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The PSPS bone model is indicated, based on patient-specific radiological images (CT scans), to assist in pre-operative orthopedic planning for patients able to undergo orthopedic procedures and able to be radiologically scanned.

The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals.

Be advised, the quality of medical images determines the accuracy of the 3D bone models. Zimmer Biomet recommends using CT Protocol PMI® Patient-Matched Implants CT Protocol. Only images obtained less than six (6) months prior should be used for simulating and/or evaluating orthopedic treatment options.

The Patient Specific Planning Solution™ 3D Bone Model is a 3-dimensional representation of the requested anatomical bone site. The Bone Models are diagnostic tools to allow the Surgeon to physically and visually aid in pre-operative orthopedic planning to facilitate the implantation of medical devices.

The Patient Specific Planning Solutions™ are designed of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized orthopedic pre-surgical plan and shipped prior to surgery. The Bone Models are provided non-sterile and are used pre-operatively for education, planning to aid in component selection, sizing, and placement based on patient specific radiological images (CT scan). Physical bone models' critical bony areas are printed at

This document does not contain the detailed information necessary to fully answer all aspects of your request, specifically regarding a multi-reader multi-case (MRMC) comparative effectiveness study, the number of experts for human-in-the-loop studies, the adjudication method, or specific effect sizes. The submission focuses on substantial equivalence to a predicate device, Mimics Medical (K183105), rather than a detailed performance study against specific acceptance criteria for a new AI algorithm.

However, based on the provided text, here's what can be extracted and inferred regarding the device's acceptance criteria and proven performance:

Device: Patient Specific Planning Solution™ Bone Models

Device Function Summary: These are 3D printed physical bone models derived from patient-specific CT scans. They are intended as diagnostic tools to visually aid in orthopedic pre-operative surgical planning and to facilitate the implantation of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily related to the geometric accuracy of the 3D-printed bone models compared to the digital input. The performance summary refers to the device utilizing the same geometric accuracy testing as its predicate.

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Biomet Comprehensive Reverse Shoulder products are 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 suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive 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.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive 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 suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive 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.

Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. 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.

Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.

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

The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy*

*The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada

Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is 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.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Huments with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy 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 Comprehensive 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.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixations. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components for anatomic and humeral tray and glenosphere components for reverse configuration. The purpose of the current submission is to add MR Conditional labeling.

Here's an analysis of the provided information, addressing your questions about acceptance criteria and study details.

Important Note: The provided document is a 510(k) FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, much of the information you've requested regarding specific acceptance criteria, performance metrics, ground truth, and human reader studies is not present in this type of document because it is not required for a 510(k) submission for this type of device (implants). The "acceptance criteria" here implicitly refer to the device not posing new questions of safety or effectiveness compared to its predicates and meeting established standards for its material properties and MR compatibility.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a shoulder replacement system seeking to add "MR Conditional" labeling, the "acceptance criteria" are related to established safety and performance standards for implants, particularly concerning their interaction with Magnetic Resonance (MR) environments. The performance data provided is entirely non-clinical and related to MR compatibility.

Table of Acceptance Criteria and Reported Device Performance

• Indications for Use: Identical to predicate.
• Materials: Identical to predicate.
• Design Features: Identical to predicate.
• Sterilization: Identical to predicate. |
  | MR Compatibility: The device should not pose an unacceptable risk or generate excessive artifacts in an MR environment and should meet established standards for MR Conditional labeling. | - ASTM F2503-20 (Labeling): Evaluation completed (implies compliance for labeling).
• ASTM F2119-07R13 (Artifact): Evaluation completed (implies acceptable artifact levels).
• ASTM F2213-17 (Torque): Evaluation completed (implies acceptable torque in MR environment).
• ASTM F2052-21 (Displacement Force): Evaluation completed (implies acceptable displacement force in MR environment).
• ASTM F2182-19E02 (RF-heating): Evaluation completed (implies acceptable RF-heating).
• Preliminary Phantom Evaluation: Completed. |

Study Details

As this is a 510(k) for a medical implant and not an AI/software device, many of the requested categories related to diagnostic performance or human reading studies are not applicable.

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

   • Test Set Sample Size: Not applicable in the context of diagnostic data. For the non-clinical MR compatibility tests, the "sample size" would refer to the number of device components tested according to the referenced ASTM standards. This specific number is not provided in the summary but would be detailed in the full test reports.
   • Data Provenance: Not applicable for diagnostic data. The MR compatibility tests are conducted in a controlled laboratory setting (likely in the US, where the company is based), not on patient data.

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

   • Not applicable. Ground truth, in the AI/diagnostic context, refers to definitively established diagnoses or classifications. For an implant, "ground truth" relates to material science and engineering principles verified by standard testing methods and accredited labs.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods are used to resolve discrepancies among expert opinions in diagnostic studies.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems, not for physical implants.

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

   • No, a standalone performance study in the AI sense was not done. The "performance" here is for the physical device's interaction with an MR field, which isn't an "algorithm-only" performance.

6. Type of Ground Truth Used:

   • For the core claims of equivalence (materials, design, etc.), the "ground truth" is established engineering and scientific principles, validated by testing against relevant ASTM standards and by comparison to the predicate devices. For MR compatibility specifically, the ground truth is defined by the objective measurements obtained through the standard ASTM test procedures (e.g., measured temperature rise, displacement force, artifact size) and compared against the limits established by those standards to determine "MR Conditional" status.

7. Sample Size for the Training Set:

   • Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

   • Not applicable, as there is no training set.

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Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is 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 neeessary.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The proposed device is an orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint in shoulder arthroplasty to provide pain relief and restore function. It is modular in design, consisting of a baseplate held to the bone with bone screws and a modular liner. The device is designed to be implanted as the glenoid component of an anatomic total shoulder with the option to convert to a reverse shoulder configuration without removal of the metal components.

The current submission is to expand the product offering by the addition of a liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE).

This document is a 510(k) premarket notification for a medical device (shoulder prosthesis) and as such, it focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing the kind of extensive performance study data that would be typical for a novel device or a clinical trial.

Therefore, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

• No "Acceptance Criteria Table" or "Reported Device Performance": The 510(k) process for this type of device (a new material liner for an existing, cleared system) primarily relies on demonstrating that the new material (Vivacit-E Liner) performs equivalently to existing materials in relevant non-clinical tests (e.g., mechanical tests). Clinical studies with specific performance metrics and acceptance criteria are generally not required for substantial equivalence for this type of modification.
• No "Study that proves the device meets the acceptance criteria" in the sense of a clinical trial: The "Summary of Performance Data" explicitly states "Clinical Tests: None provided." This means there was no multi-reader, multi-case study, no human-in-the-loop performance measurement, and no standalone algorithm performance assessment. This device is a passive implant, not an AI or diagnostic tool.

Based on the provided text, here's what can be answered or inferred:

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

• Not Applicable in the traditional sense. This submission is for a material change (Vivacit-E Liner) to an existing device. The performance data listed are non-clinical tests designed to show that the new liner material performs equivalently to existing cleared materials/devices.
• Types of Non-Clinical Tests Conducted:
  • Dissociation Testing
  • Shear Testing
  • Insertion Testing
  • Biocompatibility Assessment
  • Packaging Assessment
• "Acceptance Criteria" for these tests: While not explicitly stated with numerical values, the acceptance criterion for a 510(k) submission is that the performance of the new device (Vivacit-E Liner) is "as safe and effective as the legally marketed predicate devices" and that "any differences do not raise new questions of safety and effectiveness." This implies that the results of these non-clinical tests must fall within expected ranges or demonstrate equivalence to the predicate device for each test. Specific numerical thresholds or ranges are not provided in this summary.

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

• Sample Size: Not specified for the non-clinical tests. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ISO, ASTM) and statistical power requirements to demonstrate equivalence or meet specified performance criteria.
• Data Provenance: Not specified, but given it's a submission by Biomet Manufacturing Corp. (a US company) to the FDA, the testing would typically be conducted according to internationally recognized standards in controlled laboratory environments. The data would be specific to components manufactured by the applicant. This is not patient data.

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

• Not Applicable. This is not a study requiring expert readers or ground truth establishment in the clinical image interpretation sense. The "ground truth" for mechanical testing is the physical property being measured (e.g., force, displacement, material degradation) against defined engineering specifications.

4. Adjudication method for the test set

• Not Applicable. No human adjudication is involved in the non-clinical mechanical testing of an implantable device like this.

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

• No. The "Summary of Performance Data" explicitly states: "Clinical Tests: None provided." This device is a passive implant, not a diagnostic or AI-powered device that would involve human readers or image interpretation.

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

• No. As above, this is a physical implant, not a software algorithm.

7. The type of ground truth used

• For Non-Clinical Tests: The "ground truth" would be engineering specifications and material properties as defined by relevant standards (e.g., ISO, ASTM) and internal design requirements. For example, for "Shear Testing," the ground truth would be the measured shear strength compared to the designed minimum shear strength or the shear strength of the predicate device.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for the device itself.

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

• Not Applicable. As there is no training set for the device, this question is irrelevant.

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Biomet Comprehensive Vault Reconstruction System Components 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 suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Vault Reconstruction System Component 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 Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive Vault Reconstruction System is a glenoid baseplate for reverse shoulder arthroplasty designed to match the natural geometry of an individual patient.

The provided text is a 510(k) summary for the Biomet Manufacturing Corp.'s Comprehensive Vault Reconstruction System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it details the device description, indications for use, comparison to predicate devices, and a summary of technological characteristics and non-clinical tests to support substantial equivalence.

Therefore, I cannot extract the requested information based on the provided text. The document states "Clinical Tests: o None", which further confirms the absence of clinical study data to establish acceptance criteria or device performance in a clinical setting.

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• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Correction of functional deformity.
• 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.

5. 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.
   Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.
   The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
   The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
   The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
   The Titanium Versa-Dial Humeral Head Prosthesis is 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 is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components.

The provided text is a 510(k) summary for the Comprehensive Shoulder System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on technological characteristics and performance data. However, this document does not describe acceptance criteria for a device, nor does it detail a study proving that the device meets specific performance criteria with associated metrics (e.g., sensitivity, specificity, accuracy).

Instead, it focuses on demonstrating that the new device is "substantially equivalent" to previously cleared devices. The "Summary of Performance Data" section primarily addresses non-clinical tests related to material fatigue, porous coating characteristics, and biocompatibility, which are standard for implantable devices but do not involve "device performance" in the sense of clinical effectiveness or diagnostic accuracy that would typically have acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, experts, adjudication methods, MRMC studies, or standalone performance, as these details are not present in the provided 510(k) summary.

The closest information related to "performance" is:

• Non-Clinical Tests:
  • Fatigue testing of Titanium Alloy Forged Humeral Stems, Titanium Alloy Wrought Humeral Stems, and Cobalt Alloy Humeral Stems: Five samples of each type were subjected to a fatigue load of 400N or greater for 5 million cycles in reverse configuration at a worst-case orientation. All samples withstood the applied fatigue without fracture of the stem.
  • Porous coating characterization
  • Biocompatibility

This information describes the types of tests performed and a high-level outcome for the fatigue test (all samples withstood the load without fracture), but it does not provide specific acceptance criteria or detailed results that would allow for a direct comparison in a structured table.

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

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 Comprehensive Nano Stemless Shoulder is part of the Comprehensive Shoulder System intended for use in total shoulder arthroplasty. The humeral component is used as part of an anatomic configuration with a Versa-Dial® humeral head that articulates against the Comprehensive hybrid glenoid component. The head is connected to the Nano humeral component by a taper adaptor.

The Comprehensive Nano Stemless Shoulder is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The bone-contacting outer surface features a porous coating of plasma sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm through 40mm in 2mm increments.

Here's a breakdown of the acceptance criteria and study details for the Comprehensive® Nano Stemless Shoulder, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Comprehensive Nano Humeral Component (Investigational): 116 subjects (who reached the two-year follow-up time point or were removed from the study).
  • Comprehensive mini stem (Control): 123 subjects.
• Data Provenance: Prospective, randomized, blinded, multicenter study. The country of origin is not specified in the provided text.

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

• The document does not specify the number of experts used to establish the ground truth for the test set.
• It refers to evaluations by Principal Investigators (for adverse events) and implies clinical assessment for outcomes like ASES scores and radiographic success. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but they are implicitly qualified medical professionals conducting a clinical study.

4. Adjudication Method for the Test Set

• The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1) for the outcomes.
• The adverse events were classified by the principal investigator as definitely related, probably related, or possibly related to the device. This indicates an individual clinical assessment rather than a multi-expert adjudication panel for initial classification of device-related adverse events.
• For the co-primary endpoints (ASES scores, adverse events/revisions, radiographic success), the collection and analysis appear to be based on study protocols and clinical assessments by the investigators.

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

• No, an MRMC comparative effectiveness study was not done.
• This was a clinical trial comparing two different medical devices (the Nano Stemless Shoulder vs. the mini stem shoulder prosthesis) in human subjects, not a study evaluating human readers' performance with or without AI assistance. The "readers" here are the patients themselves (their ASES scores and outcomes), and the clinicians assessing their progress and radiographs.

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

• This is not an AI/algorithm device. The device is a physical shoulder prosthesis (Comprehensive® Nano Stemless Shoulder).
• Therefore, a standalone (algorithm only) performance study is not applicable. The study evaluated the clinical performance of the physical implant itself.

7. The Type of Ground Truth Used

• The "ground truths" in this study are derived from a combination of:
  • Clinical Outcomes Data: ASES (American Shoulder and Elbow Surgeons) scores, which are patient-reported and clinician-evaluated functional assessments.
  • Adverse Event Reporting: Documented unanticipated device-related adverse events, fractures, perforations, dislocations, and revisions/removals, classified by the principal investigator.
  • Radiographic Assessments: Measurable criteria from imaging studies (subsidence, migration, progressive lucency around components) to determine radiographic success.
• This represents real-world clinical performance data from human patients.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device (shoulder prosthesis) and not an AI algorithm, there is no "training set" in the context of machine learning.
• The study described is a clinical study to evaluate the device's performance in patients, not to train a model.

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

• Not applicable. See point 8. There is no training set for an AI algorithm.

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Comprehensive 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 Comprehensive 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.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The devices are a line extension of the Comprehensive Reverse Shoulder System and consists of new 36mm and 40mm tray and liner locking mechanism designs as well a a new 40mm glenosphere. The highly cross-linked ultrahigh molecular weight (HXPE) polyethylene liners are offered either in Prolong® (Standard) or Vivacit-E (Vitamin E). The tray taper geometry as well as the material (Ti-6AL-4V and Co-28Cr-6Mo) and thickness offerings are identical (standard, +5mm, +10mm) to the predicate. The trays will still be offered with a centric (standard) taper as well as two other offset tapers (+3 and +6) to provide more offerings to the surgeon.

The provided document is a 510(k) summary for the Zimmer Comprehensive Reverse Shoulder System, which describes a medical device rather than an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device performance (like experts for ground truth, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study (non-clinical testing) that proves it meets those criteria.

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

The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. Instead, it states that non-clinical testing "demonstrated that the proposed devices meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy." The listed tests are the means by which this performance was evaluated.

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

The document lists "Non-Clinical Tests," which typically involve physical models, simulations, or benchtop experiments rather than patient data. No sample sizes are specified for these non-clinical tests. Data provenance in terms of country of origin or retrospective/prospective is not applicable or provided.

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

Not applicable, as this is a mechanical device evaluation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation of patient data.

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

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation of medical data, which is not the case here.

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, as this is a mechanical device, not an AI-assisted diagnostic tool.

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

Not applicable, as standalone performance refers to AI algorithm performance without human intervention, which is irrelevant to a shoulder implant.

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

The "ground truth" for this device would be established by engineering standards, validated testing methodologies, and comparison to the predicate device's established performance. It's based on objective physical and mechanical properties and behaviors, not clinical interpretations or pathological findings in the context of an AI/ML algorithm.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device testing in the context of this 510(k) submission.

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

Not applicable, as there is no training set mentioned or implied.

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Indications For Use:

The Comprehensive Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• 3. Revision where other devices or treatments have failed.
• 4. Correction of functional deformity.
• 5. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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 suited to receive the implants and a functional deltoid muscle is necessary. Reverse application is limited to proximal humeral replacement in the United States.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the shoulder joint. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullay replacement of bone. The components of the Comprehensive SRS system have previously been cleared for use in hemi and anatomic total shoulder replacement. The current submission is to expand the indications to include reverse shoulder applications. All components have been previously cleared.

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA to Biomet Manufacturing Corp. It determines substantial equivalence for the Comprehensive Segmental Revision System (SRS) to legally marketed predicate devices.

Here's why I cannot fulfill your request based on this document:

• No specific acceptance criteria or performance metrics are listed for the device itself. The document only details the "Indications for Use" for the device, which are the medical conditions or purposes for which it is intended.
• The document states "No new testing provided" under "Non-Clinical Tests" and "None provided" under "Clinical Tests" for the current submission (K173411). This means the FDA's substantial equivalence determination for this specific submission was based on existing data from previous clearances (K111746) and comparison to the predicate device, not on new studies conducted for this K173411.
• The details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for either training or test sets are not present in this regulatory letter. These types of details would typically be found in the comprehensive testing reports that accompany a 510(k) submission, not in the FDA's determination letter itself.

In summary, the provided text confirms the FDA's decision regarding substantial equivalence but does not contain the specific performance data, acceptance criteria, or study details you are asking for.

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Biomet Comprehensive 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 Comprehensive 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.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.

The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating.

This document is a 510(k) Summary for the Zimmer Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, and Comprehensive Mini Baseplate. It describes the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of a medical device submission for substantial equivalence to predicates, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.

The acceptance criteria and device performance are described in terms of engineering and material characteristics for orthopedic implants.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the non-clinical tests performed to demonstrate substantial equivalence. These are not performance metrics in the sense of accuracy, sensitivity, or specificity as would be the case for AI/ML models, but rather engineering and material properties.

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

This is an orthopedic implant 510(k) submission, not a study of an AI/ML device. Therefore, the concept of a "test set" in the machine learning sense, or data provenance in terms of patient data origin and retrospectivity/prospectivity, is not applicable. The documentation refers to mechanical and material testing, which would have specific sample sizes for engineering tests (e.g., number of specimens tested for shear strength, porosity), but these details are not provided in this summary document.

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

Not applicable. This is not an AI/ML device that requires human expert review for establishing ground truth on image data or similar. The "ground truth" here refers to established engineering standards and material specifications.

4. Adjudication Method for the Test Set

Not applicable. Ground truth establishment for AI/ML model test sets.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI/ML device where human readers interact with AI assistance.

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

Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to:

• Engineering Standards and Material Specifications: The device's performance against established industry standards for orthopedic implants, including mechanical strength, durability, material composition (e.g., PPS and HA/TCP coating properties), and resistance to loosening/disassociation.
• Predicate Device Performance: The comparison of the proposed device's characteristics to those of legally marketed predicate devices, demonstrating that any differences "do not raise new questions of safety and effectiveness."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of Device and Performance Aspects from the Document:

• Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
• Purpose: Manufacturing of alternate versions of existing Comprehensive Standard and Mini Baseplates with a different porous plasma spray (PPS) coating vendor and the addition of Zimmer's Calcicoat coating. Also includes a new Comprehensive Reverse Augmented Baseplate with an augmented backside.
• Basis for Substantial Equivalence:
  • Intended Use & Indications for Use: Identical to predicate devices.
  • Materials: Substrate and porous coating are the same as the predicate; Calcicoat® coating has been previously cleared.
  • Design Features: Identical or similar to predicates.
  • Sterilization: Identical assurance level and validation methods to predicate (new vendor).
• Performance Data Provided: Non-clinical tests were conducted. These included assessments of PPS and HA/TCP Coating Pore Size and Porosity, Glenoid Loosening/Disassociation Test Method, and Shear testing justification. No clinical tests were provided.
• Conclusion: The proposed devices are deemed substantially equivalent because they have the same intended use and indications for use, similar technological characteristics, and the differences do not raise new questions of safety and effectiveness, meaning they are at least as safe and effective as the legally marketed predicate devices.

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The ExpressBraid Graft Manipulation is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.

The subject device consists of a stainless steel, straight needle attached to a strand of MaxBraid suture. The two ends of the strand of suture are crimped into the needle. The MaxBraid sutures are braided, non-absorbable sutures available in a white configuration consisting of 100% Ultra High Molecular Weight Polvethylene (UHMWPE) fibers and a blue and white co-braid configuration consisting of Deklene II, Polypropylene suture braided into 100% UHMWPE fibers. The suture is provided uncoated. The colorant used in the blue and white co-braid consists of [phthalocyaninato (2-)] copper

This document is a 510(k) premarket notification for the "ExpressBraid Graft Manipulation" device. It is a re-submission due to the addition of a new contraindication, not a new device or significant modification. As such, it relies heavily on the data and conclusions from the previously cleared K152868 submission. Therefore, detailed acceptance criteria and a new study proving performance are not present in this document because it references prior clearance.

However, based on the provided text, we can infer some information about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this 510(k) is not for a new device but for an update to its Indications for Use (specifically, adding a contraindication), explicit acceptance criteria and new performance data are not provided. The document states:

• "The performance of ExpressBraid Graft Manipulation device has not changed since its last clearance in K152868 as there are no changes to design, material, or intended use. The performance data submitted in K152868 is still valid and therefore no additional testing was performed."

Therefore, the acceptance criteria and performance would be consistent with what was submitted and accepted for the K152868 clearance. This current document simply reaffirms that the device still meets those (unspecified in this document) criteria because its fundamental design and function have not changed.

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

• Since no new testing was performed for this specific 510(k), no new sample size or data provenance details are provided. This information would be found in the K152868 submission.

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

• Not applicable for this 510(k) as no new testing was conducted, and it's not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set:

• Not applicable, as no new clinical or non-clinical tests requiring adjudication were 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. This device is a surgical suture for soft tissue approximation/ligation, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used:

• Not applicable as it is a physical medical device, not a diagnostic or AI-based product requiring ground truth for validation. The "ground truth" for a surgical suture would typically involve mechanical testing (e.g., tensile strength, knot security) and biocompatibility, which were presumably assessed in K152868.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable for the same reason as above.

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