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Hemiarthroplasty/Conventional Total Application:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Reverse Application:
Identity Revision Humeral Stem products are 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 necessary.

The Identity Revision Humeral Stem is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).

The Identity Revision Humeral Stems are comprised of titanium alloy. The diameters of the stems range in 1mm increments from 4mm to 18mm in a revision length of 133-134mm. The stem is designed with a distal portion that is cylindrical in shape with a tapered and a proximal portion that is flared, eight-sided shape. The devices have a machine finish distally and a plasma-spray titanium porous coating proximally. To support placement and bone reconstruction in fracture cases, the Identity Revision Humeral Stems feature proximal suture holes as well as etch lines for stem length respect to the native humeral head. The humeral stems employ an oval reverse taper which allows the attachment of either an Identity Humeral Stem Adapter for hemi- and anatomic total shoulder applications or an Identity Humeral Tray for reverse shoulder applications.

I apologize, but the provided FDA 510(k) clearance letter for the "Identity Revision Humeral Stems" does not contain any information about acceptance criteria or a study that proves the device meets those criteria for software-related performance.

This document is for a medical device (humeral stems, which are a type of orthopedic implant) and focuses on the mechanical, material, and design aspects of the device, comparing it to predicate devices to establish substantial equivalence.

Specifically, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section lists:

• Fatigue Testing
• Range of Motion Analysis
• Magnetic Resonance Imaging (MRI)

It explicitly states: "No animal or clinical testing provided." This reinforces that the clearance is based on bench testing and comparison to existing devices, not on a human-in-the-loop study involving AI or a comprehensive performance study as you've described in your request.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance (for AI-related metrics).
2. Sample sizes for test sets or data provenance.
3. Number of experts, qualifications, or adjudication methods for ground truth establishment.
4. MRMC studies, effect sizes, or standalone algorithm performance.
5. Type of ground truth used (expert consensus, pathology, outcomes data).
6. Sample size for the training set or how its ground truth was established.

This document pertains to a physical orthopedic implant, not a software or AI-driven diagnostic/therapeutic device that would typically involve the types of studies and acceptance criteria you've asked about.

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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment.

• The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The proposed Equinoxe Activit-E Reverse Humeral Liners are humeral liners intended to be used in reverse total shoulder arthroplasty (rTSA) as a part of the Equinoxe® Shoulder System. The proposed devices are constructed of highly crosslinked UHMWPE containing vitamin E referred to as Activit-E. There are no proposed geometric or compatibility changes as compared to the predicate humeral liner devices cleared in K223833.

The provided document is a 510(k) clearance letter and summary for a medical device, the Equinoxe® Shoulder System. This document focuses on the substantial equivalence of a new version of the device (specifically, the Humeral Liners made from Activit-E material) to a previously cleared predicate device.

The FDA 510(k) clearance process is primarily focused on demonstrating substantial equivalence, not necessarily on proving that a device meets specific "acceptance criteria" in the same way one might for a diagnostic AI algorithm. Therefore, the information typically requested in an acceptance criteria study (like sample sizes for test and training sets, expert qualifications, ground truth establishment for AI, MRMC studies, or standalone algorithm performance) is not directly present in this regulatory submission for a physical orthopedic implant.

However, I will extract the closest available information related to performance and testing, as well as explicitly state where the requested information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific medical device (Equinoxe® Shoulder System - Humeral Liners), the "acceptance criteria" are not reported as numerical thresholds like accuracy or sensitivity. Instead, the acceptance criteria are implicitly met by demonstrating that the new device performs "as intended" and is "substantially equivalent" to the predicate device through various non-clinical tests. The performance is assessed by confirming that the new Activit-E material does not negatively impact the mechanical integrity and biological interaction compared to the conventional UHMWPE.

2. Sample Sizes Used for the Test Set and the Data Provenance

This information is typically not included in a 510(k) summary for a physical implant. The "test sets" here refer to the samples of the device components used for mechanical and biological testing.

• Sample Size for Test Set: Not specified in the provided document (e.g., number of liners tested for fatigue, wear). These would be standard engineering test sample sizes as per relevant ASTM/ISO standards.
• Data Provenance: Not specified. Non-clinical bench testing is typically performed in a controlled laboratory environment. Retrospective/prospective data or country of origin are not applicable in the same way as for clinical studies or AI algorithms.

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

This information is not applicable and therefore not provided. For a physical implant like a shoulder system, "ground truth" is established through engineering specifications, material properties, and performance standards, not through expert consensus on interpretations like with medical images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical data (e.g., radiological images) to establish ground truth, which is not relevant for the bench testing of mechanical implants.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable and therefore not provided. MRMC studies are used to assess the impact of a diagnostic aid (e.g., an AI algorithm) on human reader performance, which is not relevant for the clearance of an orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable and therefore not provided. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Equinoxe® Shoulder System Humeral Liners is established through industry-recognized performance standards (ASTM and ISO standards) and engineering specifications. These standards define acceptable limits for wear, fatigue, biocompatibility, and other mechanical and biological properties. Compliance with these standards, along with demonstration of equivalence to the predicate device, forms the basis of the safety and effectiveness claims.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical implant, not an AI algorithm that requires a training set.

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

This information is not applicable and therefore not provided.

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Hemiarthoplasty/Conventional Total Application:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Reverse Application:

Zimmer Biomet Reverse Shoulder products are 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 necessary.

The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components may be used cemented or uncemented (biological fixation).

The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Comprehensive Nano Stemless Shoulder System

1. Primary total shoulder arthroplasty.
2. Non-inflammatory degenerative joint disease including

Comprehensive Nano Stemless Shoulder humeral components have a porous coated surface coating and are indicated for uncemented biological fixation applications.

The Comprehensive Modular Hybrid Glenoid is intended to be implanted with bone cement. The porous titanium peg may be inserted without bone cement.

The Identity Shoulder System is previously cleared (K213856/K240876) as a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty. The Identity Shoulder System is cleared for hemi-arthroplasty and conventional total shoulder replacement in both the anatomic and reverse configurations. The current submission is for the anatomic configuration.

The subject Comprehensive Humeral Head Adapter (CHHA) is a line extension to the Identity Shoulder System (K213856) cleared for the hemi-arthroplasty configuration and anatomic Total Shoulder Configuration.

The new CHHA (PN SAHHA002) allows additional compatibility with the previously cleared Identity Humeral Heads (K213856) and the Comprehensive humeral components, excluding fracture stems, as noted below:

• Comprehensive Humeral Stems (K193038); and
• Comprehensive Nano Stemless shoulder component (K182516).

Based on the provided FDA 510(k) clearance letter for the "Identity Shoulder System" (K250848), here's an analysis of the acceptance criteria and the study that proves the device meets them:

Crucial Observation: The provided document is a 510(k) clearance letter for a medical device that does not appear to be software or an AI/ML enabled device. It is for an orthopedic implant (shoulder system). Therefore, several of the requested points related to AI/ML (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to this type of traditional medical device submission.

The "acceptance criteria" for this device are generally based on non-clinical performance testing to demonstrate the device's physical and mechanical properties meet established standards and are substantially equivalent to predicate devices. There are no "reported device performance" metrics in the sense of clinical performance (like sensitivity/specificity for AI, diagnostic accuracy, etc.) because it's a physical implant, not a diagnostic or AI-driven system.

Acceptance Criteria and Study Details (Based on the provided document)

Since the document provided is for a physical orthopedic implant, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a traditional medical device, primarily through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For traditional orthopedic implants, specific numerical values for acceptance criteria and device performance (e.g., "Fatigue life > X cycles at Y load") are typically contained within the full 510(k) submission and are not usually detailed in the public clearance letter. The letter only states that these verifications were "successfully performed" and support the conclusion of substantial equivalence.

AI/ML Specific Questions (Answered as "Not Applicable" for this device)

Given that this is a 510(k) for a physical orthopedic implant and not an AI/ML device, the following points are not applicable (N/A):

2. Sample sizes used for the test set and the data provenance: N/A. This device does not have a "test set" of patient data in the typical sense for AI/ML validation involving images or clinical parameters. Its evaluation involves mechanical testing of physical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts for clinical data is not relevant for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. This applies to review of clinical data, not mechanical 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: N/A. MRMC studies are for evaluating human reader performance, typically with diagnostic images, in conjunction with AI. This is not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device's performance is derived from standardized mechanical testing methods and compliance with material specifications.
8. The sample size for the training set: N/A. This device does not use a "training set" as it's not an AI/ML model.
9. How the ground truth for the training set was established: N/A.

Summary of the Study:

The "study" that proves the device meets the acceptance criteria is described as a series of non-clinical verifications. These tests are designed to objectively assess the physical and mechanical properties of the Comprehensive Humeral Head Adapter (CHHA) and its compatibility within the Identity Shoulder System, thereby demonstrating its substantial equivalence to previously cleared predicate devices.

The specific non-clinical tests performed include:

• Fatigue Verification: Assesses the device's ability to withstand repeated stress without failure, simulating long-term use.
• Fretting Corrosion Verification: Evaluates the device's resistance to material degradation caused by small-amplitude oscillatory motion between contacting surfaces.
• Fixation Stability Verification: Confirms the secure attachment and stability of components under load.
• Static Modular Junction Strength Verification: Measures the strength of the connections between modular parts under static loading conditions.
• ROM Verification: Ensures the device allows for the intended range of motion within the joint.
• MRI Verification: Confirms the device's safety and compatibility when exposed to magnetic resonance imaging environments.

The results of these tests, along with the asserted identicality of intended use, indications for use, materials, packaging, and sterilization, and similarity in design features, were deemed sufficient by the FDA to conclude that:

• any differences do not raise different questions of safety and effectiveness; and
• the proposed device is as safe and effective as the legally marketed predicate device.

This conclusion of substantial equivalence is the basis for the 510(k) clearance for the Identity Shoulder System's new line extension, the Comprehensive Humeral Head Adapter.

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Archer^R PSI System is indicated as an orthopedic instrument to assist the physician in the intraoperative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone.

Archer^R PSI System must only be used conjointly with Archer™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. Archer^R PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer™ 3D Targeting' platform (K213779). Archer^R PSI System is indicated for patient population fulfilling the Archer™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting.

The device is intended for single use only.

The device is intended for adult patients.

The device has to be used by a physician trained in the performance of surgery.

The "Archer PSI System" device is a patient-matched additively manufactured single use surgical instrument (PSI). Archer PSI System is an instrument set containing a glenoid guide and its bone model and/or a humeral guide and its bone model. This patient-specific medical device is designed to fit the patient's anatomy to transfer a patient-specific pre-operative plan to the operating room. It is intended for surgical interventions in orthopaedic procedures for total shoulder arthroplasty.

The Archer PSI system instruments are designed from a draft treatment plan available via the Archer™ 3D Targeting' platform. Based on computed tomography (CT) of the shoulder anatomy, 3D CAD models of the bones and positioning and sizing of the glenoid and humeral components are submitted for evaluation to the surgeon. Upon the surgeon's approval, the guides and bone models are designed based on the validated planning and are manufactured using additive manufacturing.

The provided FDA 510(k) summary for the "Archer PSI System" does not contain the detailed acceptance criteria or the specific study that directly proves the device meets those criteria in a quantitative manner as typically expected for medical device performance studies involving sensitivity, specificity, accuracy, etc. However, it does outline the types of non-clinical and cadaveric testing performed to demonstrate substantial equivalence to a predicate device.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not overtly state quantitative "acceptance criteria" (e.g., "accuracy must be > 95%") nor does it provide "reported device performance" in terms of explicit metrics like sensitivity, specificity, or error rates. Instead, the "performance" is described in terms of demonstrating "substantial equivalence" through various engineering and cadaveric tests.

A more accurate representation, based on the provided text, would be:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Cadaveric Testing: The document states that "Cadaveric testing was executed" but does not specify the sample size (number of cadavers or procedures) used for this testing.
• Data Provenance: The cadaveric testing is implied to be prospective in nature, as it was "executed to demonstrate the substantial equivalence." There is no information provided regarding the country of origin of the cadaveric data.

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

• Number of Experts: The document states that "a pre-operative planning validated by the surgeon" is part of the process. For the cadaveric testing, it does not explicitly state the number of experts (e.g., surgeons) involved in establishing the "ground truth" or assessing the "substantial equivalence."
• Qualifications of Experts: The document mentions that the device is to be used by a "physician trained in the performance of surgery." For the validation of the pre-operative plan, the expert is identified as "the surgeon." While this indicates a medical professional, specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the cadaveric testing or any other performance evaluation. The "validation by the surgeon" for the pre-operative plan suggests a form of single-expert consensus at the planning stage, but not for the overall performance assessment.

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

• Was an MRMC study done? No.
• Effect Size: As no MRMC study was performed, no effect size of human readers improving with AI vs. without AI assistance is reported. The Archer PSI System is a patient-specific instrument, not an AI diagnostic or assistive tool in the MRMC sense. The comparison was between manual surgical techniques and PSI-assisted techniques in cadavers.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Not explicitly in terms of an "algorithm only" performance study. The device itself is a physical, patient-specific instrument derived from a digital plan. The document describes "Cadaveric testing" which evaluates the combined PSI system (planning software output + physical guide) in a simulated surgical environment, not just the planning algorithm in isolation from its physical manifestation or use.
• The "Intra- and Inter-Designer Variability testing" and "Mechanical Integrity" tests are standalone evaluations of aspects of the device's design and manufacturing, but not of the surgical guidance algorithm's performance on its own.

7. Type of Ground Truth Used

• For Pre-operative Planning: The ground truth for the design of the PSI System is based on a "pre-operative planning validated by the surgeon" using CT images and anatomical landmarks. This can be considered a form of expert consensus/validation on the desired surgical outcome/instrument design.
• For Cadaveric Testing: The "ground truth" for the cadaveric study would be the actual anatomical targets and the achieved drill/cut placements, compared to the planned placements and traditional manual techniques. While experts (surgeons) would perform and assess these, the ultimate "truth" is the physical reality within the cadaver. The document implies comparison to "manual techniques" as a reference.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set sample size." The Archer PSI System is described as being "designed from a draft treatment plan" and "manufactured from a pre-operative planning validated by the surgeon." This suggests a patient-specific design process rather than a machine learning model trained on a large dataset. The underlying "Archer™ 3D Targeting' platform (K213779)" (a separate cleared device) would be the system performing the planning, and its own 510(k) might contain training data details if it uses AI/ML. However, for the Archer PSI System itself, no training set information is present.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned for the Archer PSI System in this document, no information is provided on how its ground truth would have been established.

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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

• · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis,
• · Post-traumatic osteoarthritis.
• · Fractures,
• · Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

• · Multi-fragmental comminuted fractures of the humeral head,
• · 3- and 4-Fragment-fractures of the proximal humerus,
• · Head-splitting fractures,
• · Dislocated head-splitting fractures,
• · Humeral head depression with more than 40% of joint surface depressed,
• · Interlocking chronic dislocation with deep HILL-SACHS lesion,
• · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
• · Posttraumatic humeral head necrosis,
• · Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

• · Rotator cuff tear arthropathy,
• · Chronic trauma shoulder,
• · Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

• · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
• · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components:

• Humeral Head Components ●
• Glenoid and Glenosphere Components ●
• Humeral Stems and Stem Extension Pieces
• Metaphyseal Components ●
• Fixation and Cancellous Screws ●

The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System, focusing on new cancellous screws. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and limited performance testing of the new cancellous screws. Therefore, I cannot provide all the requested information.

Here's what I can extract and infer from the provided text, along with what is explicitly not available:

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

• Driving Torque (ASTM F543)
• Axial Pull-out Strength (ASTM F543) |
  | Predetermined acceptance criteria met (specific numeric criteria not provided) | Testing demonstrated sufficient performance and met predetermined acceptance criteria. |
  | Biocompatibility (per ISO 10993-1) | Evaluation completed per ISO 10993-1. |
  | Cleaning, sterilization, packaging, shelf-life, and endotoxin standards met | Leveraged from the predicate AGILON® XO Shoulder Replacement System (K231657). |

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

• Sample Size: Not specified for the cancellous screw testing (Torsional Properties, Driving Torque, Axial Pull-out Strength).
• Data Provenance: Not specified. The manufacturer is implantcast, GmbH, located in Buxtehude, Germany, but the location where testing was performed is not mentioned. The study is part of a 510(k) submission, generally involving laboratory testing rather than clinical data provenance in this context.

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. This device is a mechanical shoulder replacement system, and the testing described is mechanical performance (e.g., strength, torque) and biocompatibility, not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or conditions.

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

Not applicable. This device is a mechanical shoulder replacement system, not a diagnostic or AI device that requires adjudication of expert interpretations.

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 a medical device (shoulder replacement system), not an AI-assisted diagnostic tool. No AI component or human reader study is mentioned.

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

Not applicable. This is a medical device (shoulder replacement system), not a standalone algorithm.

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

For the mechanical testing of the cancellous screws, the "ground truth" is established by adherence to recognized ASTM standards (ASTM F543) and engineering principles. For biocompatibility, the ground truth is adherence to ISO 10993-1. This is not related to clinical outcomes or expert consensus on pathologies for AI model training.

8. The sample size for the training set

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device that requires a training set.

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

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device.

Summary of what is present:

The document describes the submission of a medical device (AGILON® XO Shoulder Replacement System) for regulatory clearance. The specific focus of this submission (K241944) is the addition of new cancellous screws to an existing system. The performance testing for these screws involved:

• Engineering analysis.
• Characterization per ASTM F543 for torsional properties, driving torque, and axial pull-out strength.
• Biocompatibility evaluation per ISO 10993-1.
• Leveraging existing data for cleaning, sterilization, packaging, shelf-life, and endotoxin from the predicate device (K231657).

The conclusion is that the testing demonstrated "sufficient performance for the intended use" and "met the predetermined acceptance criteria." However, the specific quantitative values for these criteria and the test results are not detailed in the provided text.

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The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. Significant disability in degenerative, rheumatic disease of the glenohumeral joint;
2. Fractures of the humeral head
3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
4. Avascular necrosis of the humeral head
5. Revision where other devices or treatments have failed.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a peqged design intended for cemented fixation only.

This document concerns the 510(k) premarket notification for the "InSet Total Shoulder System" and specifically a product line extension to add the "InSet 95 Humeral Stem." This is a medical device approval and not an AI/ML software approval.

Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly aspects related to AI/ML such as ground truth, expert adjudication, MRMC studies, and training/test set sample sizes, are not applicable to this document.

The document states under "Clinical Testing Summary": "Clinical testing was not necessary to demonstrate substantial equivalence of the InSet Total Shoulder System InSet 95 Humeral Stem to the predicate device." This indicates that the approval was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with human subjects or an AI/ML model's performance evaluation.

Here's a breakdown of what is relevant from the document in relation to the device's acceptance:

Acceptance Criteria and Device Performance (Based on information provided, specifically for this medical device approval):

Study Details (as per the document):

1. Sample size used for the test set and the data provenance: Not applicable. This was not a data-driven AI/ML study but a medical device submission based on substantial equivalence and non-clinical engineering tests. No "test set" in the context of an AI/ML model's performance on patient data was used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for patient data is not established for this type of device approval. The "ground truth" relates to engineering specifications and performance against those specifications, which were assessed via non-clinical testing and comparison to predicates.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical orthopedic implant, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device approval would be established engineering standards, material properties, and performance benchmarks derived from predicate devices and regulatory requirements. For example, mechanical strength is evaluated against established limits or performance of predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the FDA's clearance of a physical medical device (shoulder implant) based on its substantial equivalence to previously cleared devices and non-clinical engineering testing, not on the performance of an AI/ML algorithm or clinical studies involving human patient data.

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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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In Anatomic:
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• · Non-inflammatory degenerative ioint disease
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease
• · Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease
• · Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• · Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.

This FDA submission (K240716) for the AETOS Shoulder System Stemless Humeral Prosthesis does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that are typically associated with the evaluation of AI/ML software.

The submission focuses on the substantial equivalence of a new medical implant (a stemless humeral prosthesis) to previously cleared predicate devices. The evaluation criteria for this type of device are primarily based on non-clinical performance data, such as:

• Construct fatigue and corrosion resistance assessment
• Post-fatigue stability
• Static disengagement
• Dynamic stability / loosening
• Bone volume and contact analysis

The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device." This confirms that a clinical study, which would typically involve human readers or an AI algorithm, was not conducted or required for this submission.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because this submission is for a physical orthopedic implant and does not involve AI/ML.

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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

• · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• · Post-traumatic osteoarthritis,
• · Fractures,
• · Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

• · Multifragmental comminuted fractures of the humeral head,
• · 3- and 4-Fragment-fractures of the proximal humerus,
• · Head-splitting fractures,
• · Dislocated head-splitting fractures,
• · Humeral head depression with more than 40% of joint surface depressed,
• · Interlocking chronic dislocation with deep HILL-SACHS lesion,
• Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
• · Posttraumatic humeral head necrosis,
• · Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

• · Rotator cuff tear arthropathy,
• · Chronic trauma shoulder,
• · Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows:

• · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
• · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty

The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement:

Hemi Shoulder:

• Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap)
• Humeral Stems (Cementless)

Total Anatomic Shoulder:

• Humeral Head Components (AGILON® XO Cap)
• Glenoid Components (AGILON® PE-Glenoid, Cemented)
• Humeral Stems (Cementless)

Total Reverse Shoulder:

• Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
• Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere)
• Humeral Stems (Cementless)

Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations.

The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria for a novel AI/software component.

Therefore, many of the requested sections regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily relies on "Performance Testing Summary" through engineering analyses and leveraging previous predicate device testing to establish substantial equivalence for a line extension (a new 145° Metaphyseal component).

Here's an attempt to answer the questions based on the provided text, indicating when information is not available or not applicable:

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

This document does not specify quantitative acceptance criteria for a novel device performance study, nor does it report specific performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/software device. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering analysis and leveraged testing.

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. This submission concerns a physical medical device (shoulder replacement system) and a line extension, not an AI/software device requiring a test set of data. The "testing" primarily refers to engineering analyses and biocompatibility/sterilization testing, not a clinical data evaluation in the context of AI.

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 mention of experts establishing a ground truth for a test set of data, as this is not an AI/software device.

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

Not applicable. No adjudication method is mentioned as there is no human-reviewed test set data in the context of an AI/software device.

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 submission is for a physical shoulder joint replacement system, not an AI/software device designed to assist human readers.

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

Not applicable. This submission is for a physical shoulder joint replacement system, not an AI/software algorithm.

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

Not applicable. There is no mention of ground truth in the context of data for an AI/software device. The "ground truth" for a physical device refers to its physical properties, biocompatibility, and mechanical performance under various conditions, which are addressed through specifications, engineering analyses, and standardized testing (e.g., ISO for biocompatibility).

8. The sample size for the training set

Not applicable. As this is not an AI/software device, there is no training set mentioned in the document.

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

Not applicable. As this is not an AI/software device, there is no training set or associated ground truth establishment mentioned in the document.

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The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.

The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:

• . Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, .
• Avascular necrosis of the humeral head, ●
• . Traumatic/post-traumatic arthritis,
• Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains,
• . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
• . Cuff tear arthropathy (CTA Heads only).

The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).

Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.

The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:

• Rotator cuff tear arthropathy,
• Osteoarthritis with rotator cuff tear,
• Rheumatoid arthritis with rotator cuff tear,
• Massive irreparable rotator cuff tear,
• Avascular necrosis of the humeral head,
• Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,

The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.

This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems.

The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration.

The PRIMA Short Stem Plus is intended for use in cementless and cemented applications.

The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter.

The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone.

As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of medical devices to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria related to AI or diagnostic accuracy.

The document describes the PRIMA Humeral System and PRIMA TT Glenoid devices, which are shoulder joint replacement prostheses. The review focuses on their substantial equivalence in terms of intended use, design, materials, and mechanical non-clinical testing to previously cleared devices.

Therefore, I cannot provide an answer based on the given prompt about acceptance criteria and a study proving device performance in the context of diagnostic accuracy or AI assistance, as this information is not present in the provided text.

Specifically, the document states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and PRIMA TT Glenoid to the predicate devices." (Page 8)

This confirms that no clinical study for performance (like diagnostic accuracy, AI assistance, or human reader improvement) was conducted or needed for this particular 510(k) clearance.

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