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Indications For Use:

• 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.
• Humeral components with a Macrobond® surface coating are indicated for either cemented or uncemented press-fit applications.
• Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
• Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
• Humeral components with a non-coated (Interlok") surface are indicated for cemented application only.
• Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components.

The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System.

The Bio-Modular® Shoulder System is a set of components intended for total or hemi shoulder arthroplasty. It consists of humeral stems, humeral heads, and glenoid components. The only change to this system proposed by this submission is the addition of Hydroxyapatite (HA) coating to the glenoid components that utilize metal backs and are intended for biological fixation with optional screw fixation. The HA coated glenoid components are intended only for total shoulder arthroplasty.

This 510(k) premarket notification (K043100) for the Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components does not contain acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for an AI/ML medical device.

This submission is for a medical implant (shoulder prosthesis) and asserts substantial equivalence to a predicate device based on material, design, and functional characteristics, not on a performance evaluation like an AI/ML algorithm. Therefore, the requested information elements related to AI/ML device testing (sample sizes, expert ground truth, MRMC studies, standalone performance, training data) are not applicable to this document.

Here's a breakdown based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device. For this orthopedic implant, the "acceptance criteria" are generally related to demonstrating substantial equivalence in mechanical properties, biocompatibility, and manufacturing processes compared to a predicate device. The document states:

"The Bio-Modular Shoulder System with the Hydroxyapatite coated glenoid components has the same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy as the predicate device."

This statement serves as the core performance claim for substantial equivalence. No specific quantitative performance metrics (like accuracy, sensitivity, specificity) with pre-defined acceptance thresholds are provided, as this is not an AI/ML diagnostic or prognostic device.

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

Not applicable. No "test set" in the AI/ML sense was used. The submission relies on non-clinical testing (presumably mechanical and material testing) to demonstrate equivalence.

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

Not applicable. No medical expert ground truth was established for the purpose of evaluating an AI/ML algorithm.

4. Adjudication Method for the Test Set

Not applicable.

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

No. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a shoulder prosthesis submission.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

Not applicable. For this device, the "ground truth" would be established through established engineering and biocompatibility standards, mechanical testing, and material characterization, rather than clinical outcomes or expert consensus in an AI/ML context.

8. The Sample Size for the Training Set

Not applicable. No AI/ML model was trained.

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

Not applicable.

Summary of Device-Specific Information for K043100:

• Device Name: Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components
• Predicate Device: Bio-Modular® Shoulder System (K030710) – Biomet Inc.
• Basis for Substantial Equivalence: New device has the "same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy" as the predicate device, with the addition of Hydroxyapatite (HA) coating to glenoid components.
• "Study" (Non-Clinical Testing): "Non-Clinical Testing: The modified devices were found to be substantially equivalent to the predicate devices." (Details of this non-clinical testing are not provided in the 510(k) summary itself, but would have been part of the full submission).
• Clinical Testing: "No clinical testing was provided as a basis for substantial equivalence."

In conclusion, this 510(k) document is for an orthopedic implant and does not involve AI/ML technology. Therefore, the specific criteria for evaluating AI/ML devices outlined in your request are not present or applicable here.

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The components of Bio-Modular® Shoulder System included in this submission are intended for total shoulder joint arthroplasty. Indications for use include:

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
   Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Bio-Modular® Shoulder System consists of a humeral stem that is used in conjunction with a modular head and a metal backed or all polyethylene glenoid component. The Humeral Component is available in various lengths and porous coating levels. The Bio-Modular® Humeral stern features a biplaner taper to promote stress transfer down the length of the stem. Each stem has a lateral fin to provide rotational stability. Holes in the fin provide the surgeon with the option of suture attachment during fracture reconstruction. A collar minimizes subsidence. The stems are circumferentially porous coated proximally to provide fixation by tissue ingrowth. The proximal portions of the humeral stems feature a reverse Morse taper for attachment of the modular humeral head. Offset and Bi-Polar humeral heads are also available. Modular, metal backed glenoid components are available for total shoulder replacement. These devices feature a central peg and the option of using screws for immediate fixation and porous coating to provide biological fixation when used without bone cement. All polyethylene glenoid components are available for cemented application.

The provided text is a 510(k) Premarket Notification for the Bio-Modular® Shoulder System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through clinical studies as would be required for a novel device or one with a higher risk classification.

Therefore, the document does not contain the detailed information typically associated with establishing acceptance criteria and proving a device meets them through clinical or standalone studies for AI/software devices. Instead, it focuses on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

Here's an analysis based on the information provided, highlighting the absence of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify performance-based acceptance criteria for an AI/software device, nor does it report specific performance metrics for the Bio-Modular® Shoulder System in terms of diagnostic accuracy, sensitivity, specificity, etc. The "performance" demonstrated here is primarily through mechanical testing and similarity to predicate devices.

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

• Test Set Sample Size: Not applicable. No clinical test set data is provided in this submission; the primary evidence is based on mechanical testing and comparison to predicate devices, not a test set of patient cases.
• Data Provenance: Not applicable. No patient data (retrospective or prospective) is mentioned for a test set.

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

• Not applicable. There is no mention of a test set requiring expert ground truth establishment for this device.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring adjudication is described.

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

• No. An MRMC study is typically for evaluating the diagnostic performance of a reading system, often involving AI, with human readers. This device is a shoulder implant and the submission explicitly states: "Clinical Testing: None provided."

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

• Not applicable. This device is not an algorithm for which standalone performance would be typically evaluated in this manner. The "standalone" performance tested here relates to the mechanical properties of the implant itself, not an AI algorithm.

7. Type of Ground Truth Used:

• Not applicable in the context of diagnostic performance. The "ground truth" for the device's functionality is its physical and mechanical integrity, demonstrated through mechanical testing and comparison to predicate devices. For a surgical implant, the ultimate "ground truth" of its effectiveness would come from clinical outcomes data, but this submission explicitly states "Clinical Testing: None provided."

8. Sample Size for the Training Set:

• Not applicable. This application is for a medical implant and does not involve an AI algorithm with a training set.

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided document, the "study" that proves the Bio-Modular® Shoulder System meets its (implicit) acceptance criteria for substantial equivalence to predicate devices consists of:

• Mechanical Testing: Demonstrating the device's ability to perform under expected clinical conditions. While the details are not provided, this would involve standardized tests to evaluate strength, durability, fatigue resistance, and other biomechanical properties relevant to orthopedic implants.
• Porous Surface Characterization: To verify the properties of the porous coating for biological fixation.
• Comparison to Predicate Devices: Demonstrating that the materials, surface finishes, and processing methods are similar to previously cleared devices (K872454, K915596, K992119, K992899, K002998 for Bio-Modular®; K914695, K943300, K974044, K981487, K011047 for Gobal® Advantage). This similarity, combined with non-clinical testing, forms the basis for the FDA's determination of substantial equivalence, implying the new device is as safe and effective as the predicates.

Key takeaway: This 510(k) relies on non-clinical (mechanical) testing and comparison to predicate devices, rather than clinical studies or the types of performance evaluations (e.g., sensitivity, specificity, human-in-the-loop studies) typically associated with AI/software medical devices. The explicit statement "Clinical Testing: None provided." confirms this approach.

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The Bio-Modular Shoulder System is intended for partial or total shoulder ioint arthroplasty. Total shoulder replacement devices are intended to be inserted with bone cement. Non-porous coated humeral stems being implanted for hemi-arthroplasty may be press fit.

Indications for Use:

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. Treatment of acute fracture of the humeral head unmanageable using other treatment methods
6. Cuff tear arthroplasty

The Bio-Modular Shoulder System consists of humeral stems of various lengths and porous coating levels, humeral heads of various diameters and neck lengths, and both all polyethylene and metal backed polyethylene glenoid components. Each type of component will be described individually.

Humeral Stems: The Bio-Modular Humeral stem features a bi-planer taper to promote stress transfer down the length of the stem. This minimizes removal of endosteal bone and enhances the ease of stem insertion. Each stem has a lateral fin to provide rotational stability. Holes in the fin provide the surgeon with the option of suture attachment during fracture reconstruction. A collar minimizes subsidence. Stems are available in a primary lenath of 115mm in 1mm incremental stem diameters from 6 to 17mm. Longer stems (190mm) are available in 2mm incremental diameters from 7 to 13mm.
Humeral stems are available in either an Interlok (grit blasted) finish or with plasma spray porous coating. Porous stems are circumferentially porous coated proximally to enhance cement fixation. Centering sleeves are available to assist in stem alignment during cementina.

Humeral Heads: All humeral stems feature a reverse Morse taper for attachment of the modular humeral head. This means that instead of the tapered post being on the humeral stem like traditional devices, the post is on the modular head and the bore is in the stem. The advantage of the reverse taper configuration is that it allows for maximum exposure of the glenoid when the stem is in place. Therefore, the humeral stem may be implanted prior to glenoid resurfacing. Humeral heads are available in a variety of diameters and neck lengths. In addition to the standard symmetrical bearing surface, heads are available with articular extensions to enhance component stability.

Glenoid Components: Although the humeral stem and head may be implanted as a hemishoulder replacement, glenoid components are available for total shoulder replacement. All polyethylene alenoid components come in two styles. The keeled component features a triangular keel that may be trimmed for better fit during surgery. This style is available in 3 sizes and 2 thicknesses. The second style features 3 pegs to assist in fixation and is available in 3 sizes and 1 thickness. Both styles have an embedded x-ray marker.

A modular, porous coated, metal backed glenoid component provides distribution of stresses into the cement. The device features a central tapered peq and the option of screw fixation.

I am sorry, but the provided text from the K992119 document does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.

The document is a 510(k) premarket notification for the Bio-Modular Shoulder System, focusing on:

• Device Description: Details on humeral stems, heads, and glenoid components.
• Intended Use and Indications for Use: What the device is meant to treat.
• Substantial Equivalence: Comparing the device to other legally marketed predicate devices.
• FDA Decision: Granting substantial equivalence and allowing market entry.

This type of document typically focuses on demonstrating equivalence to existing devices rather than presenting the results of a standalone study against specific, novel acceptance criteria defined by the manufacturer. Therefore, I cannot extract the requested information from the provided text.

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