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The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.

When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.

Environments of Use: Clinics, hospital and home environments
Patient Population: Adult

The Avail device is a wireless, independent dual channel wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain on multiple body locations. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology and microcurrent therapy through the simple, convenient use of the dedicated Omron TENS iOS or Android App. Reusable, self-adhesive, contouring pads allow for discreet and convenient placement on multiple pain locations on the body. The Avail system can be programmed to deliver nine different TENS modes and a microcurrent therapy mode.

The system contains two main TENS units which are rechargeable and each can be attached to either a medium or large size gel pad. The pad with attached TENS unit can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Avail TENS system is completed through the available Omron TENS App. The Avail will be packaged with an Instruction Manual which provides details on setting up the device for use, installing of the Omron TENS App, setting and controlling therapy modes, and troubleshooting. The system includes two main TENS units, medium and large pads, an AC-powered charger, AC adapter, a pad holder and storage case.

The Omron Avail (Model PM601) is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the features and performance of the predicate and reference devices, as the submission aims to demonstrate substantial equivalence. The reported device performance is then compared against these.

• Product Code: Primary: NUH, Secondary: NYN, NGX (for predicate) | - Regulation: 21 CFR §882.5890
• Product Code: Primary: NUH, Secondary: NYN |
  | Indications for Use | - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household/work activities (PulseRelief, Omron Heat Pain Pro, Painmaster MCT Patch).
• Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (SmartRelief). | - Relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.
• Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Tap, Shoulder, Arm or Leg mode). |
  | Environment of Use | Clinics, hospital, and home environments (Omron Heat Pain Pro); Home (PulseRelief, Painmaster MCT Patch). | Clinics, hospital and home environments. |
  | Patient Population | Adults (all comparing devices); Over 12 years of age unless under physician supervision (Painmaster MCT Patch). | Adults. |
  | Contraindications | Similar contraindications regarding pacemakers, implanted defibrillators, other implanted electronic/metallic devices (all comparing devices). Avoid placement along neck/through head for Painmaster. | Do not use if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. |
  | Power Source | Rechargeable Lithium-ion battery (PulseRelief, Omron Heat Pain Pro); 3V CR2032 lithium battery (SmartRelief); Primary battery only, one-time use (Painmaster). | Rechargeable Lithium-ion battery. |
  | Patient Leakage Current |

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The Arcadis Orbic is a mobile x-ray system designed to provide fluoroscopic and digital spot-film imaging of the patient during surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.

The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.

The Arcadis Orbic is a mobile x-ray system which consists of a mobile C-arm configured with a high frequency generator, X-ray tube assembly, image intensifier, CCD camera, laser target devices, electronics cabinet, a monitor trolley and digital image storage system which consists of the digital memory device, image monitors, and user interface. The system is equipped with a footswitch and a hand switch for radiation release in the five modes of operation: digital radiography, fluoroscopy, pulsed fluoroscopy, subtraction, and roadmapping.

The Arcadis Orbic 3D option provides 3D imaging and is intended to be used whenever the physician benefits from intraoperatively-generated 3D information of high contrast objects and anatomical structures.

The 3D Navigation Interface option provides visual support for planning and positioning of instruments during surgical procedures.

This document is a 510(k) summary for the Arcadis Orbic mobile X-ray system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove specific performance against acceptance criteria in the same way a clinical trial for a new drug might. The focus here is on showing that the new device has the same intended use and similar technological characteristics to previously cleared devices, and does not raise new questions of safety and effectiveness.

Therefore, I cannot populate the requested table and sections based on the provided text, as this information is not present.

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For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.

The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.

The provided text describes the "Memory Staple™" device and a study performed to demonstrate its substantial equivalence to predicate devices, but it does not detail acceptance criteria in the typical sense of a diagnostic device or AI algorithm, nor does it present a study that proves the device meets specific performance thresholds in that context.

Instead, the document is a 510(k) summary, focusing on demonstrating substantial equivalence for a medical device. The "study" mentioned here is a mechanical test and a clinical observation that supports this claim, rather than a clinical trial designed to prove diagnostic performance against set criteria for an AI tool.

Therefore, many of the requested categories for AI/diagnostic studies (like MRMC, ground truth establishment, training set details) are not applicable to this submission.

Here's an attempt to answer based on the provided text, adapted to the context of a medical device submission demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable as an "AI/diagnostic acceptance criteria" table. The substantial equivalence argument for the Memory Staple relies on:

• Intended Use: Similar to predicate devices.
• Material: Nickel-Titanium shape memory alloy (similar to one predicate).
• Mechanical Strength: Demonstrated to be stronger than a predicate device.
• Clinical Use Observation: Successful in a reported series.

Since this is not an AI/diagnostic study, the following points are largely not applicable.

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

• Mechanical Test: "Prong separation tests were performed on the Memory Staple and the Landos Standard Staple." The sample size for these tests is not specified in the document.
• Clinical Observation: 315 osteotomies of the great toe.
• Data Provenance: The document does not specify the country of origin for the clinical observation data, but it refers to a report by "Barouk in 1994." It is retrospective, as it covers use between 1991-1994.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For the mechanical test, the "ground truth" is a measurement of force. For the clinical observation, "successful use" would likely be determined by the treating physician (Barouk). No panel of experts for ground truth establishment is mentioned.

4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned for the mechanical tests or the clinical observation.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.

7. The type of ground truth used

• Mechanical Test: Direct physical measurement (prong separation strength).
• Clinical Observation: Physician-reported "successful clinical use," which implicitly refers to positive patient outcomes in the context of the device's function.

8. The sample size for the training set
Not applicable. This is not an AI device and does not have a "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI device.

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