarthritis, risk of dislocation).
• Comparison to Predicate Devices: A detailed comparison of the subject device (OR30 Dual Mobility System line extension) against previously cleared predicate devices, emphasizing similarities in intended use, fundamental scientific technology, materials, and indications for use.
• Performance Data:
  • Biocompatibility: Evaluation according to ISO-10993 for permanent implants (>30 days body contact), confirming compliance with material standards (ASTM F2384-10R16 for Zr-2.5Nb alloy and ASTM F648-14 / ISO 5834-2 for XLPE). A Declaration of Conformity was provided.
  • Mechanical Testing: Listing of various ASTM and ISO standards for tests like push-out, torque to failure, lever-out, environmental fatigue, corrosion assessment, deformation, neck impingement, range of motion, and wear testing. It states that biomechanical testing and/or rationales were completed and "met the pre-determined acceptance criteria for each intended output." The submission concludes that the device does not represent a new worst-case scenario compared to predicates.
  • Non-Pyrogenicity Endotoxin Testing: Bacterial endotoxin testing was completed and met acceptable limits per FDA guidance and ANSI/AAMI ST72.

In summary, this document is a regulatory submission for a physical medical device (orthopedic implant) and does not involve AI or diagnostic imaging. Therefore, it does not contain the specific information requested in your prompt regarding AI system acceptance criteria, study design for AI evaluation, expert ground truth, or MRMC studies.

Ask a specific question about this device

The My3D® Personalized Pelvic Reconstruction system is indicated for use in patients requiring reconstruction of the pelvis and/or hip joint due to disease, deformity, trauma, or revision procedures where other treatments or revisions have failed. The device is a combination of single use guided osteotomy instruments, a pelvic implant, screws, and acetabular/ femoral components. The pelvic implant is intended for cementless application in individuals where bone quality or bony defect size cannot support a standard sized acetabular implant is intended to be fixed to the remaining pelvic anatomy using compatible bone screws to create a prosthetic acetabulum. The reconstructed prosthetic acetabulum is intended to be used with a compatible cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components to restore hip function.

The My3D® Personalized Pelvic Reconstruction system is a patient specific combination of single use resection instruments, a pelvic implant, screws, acetabular, and femoral components. The system was developed to address conditions which require reconstruction of the acetabulum and hip joint.

This patient matched device is designed from inputs including imaging, diagnosis, and surgical approach. Together with the surgeon, these inputs are then translated via a design process to create patient specific implants and, if appropriate, instruments to reconstruct the patient's pelvis. If utilized, the patient specific instruments are used to resect the bone and allow for implantation of the patient matched pelvis. The joint is then reconstructed with a cemented acetabular cup, dual mobility head (POLARCUP Insert), and femoral components.

The implants and resection instruments are single use devices. Reusable instrumentation is provided non-sterile in surgical trays which are to be re-processed per validated instructions.

I am sorry, but the provided text content does not contain enough information to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your request. The document is an FDA 510(k) clearance letter and summary for the My3D® Personalized Pelvic Reconstruction device, which primarily addresses substantial equivalence to a predicate device.

Specifically, the document mentions "Performance Data" and lists several types of testing performed (biocompatibility, manufacturing residuals, sterilization validation, mechanical testing of porous structure, fatigue testing, screw performance, cadaveric evaluation of design process). However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only lists the types of tests.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "Clinical data were not deemed necessary for the subject device." This further indicates that no human-centric validation studies (like MRMC or studies requiring expert ground truth and adjudication) were conducted or included in this submission summary. The testing mentioned appears to be primarily engineering and material performance tests.

Ask a specific question about this device

Intended Use The OR3O Dual Mobility System is intended for use in primary and revision total hip arthroplasty in skeletally mature patients.

Indications

• · Advanced degeneration of the hip joint as a result of degenerative, post-traumatic, or rheumatoid arthritis.
• · Fracture or avascular necrosis of the femoral head.

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

• · All forms of osteoarthritis.
• · Patients with hips at risk of dislocation.
• · Femoral neck fracture or proximal hip joint fracture.

The OR30 Dual Mobility System is intended for single use only. The modular OR30 Liners and Inserts are to be implanted without bone cement.

Mating components may be indicated for use without bone cement.

The OR30 Hip System is a modular dual mobility implant system. The system consists of diffusion hardened, oxidized zirconium alloy liners with a highly polished inner surface of zirconia and a machined locking taper and backside of Zr-2.5Nb alloy. The locking taper and machined outside profile is designed to mate with a dedicated Ti 6Al 4V R3 or REDAPT Modular Press-fit acetabular shell with OD sizes 48mm to 74mm. For each assembled OR30 Liner and R3 and REDAPT Modular Shell size from 48mm to 74mm, a dedicated plastic insert made of highly crosslinked ultrahigh-molecular-weight polyethylene (10Mrad irradiated and remelt-annealed UHMWPE (XLPE) according to ISO 5834-2/ASTM F648) is available. These can be combined with oxidized zirconium or CoCr alloy femoral heads of sizes 22mm (for size 48mm-52mm) and 28mm (for size 54mm-74mm). The final OR30 Dual Mobility construct will include an acetabular shell, an OXINIUM DH Liner, an XLPE Insert and a femoral head.

The purpose of this 510(k) submission is to add additional options of dual mobility implants to the Smith & Nephew collection of hip implants.

This document is a 510(k) premarket notification for a medical device, the OR30 Dual Mobility System, and focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria and study data for a diagnostic device in the usual sense (e.g., performance metrics like sensitivity, specificity, or AUC). Instead, the performance data provided is for biocompatibility and mechanical testing of the implantable device.

Therefore, many of the requested categories for a diagnostic device's acceptance criteria and study data (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.

I will interpret the request within the context of the provided document, focusing on the "acceptance criteria" for the mechanical testing of the OR30 Dual Mobility System, as this is the closest equivalent to performance evaluation in this type of submission.

Here's the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify sample sizes for any of the mechanical or biocompatibility tests.
• Data provenance is not mentioned. It can be inferred that testing was conducted as part of the device development and submission process, likely by the manufacturer or a contracted lab. This is industrial testing, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a physical device intended to be implanted. "Ground truth" for mechanical testing is based on engineering specifications and adherence to standards, not expert clinical interpretation of data.

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

• Not applicable, as this refers to clinical evaluation and consensus building for diagnostic accuracy, which is not part of this 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

• Not applicable. This is a physical implantable device, not a diagnostic AI system or a system requiring human interpretation.

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

• Not applicable. This is a physical implantable device, not an algorithm.

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

• For mechanical testing: The "ground truth" or reference for performance is established by pre-determined acceptance criteria based on engineering standards (e.g., ASTM, ISO), regulatory guidelines, and comparison to predicate devices, ensuring the device meets safety and performance requirements for its intended use. The document states the device "met the pre-determined acceptance criteria for each intended output."
• For biocompatibility: Ground truth is adherence to international standards like ISO-10993.
• For non-pyrogenicity: Ground truth is adherence to established endotoxin limits in FDA Guidance and ANSI/AAMI ST72.

8. The sample size for the training set

• Not applicable. This is a physical implantable device; there is no "training set" in the context of machine learning or diagnostic device development.

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

• Not applicable, as there is no training set mentioned in this context.

Ask a specific question about this device

The Alpine Hip Stem is intended for use in total hip replacement surgery or hemi-arthroplasty. Hip arthroplasty is intended to provide increased patient mobility and decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

This device is intended for use in total hip arthroplasty or hemi-arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis
2. Previously failed hip surgery
3. Proximal femoral neck fractures or dislocation
4. Idiopathic avascular necrosis of femoral head
5. Non-union of proximal femoral neck fractures
6. Treatment of fractures that are unmanageable using other forms of therapy
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis

The Alpine Hip Stem is a single-piece, conical tapered femoral hip prostheses, designed for single, cementless use. The stem has a neck with a 12/14 trunnion for modular attachment to femoral heads.

The Alpine Hip Stem is manufactured from titanium alloy (per ASTM F136, Ti-6Al-4V ELI) and device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The proximal portion is plasma sprayed with titanium alloy (per ASTM F1580).

This document describes the premarket notification (510(k)) for the Alpine Hip Stem. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical studies with human subjects or a defined dataset for AI/algorithm performance. The testing performed was non-clinical (mechanical and material testing). Therefore:

• Sample size for the test set: Not applicable in the context of traditional clinical or AI algorithm testing. The sample sizes would refer to the number of hip stems or components tested for each mechanical and material property. These specific numbers are not provided in the summary but are typically defined by the relevant ISO standards.
• Data provenance: Not applicable in the context of a "test set" from human data. The data originates from laboratory testing of the device and its components.

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

Not applicable. This device is a mechanical implant, and its performance is evaluated against engineering and biological standards, not through expert consensus on medical image interpretation or clinical outcomes of a "test set" established by experts.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication by medical experts. The non-clinical testing involved laboratory measurements and analysis against established engineering standards.

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

No. The document explicitly states, "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study was not conducted as this is a new mechanical device being cleared through substantial equivalence to existing devices, not an AI or diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Alpine Hip Stem is a physical medical device (hip prosthesis), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation lies in established engineering and scientific standards for hip prostheses, including:

• ISO 7206 series: Specifically, ISO 7206-6:2013 (fatigue testing) and ISO 7206-4:2010 (distal fatigue).
• ISO 21535:2007: Range of motion analysis.
• ASTM F136 and F1580: Standards for titanium alloy materials and plasma spray coatings.
• Predicate device characteristics: The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices (Ovation™ Hip Stem (K062775), Global Taper Tapered Hip System (K963509), and Novation 12/14 Press-Fit Femoral Stem (K042842)).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device undergoing mechanical and material testing, 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 an AI model, the concept of establishing ground truth for it does not apply.

Ask a specific question about this device

Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Oxinium DH femoral heads are for single use only.

The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:

The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.

Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:

• Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
• Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
• Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.

The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.

Given this context, here's the information extracted from the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.

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

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
• Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.

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

• Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
• Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
  • For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.

In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.

Ask a specific question about this device

Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only.

The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136.

This document is a 510(k) premarket notification for a hip implant, which primarily focuses on establishing substantial equivalence to previously approved devices based on design, materials, and mechanical testing. It does not contain the kind of detailed clinical study data, acceptance criteria, or performance metrics typically seen in AI/software device submissions. Therefore, I cannot provide information for many of the requested fields.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for this submission type. The submission relies on mechanical test data and substantial equivalence to predicate devices, rather than clinical performance metrics with pre-defined acceptance criteria for accuracy, sensitivity, or specificity.

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

No test set of clinical data is described or used in this submission. The "test" mentioned refers to mechanical testing.

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

Not applicable. No clinical ground truth was established for a test set.

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

Not applicable.

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

Not applicable. This is not an AI/software device submission.

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

Not applicable. This is not an AI/software device submission.

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

Not applicable for clinical performance. For mechanical performance, the "ground truth" would be the engineering specifications and established test methods for hip implants.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable.

Summary of Relevant Information from the Document:

• Acceptance Criteria (Implicit for mechanical testing): The device is "capable of withstanding expected in vivo loading without failure" and is "equivalent to devices currently used clinically." This is a general statement about mechanical integrity, not specific quantitative performance metrics.
• Study Proving Acceptance: "A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
• Sample Size for Mechanical Testing: Not explicitly stated, but mechanical testing of medical devices typically involves a specific number of samples tested to failure or for a specified number of cycles according to relevant ASTM or ISO standards. The document does not provide these details.
• Data Provenance (Mechanical Testing): The mechanical testing would have been conducted by the manufacturer, Smith & Nephew, Inc.
• Ground Truth (Mechanical Testing): Established through engineering specifications and industry-standard mechanical test protocols (e.g., ASTM F1472, ASTM F136 mentioned for materials).
• Substantial Equivalence: The primary "study" for this submission is a comparison to predicate devices, demonstrating similarity in "indications for use, design features, operational principles, and material composition."

In conclusion, this document describes a traditional medical device submission (hip implant) that relies on mechanical testing and substantial equivalence to predicate devices, not clinical studies with acceptance criteria relevant to AI or software performance.

Ask a specific question about this device