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The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;
• traumatic arthritis;
• previous tibial condyle or plateau fractures with loss of anatomy or function;
• varus deformities; and
• revision of the articular surface of a previously implanted Persona Partial Knee System providing that the tibial plate locking mechanism is not compromised and the femoral and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implant intended for implantation with bone cement.

The purpose of this submission is to add a line extension of Size B to the Persona Partial Knee system (PPK). The Persona Partial Knee System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

This FDA 510(k) clearance letter for the Persona Partial Knee is for a medical implant (a knee replacement prosthesis), not an AI/software device. Therefore, the information requested in the prompt, such as "number of experts used to establish ground truth" or "multi reader multi case (MRMC) comparative effectiveness study," is not relevant to this type of device.

The clearance is based on the substantial equivalence principle, meaning the device is shown to be as safe and effective as a previously cleared predicate device. The performance data mentioned in the document refers to non-clinical testing (e.g., mechanical tests, material characterization) to ensure the implant meets established engineering and biocompatibility standards, not an AI algorithm's diagnostic performance.

Here's why the prompt's specific questions cannot be fully answered from this document:

• No AI/Software Component: The Persona Partial Knee is a physical medical device (implant), not a digital health product driven by AI or software.
• Substantial Equivalence: The clearance relies on demonstrating the new "Size B" line extension of the Persona Partial Knee is substantially equivalent to its own previously cleared version (K161592). This typically involves showing that the new size has similar design features, materials, and performance characteristics (e.g., strength, durability, biocompatibility) to the predicate.
• Performance Data Type: The "Performance Data" referenced is non-clinical. For an implant, this would involve mechanical testing (e.g., fatigue testing, wear testing), material characterization, biocompatibility testing, etc., to ensure the device performs as intended and is safe when implanted. It does not involve human readers, expert consensus for ground truth, or analysis of diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria or details about a study evaluating AI performance from this document because it is not an AI/software device.

The document does state in the "Summary of Performance Data" section:
"The performance data provided in the performance testing section indicate the proposed devices meet the established acceptance criterion; therefore, are as safe and effective and substantially equivalent to the legally marketed predicate devices from a performance standpoint."

However, it does not detail what those acceptance criteria are or how the performance data was generated beyond stating it was "performance testing." For an implant, these acceptance criteria are typically engineering specifications (e.g., minimum load bearing capacity, maximum wear rate, specific material properties) derived from recognized standards (e.g., ISO, ASTM).

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Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is indicated for use as a component of a total hip prosthesis in complex 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.

The Trabecular Metal Acetabular Revision System (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items.

The provided FDA 510(k) clearance letter (K243571) for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through the kind of study layout often associated with novel AI/software devices.

This submission is for a medical device (hip joint prosthesis components) and the "studies" conducted are non-clinical bench tests to ensure the new device performs similarly and safely to already approved devices. Therefore, the response will reflect the information provided, which is typical for a traditional medical device 510(k) clearance.

Here's an analysis of the provided document against your requested criteria:

Acceptance Criteria and Device Performance for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)

Based on the provided 510(k) summary, the device's acceptance criteria are primarily demonstrated through non-clinical bench testing, ensuring the new device's performance is comparable to its predicate devices and meets relevant material standards. The goal is to establish substantial equivalence, not to demonstrate a specific improvement in performance over a human baseline or a novel AI-driven diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for each non-clinical test (e.g., how many liners were tested for push-out). These are typically bench tests conducted on a sufficient number of samples to statistically validate the mechanical properties. The "data provenance" in this context is from laboratory bench testing, not patient data. Therefore, concepts like country of origin or retrospective/prospective don't apply as they would for clinical studies.

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

This information is not applicable (N/A) for this type of device submission. Ground truth, typically established by expert consensus or pathology in diagnostic studies, is not a concept used for evaluating mechanical components of a hip prosthesis in a 510(k) de novo submission. The "ground truth" here is adherence to engineering standards and comparison to predicate device performance through physical testing.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods (like 2+1, 3+1, none) are relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution to establish a ground truth. For mechanical bench testing, the results are objectively measured against defined criteria or compared to predicate performance.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often comparing human readers with and without AI assistance on a set of cases. This 510(k) is for an orthopedic implant, not a diagnostic AI device.

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

This information is not applicable (N/A). This product is a physical medical device (an acetabular liner), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" in the diagnostic AI sense (expert consensus, pathology, outcomes data) is not applicable here. The "truth" or reference for this device's performance is established by:

• Engineering specifications and material standards (e.g., ASTM F648).
• Performance of legally marketed predicate devices (demonstrating substantial equivalence through comparative bench testing).
• Biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable (N/A). As there is no training set for an AI algorithm, there is no ground truth to establish for it.

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The A.L.P.S Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

The A.L.P.S. Proximal Humeral Plating System is made from a titanium alloy and is available in configurations for both the left and right sides, as well as in various lengths. This system includes both locking and non-locking screws/pegs, along with multidirectional screws crafted from titanium alloy and cobalt chromium. It comes complete with general orthopedic instrumentation and system-specific instruments designed for use during implant installation.

Implants are available in both gamma-sterilized and non-sterile options. The disposable instruments are provided only in a sterile condition, while the reusable instruments are offered non-sterile, allowing users to perform steam sterilization before use.

This FDA 510(k) clearance letter is for a medical device called the "A.L.P.S. Proximal Humerus Plating System," which is a metallic bone fixation appliance. As such, it is not an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not applicable to this submission.

The FDA clearance for this device is based on comparing its technological characteristics and intended use to a legally marketed predicate device (K143697 - Biomet Proximal Humerus Plating System) and demonstrating substantial equivalence through non-clinical mechanical testing, rather than an AI performance study.

Summary of available information relevant to device performance and clearance (not AI-related):

• Acceptance Criteria & Reported Performance: The document states that the subject device's performance was evaluated through non-clinical testing. These tests include:

  • Implant Construct Axial Load Static Testing (for plates)
  • Implant Construct Axial Load Fatigue Testing (for plates)
  • Screw and Peg Performance Testing
  • The conclusion is that "any differences do not raise any different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." Specific numerical acceptance criteria and reported performance values from these mechanical tests are not provided in this clearance letter.

• Study Type: Non-clinical (mechanical) testing, not a clinical or AI performance study.

• Sample Size (Test Set): Not applicable in the context of an AI device's test set. For mechanical testing, the number of implants/constructs tested would be used, but this is not specified.

• Data Provenance (Test Set): Not applicable for an AI device. The "data" here refers to the results from mechanical testing of the device components.

• Number of Experts & Qualifications (Ground Truth for Test Set): Not applicable, as no expert-derived ground truth for an AI model's output is relevant here.

• Adjudication Method (Test Set): Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted, as this is not an AI-assisted device.

• Standalone Performance (Algorithm Only): Not applicable, as there is no algorithm.

• Type of Ground Truth Used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering standards and physical measurements from the mechanical tests.

• Sample Size for Training Set: Not applicable, as there is no AI model.

• How Ground Truth for Training Set was Established: Not applicable.

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The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

When used with constrained acetabular liners, the Zimmer Biomet Ceramic 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.

The Zimmer Biomet Ceramic Heads are made from a composite ceramic containing approximately 75% alumina (Al2O3) and 25% zirconia (ZrO2) (percentage by weight). They are supplied with a 12/14 bore or a Type 1 bore. The scope of the subject submission is limited to the 22.2mm head diameter with multiple neck configurations.
The subject ceramic heads are intended for mating with Ti-6Al-4V alloy, Ti-6Al-7Nb alloy stems with tapered necks. They may only be used in combination with highly crosslinked or conventional polyethylene (PE) or metal-back polyethylene liners.

This document is a 510(k) clearance letter for a medical device: "Zimmer Biomet Ceramic Heads (22.2mm diameter)". It describes the device, its intended use, and states that no non-clinical or clinical tests were submitted to determine substantial equivalence.

Therefore,Based on the provided FDA 510(k) clearance letter for the "Zimmer Biomet Ceramic Heads (22.2mm diameter)", it is explicitly stated that no non-clinical and/or clinical tests were submitted to determine the substantial equivalence of the subject device with the predicate.

This means that the information requested regarding acceptance criteria and the study proving the device meets these criteria cannot be provided from this document. The clearance was based on:

• Technological Comparison: The only difference between the subject device and the predicate device (K181171, K200823) is the addition of a contraindication for the use of 22.2mm ceramic heads with stainless steel femoral stems. All other technological characteristics are identical.
• Indications for Use Comparison: The indications for use and intended use are identical to the predicate device.

Since no testing was performed or reported in this submission for device performance, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No performance data was submitted.
2. Sample sizes used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no test set was evaluated.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, as per the text "No Non-Clinical and/or Clinical Tests were submitted".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (hip prosthesis component), not an AI/software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as no training set (for an algorithm) was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance relied on substantial equivalence to a predicate device based on identical technology and indications for use, with the only change being an additional contraindication. It did not involve new performance studies.

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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  When a personalized alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:
• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones.
The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant components.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and a study that proves the device meets those criteria, as the document does not contain this information. The text is a 510(k) premarket notification letter from the FDA to Zimmer Biomet regarding the Zimmer® Persona® Personalized Knee System, confirming its substantial equivalence to previously marketed devices.

The document focuses on:

• The FDA's determination of substantial equivalence (K243293).
• Regulatory information and requirements for medical devices.
• Indications for use of the Zimmer® Persona® Personalized Knee System.
• Identification of predicate devices (K240299, K222566).
• A brief description of the device and the purpose of the submission (adding compatibility for cemented nonporous Persona tibial components with a stem extension to the Personalized Alignment surgical technique; updated geometric evaluations; shelf-life extension for specific components).
• A summary of technological characteristics comparing the subject device to the predicate device, emphasizing their similarities regarding intended use, indications for use, variants/sizes, design features, material, and sterility, and noting a similar shelf life with an extension for Vivacit-E VEXLPE components.
• A general statement about performance data indicating the proposed devices meet established acceptance criteria and are as safe and effective as predicate devices.

However, the document does NOT include:

• A table of specific acceptance criteria and detailed reported device performance against those criteria.
• Information about sample sizes for test sets, data provenance, or the nature of prospective/retrospective studies.
• Details on the number or qualifications of experts used for ground truth establishment.
• Adjudication methods.
• Statements about multi-reader, multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
• Information on standalone algorithm performance.
• The specific type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how ground truth for training sets was established.

The text primarily attests to substantial equivalence based on the similarity of the device to existing predicates and a general statement about meeting performance criteria, but it does not elaborate on the specific studies or data that would fulfill your request for detailed acceptance criteria and proof of adherence.

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The Virage® Navigation System Instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. The Virage® Navigation System Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.

The Virage Navigation System is comprised of non-sterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. These instruments are intended to be used with the Medtronic StealthStation® System to assist surgeons in precisely locating anatomical structures. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems allows the surgeon access to real-time, multi-plane 3D images) thereby providing confirmation of hardware placement.

The provided text does not describe a study involving an AI/ML device or its performance against acceptance criteria. Instead, it describes a 510(k) premarket notification for the Virage Navigation System, which is a stereotaxic instrument used in spinal surgery, not an AI/ML device.

The document focuses on demonstrating substantial equivalence to existing predicate devices (Navigated INFINITY™ Instruments and StealthStation® System) through comparisons of technological characteristics, intended use, and performance data. The "performance data" section primarily discusses accuracy testing of the stereotactic instruments according to ASTM F2554-18 and a clinical validation lab to demonstrate compatibility and safety with existing navigation and power systems.

Therefore, I cannot extract the requested information about acceptance criteria, study details for an AI/ML device (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) because this information is not present in the provided document. The device is a traditional medical instrument, not an AI/ML system.

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CaP Spheres Pellet Pack™ is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. CaP Spheres Pellet Pack™ is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. CaP Spheres Pellet Pack™ provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

CaP Spheres Pellet Pack™ is a synthetic, osteoconductive, and resorbable bone void filler device consisting of hollow and microporous biphasic calcium phosphate spheres contained within a resorbable mesh pouch to aid in intraoperative handling. The device may be implanted directly, or hydrated with saline or autologous blood, and is intended to be combined with autograft.

The provided text describes a medical device, CaP Spheres Pellet Pack™, and its FDA 510(k) submission. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML device performance.

The document is a 510(k) clearance letter and summary for a physical medical device (bone void filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, test set details, expert involvement, MRMC studies, or standalone algorithm performance, as commonly applied to AI/ML devices, is not present in this text.

The text focuses on:

• Device Description: What the CaP Spheres Pellet Pack™ is.
• Indications for Use: When and how the device should be used.
• Substantial Equivalence: Comparison to existing, legally marketed predicate devices to show it's as safe and effective.
• Performance Testing: Bench testing (physical, chemical, degradation), biological safety, sterilization, shelf-life, and an in vivo animal study.

The closest information related to "acceptance criteria" is the overall demonstration of "substantial equivalence" to predicate devices, and that all performance tests "yielded acceptable results." However, specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) are not defined, as they are not typically applicable to this type of device in the same way they are for diagnostic AI/ML products.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or answer the subsequent questions, as the input document does not contain this information for an AI/ML device.

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The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to update a contraindication related to the translation screws.

This document (K210275) is a 510(k) premarket notification for the Polaris Spinal System. It seeks clearance for a minor modification to the labeling related to a contraindication for translation screws, rather than a new device or significant design change requiring extensive performance studies.

Therefore, the typical battery of performance studies with large sample sizes, expert ground truth establishment, MRMC studies, and standalone algorithm performance evaluations are not applicable in this context.

The document explicitly states:

• "This submission is to update a contraindication related to the translation screws." (Page 3)
• "The purpose of this submission is to seek clearance for minor modifications to the labeling related to the translation screw." (Page 4)
• "No changes were made to any physical component of the Polaris Spinal System." (Page 5)
• "A risk assessment was conducted due to new information from a complaint. That risk assessment led to the inclusion of a contraindication to the labeling." (Page 5)
• "Per the FDA Guidance, The Special 510(k) Program, a Special 510(k) is appropriate when it is a change to the manufacturer's own device and performance data is not needed to evaluate the change." (Page 5)
• "Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates." (Page 5)

Given this, the requested information about acceptance criteria and detailed study designs (as they would apply to a new or significantly modified device) is not present in this 510(k) submission.

The "study" in this case was a risk assessment driven by a complaint, leading to a labeling change. It was not a performance study of the typical kind for a medical device.

Here's how to interpret the request in the context of this document:

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

• Acceptance Criteria (Implied): The acceptance criteria for this specific submission revolved around ensuring that the updated labeling (including the new contraindication) adequately addressed the identified risk and maintained the device's substantial equivalence to its predicates without introducing new safety or efficacy concerns. Since no physical changes were made, mechanical performance or clinical outcomes were not re-evaluated.
• Reported Device Performance: Not applicable in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity, computational speed). The "performance" here is that the risk assessment was completed, and the resulting contraindication was deemed appropriate to mitigate the identified risk.

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

• Not applicable. There was no "test set" of clinical data for performance evaluation. The basis for the change was "new information from a complaint" (Page 5). This suggests a single or very limited number of reported adverse events or observations that triggered the re-evaluation of risk and subsequent labeling update.

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

• Not applicable. Ground truth for a performance study was not established. The "ground truth" for the labeling change was likely the outcome of an internal risk assessment by Zimmer Biomet's regulatory, engineering, and possibly clinical teams, based on the complaint information. The qualifications of these individuals are not detailed in the FDA letter.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication was used.

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 device is a mechanical spinal fixation system, not an AI software.

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

• Not applicable. This device is a mechanical spinal fixation system, not an algorithm.

7. The type of ground truth used:

• Not applicable for a performance study. The "ground truth" for the labeling change was the company's internal assessment of the risk associated with the translation screws, likely derived from post-market surveillance (a "complaint").

8. The sample size for the training set:

• Not applicable. No training set was used as this is not a learning algorithm.

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

• Not applicable. No training set was used.

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The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ System hooks, APEX® System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.

In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy during surgery. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The provided text describes a 510(k) premarket notification for the "Vitality® Spinal Fixation System" and its substantial equivalence to predicate devices. It focuses on mechanical testing to demonstrate substantial equivalence for a medical device (spinal fixation system), not an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are typical for AI/ML device evaluations, are not present.

However, based on the provided text, I can extract the following information regarding the performance study:

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

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

• Sample Size: Not specified. The document refers to "mechanical testing of the modified screw implants" but does not quantify the number of screws or tests performed.
• Data Provenance: Not applicable in the traditional sense for AI/ML. The "data" here refers to the outcomes of physical mechanical tests.

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

• Not applicable. This is a mechanical device, not an AI/ML device requiring human expert ground truth. The "ground truth" is established by the predefined ASTM standards and the physical properties of the materials and design.

4. Adjudication method for the test set:

• Not applicable. As a mechanical device study, there is no expert adjudication process. The results are based on objective measurements against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation, which is not the function of a spinal fixation system.

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

• Not applicable in the context of AI/ML algorithms. The device itself (the spinal fixation system) is standalone in its mechanical function, but "standalone performance" usually refers to an AI algorithm operating without human intervention.

7. The type of ground truth used:

• Engineering Standards: The ground truth for performance is based on established engineering standards (ASTM F1717 and ASTM F1798) for spinal implant mechanical testing. These standards define the acceptable performance parameters.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device design and manufacturing processes are informed by engineering principles and previous designs, not by a data-driven training set.

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

• Not applicable. As there's no training set for an AI/ML algorithm, this question is irrelevant to this device.

In summary, the provided document describes a 510(k) submission for a spinal fixation system, focusing on demonstrating substantial equivalence through mechanical testing against established ASTM standards. It does not pertain to an AI/ML device, and thus, many of the questions related to AI/ML specific evaluation criteria are not applicable.

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The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities:

• Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• • Spinal Stenosis (indicated for L1-S1 only);
• • Spondylolisthesis;
• • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• • Trauma (i.e., fracture, dislocation, or subluxation);
• • Spondylolysis;
• • Tumor;
• • Pseudoarthrosis: and/or
• • Failed previous fusion

The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.

The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:

• • Pseudoarthrosis and failed previous fusions;
• • Spondylolisthesis;
• • Spondylolysis;

• Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;

• • Degeneration of the facets with instability and;
• • Trauma including spinal fractures and/or dislocations.

The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.

The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Alpine XC Adjustable MIS Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.

The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); and/or tumor. The Aspendevice is intended for use with bone graft material, not intended for stand-alone use.

The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The LPlate device is intended for use with bone graft material, not intended for stand-alone use.

The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.

The provided text is a 510(k) summary for several Zimmer Biomet Spine fixation systems. It explicitly states that "Performance testing is not necessary" for this particular submission because the systems themselves are identical to already marketed predicate devices. The purpose of this submission is solely to obtain clearance for modified product labeling establishing the safety and compatibility of these existing passive implants in the magnetic resonance (MR) environment.

Therefore, the document does not contain information about acceptance criteria or a study demonstrating device performance in the traditional sense of evaluating efficacy or accuracy against a pre-defined standard. It's a regulatory filing based on demonstrating substantial equivalence to already cleared devices.

Based on the provided text, I can extract the following information:

1. Table of acceptance criteria and the reported device performance: This information is not present in the document. The document states "Performance testing is not necessary to evaluate the effects within magnetic fields during Magnetic Resonance Imaging (MRI) on the subject Miscellaneous Spinal Fixation Systems." The submission is for modified labeling regarding MRI safety of existing devices, which are substantially equivalent to their predicates.

2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this submission.

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

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is about spinal fixation systems, not AI-powered medical imaging devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about spinal fixation systems, not standalone algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance testing.

8. The sample size for the training set: Not applicable. This document is about physical medical devices, not machine learning models with training sets.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth was established.

In summary, the provided FDA 510(k) summary (K202309) primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for the purpose of clarifying MRI safety labeling. It explicitly states that performance testing is not necessary because the devices themselves are identical to their predicates, and the changes are limited to labeling regarding MRI compatibility. Therefore, the details requested about acceptance criteria, study design, and performance metrics are not present in this specific document.

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