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The restor3d rTSA System is 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 restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Humeral components with porous surface are indicated for either cemented or uncemented applications.

The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws).

The provided text is a 510(k) clearance letter for a medical device: the restor3d Reverse Total Shoulder Arthroplasty System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states, "The restor3d Reverse Total Shoulder Arthroplasty System was subject to the following non-clinical performance tests to support the assertion of substantial equivalence."

Therefore, the document describes engineering and material performance testing, not a clinical study involving human patients or analysis of clinical images/data using an AI algorithm. The questions posed in your prompt (e.g., acceptance criteria for device performance/accuracy, sample size for test set/training set, number of experts for ground truth, MRMC study, standalone performance) are typically relevant for AI/ML-enabled medical devices or devices requiring clinical performance studies.

Since the provided text does not describe an AI/ML-enabled device or a clinical study that would generate "device performance" in terms of accuracy, sensitivity, specificity, etc., against a clinical ground truth, I cannot fill out the requested table or answer most of the specific questions.

Here's an explanation based on the provided text, highlighting why the requested information isn't present:

Context from the document:

• Device Type: Reverse Total Shoulder Arthroplasty System (a physical implant)
• Regulatory Pathway: 510(k) (seeking substantial equivalence to a legally marketed predicate)
• Testing Described: "Non-Clinical Testing" which includes:
  • Glenoid Baseplate Loosening per ASTM F2028
  • Glenoid Baseplate Fatigue and corrosion analysis
  • Morse Taper Disassembly Strength per ASTM F2009
  • Humeral Stem Fatigue and corrosion analysis
  • Bone Screw Testing per ASTM F543
  • Poly Liner Performance Tests per ASTM F1820
  • Range of Motion Analysis per ASTM F1378
  • Wear Analysis

These are all benchtop, mechanical, and material science tests designed to show that the new device performs similarly from an engineering standpoint to the predicate and meets established ASTM standards for orthopedic implants. They do not involve "device performance" in terms of clinical accuracy or an AI algorithm's predictive capability.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies typically associated with AI/ML or diagnostic devices that produce "performance" metrics against clinical ground truth.

However, if we interpret "acceptance criteria" and "device performance" within the context of mechanical/material testing as presented in the document, here's what could be inferred, though it won't directly answer your specific table columns:

The "acceptance criteria" for this device would be implicit in meeting the requirements of the cited ASTM standards, such as surviving a certain number of fatigue cycles at a given load, or meeting specific wear rates, or exhibiting particular disassembly strengths. The "reported device performance" would be the results from these bench tests, demonstrating that the device did indeed meet those standard specifications.

To directly address your prompts based on the absence of the requested information in the provided document:

Description of Acceptance Criteria and Study to Prove the Device Meets Them (Based on provided document)

The provided FDA 510(k) clearance letter for the restor3d Reverse Total Shoulder Arthroplasty System primarily relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. This submission does not describe a clinical study of diagnostic or predictive performance, nor does it discuss AI model performance. Therefore, the requested information regarding AI/ML-specific acceptance criteria, test set details, expert involvement for ground truth, or MRMC studies is not present in this document.

The "acceptance criteria" for this device are implicitly tied to its ability to meet the performance requirements of established ASTM (American Society for Testing and Materials) standards for orthopedic implants, and to demonstrate comparable mechanical and material characteristics to its predicate device. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical benchtop tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided 510(k) summary only lists the types of tests performed and states they support substantial equivalence. It does not provide the specific numerical acceptance thresholds or the detailed numerical results from these non-clinical tests. This level of detail would typically be found in the full 510(k) submission not in the public clearance letter summary.

Regarding other specific questions (not applicable based on the document's content):

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

• Not applicable. The "test set" here refers to physical implant samples subjected to bench testing, not a dataset of clinical cases for an AI algorithm. The document does not specify the number of physical samples used for each test. Data provenance (country, retrospective/prospective) is not relevant for bench testing of a physical implant.

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

• Not applicable. Ground truth in this context is established by engineering standards (e.g., ASTM specifications, material properties) and physical measurements on the device, not by expert medical review of clinical data.

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

• Not applicable. This method applies to expert review of clinical cases, 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:

• Not applicable. An MRMC study is for evaluating human performance (often with or without AI assistance) in interpreting clinical data. This document describes a physical implant, not an AI diagnostic tool.

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

• Not applicable. This refers to AI algorithm performance. No AI algorithm is described.

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

• Not applicable in the clinical sense. Ground truth for this device is based on engineering standards (ASTM), material specifications, and physical measurements demonstrating the device's mechanical and material properties are equivalent to the predicate and meet safety requirements.

8. The sample size for the training set:

• Not applicable. This refers to AI model training data. No AI model is described.

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

• Not applicable. This refers to AI model training data. No AI model is described.

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The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatic arthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function.

· Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

The iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System is a tricompartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component. The product design incorporates a bone preserving approach for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. The joint restoring design provides for more natural kinematics by maintaining the patient specific femoral sagittal curves, preserving the patient specific femoral offset, preserving the medial and lateral joint lines and having a patient specific fit. It is intended for use in those patients whose condition cannot be appropriately or effectively addressed using a device that treats only one or two compartments of the knee (i.e. a unicompartmental, bicompartmental, or patellofemoral prosthesis).

Using patient imaging (CT scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of an uncemented metallic device designed from the patient's natural bone geometry. The femoral component is additively manufactured from a cobalt chromium molybdenum ("CoCrMo") alloy. The tibial tray is additively manufactured from titanium ("Ti-6Al-4V") alloy. The tibial inserts are manufactured and offered in either ultra-high molecular weight polyethylene (iPoly®) or highly crosslinked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly® XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly®) with a porous Ti6Al4V metal backing. The femoral, tibial, and patellar implants are additively manufactured using proprietary TIDAL Technology™ which allows biological fixation without the need for bone cement. The iTotal® ldentity™ CR 3DP Porous KRS is designed for press-fit use without cement, but may be used with a cemented technique if desired.

The iTotal® Identity™ CR 3DP Porous KRS is supplied with disposable, patient-specific instrumentation (ilig®) designed for use with the system. These patient-specific guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. Each set of instruments is designed for one-time use, specifically for one patient. The iJig® instrument set is manufactured from biocompatible nylon material and supplied sterile along with the implants.

The provided text describes a medical device, the "iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System," and its submission for FDA 510(k) clearance. However, it explicitly states that "No clinical testing was warranted for the subject device."

This means that the information you requested regarding acceptance criteria and the study that proves the device meets those criteria cannot be found in this document because a clinical study was not conducted or submitted for this particular clearance.

Therefore, I cannot provide the following information:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample size used for the test set and the data provenance: No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No clinical test set.
4. Adjudication method for the test set: No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable as no clinical study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical implant, not a software algorithm.
7. The type of ground truth used: No clinical ground truth established.
8. The sample size for the training set: No clinical training set.
9. How the ground truth for the training set was established: No clinical training set.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluation, which includes various biomechanical and material tests. These non-clinical tests are listed, but their specific acceptance criteria and detailed results are not provided in this summary.

Non-Clinical Performance Evaluation (as listed in the document):

• Patella static tensile test
• Patella static shear test
• Patella shear fatigue test
• Tibial tray fatigue test
• Femoral fatigue test
• Tibial micromotion
• Tibiofemoral constraint test
• Tibiofemoral contact area, stress and wear test
• Tibial interlock test
• Patellofemoral subluxation, contact area and stress test
• Particle characterization
• Porous coating testing per FDA guidance on modified metallic surfaces
• Biocompatibility assessment

Conclusion from the document: "The results of the testing demonstrate that the subject device iTotal® Identity™ CR 3DP Porous KRS is as safe and effective and is substantially equivalent to the cleared predicates... and the differences between the subject and predicates do not raise different questions of safety or effectiveness."

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The Kinos Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The Kinos Total Ankle System is intended for cement use only.

The subject Kinos Total Ankle System consists of implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The subject device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain, and providing flexion- extension movement within the ankle joint. The tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components - a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibiotalar joint. The subject line extension includes tibial segments which are assembled intraoperatively to the tibial base plate to enhance tibial fixation height in the tibia.

This document is a 510(k) Summary for the Kinos Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly not in the context of an AI/ML-driven device.

The Kinos Total Ankle System is a physical medical device (an ankle prosthesis), and the submission is for an expansion of indications for use. The performance testing section specifically states: "No performance testing was performed to establish substantial equivalence of the subject device to the predicates." Instead, a "dimensional analysis comparison of device components and a surgical technique comparison" was conducted.

Therefore, I cannot provide the requested information, as the provided text relates to a traditional medical device and its regulatory submission, not a study validating an AI/ML device's performance against specific acceptance criteria.

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