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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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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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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 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 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 is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Identity Shoulder System cleared previously in K213856 is 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 in the anatomic configuration is comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing, This construct is intended to be used with a compatible glenosphere/baseplate component.
The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.

This document is a 510(k) premarket notification decision letter from the FDA to Zimmer Inc. for their Identity Shoulder System. It primarily discusses the substantial equivalence of the device to previously marketed predicate devices.

Based on the provided text, there is no information about testing related to acceptance criteria for an AI device. The document describes a medical device (shoulder system implants), not an AI/software device that would typically have the associated performance metrics (e.g., sensitivity, specificity, accuracy).

The "Non-Clinical Tests Summary & Conclusions" section on page 6 of the provided document does not mention any AI-related tests or performance metrics. The tests listed are:

• Finite Element Analysis (FEA)
• Range of Motion Analysis
• Magnetic Resonance Imaging (MRI)

These are standard engineering and safety tests for implantable medical devices, not performance evaluations for an AI diagnostic or assistance tool. The conclusion states that "Non-clinical testing demonstrated that the new devices do not represent new worst-case configurations than the predicate, and the subject device is substantially equivalent to the predicate device identified." This reinforces that the evaluation was for the physical implant components, not an AI system's performance.

Therefore, since the input document does not pertain to an AI device, I cannot fulfill the request to describe acceptance criteria and associated studies as requested in the prompt's points 1-9.

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The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.

The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:

• . Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, .
• Avascular necrosis of the humeral head, ●
• . Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains,
• . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• . Cuff tear arthropathy (CTA Heads only).

The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.

The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:

• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,

The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems.

The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration.

The PRIMA Short Stem Plus is intended for use in cementless and cemented applications.

The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter.

The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone.

As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of medical devices to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria related to AI or diagnostic accuracy.

The document describes the PRIMA Humeral System and PRIMA TT Glenoid devices, which are shoulder joint replacement prostheses. The review focuses on their substantial equivalence in terms of intended use, design, materials, and mechanical non-clinical testing to previously cleared devices.

Therefore, I cannot provide an answer based on the given prompt about acceptance criteria and a study proving device performance in the context of diagnostic accuracy or AI assistance, as this information is not present in the provided text.

Specifically, the document states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and PRIMA TT Glenoid to the predicate devices." (Page 8)

This confirms that no clinical study for performance (like diagnostic accuracy, AI assistance, or human reader improvement) was conducted or needed for this particular 510(k) clearance.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
• inflammatory degenerative joint disease such as rheumatoid arthritis; ●
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• . revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid ● Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Hybrid Glenoid System (K223876) is a modular system intended to be used in combination with previously cleared devices of the SMR Shoulder System. The system consists of a SMR Hybrid Glenoid component to be used in anatomical shoulder configuration and a reverse baseplate with screws and glenosphere that are used in reverse shoulders.

The SMR Hybrid Glenoid is a cemented glenoid component composed of a polyethylene baseplate connected to a central peg made of Trabecular Titanium. The baseplate has two peripheral pegs intended to be cemented into the native glenoid with the central peg being uncemented. The SMR Hybrid Glenoid is available in different sizes of baseplate and peg.

If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the anatomic polyethylene baseplate and leaving the metal peg in place. A metal SMR Hybrid Glenoid Reverse Baseplate is then connected to the central peg and a SMR Glenosphere coupled to the metal SMR Hybrid Glenoid Reverse Baseplate to articulate with a SMR Reverse Shoulder humeral liner, body and stem assembly on the humeral side. The metal SMR Hybrid Glenoid Reverse Baseplate and central porous peg assembly is intended for uncemented use with the addition of screws for fixation in reverse shoulder reconstructions.

This 510(k) is to introduce Selective Laser Melting (SLM) as a manufacturing option for central peg comprised of Trabecular Titanium. The subject device peg, made by SLM, has the same design of the predicate SMR Hybrid Glenoid System (K223876) and features the same net on the external surface.

This document is a 510(k) Premarket Notification from the FDA regarding the "SMR Hybrid Glenoid System." It primarily concerns the substantial equivalence of a new manufacturing method (Selective Laser Melting - SLM) for a component (central TT peg) of an already cleared medical device, rather than the initial clearance of an AI/ML medical device.

Therefore, many of the typical acceptance criteria and study elements associated with AI/ML device clearances (like those relating to diagnostic accuracy, human-in-the-loop performance, ground truth establishment by experts, etc.) are not applicable to this specific submission. This submission focuses on demonstrating that the new manufacturing process for a physical implant component does not change the core safety and effectiveness of the device as previously cleared.

Here's an analysis based on the provided text, addressing the points where information is available and explaining why other points are not relevant to this type of submission:

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

The acceptance criteria for this 510(k) are based on demonstrating that the SLM manufactured central TT peg performs equivalently to the peg made by the previous manufacturing method of the predicate device (K223876). This is primarily established through non-clinical testing.

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

• Sample Size: Not specified in the text. For non-clinical (mechanical) testing, sample sizes are typically determined by relevant ASTM/ISO standards to achieve statistical significance for the properties being measured.
• Data Provenance: The testing was "conducted according to the following test standards," implying laboratory testing. The specific country of origin for the lab data is not stated, but the manufacturer is based in Italy. This is retrospective in the sense that the testing was performed, and the results were subsequently submitted to the FDA. It is not human subject data (clinical data).

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

Not applicable. This submission is not for an AI/ML device requiring human expert annotation or ground truth for diagnostic accuracy. The "ground truth" here is the performance of the predicate device's component and the established engineering standards for orthopedic implants.

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

Not applicable. No expert adjudication process similar to those used for clinical image review or diagnostic ground truth was performed or required.

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

Not applicable. This is a physical implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

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

Not applicable. This is a physical implant, not a software algorithm.

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

The "ground truth" for this engineering submission is based on:

• Established Material and Mechanical Standards: Such as ISO 5832-3 for Ti6Al4V, and various ASTM standards for tensile strength, shear, fatigue, and abrasion (e.g., ASTM E8, F1044, F1147, F1160, F1978). These standards define the expected performance benchmarks for the material and component.
• Performance of the Predicate Device Component: The existing SMR Hybrid Glenoid System (K223876) serves as the benchmark, demonstrating that the new manufacturing process yields an equivalent product.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set. If referring to the manufacturing process, the "training" involves optimizing the SLM parameters, though "sample size" in a machine learning context is irrelevant here.

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

Not applicable. As above, no training set in the AI/ML sense was used. For the manufacturing process, "ground truth" would relate to achieving desired material properties and geometric accuracy, established through quality control, material characterization, and metrology.

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Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems).
• Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems).
• Difficult clinical management problems where other methods of treatment may not be inadequate.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

The INHANCE™ Convertible Glenoid system consists of a Baseplate with minor modifications compared to the previously cleared Baseplate in K212737 and a poly insert that locks atop the Baseplate to allow for an anatomic procedure. The Convertible Glenoid Insert implants are offered in four sizes: Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Convertible Glenoid Insert implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and an interrupted fixation ring along with a finned central fixation post to facilitate poly locking to the Convertible Glenoid Baseplate.

The INHANCETM Convertible Glenoid Insert Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the INHANCE Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty.

The INHANCE™ Convertible Glenoid Baseplates, previously cleared in K212737, were modified to provide for a means of mechanical fixation between the Convertible Glenoid Inserts and Baseplates.

The INHANCE Convertible Glenoid implants are compatible with the implants and instruments previously cleared for use in the INHANCE Anatomic Shoulder System (K202716), the INHANCE Stemless Anatomic Shoulder System (K203108), and the INHANCE Reverse Shoulder System (K212737).

This document describes the regulatory approval for the INHANCE™ Convertible Glenoid device. It is a medical device, specifically a component of a shoulder arthroplasty system. Therefore, the "acceptance criteria" and "device performance" refer to the successful completion of specific non-clinical (mechanical, material, and biocompatibility) tests according to established standards, rather than the performance of an AI algorithm based on clinical data.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes the regulatory approval for a medical device (orthopedic implant), not an AI algorithm. Therefore, the concepts of "test set" and "data provenance" specifically for AI evaluation are not applicable in this context. The "test sets" here refer to the samples of the physical device or its materials subjected to various non-clinical (mechanical, material, biological) tests as outlined above. The provenance of these test articles would be the manufacturing process of the INHANCE™ Convertible Glenoid components.

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

This information is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM, ISO), which dictate testing methodologies and performance thresholds. These standards are developed and maintained by expert committees in relevant engineering and medical fields, but there isn't a "number of experts" establishing ground truth for a specific test set in the same way clinical data is evaluated for AI.

4. Adjudication Method for the Test Set

This information is not applicable. "Adjudication method" usually refers to resolving disagreements among human reviewers (e.g., radiologists) in AI or clinical studies. In the context of device testing, results are typically objective measurements against a standard, which are then analyzed and interpreted by qualified engineers/scientists.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An MRMC study is relevant to AI/diagnostic imaging devices. This document concerns the mechanical and material performance of an orthopedic implant.

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

This information is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this medical device, the "ground truth" is based on:

• Adherence to established international and national standards (e.g., ASTM F1378, ISO 10993-1, ASTM F2028, ASTM F1829, ASTM F2695, ISO 11607-1, ISO 11607-2, ISO 11137-1, ISO 11137-2).
• Engineering justifications and characterizations demonstrating equivalence to predicate devices and acceptable performance (e.g., non-worst-case for wear, identical material properties).
• Quantitative data derived from physical testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI algorithm and thus no training set.

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

This information is not applicable. There is no AI algorithm and thus no training set or ground truth for it.

Summary of Device-Specific Information:

The INHANCE™ Convertible Glenoid is a shoulder arthroplasty component. Its acceptance for market (substantial equivalence to predicate devices) was based on a comprehensive series of non-clinical tests and evaluations covering:

• Range of Motion
• Biocompatibility
• Porous Structure Characterization
• AO-HXLPE Material Characterization
• Glenoid Wear Rate Evaluation
• Dynamic Evaluation of Loosening/Disassociation
• Static Evaluation of Locking Mechanism
• Glenoid Fatigue Resistance
• MRI Compatibility
• Shelf-Life
• Sterilization Validation

All these tests met their respective acceptance criteria as defined by national and international standards (ASTM, ISO) and FDA guidance, ensuring the device's safety and effectiveness. Clinical testing was explicitly stated as "not necessary to demonstrate substantial equivalence."

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis; ●
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains);
• . cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid ● Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient ioint with severe arthropathy (disabled shoulder). The patient's ion t must be anatomically suited to receive the selected implants and a functional deltoid muscle is neces sary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The SMR Shoulder System is a complete system intended to be used in primary or revision total shoulder joint replacement in either anatomic or reverse configurations. The SMR Shoulder System was cleared via several 510(k) submission, up to the latest approval under K220792.

The new compatibilities introduced with this 510(k) are related to the system when used in reverse shoulder configuration only.

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The SMR Shoulder System in reverse configuration consists of humeral stems, reverse humeral bodies, reverse liners, glenospheres, metal back glenoid components and pegs. The metal back glenoid component, when used as part of a reverse shoulder replacement, is intended for cementless fixation with bone screws.

Glenoid components of the SMR Shoulder System are cleared for use also with the humeral components of the PRIMA Humeral System (K212800). When used in combination with the PRIMA Humeral System, the device consists of a humeral stem, tray, reverse insert, glenospheres, metal back glenoid components and pegs.

With this Traditional 510(k) submission, new compatibilities between already cleared devices of the SMR Shoulder System are introduced:

• Bone Screws dia. 5.0 mm (K210717) compatible with SMR Metal Back Glenoid -(K113254) and SMR TT Baseplate (K133349);
• -SMR TT Hybrid Glenoid Reverse Baseplate (K163397) compatible with SMR Glenosphere dia. 42 mm (K212800).

No changes in indications for use, materials, manufacturing processes, packaging and sterilization are introduced with this 510(k) on already cleared devices.

The provided document is a 510(k) summary for the SMR Shoulder System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technological characteristics. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML device.

This document specifically states: "Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device." This indicates that the device's performance was evaluated through non-clinical means (mechanical tests), not through studies involving clinical data or AI performance metrics.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria, as the document does not describe such a study for an AI/ML device.

However, I can extract the information related to the device and its testing as presented:

Device: SMR Shoulder System

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

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

• Sample Size: Not specified for mechanical testing. The phrase "worst case components" suggests a targeted selection rather than a large statistical sample.
• Data Provenance: Not applicable. The testing was non-clinical (mechanical).

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

• Not applicable. This was a non-clinical mechanical test, not an evaluation requiring expert-established ground truth for an AI/ML device.

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

• Not applicable. This was a non-clinical mechanical test, not an evaluation requiring adjudication for an AI/ML device.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence." This type of study is relevant for AI/ML devices involving human readers interpreting clinical data, which is not the case here.

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

• Not applicable. This device is a shoulder implant system, not a software algorithm or AI. The testing was on the physical components.

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

• Not applicable in the context of clinical or AI/ML ground truth. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance standards (e.g., ASTM F2028).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device; therefore, there is no training set.

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

• Not applicable. This is not an AI/ML device; therefore, there is no training set or associated ground truth establishment.

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The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

The PRIMA TT Glenoid, that is part of the PRIMA Glenoid System, is a modular shoulder system intended to be used in combination with the previously cleared humeral components of the SMR Shoulder System (K220792) and PRIMA Humeral System (K212800).

The new system components include a monoblock glenoid baseplate, a modular glenoid baseplate and the related glenoid peg, a glenosphere connector with screw, central and peripheral bone screws and locking caps.

The baseplates are provided in different angulations, ranging between 10° and 20°, and in different offsets, up to +4mm lateralization. The glenosphere has articular diameter 36, 40 and 42mm and the connector with screw is available in low, medium and high lateralization. Central compressive screws are available in dia. 5 and 6.5mm and in length ranging between 25 and 50mm, while peripheral screws are available in dia. 5mm and in length ranging between 18 to 50mm.

Baseplates, peg, screws and locking cap are made of Ti6Al4V, the glenosphere is made of CoCrMo and the glenosphere connector with screw is made of Ti6Al4V and UHMWPE.

This document is a 510(k) Premarket Notification for the PRIMA TT Glenoid, a shoulder implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing, and explicitly states that clinical testing was not necessary. Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria based on clinical performance data.

Specifically, the document states: "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA TT Glenoid to the predicate devices."

As a result, I cannot provide the detailed information requested in points 1-9 regarding a study that proves the device meets acceptance criteria through clinical performance. The provided text only discusses non-clinical mechanical testing for equivalence.

However, I can extract information related to the non-clinical testing performed:

Non-clinical Testing Information Provided:

• Type of Testing: Mechanical tests.
• Purpose: To demonstrate that device performance fulfilled the intended use and that the device is substantially equivalent to the predicate devices.
• Tests Performed:
  • Evaluation of modular connection dissociation strength
  • Fatigue fretting test on glenoid baseplates in reverse shoulder configuration
  • Evaluation of modular connection dissociation strength post-fatigue
  • Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)
  • Evaluation of range of motion for worst case devices
• Components Tested: Worst case components or constructs.

Since clinical performance data and associated acceptance criteria are not present in the provided text, the table for clinical acceptance criteria and the detailed study information cannot be generated from this document.

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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 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 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.

The Identity Shoulder System is 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 in the anatomic configuration is comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing. This constructed is intended to be used with a compatible glenospheres/baseplate component.

This FDA 510(k) summary for the "Identity Shoulder System" does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The document is a premarket notification for a medical device seeking substantial equivalence to previously cleared devices. It primarily focuses on:

• Indications for Use: What the device is intended for (e.g., non-inflammatory degenerative joint disease, rheumatoid arthritis, fractures).
• Device Description: A high-level overview of the components and configurations (hemiarthroplasty, total shoulder replacement, reverse configuration).
• Technological Characteristics: How the device is similar to predicate devices in terms of intended use, indications for use, materials, design features, and sterilization.
• Non-Clinical Tests/Justifications: A list of non-clinical tests performed (e.g., FEA, Axial Pull Off, Fatigue, Corrosion) to support substantial equivalence, but no results or acceptance criteria are provided for these tests in this summary document.
• Clinical Tests: Explicitly states "None provided."

Therefore, based solely on the provided text, I cannot answer the requested questions regarding acceptance criteria and studies proving the device meets them because this information is not present. This type of detail is typically found in the full 510(k) submission, not in the public summary.

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