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The Discovery Elbow - X-Small is intended for cemented use in patients with the following conditions:

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 or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.

The provided text is a 510(k) summary for the Discovery™ Elbow - X-Small, an elbow prosthesis. It is a submission to the FDA for market clearance and discusses the device description, intended use, and comparison to a predicate device.

Based on the information provided, no acceptance criteria or a study that proves the device meets specific acceptance criteria are described in the typical format of a clinical trial or performance study for a medical device with measurable outcomes (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Discovery™ Elbow, K013042 and K051975). This is a regulatory pathway that primarily relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.

Here's an analysis of the provided information in the context of your request:

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

• Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate device. This means it must:
  • Have the same intended use.
  • Have the same technological characteristics, or have different technological characteristics that do not raise different questions of safety and effectiveness.
  • If there are different technological characteristics, data must demonstrate that the device is as safe and effective as the predicate device.
• Reported Device Performance:
  • Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This is a very general statement and does not provide specific performance metrics, methodology, or results in a table format. It implies mechanical and material testing, but no details are given.
  • Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical performance data was used to demonstrate substantial equivalence for this particular submission.

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

• Not applicable. There is no "test set" in the context of clinical or device performance data described in this 510(k) summary because no clinical testing was performed for this submission. Non-clinical (laboratory) testing was mentioned but no sample sizes or data provenance for that testing are provided.

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

• Not applicable. As no clinical testing was performed and no "ground truth" for a test set was established in this submission.

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

• Not applicable. No test set or associated adjudication method is mentioned.

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

• Not applicable. This device is an elbow prosthesis (a physical implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

• Not applicable. As above, this is a physical medical device, not an algorithm.

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

• Not applicable. No clinical ground truth data was used for this submission. The "ground truth" for substantial equivalence is effectively the performance (safety and effectiveness) of the predicate device, which is assumed to be established.

8. The sample size for the training set

• Not applicable. There is no "training set" mentioned or relevant for this type of 510(k) submission for an elbow prosthesis.

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

• Not applicable. As above, no training set is mentioned.

In summary, the provided 510(k) summary details a regulatory submission based on substantial equivalence to a predicate device, supported by non-clinical laboratory testing. It does not contain information about specific acceptance criteria for performance metrics, clinical studies, or expert-adjudicated ground truth data, as these are typically not required for this type of submission when demonstrating substantial equivalence without clinical data.

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The Porous Coated Discovery™ Elbow is intended for cemented use in patients with the following conditions:

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 severe functional deformity.
5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.

The Porous Coated Discovery™ Elbow is a total elbow prosthesis comprised of an unfidrar components of components. The humeral components. The humeral through the unfar anticulation into the une and ulnar components are porous coated to provide enhanced fixation.

The provided text is a 510(k) summary for the "Porous Coated Discovery™ Elbow." It describes the device, its intended use, and states that substantial equivalence is claimed to a predicate device based on non-clinical mechanical testing. Crucially, it explicitly states "Clinical Testing: None provided as a basis of substantial equivalence."

Therefore, a detailed breakdown of acceptance criteria, study design, and performance metrics as typically derived from clinical studies cannot be provided because no clinical studies were submitted.

Here's a summary of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics within the provided document. The basis for substantial equivalence is "Non-Clinical Testing: Mechanical testing was provided to demonstrate that devices ability to perform." The acceptance criteria would likely be conformity to established mechanical testing standards for this type of prosthetic, demonstrating comparable safety and effectiveness to the predicate device.
• Reported Device Performance: The document states that the mechanical testing demonstrated the device's "ability to perform." No specific performance metrics (e.g., strength, durability, wear characteristics) or their numerical results are reported in this summary.

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

• Sample Size for Test Set: Not applicable for clinical data, as no clinical testing was performed for substantial equivalence. For non-clinical mechanical testing, the sample size is not specified in this summary.
• Data Provenance: Not applicable for clinical data. For non-clinical mechanical testing, the provenance of the test articles would be from the manufacturer (Biomet Manufacturing Corp.).

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

• Not applicable as no clinical testing was performed and therefore no ground truth established by experts in a clinical context.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical testing was performed.

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

• No MRMC comparative effectiveness study was done, as explicitly stated: "Clinical Testing: None provided as a basis of substantial equivalence."

6. Standalone Performance Study (Algorithm Only):

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

7. Type of Ground Truth Used:

• For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and established performance standards for elbow prostheses. The document does not specify if these standards were internal, industry-wide, or regulatory.

8. Sample Size for the Training Set:

• Not applicable for physical device testing in this context. Training sets are relevant for machine learning algorithms.

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

• Not applicable.

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The indications for use for the Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Revision procedures where other treatments or devices have failed
4. Correction of functional deformity
5. Treatment of acute and chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
6. Oncology applications
   This device is intended to be used with bone cement.

The Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System is an elbow replacement device designed for use in cases where there is distal humeral bone loss. The device consists of a ulnar stem with a pre-assembled bearing, a distal humeral component which, with a humeral condyle kit, completes the hinge of the elbow, an extramedullary modular distal segment for bone replacement and a intramedullary humeral stem. Soft tissue attachment sleeves and canal cement plugs complete the system.

The provided text is a 510(k) Summary for a medical device (Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Instead, it's a submission to the FDA for market clearance, primarily demonstrating substantial equivalence to pre-existing devices. This type of submission often relies on a comparison to predicate devices, rather than new performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The output would be:

No information regarding acceptance criteria or a study proving the device meets those criteria is present in the provided document.

To elaborate on why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on indicating uses and comparing the new device to existing predicate devices.
2. Sample sized used for the test set and the data provenance: No test set is mentioned, as no performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
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 document pertains to a physical elbow prosthesis, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Non-Clinical Testing/ Clinical Testing: None was provided as a basis of substantial equivalence" statement explicitly indicates that no new performance studies were submitted for this clearance.

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The Constrained Elbow is indicated for use in the following conditions:

• Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Revisions where other treatments or devices have failed
• Correction of severe functional deformity
• Treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
  This device is intended for cemented use.

The Constrained Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. The humeral components are available with or without an anterior flange. All ulnar and humeral components are manufactured with or without Bond coat.
The device design allows the load to be carried at the primary articulation. The primary articulation is the spherical interface between the humeral condyles and the ulnar bearing. The secondary articulation is the axle attached to one condyle, which fits into the hole of the opposite condyle. The geometry of the components is designed to minimize bone loss and eliminate sharp resection cuts.
The humeral stem has been designed to incorporate a five degree carrying angle with a five degree internal rotation to closely match the anatomical morphology. The ulnar component incorporates a bowed stem and neck angle also designed to closely match the anatomical morphology.

The provided document is a 510(k) premarket notification for a medical device called the "Discovery Elbow." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing new performance criteria through clinical trials. Therefore, the document does not contain the information required to populate a table of acceptance criteria and reported device performance based on a study of the device itself.

Here's why and what information is available:

• No Acceptance Criteria and Reported Performance Table: The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence." This means there was no study conducted on the Discovery Elbow to measure its performance against predefined acceptance criteria. Instead, substantial equivalence was established through non-clinical testing (Finite Element Analysis) and by comparing its technological characteristics (materials, design, sizing, and indications) to a predicate device.

Therefore, I cannot provide the requested table or answer most of the detailed questions about a study on the Discovery Elbow.

However, I can extract information relevant to how substantial equivalence was determined:

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

• Not applicable. No clinical study was performed on the Discovery Elbow to generate performance data against acceptance criteria. Substantial equivalence was based on comparison to a predicate device.

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

• Not applicable. No clinical "test set" was used for the Discovery Elbow itself. The evaluation relied on non-clinical data (Finite Element Analysis) and comparison to a predicate device for which clinical data presumably existed but is not detailed here.

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

• Not applicable. No clinical "test set" was established for the Discovery Elbow.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 device is an elbow prosthesis, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is an elbow prosthesis.

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

• Not applicable. For substantial equivalence, the "ground truth" was the performance and characteristics of the legally marketed predicate device (Constrained Elbow, K003253). The Discovery Elbow was deemed equivalent based on its design, materials, and intended use aligning with that predicate, supported by Finite Element Analysis.

8. The sample size for the training set:

• Not applicable. No training set was used as this is not a machine learning device, and no clinical study was conducted.

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

• Not applicable.

Summary of Device and Equivalence Information from the document:

• Device Name: Discovery Elbow
• Predicate Device: Constrained Elbow, K003253
• Intended Use (for both Discovery Elbow and implied for predicate):
  • Non-Inflammatory Degenerative Joint Disease (osteoarthritis, avascular necrosis)
  • Rheumatoid arthritis
  • Revisions where other treatments or devices have failed
  • Correction of severe functional deformity
  • Treatment of acute or chronic fractures with humeral epicondyle involvement unmanageable by other methods
• Method of Substantial Equivalence Demonstration:
  • Non-Clinical Testing: Finite Element Analysis was performed.
  • Clinical Testing: Explicitly stated: "Clinical testing was not used to establish substantial equivalence."
  • Technological Characteristics Comparison: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.

This document serves as an FDA clearance letter based on substantial equivalence, not a report of a performance study with acceptance criteria.

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