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The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
• In cases of bone defect in proximal humerus.
  The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
  The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

Indications for RSP Humeral Stem Adapters:
The Reverse® Shoulder Prosthesis (RSP) is indicated for treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy failed joint replacement with a grossly rotator cuff deficient shoulder 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder hymeral head should be used. For the monoblock stem, the Turon humeral head should be used. This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

The RSP Monoblock system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup that is joined to the humeral stem. The components included in this system are a glenoid head, a humeral socket joined with humeral stem, a glenoid baseplate screws.
The modification outlined in this application consists of an addition to the Indications for Use for the humeral stem to allow for cementless implantation. There is no change to the fundamental scientific technology of the RSP Monoblock with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.

The provided text is a 510(k) summary for a medical device called the "Reverse® Shoulder Prosthesis Monoblock." This document is a regulatory submission to the FDA for market clearance and does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of an AI model.

Instead, it details a modification to an existing shoulder prosthesis (allowing cementless implantation of the humeral stem) and asserts its substantial equivalence to predicate devices based on comparable features (material, indications, surgical technique, intended use).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this document. The sections you asked about pertain to AI/ML device evaluations, which are not present here.

Here's why each point cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document discusses a physical medical implant, not a software device with performance metrics like accuracy, sensitivity, or specificity against predefined criteria.
2. Sample sized used for the test set and the data provenance: Not an AI/ML device; no test set in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device; no ground truth establishment for a test set.
4. Adjudication method for the test set: Not an AI/ML device; no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used: Not an AI/ML device; no ground truth in the AI/ML sense.
8. The sample size for the training set: Not an AI/ML device; no training set.
9. How the ground truth for the training set was established: Not an AI/ML device; no ground truth for a training set.

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The Reverse® Shoulder Prosthesis (RSP) is indicated for treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder humeral head should be used. For the monoblock stem, the Turon humeral head should be used.

This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

A monoblock humeral stem with socket that is joined with an adapter to mate with a humeral head for use in hemi-arthroplasty applications.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the "Reverse® Shoulder Monoblock Stem with Hemi Adapter." It is not applicable to the request for acceptance criteria and study results for an AI/ML powered medical device.

Reasoning:

The document concerns a traditional implantable medical device (shoulder prosthesis) and its regulatory clearance process based on substantial equivalence to predicate devices. It explicitly states:

• "Clinical Testing: None provided." This directly indicates that no clinical study, of any kind, was conducted or provided for this submission.
• The entire document describes a 510(k) submission, which primarily relies on comparing the new device to existing legally marketed predicate devices, rather than exhaustive new clinical studies, especially for mechanical devices.
• There is no mention of any AI or Machine Learning component in the device or its function.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML powered device cannot be extracted from this document.

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The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• . In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
• In cases of bone defect in proximal humerus. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff. failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. The RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The components included in this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws.

The Monoblock design consists of:

• . a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
• . humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
• . glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066

Here's an analysis of the provided text regarding the Reverse® Shoulder Prosthesis Monoblock, focusing on the requested acceptance criteria and study information:

Based on the provided text, the device is a medical implant (shoulder prosthesis), and the information is from an FDA 510(k) clearance document. For this type of device, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, biocompatibility, and functional integrity under simulated physiological conditions. The document does NOT describe the acceptance criteria or reported device performance for a software-based AI/ML device. The questions about AI-specific criteria (sample size, experts, adjudication, MRMC, standalone performance, training data) are not applicable to this medical device submission.

Here's a breakdown of what is available in the document related to testing, rephrased to fit the structure of your request where possible, and indicating where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical implant and not a software AI/ML device, the table below reflects the type of information that would be relevant for such a device. The provided text does not include specific numerical acceptance criteria or detailed reported performance values for the device's mechanical properties, as these studies were already completed for previous versions.

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

• Sample Size: Not explicitly stated for specific mechanical tests in this document. The document refers to "prior non-clinical testing" performed for previously cleared components (K100741, K092873, K051075, and K041066). The current submission states no additional testing was necessary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. For mechanical testing, this typically refers to the lab where the tests were conducted, which is not detailed here.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from data.

4. Adjudication method for the test set

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires adjudication of expert opinions.

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 question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool. The document explicitly states "Clinical Testing: None provided."

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

7. The type of ground truth used

• This question is not applicable in the context of AI/ML ground truth from expert consensus, pathology, or outcomes data. For a mechanical device, "ground truth" would be the known mechanical properties of materials, validated engineering models, and the performance of predicate devices against established standards during non-clinical testing.

8. The sample size for the training set

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm. The "ground truth" for mechanical testing is established through standardized engineering test methods and material science principles.

Summary of Device-Specific Information from the Text:

The document concerns the "Reverse® Shoulder Prosthesis Monoblock," an update to an existing shoulder implant. The submission is for a 510(k) clearance, indicating it is a "substantially equivalent" device to a predicate (K082120 - Tornier Aequalis@-Reversed Fracture prosthesis).

The key takeaway regarding testing is:

• Non-Clinical Testing: "After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence." This means the current device leverages prior testing data for its components or overall system design, implying that component-level mechanical, material, and biocompatibility requirements were met previously and are assumed to hold for the new configuration due to design similarities to the predicate and previously cleared components.
• Clinical Testing: "None provided." This is common for 510(k) submissions, especially for modifications of existing devices or when non-clinical testing is deemed sufficient to establish substantial equivalence.

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For treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The modification consists of creating a monoblock device by joining the humeral socket with the humeral stem and to add additional humeral insert sizes. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to packaging or sterilization.

This document is a 510(k) premarket notification for a medical device called the "Reverse Shoulder Prosthesis". It states that no clinical testing was performed. The submission relies on non-clinical mechanical testing and a comparison to predicate devices to demonstrate substantial equivalence.

Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, specifically concerning performance with human data, cannot be extracted from this document.

The document does provide information relevant to a non-clinical study, which is included below for completeness:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Test Set Sample Size: Not applicable, as this was non-clinical testing. The "test set" consisted of physical prototypes and design specifications for mechanical analysis.
• Data Provenance: Not applicable for clinical data. The data originates from internal engineering analysis and mechanical testing performed by the manufacturer (Encore Medical, L.P. / DJO Surgical).

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

• Not applicable as this was non-clinical mechanical and design equivalence testing, not clinical human performance evaluation. The "ground truth" was established by engineering specifications, material science standards, and accepted biomechanical testing methodologies.

4. Adjudication method for the test set

• Not applicable as this was non-clinical testing. Verification activities were performed, implying internal review and assessment against design specifications and predicate device characteristics.

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 was a non-clinical submission for a shoulder prosthesis, not an AI-based diagnostic or treatment device involving human readers.

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

• No. This was a non-clinical submission for a shoulder prosthesis, not an algorithm.

7. The type of ground truth used

• For the non-clinical testing, the "ground truth" was based on:
  • Engineering design specifications.
  • Material property standards.
  • Biomechanical principles and accepted testing methodologies (e.g., for socket lever out strength, stress analysis).
  • Characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There was no machine learning or AI involved requiring a training set.

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

• Not applicable. There was no machine learning or AI involved requiring a training set.

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