(31 days)
The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine.
This device has a diameter of .0625" and is available in lengths of 35mm, 45mm, and 55mm. The Acumed Tension Band Pin is manufactured from 316L stainless steel and is provided pre-sterile. Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation. Validation of sterility is maintained on site. Sterility level is10.4. Information regarding packaging and labeling have been provided.
Here's a breakdown of the requested information based on the provided text for K964500:
It's important to note that the provided text is a 510(k) summary for a medical device (a surgical pin), not an AI/ML algorithm or software. Therefore, many of the questions related to performance metrics, expert reviews, and study methodologies for AI will not be directly applicable or present in this type of document. The acceptance criteria in this context are related to the physical properties and intended use of the pin, and the "study" is a comparison to predicate devices, not clinical trials in the AI sense.
K964500: Acumed Tension Band Pin
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Fracture Fixation | "Used in conjunction with orthopedic wire to address malleolar, patella, and olecranon fracture fixation in tension band wiring procedures." |
| Anatomical Scope | "Not intended for usage in the spine." | |
| Material | Composition | "Manufactured from 316L stainless steel." |
| Dimensions | Diameter | "Diameter of .0625 inches." |
| Lengths | "Available in lengths of 35mm, 45mm, and 55mm." | |
| Sterility | Method | "Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation." |
| Sterility Level | "Sterility level is 10^-4." | |
| Validation | "Validation of sterility is maintained on site." | |
| Similarity to Predicates | Material | "Similar to the Acumed Fixation Pin and the Howmedica Kirschner Wire in material." |
| Design | "Similar to the Acumed Fixation Pin and the Howmedica Kirschner Wire in... design." | |
| Intended Use | "Like Howmedica's Kirschner Wire, the Acumed Tension Band Pin is intended to be used in tension band wiring procedures addressing malleolar, patella, and olecranon fractures." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable to this type of device submission. There isn't a "test set" in the context of an algorithm's performance. The "study" here is a substantial equivalence comparison, which relies on demonstrating similarity to already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the AI sense, is not established for this type of device. The assessment is primarily engineering and regulatory.
4. Adjudication Method for the Test Set
This information is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a physical surgical pin.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is effectively established by:
- Material specifications: Conformance to 316L stainless steel standards.
- Dimensional accuracy: Conformance to specified diameter and lengths.
- Sterilization efficacy: Demonstrated ability to achieve and maintain a sterility assurance level (SAL).
- Predicate device characteristics: The established safety and effectiveness of the Acumed Fixation Pin and Howmedica Kirschner Wire serve as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" for a physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable.
Summary of Device Acceptance and "Study"
The Acumed Tension Band Pin meets its "acceptance criteria" by demonstrating substantial equivalence to legally marketed predicate devices (Acumed Fixation Pin and Howmedica Kirschner Wire). The "study" proving this is a comparison of the new device's material, design, and intended use to those of the predicate devices.
The key statements proving equivalence are:
- "The Acumed Tension Band Pin is similar to the Acumed Fixation Pin and the Howmedica Kirschner Wire in material and design."
- "Like Howmedica's Kirschner Wire, the Acumed Tension Band Pin is intended to be used in tension band wiring procedures addressing malleolar, patella, and olecranon fractures."
- "Based on the similarities between the Acumed Tension Band Pin and both the Acumed Fixation Pin and Howmedica Kirschner Wire, the safety and effectiveness is expected to be similar to the Acumed Fixation Pin and Howmedica Kirschner Wire."
This type of submission relies on the premise that if a new device is sufficiently similar to one already cleared by the FDA, it can be presumed safe and effective without requiring new clinical performance studies.
§ 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.