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The indications for the OrthoFlex Rod include:

• Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
• Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
• Revision of a failed arthroplasty or arthrodesis

The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.

This OrthoFlex Rod 510(k) summary explicitly states that "No clinical studies were performed" and therefore no acceptance criteria or studies proving device performance against such criteria are provided in the document.

The submission focuses on establishing substantial equivalence to predicate devices based on intended use, design, material, and function, rather than demonstrating performance through clinical studies and predefined acceptance criteria.

Therefore, the requested tables and information cannot be generated from the given text.

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The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.

The TC Plating System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplied with the system to facilitate implantation.

The provided text is a 510(k) summary for the TC Plating System. This document is a regulatory submission for a medical device that demonstrates substantial equivalence to a legally marketed predicate device. It does not contain information about acceptance criteria, device performance studies, or clinical trial data.

The 510(k) summary explicitly states:

• Comparison of the technological characteristics of the device to predicate and legally marketed devices: 6. The TC Plating System is equivalent to the predicate devices in terms of:
  • Have the same indications for use and intended use.
  • Have the same basic shape/design.
  • Use the same operating principle.
  • Utilize the same materials.

This indicates that the submission relies on the established safety and effectiveness of predicate devices, rather than presenting new performance data from a specific study. Manufacturers of Class II devices (like the TC Plating System) can demonstrate substantial equivalence by showing that their device is as safe and effective as a legally marketed predicate device and does not raise different questions of safety and effectiveness. This often involves demonstrating similar technological characteristics and intended use, rather than conducting new clinical performance studies with acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text. The document focuses on regulatory equivalence rather than clinical performance study results.

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The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.

These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. These screws are of the self-tapping type. This device is manufactured from Ti-6A1-4V alloy and is available in a variety of sizes.

This 510(k) summary describes a bone screw, which is a physical medical device, not an AI/ML enabled device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device based on material, indications for use, and similar thread form, which are criteria relevant to physical orthopedic implants.

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The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:

• Severely pronated foot
• Walking intemperance
• Calcaneal stance position greater than 5°
• Manually correctable deformities
• Mid-tarsal breech (arch pain)
• Forefoot varus greater than 10°

The Ortho-Pro STS Screw consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The document is a 510(k) summary for the Ortho-Pro STS Screw, a bone screw. It describes the device, its intended use, and its technological characteristics compared to a predicate device. It also includes the FDA's clearance letter for the device.

Therefore, I cannot provide the requested table and information as it is not present in the given input.

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