(28 days)
SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.
SmartPin® is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical Dearing 'oches, 'osteochonies and cancellous/non-load bearing fragments.
SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and Sthart mis is not intended for assess cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) treatment of which patient co operation callier see effect of SmartPin® upon the healing of growth plate has not been tested clinically.
The device description of SmartPin® is as follows:
- Composed of poly-96L/4D-lactide copolymer -
- Tapered, smooth pins -
- Lengths 10 70mm -
- Diameters 1.1, 1.5, 2.0, 3.2 and 4.5 mm -
The dimensions and shape are completely identical with Linvatec Biomaterials The unnersholis and brin) (K010983), SmartPin® PDX (the previous PLGA Pin) (K003659) and Biofix SR-PGA Pin (K890902).
This document is a 510(k) premarket notification for a medical device called SmartPin®, submitted by Linvatec Biomaterials Ltd. in 2004. The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not require a PMA (Premarket Approval). This type of submission does not typically involve the presentation of clinical study data with acceptance criteria for device performance as would be required for a novel device or one requiring a PMA.
The information provided describes the device, its intended use, and its similarities to previously cleared predicate devices. The FDA's letter (K041288) confirms that the device is substantially equivalent to the predicate devices and can be marketed.
Therefore, many of the requested categories related to clinical study data, acceptance criteria, and performance metrics are not applicable in this 510(k) context.
Below is an attempt to address your request based on the provided document, indicating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission based on substantial equivalence, the primary "acceptance criterion" is demonstrating that the new device has the same or similar intended use, operating principle, basic design, manufacturing process, packaging, and sterilization as the predicate devices, and does not raise new questions of safety or effectiveness.
- Reported Device Performance: The document does not report specific quantitative performance metrics against pre-defined acceptance criteria, as this is a substantial equivalence claim rather than a de novo or PMA submission. The performance is implicitly considered equivalent to the predicate devices.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as per substantial equivalence claim) |
|---|---|
| Same or similar intended use | "has the same or similar indicated use" |
| Same operating principle | "use the same operating principle" |
| Same basic design | "incorporate the same basic design" |
| Manufactured by same machinery | "is manufactured by same machinery" |
| Packaged and sterilized using same materials and processes | "is packaged and sterilized using the same materials and processes" |
| No new questions of safety or effectiveness | Implied by the FDA's substantial equivalence determination |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This 510(k) submission relies on demonstrating substantial equivalence to predicate devices, not on new clinical study data with a specific test set. The document leverages information about previously cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No new clinical study data with ground truth establishment is described in this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No new clinical study data with adjudication is described in this 510(k) submission.
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 a device for bone fixation, not an AI/imaging diagnostic device. No MRMC study was conducted or is relevant to this 510(k).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone fixation pin), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No new clinical study data requiring ground truth is described in this 510(k) submission. The "ground truth" for this submission is the regulatory precedent set by the predicate devices.
8. The sample size for the training set
- Not applicable. No training set for an algorithm or new clinical data is described.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment relevant to an algorithmic or novel device performance study is described here.
§ 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.