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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a 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 necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intended for primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components – glenophere, baseplate, and fixation component (screw or post). All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The subject submission seeks to gain clearance for design modifications to the existing device components.

The provided FDA 510(k) clearance letter for the JARVIS Glenoid Reverse Shoulder Prosthesis does not contain any information regarding clinical studies, acceptance criteria for an AI/CADe device, or performance data related to AI assistance.

The document describes a traditional medical device (a shoulder prosthesis), not an artificial intelligence (AI) or computer-assisted detection/diagnosis (CADe/CADx) device. Therefore, it lacks the specific details requested in your prompt, such as:

• Table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types and methods for establishing ground truth.
• Training set sample size and ground truth establishment for AI.

The "Performance Testing" section explicitly states: "Engineering analysis was conducted on the modified locking screws and concluded that the compressive force of the subject screws is equivalent to that of the predicate and therefore locking capabilities are equivalent. Therefore, all previous performance testing and validations are still applicable and no additional testing is necessary." This refers to mechanical testing of the physical implant components, not performance of an AI algorithm.

In summary, the provided text is for a physical medical implant, not an AI-based or software-as-a-medical-device (SaMD) product that would require the kind of data and studies you are asking about.

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The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a 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 necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

This document is an FDA 510(k) summary for the JARVIS Glenoid Reverse Shoulder Prosthesis. It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device.

The provided text describes a traditional medical device (shoulder prosthesis) and its mechanical and biocompatibility testing, which are standard for such devices to demonstrate substantial equivalence to legally marketed predicates.

To answer your specific questions about an AI/ML device, the input document would need to describe such a device, its intended use, and the performance studies conducted to support its claims.

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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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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 an addition of a size 44mm glenoid head and size 44mm humeral poly socket. 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 materials, design, or method of manufacture.

This document is a 510(k) premarket notification for a medical device called the "Reverse® Shoulder Prosthesis." It describes a modification to an existing device, specifically the addition of a size 44mm glenoid head and a size 44mm humeral poly socket.

Based on the provided text, there is no acceptance criteria or study that proves the device meets acceptance criteria in the traditional sense of an AI/ML device evaluating performance against specific metrics. This document is for a mechanical medical device (a prosthetic joint), and the submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the structure provided in your prompt, highlighting why many sections are not applicable to this type of device submission:

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

   • Not Applicable. This document does not establish performance criteria in terms of accuracy, sensitivity, specificity, etc., as would be done for an AI/ML device. The "performance" for this mechanical device is assessed through "Non-Clinical Testing" which demonstrated its ability "to perform under expected clinical conditions."
   • The submission is for a modification, and the core claim is "no change to the intended use or fundamental scientific technology...no changes to materials, design, or method of manufacture" other than the size addition.

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. No human clinical "test set" data is mentioned. The "Non-Clinical Testing" likely refers to bench testing (mechanical strength, wear, etc.). The sample size for such tests would be for the number of prostheses tested, not patient data.

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. There is no "ground truth" establishment in the context of diagnostic interpretation or algorithmic output for this mechanical device.

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

   • Not Applicable. No human interpretation or adjudication of a test set is discussed.

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-assisted device.

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. For mechanical devices like this, the "ground truth" often relates to engineering specifications and material properties verified through non-clinical testing. While clinical outcomes are ultimately important, they are not part of this specific 510(k) submission to demonstrate substantial equivalence for a minor modification.

8. The sample size for the training set

   • Not Applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not Applicable. There is no "training set" for this mechanical device.

Summary of what is provided in the document:

• Device Name: Reverse® Shoulder Prosthesis
• Regulation Number/Name: 21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented prosthesis
• Regulatory Class: Class II
• Product Code: PHX, KWS
• Modification: Addition of a size 44mm glenoid head and size 44mm humeral poly socket.
• Claim: "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 materials, design, or method of manufacture."
• Non-Clinical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." (No specifics on the nature or results of this testing are provided in this summary document).
• Clinical Testing: "None provided."
• Predicate Device: DJO Surgical Reverse Shoulder Prosthesis (K041066 & K051075)

This document is a formal communication from the FDA to the manufacturer regarding a 510(k) submission. It confirms the FDA's determination of "substantial equivalence" based on the information provided by the manufacturer. The core of this type of submission for a mechanical device modification is to show that the modified device is as safe and effective as a legally marketed predicate device, often relying heavily on non-clinical (bench) testing rather than human clinical studies for minor changes.

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The Encore Reverse Shoulder Prosthesis (RSP) is intended for use in 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, if the glenoid bone stock appears "insufficient" to bear the load of the glenoid baseplate, a RSP humeral stem adapter can be used to convert the RSP humeral stem to a hemiarthroplasty prosthesis. During revision surgery of an RSP, if the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device; a RSP Humeral Stem Adapter is used to convert the RSP device to a hemiarthroplasty prosthesis.

The Encore 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. Unlike traditional total shoulders, 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 RSP Humeral Stem Adapter is used to convert the RSP to a hemiarthroplasty when the glenoid bone stock appears to be "insufficient" to bear the load of the glenoid baseplate device. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

The provided text describes a medical device, the Encore Reverse Shoulder Prosthesis (RSP), and its approval via a 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving specific performance acceptance criteria. The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." and "The modified Encore RSP is similar in design, materials, and intended use to the previously cleared Encore RSP devices, K041066 and K051075."

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your specific questions, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document does not describe specific performance criteria or a study that measures the device against them.
2. Sample sized used for the test set and the data provenance: Not available. No "test set" in the context of performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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 a shoulder 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 is a physical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available. The approval is based on substantial equivalence to predicate devices, not on direct performance against a "ground truth" as might be seen for diagnostic devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Encore Reverse Shoulder Prosthesis® (RSP) is indicated for use in 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 Encore Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff, failed hemi or total shoulder arthroplasty with irreparable rotator cuff, in operation our, half, half hand rotator cuff are irreparable. Unlike traditional total shoulders, 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. buooplate, and this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws. The glenoid baseplate is intended for cementless a glondia baouplate, and bon of screws for fixation. The humeral stem is intended for cemented use only. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission.

The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is primarily a 510(k) summary and an FDA clearance letter for the Encore Reverse Shoulder Prosthesis (RSP), stating its indications for use and substantial equivalence to a previously cleared device.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The information about the device's technical specifications and the regulatory clearance process is present, but not the performance evaluation data you're asking for.

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The Reverse Shoulder is indicated for use in patients with a grossly rotator cuff deficient shoulder joint and one of the following:

1. Pseudoparalysis of the shoulder.
2. Severely painful and functionally impaired shoulder joint.
3. 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 Reverse Shoulder Prosthesis is a total shoulder prosthesis 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 shoulders, the Reverse Shoulder is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into the humeral stem. The distal surface of the glenoid baseplate is porous coated with an incorporated 6.5 cancellous screw and is intended to be used with 4 peripheral screws (3.5 non-locking and/or 5.0mm locking and non-locking) for additional fixation.

The provided text is a 510(k) premarket notification for the Encore Reverse Shoulder Prosthesis. This type of regulatory document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove effectiveness or meet specific performance criteria beyond those of the predicate.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets said criteria in the way you've outlined for a typical diagnostic algorithm or AI study. Instead, it relies on demonstrating that the new Encore Reverse Shoulder is substantially equivalent to the DePuy Delta Shoulder (K0231478).

Here's why the information you're asking for isn't present in this type of document:

• Medical Device Equivalence: 510(k) clearances are for demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is often done through comparison of technological characteristics, indications for use, and possibly bench testing or non-clinical data, but not typically through new clinical trials with acceptance criteria for performance metrics like sensitivity, specificity, accuracy, etc.
• Physical Prosthesis vs. AI/Diagnostic Device: The Encore Reverse Shoulder Prosthesis is a physical implant, not a diagnostic algorithm or an AI-powered device. Therefore, the concepts of a "test set," "ground truth," "expert adjudication," "MRMC study," or "standalone algorithm performance" are not applicable in this context. Performance for such devices usually relates to biocompatibility, mechanical strength, surgical outcomes (which would be tracked post-market), and safety, rather than classification metrics.

In summary, the information requested in your prompt (Table of acceptance criteria, sample sizes for test/training, number/qualifications of experts, adjudication, MRMC, standalone performance, ground truth types, etc.) is not present in the provided 510(k) document because it pertains to a different type of device and regulatory approval pathway.

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