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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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Hemiarthroplasty/Conventional Total Application:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Reverse Application:
Identity Revision Humeral Stem products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Identity Revision Humeral Stem is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).

The Identity Revision Humeral Stems are comprised of titanium alloy. The diameters of the stems range in 1mm increments from 4mm to 18mm in a revision length of 133-134mm. The stem is designed with a distal portion that is cylindrical in shape with a tapered and a proximal portion that is flared, eight-sided shape. The devices have a machine finish distally and a plasma-spray titanium porous coating proximally. To support placement and bone reconstruction in fracture cases, the Identity Revision Humeral Stems feature proximal suture holes as well as etch lines for stem length respect to the native humeral head. The humeral stems employ an oval reverse taper which allows the attachment of either an Identity Humeral Stem Adapter for hemi- and anatomic total shoulder applications or an Identity Humeral Tray for reverse shoulder applications.

I apologize, but the provided FDA 510(k) clearance letter for the "Identity Revision Humeral Stems" does not contain any information about acceptance criteria or a study that proves the device meets those criteria for software-related performance.

This document is for a medical device (humeral stems, which are a type of orthopedic implant) and focuses on the mechanical, material, and design aspects of the device, comparing it to predicate devices to establish substantial equivalence.

Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section lists:

• Fatigue Testing
• Range of Motion Analysis
• Magnetic Resonance Imaging (MRI)

It explicitly states: "No animal or clinical testing provided." This reinforces that the clearance is based on bench testing and comparison to existing devices, not on a human-in-the-loop study involving AI or a comprehensive performance study as you've described in your request.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance (for AI-related metrics).
2. Sample sizes for test sets or data provenance.
3. Number of experts, qualifications, or adjudication methods for ground truth establishment.
4. MRMC studies, effect sizes, or standalone algorithm performance.
5. Type of ground truth used (expert consensus, pathology, outcomes data).
6. Sample size for the training set or how its ground truth was established.

This document pertains to a physical orthopedic implant, not a software or AI-driven diagnostic/therapeutic device that would typically involve the types of studies and acceptance criteria you've asked about.

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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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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, hemi-arthroplasty 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.

The Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation in 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 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 and the taper, the entire surface of the stem is grit-blasted, proximally sprayed with a Ti-6Al-4V titanium alloy plasma coating, and 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 stems are compatible with previously cleared Zimmer Biomet modular femoral heads and/or acetabular components.

The provided text is an FDA 510(k) clearance letter for the Z1 Hip System, which is a medical device for hip arthroplasty. The document details the administrative aspects of the clearance, the device description, intended use, and a summary of non-clinical testing.

However, the question asks for information related to a "study that proves the device meets the acceptance criteria," specifically in the context of an AI/Software as a Medical Device (SaMD). The Z1 Hip System is a physical orthopedic implant, not an AI/SaMD. The document clearly states:

• "No clinical testing was conducted." (Page 6)
• The tests performed are "Distal Fatigue Testing per ISO 7206-4", "Proximal Fatigue Testing per ISO 7206-6", "Evaluation of Compatibility with Femoral Heads", and "Evaluation of Range of Motion" (Page 6). These are all mechanical and performance tests for a physical implant, not studies involving AI algorithms, expert reads, or clinical outcomes data as would be relevant for an AI/SaMD.

Therefore, I cannot provide the requested information as the provided text does not contain any details about acceptance criteria or a study design relevant to an AI/SaMD. The information requested (multi-reader multi-case studies, ground truth establishment, sample size for training sets, etc.) is specific to the validation of AI algorithms, which is not applicable to the Z1 Hip System described in this 510(k) clearance.

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CoolTone is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
• Strengthening, Toning and Firming of buttocks and thighs.

The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm abdomen, buttocks and thighs.

The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels.

Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. The CoolTone is equipped with the securement system which is designed to maintain applicator position throughout treatment.

A large color touch screen facilitates the use of the device. The on-screen information guides the user step-by-step through the entire treatment process. The treatment is operated through parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.

The provided FDA 510(k) clearance letter pertains to the CoolTone device (K251378). It states that this device is substantially equivalent to a previously cleared CoolTone device (K220601).

Crucially, the document explicitly states: "No clinical testing was required for this change." This means that for the K251378 submission, no new studies were performed to prove the device meets acceptance criteria. Instead, the clearance relies on its substantial equivalence to the predicate device, which presumably had clinical data supporting its initial clearance.

Therefore, many of the requested information points regarding acceptance criteria and study details cannot be directly extracted from this specific 510(k) clearance letter. The information below reflects what can be inferred or directly cited from the provided text about K251378, with an acknowledgement that the core "proof" resides within the documentation for the predicate device (K220601).

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no new clinical study was conducted for this specific 510(k) submission (K251378). Therefore, there are no new acceptance criteria or reported device performance for this updated device. The clearance is based on the identical technological characteristics and indications for use to the predicate device (K220601). The "acceptance criteria" for K251378 are implicitly met by demonstrating substantial equivalence to the predicate device, meaning it performs as safely and effectively for the stated indications.

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

Not applicable for K251378 as no new clinical testing was performed for this submission. The substantial equivalence argument relies on prior data for the predicate device (K220601).

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

Not applicable for K251378 as no new clinical testing was performed for this submission.

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

Not applicable for K251378 as no new clinical testing was performed for this submission.

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

Not applicable for K251378. The CoolTone device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable for K251378. The CoolTone is a physical device for muscle stimulation.

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

Not applicable for K251378 as no new clinical testing was performed. For the predicate device (K220601), clinical trials would likely have used objective measurements (e.g., imaging to assess muscle thickness, physical measurements for circumference changes, or patient/physician reported outcomes on tone/firmness) to establish the ground truth for muscle strengthening, toning, and firming.

8. The sample size for the training set

Not applicable for K251378 as no new clinical testing or algorithm training was performed for this submission.

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

Not applicable for K251378 as no new clinical testing or algorithm training was performed for this submission.

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Hemiarthoplasty/Conventional Total Application:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Reverse Application:

Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants, and a functional deltoid muscle is necessary.

The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).

The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Comprehensive Nano Stemless Shoulder System

1. Primary total shoulder arthroplasty.
2. Non-inflammatory degenerative joint disease including

Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications.

The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.

The Identity Shoulder System is previously cleared (K213856/K240876) as a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System is cleared for hemi-arthroplasty and conventional total shoulder replacement in both the anatomic and reverse configurations. The current submission is for the anatomic configuration.

The subject Comprehensive Humeral Head Adapter (CHHA) is a line extension to the Identity Shoulder System (K213856) cleared for the hemi-arthroplasty configuration and anatomic Total Shoulder Configuration.

The new CHHA (PN SAHHA002) allows additional compatibility with the previously cleared Identity Humeral Heads (K213856) and the Comprehensive humeral components, excluding fracture stems, as noted below:

• Comprehensive Humeral Stems (K193038); and
• Comprehensive Nano Stemless shoulder component (K182516).

Based on the provided FDA 510(k) clearance letter for the "Identity Shoulder System" (K250848), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Crucial Observation: The provided document is a 510(k) clearance letter for a medical device that does not appear to be software or an AI/ML enabled device. It is for an orthopedic implant (shoulder system). Therefore, several of the requested points related to AI/ML (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of traditional medical device submission.

The "acceptance criteria" for this device are generally based on non-clinical performance testing to demonstrate the device's physical and mechanical properties meet established standards and are substantially equivalent to predicate devices. There are no "reported device performance" metrics in the sense of clinical performance (like sensitivity/specificity for AI, diagnostic accuracy, etc.) because it's a physical implant, not a diagnostic or AI-driven system.

Acceptance Criteria and Study Details (Based on the provided document)

Since the document provided is for a physical orthopedic implant, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a traditional medical device, primarily through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For traditional orthopedic implants, specific numerical values for acceptance criteria and device performance (e.g., "Fatigue life > X cycles at Y load") are typically contained within the full 510(k) submission and are not usually detailed in the public clearance letter. The letter only states that these verifications were "successfully performed" and support the conclusion of substantial equivalence.

AI/ML Specific Questions (Answered as "Not Applicable" for this device)

Given that this is a 510(k) for a physical orthopedic implant and not an AI/ML device, the following points are not applicable (N/A):

2. Sample sizes used for the test set and the data provenance: N/A. This device does not have a "test set" of patient data in the typical sense for AI/ML validation involving images or clinical parameters. Its evaluation involves mechanical testing of physical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts for clinical data is not relevant for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. This applies to review of clinical data, not mechanical testing.
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: N/A. MRMC studies are for evaluating human reader performance, typically with diagnostic images, in conjunction with AI. This is not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device's performance is derived from standardized mechanical testing methods and compliance with material specifications.
8. The sample size for the training set: N/A. This device does not use a "training set" as it's not an AI/ML model.
9. How the ground truth for the training set was established: N/A.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is described as a series of non-clinical verifications. These tests are designed to objectively assess the physical and mechanical properties of the Comprehensive Humeral Head Adapter (CHHA) and its compatibility within the Identity Shoulder System, thereby demonstrating its substantial equivalence to previously cleared predicate devices.

The specific non-clinical tests performed include:

• Fatigue Verification: Assesses the device's ability to withstand repeated stress without failure, simulating long-term use.
• Fretting Corrosion Verification: Evaluates the device's resistance to material degradation caused by small-amplitude oscillatory motion between contacting surfaces.
• Fixation Stability Verification: Confirms the secure attachment and stability of components under load.
• Static Modular Junction Strength Verification: Measures the strength of the connections between modular parts under static loading conditions.
• ROM Verification: Ensures the device allows for the intended range of motion within the joint.
• MRI Verification: Confirms the device's safety and compatibility when exposed to magnetic resonance imaging environments.

The results of these tests, along with the asserted identicality of intended use, indications for use, materials, packaging, and sterilization, and similarity in design features, were deemed sufficient by the FDA to conclude that:

• any differences do not raise different questions of safety and effectiveness; and
• the proposed device is as safe and effective as the legally marketed predicate device.

This conclusion of substantial equivalence is the basis for the 510(k) clearance for the Identity Shoulder System's new line extension, the Comprehensive Humeral Head Adapter.

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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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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.

Porous components may be used cemented or uncemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and femoral and tibial augment components are indicated for cemented use only.

The purpose of this submission is to add a new component to the Persona Revision Knee System, the component is the Persona Revision SoluTion Femoral Components. The addition of these components do not change the intended use or fundamental scientific technology of the device system.

The Persona Revision Knee System is a semiconstrained modular knee prosthesis designed to resurface of the femoral and tibial bones. With this submission a new Ti-6Al-4V femoral component will be added to the system. These femoral components articulate against an articular surface of the tibial component, as well as, a pat of a total knee system. The new femoral components are compatible with a variety of augments, cones, and stem extent of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

This document is a 510(k) Premarket Notification from the FDA regarding the "Persona® Revision Knee System (Persona Revision Solution™ Femoral Components)." It does not contain acceptance criteria for a study, nor does it present the results of a study to demonstrate that a device meets such criteria.

Instead, this document is a notification of the FDA's decision that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a review of information provided by the manufacturer, Zimmer, Inc., which includes a summary of non-clinical tests performed.

The relevant section, "Non-Clinical and/or Clinical Tests Summary & Conclusions" on page 5, lists several non-clinical tests that were performed (e.g., fatigue evaluations, wear evaluation, constraint assessment, augment shear and torque, stem junction fatigue, stem static axial pull-off and torque-off, RF-induced heating simulations, fretting corrosion assessment).

However, for each of these tests, the document only lists the test name. It does not provide:

• Acceptance criteria: What performance metrics were deemed acceptable for each test.
• Reported device performance: The actual results obtained from these tests.
• Study details: Such as sample sizes, data provenance, ground truth establishment, or any information related to expert involvement (for clinical studies, which are explicitly stated as "Not Applicable" here).
• Comparative effectiveness study (MRMC) or standalone performance: These are not discussed as the tests are non-clinical.

In summary, the provided document explicitly states "Clinical Testing Not Applicable" and lists non-clinical tests without presenting their results or acceptance criteria. Therefore, it is not possible to provide the requested information.

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The Affixus® Tibial Nailing System is indicated for temporary stabilization of tibial fractures and osteotomies including proximal, metaphyseal, and distal shaft fractures, closed fractures, open fractures, pathologic fractures, non-unions, malunions and deformity corrections.

The Affixus Tibial Nalling System is a long bone nailing system that offer implants designed to treat a range of tibial fractures from simple to complex, with versatile locking options. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Screws and End Caps are included in the system. All implants are made of Ti-6Al-4V. The Affixus platform of instrumentation is designed to provide options and flexibility for many intraoperative approaches while maintaining ease of use and commonality. This submission introduces 4mm Cortical Bone Screws are also made of Ti-6AL-4V and feature a double-lead thread design with a self-tapping tip. Screw options include Ø4mm: 20mm - 60mm, increments of 2 mm 60mm - 90mm, increments of 5mm Note: 4mm Screws are inserted through distal locking holes of 8mm Tibia nails only.

It appears that the provided document is an FDA 510(k) clearance letter for a medical device (Affixus Tibial Nailing System - 4mm screws). This type of document is for device clearance based on substantial equivalence to a predicate device, not for the clearance of an Artificial Intelligence/Machine Learning (AI/ML) device.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/ML model
• Study design for testing an AI/ML model's performance
• Sample sizes for test or training sets for an AI/ML model
• Expert involvement in ground truth establishment or adjudication for an AI/ML model
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Ground truth types specific to AI/ML
• Training set details for an AI/ML model

The clearance is based on the device's material, design, packaging, and sterilization being substantially equivalent to existing predicate devices, and supported by non-clinical tests demonstrating mechanical properties (e.g., fatigue strength, bending strength, torque, pullout strength) and MR compatibility.

Conclusion:

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves an AI/ML device meets those criteria, as this document pertains to a traditional medical device (intramedullary fixation rod) and not an AI/ML product.

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