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The INTEGRA® Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The INTEGRA® Freedom Wrist Arthroplasty System is intended for cemented use.

The INTEGRA® Freedom Wrist Arthroplasty (IFW) System three part semi-constrained implant system designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint. IFW is intended for patients with intractable pain and loss function due to traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis. The system consists of three major components:

• Radial implant made from Cobalt Chromium Molybdenum Alloy (CrCoMo) .
• . Carpal plate - (includes two variable angle screws with locking caps) - made from Titanium Alloy
• . Carpal Poly bearing - made from Ultra-High-Molecular-Weight Polyethylene (UHMWPe)
  Portions of the radial implant and carpal plate have a titanium plasma sprayed coating. The implant system is provided with instrumentation necessary to complete the procedures for which the system is indicated. The components are intended to be implanted together as a system, not individually as hemi-arthroplasty components and are intended for cemented fixation.

The Integra® Freedom Wrist Arthroplasty System is a medical device, and the provided document is a 510(k) summary for its clearance. This summary details non-clinical tests performed to demonstrate substantial equivalence to previously cleared devices. It does not describe a study involving human subjects, AI systems, or the specific criteria typically associated with clinical performance evaluation of an AI/ML device.

Therefore, the requested information components related to AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this document. This document focuses on the mechanical and material performance of the implant itself.

Here's a breakdown of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The results of these performance tests met their respective acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test, only that the device met them.

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

Not applicable. The tests mentioned are non-clinical (mechanical/material performance) rather than studies on a "test set" of patient data.

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 the context of AI/ML, refers to clinically validated diagnoses or outcomes. These are non-clinical engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in clinical trials or expert review processes for diagnostic accuracy, not physical device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a non-clinical device clearance for a physical implant, not an AI/ML diagnostic or assistive tool.

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

No, a standalone algorithm performance study was not done. This refers to the performance of an AI/ML algorithm without human intervention, which is not relevant to this physical implant.

7. The Type of Ground Truth Used

Not applicable in the AI/ML context. For these non-clinical tests, "ground truth" would be the objectively measured physical properties/performance of the device under specific test conditions (e.g., maximum load bearing before failure, precise wear rates). The standards referenced (ASTM F543, F1160, F1044, F1147, F1978) define the methods for establishing these objective measurements.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML "training set" for this physical device.

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

Not applicable. There is no AI/ML "training set" for this physical device.

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The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.

The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.

The provided text describes the Integra™ LED Headlight System, a surgical headlight. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, the document focuses on:

• 510(k) Summary details: Contact information, device trade name, common name, classification, product code, and predicate device.
• Device Description: Discusses the power options (battery/direct), LED light source, and active cooling system.
• Indications For Use: States that the device provides illumination for visualization during minor surgical, diagnostic, or therapeutic procedures.
• Performance Standards: Lists various international electrical and medical safety standards (CAN/CSA, EN, IEC, UL) that the device conforms to, but these are general safety standards, not specific performance acceptance criteria for its intended function (illumination quality, brightness, etc.).
• Technological Characteristics: Compares features of the Integra LED Surgical Headlight with its predicate device (Welch Allyn Solid State Headlight), highlighting improvements in user control of attenuated light level, fan monitoring/control, and over-temperature monitoring/control.
• Substantial Equivalence: Concludes that the Integra LED Surgical Headlight is substantially equivalent to the predicate device based on performance testing (though the specific performance testing data and acceptance criteria are not detailed in this summary).
• FDA Communication: A letter from the FDA confirming the 510(k) clearance based on substantial equivalence to the predicate device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them, because this information is not present in the provided text.

The document states: "The Integra™ LED Surgical Headlight is substantially equivalent to the legally marketed predicate device based on performance testing. The Integra™ LED Surgical Headlight System has the same intended use, technological characteristics, and general operation as the predicate device identified. Minor differences between these devices simply improve performance and operating characteristics of the device and do not raise any new questions in regards to the system's safety or effectiveness." This implies that performance testing was conducted, but the specifics of what was tested, what the acceptance criteria were, and what the reported performance was are not provided.

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The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period on the Integrity Spinal Care System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

The Integrity Spinal Care System is a multi-function distraction table designed to apply distraction forces and controlled by a computer console. It has similar components for treatment and measurement, similar size, power source, and performance to the predicate devices. Key elements include a stand on/stand off tilt type bed, a split bed with two slideable cushions, a traction unit mounted to both ends of the bed with a belt pulley system attached to a vertical movable platform, a control panel for programming and controlling the traction unit, continuous monitoring of treatment parameters shown by LCD readout, automatic return to zero tension at the conclusion of treatment, an incorporated DVD player and headphones, and instantaneous release of tensions via a patient safety switch or stop buttons.

The provided text is related to a 510(k) summary for the "Integrity Spinal Care System," a traction equipment device. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's technical characteristics, intended use, indications for use, and safety features.

However, the document does not contain information about:

• Specific acceptance criteria for device performance (beyond compliance with recognized standards).
• A "study that proves the device meets the acceptance criteria" in terms of clinical performance or a formal performance study with a test set, ground truth, or expert review.
• Sample sizes for test or training sets.
• Data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with performance evaluation of diagnostic or AI-based devices.

The document mainly states that "Non-clinical Tests: The Integrity Spinal Care System is as safe and effective as the predicate devices demonstrating compliance to FDA recognized Consensus Standards. A calibrated dynamometer won placed between the tower and bed to stimulate a patient. Measurements of tension demonstrate the tension readings displayed and noted from the calibrated dynamometer are compirative to predicate devices." This describes a basic technical comparison rather than a detailed performance study against acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the text:

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

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

• The document describes non-clinical bench testing using a "calibrated dynamometer" to simulate a patient. It does not involve a "test set" of patient data.
• Sample Size for Test Set: Not applicable / Not provided. The testing involved a dynamometer, not patient samples.
• Data Provenance: Not applicable / Not provided, as it was bench 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. No ground truth based on expert review was established for this non-clinical test.

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

• Not applicable. No adjudication method for a test set was mentioned.

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

• Not applicable. This device is a traction equipment, not an AI-based diagnostic device where MRMC studies would typically be performed.

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

• Not applicable. This device does not involve an algorithm for standalone performance evaluation in the context of diagnostics.

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

• Not applicable for a typical medical device performance study. For the non-clinical testing, the "ground truth" was the expected/designed tension readings and compliance with specified engineering and safety standards, as measured by a calibrated dynamometer.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

• Not applicable. This device does not involve a training set.

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