Search Results

Anatomic Applications

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

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

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

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

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

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

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

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

Here's why and what information can be extracted:

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

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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.

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A Delta Total shoulder prosthesis is indicated for use in: Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional Deltoid muscle is necessary to use the device.

The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.

The Delta Shoulder prosthesis is a modular total shoulder prosthesis that was designed specifically for use in patients with non-functional rotator cuffs. The articulation of this design is "inverted" compared to traditional total shoulder prosthesis. Unlike traditional total shoulder prosthesis, the Delta Shoulder is designed such that the "ball" of the articulation is incorporated into the glenoid prosthesis, and the "cup" of the articulation is incorporated in the humeral prosthesis. The distal surface of the metaglene components are coated with a hydroxyapatite coating (HA) and are intended to be used with 4 metaglene screws for fixation.

This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-based medical devices.

Instead, this document pertains to a traditional medical device (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This regulatory pathway does not typically involve the kind of performance metrics, clinical studies, or AI/ML-specific validation often seen in submissions for software-as-a-medical-device (SaMD) or AI-enabled devices.

Here's why the requested information cannot be fully provided based on the given text:

• Device Type: The "Delta Shoulder" is a physical medical implant (a shoulder prosthesis), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "device performance" in terms of accuracy, sensitivity, or specificity against ground truth, as would be relevant for AI, does not apply in the same way.
• Regulatory Pathway: The 510(k) pathway for traditional devices primarily involves demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, design, materials, sterilization, packaging, and often includes bench testing (e.g., mechanical strength, wear) and sometimes animal studies, but generally not human clinical trials with performance metrics against a defined ground truth as would be done for an AI algorithm.
• Content of the Document: The provided text is a 510(k) summary and the FDA clearance letter. It describes the device, its indications for use, identifies predicate devices, and states that substantial equivalence was determined based on "detailed device description, design rationale, product testing, literature and conformance with voluntary performance standards." However, it does not detail the specific "product testing" or "voluntary performance standards" in a way that allows for the extraction of acceptance criteria and reported performance metrics in the format requested for AI/ML devices.

Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can extract the relevant information regarding the basis for clearance and what's available:

1. Table of acceptance criteria and the reported device performance:

• Similarity in Indications for Use: The device is intended for "Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint," requiring an anatomically and structurally suited joint and a functional Deltoid muscle.
• Similarity in Design: Modular total shoulder prosthesis, "inverted" articulation (ball on glenoid, cup on humeral), HA-coated metaglene component for cementless application with screws, other components for cemented use.
• Similarity in Sterilization and Packaging.
• Product Testing: Not detailed, but typically involves mechanical and biocompatibility testing for implants.
• Literature and conformance with voluntary performance standards: Specific standards are not listed but are implied to have been met. |
  | Biocompatibility: | Implied to have been demonstrated through material selection and potentially testing, consistent with predicate devices and voluntary standards. |
  | Mechanical Performance: | Implied to have been demonstrated through "product testing" and "conformance with voluntary performance standards," ensuring the device can withstand physiological loads and wear over its intended lifespan, comparable to predicate devices. This typically includes fatigue, static strength, and wear testing, but specific results or acceptance criteria are not provided in this summary. |

The following points cannot be addressed from the provided text as they are not relevant to a 510(k) submission for a physical implant device in this context:

2. Sample sizes used for the test set and data provenance: No "test set" in the context of AI/ML performance evaluation is discussed. The validation is primarily against predicate devices and design verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI is not established here.
4. Adjudication method for the test set: Not applicable.
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 not an AI-enabled device that assists human readers.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for a physical implant is typically its ability to function safely and effectively within the human body, assessed through engineering principles, preclinical testing, and post-market surveillance.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for a traditional, physical shoulder prosthesis. The "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to existing devices through design comparison, product testing (not detailed here), and adherence to standards, rather than through performance metrics of an AI/ML algorithm against a ground truth.

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The Comprehensive Humeral Fracture Stems are indicated for 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; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

The Interlok® finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBond™ coated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.

The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an Interlok® finish for cement fixation or with a thin layer of plasma spray coating known as MacroBond™ for press-fit. The device is fluted distally which allows for a cement mantle and an increase in anti-rotational stability. The proximal body of the stem incorporates a reverse Morse taper for the Bio-Modular Heads and 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. A collar also exists to minimize subsidence.

The provided document is a 510(k) premarket notification for a medical device, the "Comprehensive Humeral Fracture Stems." It outlines the device description, classification, predicate devices, indications for use, and a summary of testing.

Crucially, the document explicitly states:

• "No clinical testing was provided as a basis for substantial equivalence."
• "Non-Clinical Testing: Mechanical Testing and a Finite Element Analysis determined that the Comprehensive Humeral Fracture Stems presented no new risks and were, therefore, substantially equivalent to the predicate devices."

Therefore, based on the provided text, there is no study detailing acceptance criteria and device performance in the context of an AI/algorithm-based system. The regulatory clearance was based on substantial equivalence to predicate devices through non-clinical mechanical testing and finite element analysis, not on clinical performance data or AI model validation.

Because no clinical or AI-related study was performed, I cannot provide information for the following points:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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