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The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

· Severe arthropathy with a grossly deficient rotator cuff;

• · Previously failed joint replacement with a grossly deficient rotator cuff:
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture,
• displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• · Bone defect in proximal humerus;
• · Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/ or glenoid;
• · Inflammatory arthritis including rheumatoid arthritis:
• · Correction of functional deformity

The humeral stems are intended for cemented or uncemented applications.

The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

The Catalyst R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant.

This submission is to add optional sizes of the glenospheres and baseplates to the R1 Reverse Shoulder System. The additional sizes of the glenospheres and baseplates are a design modification of the glenospheres and baseplates cleared in K202611. The glenospheres and baseplates in this submission are not replacing the glenospheres and baseplates cleared in K202611 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.

This document, K223655, is a 510(k) premarket notification for a medical device called the "Catalyst R1 Reverse Shoulder System." The submission seeks to add optional sizes of glenospheres and baseplates to an already cleared system.

Based on the provided text, the device in question is a mechanical implant, not an AI/software-based device that would typically involve a "study that proves the device meets the acceptance criteria" in the sense of accuracy, sensitivity, specificity, and human reader performance. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria as typically understood for AI-driven diagnostic devices is not applicable here.

Instead, the "acceptance criteria" for this mechanical device relate to demonstrating substantial equivalence to a predicate device through non-clinical performance testing and ensuring no new questions of safety and effectiveness are raised by the design modification.

Here's a breakdown of the relevant information provided, structured to address your points where applicable:

A summary of the acceptance criteria and performance for this type of device, as gleaned from the document, is as follows:

Acceptance Criteria and Reported Device Performance (Non-Clinical/Mechanical Testing Focused):

Addressing your specific points based on the provided text, and highlighting what is not applicable for this type of device submission:

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

   • See the table above. These are derived from the "Performance Data / Non-Clinical Testing" section and the comparison of technologies.

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

   • This section describes mechanical testing, not patient data or a clinical study. Therefore, "sample size" would refer to the number of test articles (e.g., glenospheres or baseplates) that underwent mechanical testing. The document states "Mechanical tests... were completed" but does not specify the number of test articles (i.e., "sample size") used for these mechanical tests.
   • "Data provenance" (country of origin, retrospective/prospective) is not applicable here as it's not a clinical study on human subjects but rather laboratory mechanical testing.

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. "Ground truth" in the context of mechanical device testing typically refers to adherence to engineering standards (e.g., ASTM standards) and meeting predetermined biomechanical performance benchmarks. It does not involve human expert interpretation of data in the way a diagnostic AI would.

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

   • Not applicable. Adjudication is for resolving discrepancies in human expert interpretation or labeling, which is not part of mechanical device testing.

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

   • Not applicable. This is a mechanical implant device, not an AI-driven diagnostic tool. MRMC studies are used to assess the impact of AI on human reader performance.

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

   • Not applicable. This is not an algorithm. "Standalone" performance would describe the device's mechanical integrity and function as an implant in a mechanical test environment (e.g., fatigue machine). The document confirms these mechanical tests were done.

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

   • The "ground truth" for this device type is adherence to established engineering and material standards (e.g., ASTM F2028, ASTM F1378) and demonstrating that the mechanical properties of the new components are within acceptable limits and equivalent to the predicate. There is no biological "ground truth" (like pathology or outcomes data) required for this specific filing, as it's a modification to an existing cleared device primarily based on mechanical equivalence.

8. The sample size for the training set:

   • Not applicable. This is a mechanical device, not an AI model requiring a training set.

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

   • Not applicable. No training set is involved.

In summary, the K223655 submission for the Catalyst R1 Reverse Shoulder System is a 510(k) for a physical medical device. The "study" that proves it meets acceptance criteria is non-clinical, mechanical performance testing (e.g., fatigue, loosening, disassembly per ASTM standards), aimed at demonstrating substantial equivalence to a previously cleared predicate device. This process differs significantly from the AI/software-validation paradigm your questions are designed for.

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The nucleus, humeral head coupler and humeral head are used in conjunction with a glenoid implant as a total replacement.

The Tornier Perform® Humeral System - Stemless is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide mobility, stability, and to relieve pain. The Tornier Perform Humeral System -Stemless is indicated for use as a replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
• · Post-traumatic arthritis

Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.

All components are single use and intended for cementless use.

The Tornier Perform Humeral System - Stemless is intended to be used with cemented polyethylene glenoid components, in an anatomic total shoulder arthroplasty.

The Tornier Perform Humeral System - Stemless is metaphyseal humeral system intended for anatomic total shoulder arthroplasty. The Perform Humeral System - Stemless is implanted with existing Tornier anatomic glenoid systems.

The Tornier Perform Humeral System – Stemless includes new titanium nucleus components and previously-cleared modular humeral heads (K201315). The system also includes reusable instruments used to implant the shoulder prosthesis.

The provided document is a 510(k) premarket notification for a medical device, the Tornier Perform Humeral System - Stemless. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies proving acceptance criteria through device performance.

Therefore, the requested information on acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance, is largely not applicable to this document. The document explicitly states: "No clinical studies were performed."

However, I can extract information about the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose in the context of a 510(k) by showing the device performs comparably to an already cleared device.

Here's a breakdown of the available information based on your request:

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

Since no clinical studies were performed to establish performance against pre-defined acceptance criteria in terms of human-in-the-loop performance or diagnostic accuracy, such a table cannot be created from this document. The document focuses on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing.

The types of "performance" mentioned are related to mechanical and material properties:

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

Not applicable. No "test set" in the context of clinical or AI performance evaluation was used. The testing was non-clinical (laboratory/mechanical).

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

Not applicable. No "ground truth" for a test set based on expert review was established or required for this type of submission focused on mechanical device equivalence.

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

Not applicable. No "test set" requiring adjudication by experts was used.

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 mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance in that context.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm or AI.

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

Not applicable. The "ground truth" for the non-clinical tests would have been established engineering specifications, material standards, and performance of the predicate device.

8. The sample size for the training set:

Not applicable. This is a mechanical orthopedic implant, not an AI or algorithm that requires a training set.

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

Not applicable.

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Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
• Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).

The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.

The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."

The non-clinical testing performed includes:

• Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
• Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
• Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
• Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Identical to previously cleared devices.
• Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
• Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
• MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
• Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.

These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically 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 Lateralized Glenosphere are line extensions to the Medacta Shoulder Reverse System (K170452) and are compatible with the other Medacta cleared products Threaded Glenoid Baseplate (K171058), Glenoid Polyaxial Non-Locking Screws (K181826) and the Short Humeral Stem (K180089).

The Lateralized Glenosphere implants subject of this submission are comprised of the following products (9 sizes):

• Size Ø 32: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5mm
• Size Ø 36: to be coupled with Medacta Glenoid Baseplate Ø 22 or Ø 24.5 or Ø27mm
• Size Ø 39: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm
• Size Ø 42: to be coupled with Medacta Glenoid Baseplate Ø 24.5 or Ø27mm

The Lateralized Glenosphere implants are part of the Medacta Shoulder Reverse System. The Medacta Shoulder Reverse System consists of the following components:

• Humeral Diaphysis Cemented;
• Humeral Diaphysis - Cementless;
• Humeral Reverse Metaphysis;
• Humeral Reverse HC Liner (also referred to as PE Liner);
• Glenoid Baseplate - Pegged;
• Glenoid Baseplate Threaded;
• Glenosphere;
• Glenoid Polyaxial Locking Screw;
• Glenoid Polyaxial Non-Locking Screw;
• Reverse Metaphysis Screw; and
• Glenosphere Screw.

The glenosphere is attached to the glenoid baseplate and secured by means of a taper connection and a fastening screw.

The purpose of the current submission is to gain clearance for the Lateralized Glenospheres, whose center is more lateralized respect to Medacta predicate device Glenosphere (Medacta Shoulder Reverse System - K170452).

The new option of lateralization allows the surgeon to intraoperatively select the desired level of ROM and resulting joint tension based on the patient's anatomy.

The Lateralized Glenosphere is made of CoCrMo ISO 5832-12 (Second Edition 2007-05-01) Implants For Surgery - Part 12: Wrought Cobalt- Chromium-Molybdenum Alloy [Including: Technical Corrigendum 1 (2008)], while the Glenosphere screw packed with the implant is made of Ti alloy (Ti-6A1-4V), enhanced with Type-II anodization, according to ISO 5832-3:2016 Implants For Surgery -Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy.

The provided text describes a 510(k) premarket notification for a medical device called the "Lateralized Glenosphere." This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or predictive AI device.

Therefore, the requested information cannot be fully extracted as there is no study that proves the device meets specific acceptance criteria in the context of a diagnostic AI product, because this is a physical implant. The performance data section refers to mechanical tests on the implant itself, not a study of a diagnostic algorithm.

Here's an analysis of what information can be provided based on the input:

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

Based on the document, there isn't a table of acceptance criteria and reported device performance in the way one would describe for a diagnostic AI device (e.g., sensitivity, specificity, accuracy). Instead, there are mechanical tests performed with acceptance criteria based on established standards for shoulder prostheses.

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic accuracy. The "test set" here refers to the physical samples of the medical device (Lateralized Glenosphere and associated components) that underwent mechanical testing. The exact number of physical devices or components tested for each mechanical study is not specified in this summary.
• Data Provenance: The mechanical tests were conducted in a laboratory setting according to written protocols. There's no information about the country of origin or whether it was retrospective/prospective as it relates to patient data.

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

• Not applicable. This device is a physical implant, not a diagnostic AI device requiring expert-established ground truth for a test set. The "ground truth" for the mechanical tests would be the established engineering standards (ASTM, ISO, European Pharmacopoeia, USP) and the physical properties observed during testing.

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

• Not applicable. Adjudication methods like 2+1 are used for establishing ground truth in diagnostic studies, not for mechanical testing of physical implants. The "adjudication" for mechanical tests is agreement with the predefined acceptance criteria of the standards.

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 diagnostic device. No human reader studies (MRMC) were conducted as the device is a physical implant.

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

• Not applicable. This is not an AI algorithm. The performance data refers to the mechanical integrity and biological safety of the physical medical device itself.

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

• The "ground truth" for the performance data is based on recognized engineering standards (ASTM F2028-17, ASTM F1378-17), pharmacopoeia guidelines (European Pharmacopoeia §2.6.14, USP , USP ), and design validation reports for the mechanical and biocompatibility aspects of the implant.

8. The sample size for the training set:

• Not applicable. This device is a physical implant, not an AI model that requires a training set.

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

• Not applicable. As there is no AI model or training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "performance data" refer to mechanical and biocompatibility testing against established engineering and medical device standards, not to the performance of a diagnostic or AI-driven system. Therefore, most of the requested information, which is typically relevant for AI/diagnostic device evaluation, is not applicable or provided in this context.

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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder 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 Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

The SMR Connectors are used to couple the glenosphere to the metal-backed glenoid. Connectors are made from Ti6Al4V alloy (ASTM F1472 - ISO 5832-3) and are characterized by a double male taper. To increase the solidity of the system, a screw is used to link the glenosphere to the glenoid component. No.5 additional sizes (Lateralized connectors) are available in both Small-STD and Small-R configuration to allow lateralization of Center of Rotation.

The provided document is a 510(k) premarket notification for a medical device called "SMR Lateralized Connectors with screws". This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving efficacy or safety through extensive clinical trials. Therefore, much of the information requested about acceptance criteria and detailed study designs (especially relating to AI or expert adjudication) is not applicable or present in this document.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the available information:

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

The document does not provide a specific table of numerical acceptance criteria or reported device performance in the format typically seen for novel device performance claims. Instead, it states that mechanical tests "demonstrated device performances fulfill the intended use and are substantially equivalent to the predicate devices." This implies that the performance met predefined internal criteria for equivalence, but these criteria are not explicitly detailed.

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

The document mentions "Mechanical testing was performed on worst case components or constructs." It does not specify the exact sample size for these mechanical tests. The data provenance is internal to Limacorporate S.p.A. and the tests are non-clinical (experimental/lab-based), not derived from patient data.

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

This is not applicable as the study described is non-clinical mechanical testing, not a study involving human interpretation or ground truth establishment by experts for diagnostic or prognostic purposes.

4. Adjudication method for the test set

This is not applicable for the same reason as point 3.

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, an MRMC study was not done. The device is a mechanical implant, not an AI-powered diagnostic or assistive tool for human readers.

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

No, a standalone AI algorithm performance study was not done. The device is a mechanical implant.

7. The type of ground truth used

For the non-clinical mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks derived from the predicate devices and relevant ASTM/ISO standards (e.g., ASTM F2028-18). The device's performance was compared against these established standards and predicate device characteristics to demonstrate substantial equivalence.

8. The sample size for the training set

This is not applicable as there is no AI algorithm being trained.

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

This is not applicable as there is no AI algorithm being trained.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical structure for AI/diagnostic device evaluation, it does provide clear information about the type of acceptance criteria and study performed for this medical device:

• Acceptance Criteria (Implied): Substantial equivalence to predicate devices, fulfilling intended use, and meeting relevant mechanical testing standards (e.g., ASTM F2028-18 for dynamic evaluation of glenoid loosening and dissociation, and standards for fatigue-fretting behavior and endurance stability of taper connections).
• Study Type: Non-clinical mechanical testing.
• Specific Tests Mentioned:
  • Dynamic evaluation of glenoid loosening and dissociation per ASTM F2028-18.
  • Fatigue-fretting behavior.
  • Endurance stability of the taper connection, followed by evaluation for corrosion.
• Sample Size for Testing: "worst case components or constructs" (specific number not provided).
• Data Provenance: Laboratory testing (non-clinical).
• Ground Truth for Testing: Engineering specifications, performance benchmarks of predicate devices, and relevant international standards (ASTM, ISO).
• Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of SMR Connectors to the predicate devices."

The document primarily focuses on demonstrating that the new SMR Lateralized Connectors with screws are safe and effective because their design, materials, and mechanical performance are equivalent to predicate devices already cleared for market, negating the need for novel clinical data.

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The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery. CAUTION: In the United States, the ankle prosthesis is intended for cement use only.

The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The talar dome is manufactured using additive manufacturing technology.

The provided text is a 510(k) premarket notification for the INFINITY Total Ankle System. It outlines the regulatory review process and the basis for the FDA's substantial equivalence determination. However, it does not contain information about acceptance criteria for a device's performance (e.g., accuracy, sensitivity, specificity, or other performance metrics) nor details of a study proving the device meets those criteria, especially in the context of an AI/ML-based device.

The document states:

• "(b)(1). Substantial Equivalence- Non-Clinical Evidence" lists various bench performance tests (e.g., Chemical Analysis, Abrasion Resistance, Fatigue Testing, MRI Safety Analysis, DMLS Process Validation). These are engineering tests for the physical properties and manufacturing of the implant, not performance metrics of an AI/ML system.
• "(b)(2). Substantial Equivalence- Clinical Evidence" explicitly states: "Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices."

Therefore, I cannot provide the requested information as it is not present in the given text. The device described (an ankle prosthesis) is a physical implant, not a software device or an AI/ML-based system that would typically have performance criteria related to classification, diagnosis, or prediction, and associated test sets, ground truth establishment, or MRMC studies.

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