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510(k) Data Aggregation
(215 days)
ORTHOCHUCK
- Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.
The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin. The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.
This 510(k) premarket notification (K964252) focuses on establishing substantial equivalence for the ORTHOCHUCK™, a device designed to convert standard keyed metal chuck head surgical drives into keyless chuck drives. The submission primarily relies on a comparison to existing predicate devices rather than independent performance studies with detailed acceptance criteria and standalone performance metrics.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal quantitative acceptance criteria for device performance. Instead, it uses a comparison table to demonstrate how the ORTHOCHUCK™ is functionally equivalent to or improves upon predicate devices. The "reported device performance" is essentially its functional characteristics relative to these predicates.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (OrthoChuck™) |
|---|---|---|
| Intended Use | Must actuate chuck of powered surgical drives. | Actuates chuck of powered surgical drives. (Matches predicate) |
| Method of Operation | Must tighten or loosen chuck jaws. | Spur Gears Turn Sleeve Gear of Chuck. Tightens or Loosens Chuck Jaws. (Matches predicate in function) |
| Effect on Chuck Capacity | Must not alter the existing chuck's capacity. | None. (Matches predicate) |
| Effectiveness | Must tighten or loosen chuck jaws effectively. | Tightens or loosens chuck jaws. (Matches predicate) |
| Ease of Use | Must be easily operable, ideally improving upon keyed chucks. | On-the-fly One Hand, Insert, Tighten or Loosen. (Improved over predicate requiring two hands and drive stopped) |
| Safety (Gloves) | Must reduce risk of glove cuts/pinches compared to keyed chucks. | Eliminates necessity to use usual chuck key, significantly reduces chance that a glove could be cut or pinched in exposed metal gears of chuck and key. |
| Sterility | Must be supplied sterile and maintain sterility during use. | Mfg. Gamma sterilized. Supplied sterile. Disposable (not reusable). |
| Adaptability | Must adapt an existing keyed Jacob's-type chuck to keyless concept. | Adapts an existing keyed Jacob's-type chuck to the keyless concept. |
| Materials | Must be suitable for medical devices and sterilization. | Synthetics (Nylon, Kevlar, glass, Teflon, Carbon fiber, Kraton-G-2705). (Different from metal predicate) |
| Disposable | N/A (a differentiating feature, not an acceptance criterion) | Yes. (Differentiates from reusable metal predicates) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a formal performance study with a "test set" in the sense of clinical or laboratory data for statistical analysis. The determination of substantial equivalence is based on a comparison of design, materials, and intended use with legally marketed predicate devices.
- Sample Size: Not applicable as no specific test set data is presented.
- Data Provenance: Not applicable. The "data" consists of the features and characteristics of the device and its predicate devices, as described in the comparison table and device description.
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)
No external experts were used to establish "ground truth" for a test set, as no test set data was presented. The ground truth, in this context, refers to the established functional characteristics of existing surgical chucks, which are common knowledge in the orthopaedic surgical field. The comparison is made against these known characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
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 device is a mechanical surgical accessory, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The ORTHOCHUCK™ is a mechanical accessory designed to be used by a human surgeon or assistant. It does not operate as an algorithm or autonomously.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this submission is the established functional performance and safety characteristics of existing legally marketed predicate devices (both keyed and keyless chucks), combined with the detailed design and material specifications of the ORTHOCHUCK™ itself. This reflects an engineering and functional comparison, rather than a clinical outcomes study.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning system, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
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