(59 days)
The Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for inplants or implantation through the skin so that traction may be applied to the skeletal system.
The Tyber Medical Pin and Wire System is designed for hand, foot, and small bone fragment repairs or fusions. Uses include fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. It is manufactured from stainless steel, and Titanium Alloy. They are available in a variety of lengths, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile, single use. Non-sterile devices are intended to be sterilized at the point of use. The pins and wires are made from stainless steel (316L per ASTM F-138) and titanium alloy (Ti-Al-4V ELI per ASTM F136).
This FDA 510(k) summary provides limited information regarding formal acceptance criteria or a detailed study proving the device meets specific performance criteria. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a standalone performance study with predefined acceptance criteria.
However, based on the provided text, here's an analysis of what can be inferred and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or quantitative performance metrics are listed in the document. The submission is based on substantial equivalence, implying that the device's performance is considered acceptable if it is comparable to the predicate devices.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Indications for Use Equivalence | Similar indications for use to predicate devices | "The indications for use are similar in both the subject and predicate devices." |
| Technological Characteristics Equivalence | Similar design, material, chemical composition, and principle of operation to predicate devices | "The subject device has similar technological characteristics (design, material, chemical composition and principle of operation) as the predicate device identified above." |
| Safety and Effectiveness Equivalence | No new or different questions raised regarding safety and effectiveness when compared to the predicate devices | "The Tyber Medical Pin and Wires has been determined to be safe and effective as the predicatedevice and no new or different quereraised regarding the safety and effectiveness when compared to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No "test set" in the context of an AI/algorithm performance study is mentioned as no clinical or performance study was conducted.
- Data Provenance: Not applicable. No data or test sets were used for a performance study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. No ground truth establishment by experts is mentioned as no performance study was conducted requiring such a process.
4. Adjudication Method:
Not applicable. No adjudication method is mentioned as no performance study was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was preformed."
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study was not done. The document explicitly states: "No clinical testing was preformed." The device described is a physical medical device (Pin and Wire System), not an algorithm or AI.
7. Type of Ground Truth Used:
Not applicable. As no performance study was conducted, no ground truth was established for the purpose of validating the device's performance in a study setting. The "ground truth" in this context is the performance and safety profile of the predicate devices against which the new device is compared for substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set and corresponding ground truth.
Summary of the Study (or lack thereof) to Prove Acceptance Criteria:
The provided document describes a 510(k) Premarket Notification for the Tyber Medical Pin and Wire System. The "study" proving the device meets "acceptance criteria" is based on the principle of Substantial Equivalence (SE) to legally marketed predicate devices (K083490 - BioPro K-Wire and K100736 - SMT Schilling Metalltechnik GmbH).
The core of the submission's argument is:
- Indications for Use: The new device has similar indications for use as the predicate devices.
- Technological Characteristics: The new device shares similar design, material (stainless steel, titanium alloy), chemical composition, and principle of operation with the predicate devices.
- Manufacturing and Sterilization: The new device is manufactured and intended to be sterilized using the same materials and processes as the predicate devices (though the devices are provided non-sterile for point-of-use sterilization).
Based on these similarities, the FDA has determined that the Tyber Medical Pin and Wire System is substantially equivalent to the predicate devices. This determination implies that the new device is considered "safe and effective" without the need for new clinical or non-clinical performance studies, as no new or different questions regarding safety and effectiveness were raised compared to the predicate devices.
Key takeaway: This document is not about a performance study of an AI/algorithm. It's a regulatory submission for a physical medical device, demonstrating substantial equivalence to pre-existing, legally marketed devices. Therefore, many of the requested categories (like sample sizes, expert qualifications, and ground truth for AI performance) are not applicable to this type of submission.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.