Search Results

Z1 Cemented Hip System is intended for total or partial (hemi-) hip arthroplasty and is indicated for the following conditions:

• · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
  · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR).
  · Acute traumatic fracture of the femoral head or neck.
  · Avascular necrosis of the femoral head.
  Z1 Cemented Hip System consists of implants that are for cemented use only.

The Z1 Cemented Hip System consists of femoral hip stems intended for use in total or partial (hemi-) hip arthroplasty. The stem is designed for cemented implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or partial (hemi-) hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from forged stainless steel and have a wedge-shaped design, with a proximal-to-distal taper. Offered in multiple sizes and neck lengths, the stems are available in standard and high offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Cemented Hip System femoral stems. The Z1 Cemented Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, acetabular shells, acetabular liners, and distal centralizers / positioners identified in the package insert as compatible components.

This document is an FDA 510(k) clearance letter for a medical device called the "Z1 Cemented Hip System." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance as typically understood in the context of an AI/software device.

The information provided describes the hip system itself, not an AI or software component. Therefore, the questions about sample size for test/training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance are not applicable to this document. The document discusses mechanical performance testing of a physical implant.

However, I can extract information related to the physical device's "acceptance criteria" and the studies used to prove it meets those criteria based on the provided text.

Here's the breakdown of what's provided, framed as closely as possible to your request, but with the understanding that this is about a physical orthopedic implant, not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but does not provide specific quantitative acceptance criteria or reported values for the Z1 Cemented Hip System. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence to the predicate device and to demonstrate the subject device performs as intended." This implies that the acceptance criteria are met if the device performs comparably to the predicate or within established safety and efficacy standards for such devices.

Note: The document states "engineering analysis" or "evaluation" was performed. Specific numerical results or pass/fail thresholds are not detailed in this summary, as is typical for 510(k) summaries which focus on demonstrating equivalence rather than raw data.

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

This document describes pre-market testing of a physical medical device, not a software or AI algorithm. Therefore, the concept of a "test set" in the context of data points is not directly applicable.

• Sample Size: The document mentions that "All testing was performed on worst case implants as dictated by the relevant performance standards." This implies a representative sample of the manufactured device variants (e.g., different sizes, offsets) were tested, focusing on the configurations most likely to fail. Specific numbers of units tested are not provided in this summary.
• Data Provenance: Not applicable in the context of data origin; this refers to the origin of the physical products tested, which would be the manufacturer, Orchard Medical Development, LLC. The testing is described as pre-market, implying prospective testing of newly manufactured devices.

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

Not applicable. This is a physical device where "ground truth" is established through standardized engineering and material testing methods, not expert consensus on image interpretation or clinical outcomes data.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to expert review processes, which are not relevant for the mechanical and material testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. MRMC studies are used for evaluating the effectiveness of diagnostic tools (often imaging-based AI) on human reader performance. This document is about a hip implant.

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

Not applicable. This is a physical hip implant, not an algorithm.

7. The Type of Ground Truth Used

For this physical device, "ground truth" is established by:

• Adherence to recognized industry standards (e.g., ISO 7206-4, ISO 7206-6, ISO 21535, ISO 10993) for mechanical, material, and biocompatibility testing.
• Engineering analyses and calculations demonstrating design robustness.
• Comparison to the performance characteristics of an existing, legally marketed predicate device (K193030 Zimmer, Inc. Avenir Cemented Hip Stem).

8. The Sample Size for the Training Set

Not applicable. There is no AI training set for this physical device.

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

Not applicable. There is no AI training set for this physical device.

Ask a specific question about this device

Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

• · Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
• · Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR).
• · Acute traumatic fracture of the femoral head or neck.
• · Avascular necrosis of the femoral head.
  Z1 Hip System is for cementless use only.

Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region, the entire surface of the stem is grit-blasted and sprayed with a Ti-6Al-4V titanium alloy plasma coating followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in Standard, High Offset, and Coxa Vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The Z1 Hip System is for use only with the Zimmer Biomet femoral heads and adapters, bipolar heads, and acetabular shells and liners identified in the package insert as compatible components.

This document describes the Z1 Hip System, a medical device for hip arthroplasty. However, the provided text does not contain any information regarding clinical studies with human subjects, acceptance criteria for such studies, or information about AI/algorithm performance. The document is a 510(k) premarket notification to the FDA, focusing on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, I cannot provide details for most of your requested points, as they pertain to clinical trials and AI/algorithm performance, which are not present in this document.

Here's what can be extracted based on the provided text:

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

The document provides a summary of non-clinical performance testing performed according to various ISO and ASTM standards. The "acceptance criteria" discussed are related to the successful completion of these engineering tests, demonstrating that the device meets the requirements of the standards and is substantially equivalent to the predicate device. The document does not specify quantitative acceptance criteria with reported numerical values for each test in a comparative table format. Instead, it states that "All necessary testing has been performed... to assure substantial equivalence... All testing was performed on worst case implants or test coupons as dictated by the relevant performance standards." and "Based on the similarities of... the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device."

Here's an interpretation based on the non-clinical tests mentioned:

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

This document discusses non-clinical performance testing (mechanical, material, sterilization, etc.) on implants or test coupons, not clinical data from human subjects. Therefore, the concepts of "test set," "data provenance," "country of origin," "retrospective or prospective," and "sample size" in the context of human data are not applicable here. The document refers to "worst case implants or test coupons" for testing.

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 document describes non-clinical engineering and material testing, not human-read clinical data requiring expert ground truth establishment.

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

This is not applicable, as there is no clinical test set or adjudication process described.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a physical hip implant (Z1 Hip System).

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

This is not applicable, as the document refers to a physical hip implant and not an algorithm or AI product.

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

For the non-clinical testing, the "ground truth" is defined by the specifications and requirements of the referenced ISO and ASTM standards (e.g., a specific fatigue load cycle, a particular coating thickness range, sterility assurance level). The device's performance is compared against these engineering and material standards.

8. The sample size for the training set

This is not applicable, as there is no training set mentioned for an algorithm or AI.

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

This is not applicable, as there is no training set mentioned for an algorithm or AI.

Ask a specific question about this device

The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is 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 intraoperative instability and for whom all other options to constrained acetabular components have been considered.

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; and
• revision procedures where other treatments or devices have failed.

This stem is to be press-fit. This stem is intended for cementless use.

The EMPOWR™ blade stem represents the latest generation of a press-fit, porous coated, wedge style femoral stem. Building on the design principles of its predicate, Linear® Hip Stem, the EMPOWR™ blade stem system features enhancements such as addition of coxa vara offset, neck angle update, and distal angle reduction for wider application.

The EMPOWR™ blade stem is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures in all age groups. It offers a stem design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation. The EMPOWR™ blade stem features streamlined and accurate instrumentation that is highly adaptable to any surgical approach.

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the detailed information necessary to fully answer your request. The document describes a medical device, the EMPOWR™ blade stem, and its substantial equivalence to predicate devices based on technological characteristics and performance testing.

However, it explicitly states:

• "No animal data submitted."
• "No clinical data submitted."

This indicates that the submission did not include studies involving human or animal subjects to evaluate the device's performance in a clinical setting, nor did it involve an AI/ML component. Therefore, there is no information in this document regarding:

• Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• Any "AI-assisted" studies or "standalone" algorithm performance.
• Sample sizes for test or training sets related to AI models.
• Ground truth establishment by experts, adjudication methods, or MRMC studies.

The performance testing mentioned (CAD Based Range of Motion, Distal Stem Fatigue, Neck Stem Fatigue) refers to mechanical and physical performance of the implant itself, not the performance of a diagnostic or AI-driven system.

In summary, this document is a 510(k) submission for a hip implant, not an AI/ML medical device, and therefore does not contain the information you are seeking regarding AI acceptance criteria and study data.

Ask a specific question about this device

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.

Ask a specific question about this device

Avenir Complete Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

· Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.

• · Failed previous hip surgery including joint reconstruction (osteotomy), arthroplasty or total hip replacement (THR).
• · Acute traumatic fracture of the femoral head or neck.
• · Avascular necrosis of the femoral head.

Avenir Complete Hip System is for cementless use only.

The purpose of this 510(k) premarket notification is to introduce two Size 0 Coxa Vara Avenir Complete™ Hip System femoral stems; one with a collar and one without a collar. The stems are manufactured from a forged titanium alloy Ti-6Al-4V and feature a wedge-shaped design with a proximal-to-distal taper and reduced distal geometry. The Coxa Vara offset provides a 126.5° neck angle. Below the highly polished femoral neck region, the surface is gritblasted and plasma sprayed with commercially pure titanium (CP-Ti) and hydroxyapatite (HA) coating. The stems are designed for cementless implantation into the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are provided sterile and are for single-use only.

This document is a 510(k) premarket notification for a medical device and thus the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical trial report or a post-market surveillance study would.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in the context of a clinical performance study with specific endpoints and statistical measures. Substantial equivalence is established through comparison of intended use, indications for use, technological characteristics, and performance data (primarily non-clinical in this case).

However, I can extract the information relevant to what you've asked, focusing on the performance data presented to support substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As specific "acceptance criteria" are not explicitly defined in terms of sensitivity, specificity, or other clinical performance metrics in this document, the table below will summarize the comparative performance claims made regarding the proposed device in relation to its predicate and reference devices, and how these claims support "substantial equivalence." The "acceptance criteria" for a 510(k) typically align with demonstrating that the new device is "at least as safe and effective" as the predicate.

• Distal Stem Fatigue Strength equivalent to predicate/reference device | Proposed device determined to have distal stem fatigue strength equivalent to the legally marketed reference device (K120030). |
  | Mechanical Performance:
• Proximal Stem Fatigue Performance not a "new worst-case" compared to predicate device | Proposed device not a new worst-case for proximal stem fatigue testing compared to the previously evaluated predicate Avenir Complete™ Hip System (K182048). |
  | Material Properties:
• Ti/HA Coating Characteristics similar to predicate | Ti/HA Coating Characterization Evaluation was performed (details not provided, but implies similarity as part of overall SE reasoning). |
  | Biocompatibility/Safety:
• Corrosion Fatigue performance acceptable | Corrosion Fatigue Evaluation was performed (details not provided, but implies acceptable performance for SE). |
  | Functionality:
• Range of Motion compatible with intended use | Range of Motion Analysis was performed (details not provided, but implies compatibility for SE). |
  | Assembly/Fixation:
• Pull-Off Strength adequate for intended use | Pull-Off Strength Evaluation was performed (details not provided, but implies adequacy for SE). |
  | Imaging Compatibility:
• MRI Compatibility for diagnostic purposes | Magnetic Resonance Imaging Compatibility (MRI) testing was performed (details not provided, but implies compatibility for SE). |

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

• Sample Size for Test Set: The document indicates that non-clinical performance testing and engineering evaluations were conducted. While specific sample sizes for each test (e.g., number of stems tested for fatigue) are not explicitly stated in this summary, it refers to "fatigue testing," "pull-off strength evaluation," etc. These are typically performed on a statistically relevant number of samples for mechanical testing, but the exact numbers are not in this public summary.
• Data Provenance: The data is generated from non-clinical laboratory testing and engineering evaluations. There is no mention of country of origin for this testing, which is typical for such submissions. This is retrospective in the sense that the testing was performed before the submission for clearance.

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

• This question is not applicable as the ground truth here is based on engineering and physical measurements from non-clinical testing, not expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as above. No human adjudication is involved in determining the results of mechanical fatigue tests or material characterization.

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

• No, an MRMC comparative effectiveness study was not done. This submission explicitly states: "Clinical data and conclusions were not needed for this device."

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

• This question is not applicable as the device is a physical hip implant system, not an algorithm or AI-driven software device.

7. The Type of Ground Truth Used

• The "ground truth" for the performance data presented is based on laboratory measurements and engineering analyses derived from physical testing (e.g., force, cycles to failure, material composition analyses). It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

• This question is not applicable for the same reason as above.

Ask a specific question about this device