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Universal Tendon Spacer is a medical device used in the reconstruction of the flexor and extensor tendons of the hand. The device is implantable for 2 to 6 months and intended for single use.

This device is used for:

Adherent or mutilated tendons following trauma or a primary repair which has failed. Absence of the tendon sheath. Non-functioning, mutilated or adherent tendon pulleys. Ruptured tendons. The patient must be in good health with sufficient tissue cover. Sufficiently healthy joints, bone marrow and adequate vascular and neuro-muscular conditions are also necessary to facilitate a definite functional improvement using this reconstruction technique. The patient must be cooperative, especially concerning the need for rehabilitation measures.

Universal Tendon Spacer (UTS) is a medical device made of silicone for temporary implantation (two to six months) for use in the twostage reconstruction of the flexor and extensor tendons of the hand. When implanted, UTS is in contact with the tissues and bones of the fingers for a long-term contact duration (>30 days).

This medical device contributes to the rehabilitation of the digital canal by creating a neo-sheath which should be as large as possible depending on the patient's anatomy. It is the body with the silicone which makes it possible to obtain the synovial neosheath which will receive, during the second operative time, a tendon of the formation of this neo-sheath the tendon will be able to slide again in the sheath and will make the finger of the patient work.

The Universal Tendon Spacer is a single size ovoid-shaped rod whose over its entire length. The rule is for the larger diameter to always be twice that of the smaller diameter.

The principle is the same as those of rival man difference being that the four different sizes generally provided are all available on one single rod. The UTS is made of long-term nigh performance implantable silicone to which barium sulfate has been added to make the rod radio-opaque for X-ray examination. Raw materials of Universal Tendon Spacer meet USP Class VI test requirements.

Only one reference exists for this device, and it is not intended to be assembled with any other device.

The intended patient population is adults and children. The device is for single use only and is provided sterile.

The provided text is a 510(k) Premarket Notification for a medical device called "Universal Tendon Spacer." It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.

However, the provided document does not contain information about acceptance criteria or specific study results that prove the device meets performance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.

The document primarily focuses on the physical and mechanical properties, biocompatibility, and packaging of the Universal Tendon Spacer in comparison to a predicate device. It demonstrates equivalence through:

• Indications for Use Comparison: States the subject device has the exact same indications for use as the predicate device.
• Technological Comparison: Asserts substantial equivalence in material, design features, size, and mechanical strength. This is supported by:
  • Function and principle of operation (same purpose and two-step reconstruction).
  • Design (unique size implant with oval cross-section, exact same design and dimensions as the predicate).
  • Material (same medical-grade silicone elastomer and barium sulfate from the same raw material supplier).
  • Manufacturing process (same injection-molding, cleaning, packaging, and sterilization).
  • Mechanical strength (mechanical testing performed, and results indicate equivalence to the predicate according to NF EN ISO 527-2 for tensile strength, elongation, and strain at break).
• Biocompatibility Testing: Conducted according to FDA and ISO 10993-1 guidelines, including cytotoxicity, sensitization, irritation, and pyrogenicity. The material conforms to USP Class VI.
• Packaging Testing: Performed to validate integrity and shelf-life (5 years) after real-time and accelerated aging, including visual inspection, dye penetration, and seal strength tests (ISO 11607-1, ISO 11607-2, NF EN 868-5 standards).

Therefore, I cannot provide the requested information regarding acceptance criteria for an AI/algorithm device or the study details related to AI performance because this document describes a physical medical device (tendon spacer) and does not involve AI or software performance evaluation in the context of diagnostic or prescriptive capabilities.

The questions you've asked (about sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details, etc.) are highly relevant for the submission of AI/machine learning-based medical devices. This document, however, does not pertain to such a device.

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Surgical indications for the Single Size Tendon Spacers include: Scarred or adhering tendons due to trauma or failed primary repair. Absence of tendon sheath. Scarred or adherent non-functional tendon pulleys. Ruptured tendon. The device is single use, temporary implantation for 2 to 6 months.

The Single Size Tendon Spacer is designed to facilitate the two-step tendon reconstruction surgery. The device is 50 cm long, and its oval cross section increases progressively over its length from 3.0 x 1.5 mm to 3.0 mm. The spacer slope is designed to match shapes and dimensions of the digital canal. The spacers are made of high performance medical grade silicone elastomer containing barium suffate to provide radio-opacity. During the first stage of the reconstruction surger is placed into the reconstructed tendon bed and slid until optimum fit is achieved. The tendon is attached to the distal phalanx and the proximal spacer end is left free in the palm or forelimb. Excess spacer material is cut off. The second stage of surgery is performed 2 to 6 months later, once an appropriate pseudo-sheath has been created around the spacer, and tissues are soft and pliable. The spacer is then removed and replaced by a permanent active tendon autograft. The device is not intended as permanent implant or to function as a replacement for a ligament or tendon.

I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a "Single Size Tendon Spacer" and primarily focuses on establishing substantial equivalence to a predicate device.

The document does not contain any information regarding:

• Specific acceptance criteria metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond "equivalent mechanical strength").
• A detailed study design or reported device performance metrics against defined criteria.
• Sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
• Training set details or how their ground truth was established.

The "Performance data" section only states: "Studies demonstrated that the Single Size Tendon Spacer devices have the equivalent mechanical strength and biocompatibility performances to the predicate device." This is a very high-level statement without any specific data or methodology.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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