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ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on the patient's pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations.

The software application consists of an automated templating system and a web-based templating user interface.

The provided document is an FDA 510(k) clearance letter for the ONE Planner™ Hip, a software device for preoperative surgical planning in total hip arthroplasty. It details the device's intended use, technological characteristics, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does not provide information on:

• Specific acceptance criteria and reported device performance in a table format.
• Details of the test set: sample size, data provenance, number/qualifications of experts, or adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used for performance evaluation.
• Details about the training set: sample size, or how its ground truth was established.

The document explicitly states:

• "Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process)."
• "The software is considered a 'moderate' level of concern, a malfunction in the device could lead to a minor injury."
• "Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended."
• "Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the clearance was based on non-clinical software verification and validation, and usability/performance testing, demonstrating that the device functions as intended and does not introduce new questions of safety and effectiveness compared to the predicate device. It does not describe a study involving an AI component with specific performance metrics against a ground truth, expert readers, or a test/training set in the context of an AI-driven medical device. The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or reader improvement) are not present in this document.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the available information, here's what can be addressed:

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

• Not provided in the document. The document mentions "Software verification and validation testing" and "Non-clinical testing to assess the usability and performance...to demonstrate that the device functions as intended." It does not specify quantitative performance metrics or acceptance criteria for those metrics.

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

• Not provided in the document. The document refers to "non-clinical testing" but does not detail the size or provenance of any "test set" in the context of evaluating an AI model's performance; instead, it refers to software V&V and usability.

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

• Not provided in the document. Since "clinical testing was not necessary" and no AI performance study with a test set evaluated by experts is described, this information is absent.

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

• Not provided in the 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 provided in the document. The document does not describe any MRMC study or AI assistance to human readers.

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

• Not provided in the document. The device is described as "interact[ing]" with the user, suggesting a human-in-the-loop, but no standalone performance data is presented.

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

• Not provided in the document.

8. The sample size for the training set

• Not provided in the document. There is no mention of a training set as would be relevant for an AI model.

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

• Not provided in the document.

Summary of what's described in the document regarding testing:

• Type of Testing: Software Verification & Validation Testing and Non-Clinical Testing (Usability and Performance).
• Purpose of Testing: To satisfy FDA guidance (IEC 62304) and demonstrate that the device functions as intended and does not introduce new safety and effectiveness questions compared to the predicate device.
• Level of Concern: Moderate (malfunction could lead to minor injury).
• Clinical Testing: Not deemed necessary for substantial equivalence determination.

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• The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

• Hemi-Arthroplasty indication is for use with Bipolar Systems only.
  • The Zimmer Biomet 12/14 CoCr Freedom® Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.

This traditional 510(k) premarket notification is being submitted to obtain clearance for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. The heads are made from Freedom® Heads cobalt-chromiummolybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11.

This document describes the 510(k) premarket notification for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. It outlines the device's characteristics, intended use, indications for use, and a summary of performance data to support its substantial equivalence to predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not present explicit acceptance criteria in a formal table format with numerical targets that the device performance must meet. Instead, the "Substantial Equivalence Conclusion" section functions as a high-level summary of how the device meets the criteria for 510(k) clearance, which is demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria (Implied by 510(k) Requirements):

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

The document does not specify sample sizes for the non-clinical tests (e.g., how many heads were subjected to pull-off testing). It only lists the types of non-clinical tests performed.

Regarding data provenance:

• Country of Origin: The manufacturer is listed as Zimmer, Inc., Warsaw, IN, USA, with a contact person in the UK (Zimmer Biomet UK, Bridgend). The specific location where the non-clinical tests were conducted is not detailed.
• Retrospective or Prospective: The non-clinical tests described are by nature prospective tests performed specifically for this submission to demonstrate substantial equivalence.

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

This information is not applicable. The device is a mechanical implant (femoral head for hip arthroplasty), and its performance is evaluated through engineering and material science testing (non-clinical tests), not through analysis of medical images or patient data that would require expert human interpretation and "ground truth" establishment in the way an AI diagnostic device would.

4. Adjudication method for the test set

This is not applicable as the study involves non-clinical mechanical and material testing, not human-read test sets requiring adjudication.

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 is not applicable. The device is a hip implant component, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the engineering standards and test methodologies (e.g., ISO, ASTM standards, internal validated test protocols) and the resulting objective measurements (e.g., force, cycles to failure, corrosion rates). There isn't a "ground truth" in the sense of expert consensus, pathology, or outcomes data, as these tests are simulating mechanical and material performance rather than diagnosing a condition.

8. The sample size for the training set

This is not applicable. The device is a mechanical implant. There is no concept of a "training set" for an algorithm in this context. The manufacturing process and materials used are based on established engineering principles and prior validated designs.

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

This is not applicable. As there is no training set for an algorithm, there is no ground truth to be established in that context.

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Joint replacement is indicated for patients suffering from disability due to:

• · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis:
• · correction of functional deformity;
• · femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is indicated for cementless use.

The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.

This looks like a 510(k) summary for a medical device that does not involve AI. Therefore, most of the questions about acceptance criteria, study design, ground truth, and expert involvement are not applicable in the context of AI/ML devices.

Here's a breakdown based on the provided document:

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

The provided document describes a traditional medical device (hip implant) and does not specify quantitative acceptance criteria in the way you would expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly that the device performs equivalently to the predicates in non-clinical mechanical testing.

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

This device clearance did not involve clinical testing as stated: "Clinical Testing: Clinical testing was not required". Therefore, there is no "test set" of patient data in the context of an AI/ML study. The "testing" referred to is mechanical testing of the physical device components. The document does not specify sample sizes for these mechanical tests, nor is data provenance (country, retrospective/prospective) relevant here.

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, as no clinical testing or AI/ML ground truth was established by experts.

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

Not applicable, as no clinical testing or AI/ML ground truth was established.

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 hip implant device, not an AI/ML diagnostic or assistive 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. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to predicate device performance under controlled laboratory conditions, rather than clinical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable. There is no AI/ML model to train.

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

Not applicable. There is no AI/ML model to train.

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

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

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

· Avascular necrosis of the femoral head

· Acute traumatic fracture of the femoral head or neck

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical studies were conducted."

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

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

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

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

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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 acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

Additional indications for Biomet G7 Freedom Constrained Liners:

The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. Further liner options are being added to the G7 Acetabular System which include: Neutral +5mm liner in ArComXL or E1; G7 Freedom Constrained Liners in two new profiles, the +5mm and the 10 Degree in E1. as well as a line extension to include G7 Freedom Neutral Liners in a size 32mm: and a new Femoral Constrained Head in Size 32mm (Cobalt Chrome, ASTM F1537).

The provided document is a 510(k) Premarket Notification from the FDA regarding the "G7 Freedom and Offset Liners, Freedom Head, Size 32" total hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or de novo diagnostic study does not directly apply to this document. Instead, the "acceptance criteria" here are essentially the demonstration that the new device shares the same fundamental technological characteristics, intended use, and indications for use as legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.

The "study that proves the device meets the acceptance criteria" is, in this context, the non-clinical performance testing and engineering analysis comparing the new device to its predicates.

Here's an attempt to extract and present the requested information based on the provided document, acknowledging the different nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k), "acceptance criteria" are implied by the comparison to predicate devices, and "reported device performance" refers to the new device demonstrating similar mechanical behavior.

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

• Sample Size for Test Set: Not specified in terms of number of devices tested for each mechanical test. The document mentions "engineering analyses" and "mechanical tests" but does not give specific quantities of samples for these tests.
• Data Provenance: The data is generated from in vitro mechanical testing and engineering analysis performed by the manufacturer, Biomet, Inc. There is no information regarding country of origin of data in terms of geographical location of patients, as this is not a clinical study. The testing is non-clinical.

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

This question is not applicable. For a 510(k) relying on non-clinical testing, "ground truth" is established by adherence to recognized standards (e.g., ASTM standards for materials and testing) and engineering principles, not through expert consensus on medical images or clinical outcomes. The "experts" involved would be the engineers and scientists conducting the testing and analysis at Biomet, Inc.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for diagnostic accuracy assessments where multiple human readers interpret data that may be equivocal. This document describes non-clinical engineering tests.

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

No. An MRMC comparative effectiveness study is a clinical study involving human readers (e.g., radiologists, pathologists) interpreting medical cases. This document focuses on non-clinical engineering and material characteristic comparisons to establish substantial equivalence.

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

This question is not applicable. This device is a physical medical implant (hip prosthesis components), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

For the non-clinical performance and material characterization, the "ground truth" is based on:

• Established engineering specifications and design parameters.
• Material standards (e.g., ASTM F648 for UHMWPE, ASTM F136 for titanium alloy, ASTM F1537 for cobalt chrome).
• Mechanical testing protocols designed to assess properties like pull-out strength, lever-out resistance, and fatigue life.
• Comparison to the known characteristics and performance of the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. This is not a machine learning or AI device, so there is no "training set."

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

This question is not applicable, as there is no training set for this type of medical device submission.

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1. Noninflammatory 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 acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

Indications for Biomet G7 Freedom Constrained Liners:

The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7™ Finned Acetabular Shell is a medical device intended to be used as part of a hip joint replacement in Total Hip Arthroplasty procedure by qualified surgeons in the field of orthopaedics. The G7™ Finned Acetabular Shell is utilized to replace the acetabulum, and will be used in conjunction with the existing G7 Acetabular Cup bearing system (K121874), instruments and modular femoral system. The G7™ Finned Acetabular Shell will have the same internal geometry, liner locking system and PPS coating as the G7 Acetabular Cup System Shells (K121874) but will feature fins to provide improved primary fixation and anti-rotational stability.

The provided text describes a 510(k) premarket notification for a medical device, the G7™ Finned Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, experts, ground truth, MRMC studies, standalone performance), and training set ground truth are not applicable in this context. The document does not describe an acceptance criteria table, device performance against such criteria, or a study designed to meet specific performance targets.

Instead, the document focuses on demonstrating that the G7™ Finned Acetabular Shell is substantially equivalent to existing predicate devices based on:

1. Indications for Use: The G7™ Finned Acetabular Shell has the same intended use and indications for use as the predicate devices.
2. Technological Characteristics: The device shares similar materials (Ti4Al6V alloy), design features (with the addition of fins for improved primary fixation and anti-rotational stability), and sterilization methods (Gamma irradiated) as the predicate devices.
3. Non-Clinical Testing: The submission includes non-clinical tests to support substantial equivalence.

Here's the information that can be extracted or inferred from the provided text, related to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This document is a 510(k) submission for a physical medical device (acetabular shell) based on substantial equivalence to predicate devices, not a study evaluating performance of an AI/software device against predefined acceptance criteria. There is no such table in the document.

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

• Not applicable. No "test set" in the context of an AI/software device performance study is mentioned. The non-clinical tests conducted (Push-In, Torque-out, Deformation, Comparison fatigue via FEA, Tolerance Analysis) are laboratory-based mechanical tests, not based on patient data sets. The document does not specify sample sizes for these tests, nor data provenance in the sense of patient data.

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

• Not applicable. "Ground truth" in the context of an AI/software device is not relevant here. The substantial equivalence claim is based on engineering analyses and mechanical testing, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set:

• Not applicable. As there is no clinical "test set" or ground truth adjudication in the AI/software sense, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. The document explicitly states: "Clinical Tests: None provided as a basis for substantial equivalence." Therefore, no MRMC study, which is a type of clinical comparative effectiveness study, was performed or presented for this 510(k). The concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is a physical hip implant component, not an algorithm or software device. The concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used:

• Not applicable (in the AI sense). For the engineering tests, the "ground truth" would be the physical properties and performance characteristics measured in the lab environment or predicted by validated models (e.g., Finite Element Analysis). These are engineering specifications and measurements rather than clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. No training set for an AI/software device is mentioned or used for this 510(k) submission.

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

• Not applicable. As no training set is relevant, this question is not re-applicable.

Summary of Non-Clinical Performance Data Provided:

The document lists the following non-clinical tests performed to support substantial equivalence:

• Push-In testing of Acetabular Shell
• Torque-out testing of Acetabular Shell
• Deformation testing of Acetabular Shell
• Comparison fatigue testing with Predicate device (Finite Element Analysis)
• Comparison with Predicate device (Tolerance Analysis)

The conclusion states that these tests demonstrate:

1. Any differences (e.g., the addition of fins) do not raise new questions of safety and effectiveness.
2. The proposed device is at least as safe and effective as the legally marketed predicate device.

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