Search Results

The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
  Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees.

The provided text is a 510(k) summary for the Catalyst CSR 3 Peg Glenoids, a shoulder prosthesis. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device.

The document discusses non-clinical testing for the glenoid components (static lever-out, static torque-out, dynamic shear testing, and Bacterial Endotoxin Testing) and concludes that "the performance of the Catalyst CSR Shoulder System is adequate for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed results of these tests.

It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices." This means a clinical study to establish performance against acceptance criteria in a human population, or a comparative effectiveness study, was not performed for this submission.

Therefore, many of the requested sections regarding AI/ML device performance are not applicable based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be created. The document states that non-clinical tests (static lever-out, static torque-out, dynamic shear testing, bacterial endotoxin testing) were performed and indicated "adequate performance for its intended use." However, it does not provide specific quantitative acceptance criteria (e.g., minimum load for lever-out, maximum endotoxin level) nor does it report the specific performance values achieved by the device in these tests.

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

• Not applicable for clinical performance. Clinical testing was not deemed necessary. For the non-clinical tests, the sample sizes and data provenance are not detailed in this summary document.

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. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission.

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

• Not applicable. No clinical test set or adjudication was performed.

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. An MRMC comparative effectiveness study was not performed. This device is a shoulder prosthesis, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device (shoulder prosthesis), not an algorithm or AI.

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

• Not applicable. No clinical ground truth was established for this submission. The "ground truth" for the non-clinical tests would be the established engineering standards or physical properties being measured.

8. The sample size for the training set

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set.

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

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary of relevant information from the document related to "acceptance criteria" and "study":

The document focuses on establishing substantial equivalence to predicate devices for a shoulder prosthesis, rather than demonstrating performance against novel acceptance criteria in a clinical study.

Non-Clinical Testing:

• Tests Conducted:
  • Static lever-out
  • Static torque-out
  • Dynamic shear testing (per ASTM F2028-14)
  • Bacterial Endotoxin Testing
• Reported Performance: "The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use." (Specific quantitative results or formal acceptance criteria are not provided in this summary.)
• Bacterial Endotoxin: "endotoxin limit of 20EU/device was met." (This is the only explicit acceptance criterion given, and the device met it for the predicate component, with the new glenoids not creating a new worst case).
• Clinical Testing: Explicitly stated as "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices."

In essence, the "study" proving the device met "acceptance criteria" for this 510(k) was a set of non-clinical, mechanical, and biocompatibility tests intended to show that the new components perform similarly to the predicate devices and meet basic safety and performance requirements for the indicated use, without requiring new clinical data.

Ask a specific question about this device

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

The Modular Hybrid Glenoid is intended to be inserted 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 Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.

The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.

The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.

The provided document is a 510(k) summary for the Biomet Orthopedics, Inc. Modular Hybrid Glenoid device. It describes the device, its indications for use, and a comparison to predicate devices, but does not contain information about studies proving the device meets acceptance criteria in the way a diagnostic AI/ML device would be evaluated.

This document pertains to a medical device, not an AI/ML diagnostic algorithm. Therefore, the specific criteria for evaluating AI/ML algorithms (such as sensitivity, specificity, AUC, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this submission.

Instead, the acceptance criteria for this type of medical device are generally based on non-clinical mechanical testing and establishing substantial equivalence to existing legally marketed devices.

Here's how the provided information relates to acceptance criteria for this specific medical device:

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

Since this is a mechanical orthopedic implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the document states:

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 for Test Set: Not applicable. The "testing" here refers to mechanical engineering tests of the device itself, not a clinical study on patients or an evaluation of an algorithm on a dataset.
• Data Provenance: Not applicable for clinical data. The mechanical tests would have been performed in a laboratory setting.

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

• Not applicable. "Ground truth" in the context of an AI/ML algorithm evaluation (e.g., radiologist diagnoses) is not relevant for this device's mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.

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

• Not applicable. This refers to consensus methods for interpreting medical images or data, which is not relevant for mechanical device 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:

• No. This type of study is specifically for evaluating diagnostic AI/ML algorithms used in conjunction with human readers. This document explicitly states: "Clinical Testing: None provided."

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

• Not applicable. This refers to the performance of an AI/ML algorithm by itself.

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

• Not applicable in the context of clinical "ground truth." For mechanical tests, the "ground truth" is derived from established engineering principles, material science, and testing methodology to ensure the device meets specified strength, fatigue, and other performance parameters.

8. The sample size for the training set:

• Not applicable. The concept of a "training set" is for AI/ML models. This is a physical medical device.

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

• Not applicable. (See #8)

Summary regarding AI/ML evaluation:

The provided document details a 510(k) submission for an orthopedic implant. It specifically states "Clinical Testing: None provided." The acceptance criteria and "study" are based on non-clinical mechanical testing and a demonstration of substantial equivalence to predicate devices, which is a different regulatory pathway and set of evaluation criteria than those used for AI/ML diagnostic devices.

Ask a specific question about this device

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.

Ask a specific question about this device

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the gleno-humeral joint; non-union humeral head fracture; displaced 3 and 4 proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.

The Aequalis Universal Shoulder Glenoid is intended for cemented use as the glenoid component in total shoulder arthroplasty, completed using humeral components of the Tornier Aequalis Total Shoulder System. The Aequalis Universal Shoulder Glenoid is manufactured in four sizes from Ultra High Molecular Weight Polyethylene (UHMWPE). The component's articulating (or lateral) surface is concave and is designed to articulate with the head of an existing, commercially available Tornier Aequalis Shoulder humeral prosthesis. The Aequalis Universal Shoulder Glenoid aticulating surface has a radius of curvature greater than the corresponding humeral head. This mismatch between the glenoid and the humeral head is intended to allow the translation of the head in the superior/inferior and anterior/posterior directions.

The back surface of the Aequalis Universal Shoulder Glenoid is spherical in geometry, in order to conform to the geometry of the glenoid fossa. It is grooved in order to increase the interface glenoid implant / bone cement.

The back (or medial) surface of the component has either a keel or four pegs for fixation in the glenoid. These glenoid components are 4 mm thick and available in four sizes (small, medium, large and X-large) for each component, the keeled and pegged components.

• The Aequalis Universal pegged Glenoid features one centrally located peg and three t peripheral pegs placed in a triangular configuration. The peripheral pegs are fitted with transversal grooves that provide enhanced cement fixation. The three peripheral pegs provide resistance to rocking and rotational motion caused by translation of the prosthetic humeral head. The central peg features an X-ray marking wire in Cobalt-Chromium alloy.
• -The Aequalis Universal keeled Glenoid features a centrally located keel to provide translational and rotational stability of the implant. A groove around the middle of the keel provides enhanced cement fixation. The keel features an X-ray marking wire in Cobalt-Chromium alloy.

Materials. The Aequalis Universal Shoulder Glenoid is manufactured from implant grade ultrahigh molecular weight polyethylene (UHMWPE) according to ISO5834-2, with a small Cobalt-Chromium wire included as an opaque radiographic marker.

The provided text describes the 510(k) summary for the Aequalis Universal Shoulder Glenoid, a Class III medical device. However, it does not include information about specific acceptance criteria or a study designed to prove the device's performance against such criteria in the manner typically expected for AI/software-based medical devices (e.g., sensitivity, specificity, or reader performance metrics). Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices.

The document primarily discusses:

• Device Description: What the Aequalis Universal Shoulder Glenoid is made of (UHMWPE), its design (concave articulating surface, spherical back surface with grooves, keel or pegs for fixation), and its intended use (cemented glenoid component in total shoulder arthroplasty).
• Voluntary Standards: Tornier, S.A. Standard Operating Procedures (SOP), vendor certifications and qualification procedures, Quality System Regulations (QSR), ISO9001 & EN46001, and EN552 for sterilization.
• Premarket Notification (K994393): The process of seeking FDA clearance based on substantial equivalence.
• Comparison to Predicate Devices (Table 1): A table comparing features of the Aequalis Universal Shoulder Glenoid to other commercially available shoulder glenoid components (e.g., materials, method of fixation, presence of keel/pegs, indications for use, and an UHMWPE standard).
• Summary of Safety and Effectiveness: This section outlines potential risks (procedure-related like infection, nerve injury; device-related like component disassociation, wear debris, loosening) and argues that the Aequalis Universal Shoulder Glenoid's design (all-polyethylene, similar fixation methods) makes its expected failure modes and frequencies comparable to existing devices.

Missing Information related to your specific questions:

The document does not contain the following:

1. A table of acceptance criteria and reported device performance (in the context of quantitative functional performance like accuracy, precision, or reader study results). The "reported device performance" is essentially a qualitative comparison to predicate devices and an assessment of expected failure modes based on material and design.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, nor effect sizes.
6. Standalone (algorithm-only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Conclusion based on the provided text:

This submission is for a physical orthopedic implant (Aequalis Universal Shoulder Glenoid) seeking clearance based on substantial equivalence to existing legally marketed devices, rather than a new AI/software medical device that would typically undergo rigorous performance studies with specific acceptance criteria related to diagnostic accuracy, sensitivity, or specificity. Therefore, the questions regarding AI performance criteria, ground truth, expert adjudication, and training/test set details are not applicable or addressed in this type of 510(k) submission.

The "study" that proves the device meets "acceptance criteria" here is primarily the comparison to predicate devices (Table 1) and a qualitative risk assessment detailed in the "Class III Summary," arguing that the Aequalis Universal Shoulder Glenoid's design and materials are comparable to existing devices, and thus its safety and effectiveness can be expected to be similar. The "acceptance criteria" are implied by the features and performance of the predicate devices.

Ask a specific question about this device