(120 days)
Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
All Ortho Solutions Sterile Single-Use Drills Bits are manufactured from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.
The provided 510(k) summary for Ortho Solutions Sterile Drill Bits (K102743) states that the device is substantially equivalent to the Synthes K962913 Sterile Drill Bits. This means that the device's acceptance criteria and the study proving it meets these criteria are based on demonstrating equivalence, rather than a standalone clinical study with detailed performance metrics.
Here's the information extracted from the provided text, recognizing the nature of a 510(k) SE submission:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Acceptance Criteria (Implied by SE) | Reported Device Performance (Implied by SE) |
|---|---|---|
| Material | Identical to predicate device | Identical to Synthes Sterile Drill Bits |
| Geometry Design/Markings | Identical to predicate device | Identical to Synthes Sterile Drill Bits |
| Indications for Use | Identical to predicate device | Identical to Synthes Sterile Drill Bits (Intended use: "to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.") |
| Sterilization Method | Gamma Radiation | Gamma Radiation used |
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a separate test set. The claim of "identical" in material, geometry, and indications implies that the design and manufacturing specifications of the Ortho Solutions drill bits conform to the established characteristics of the predicate device (Synthes K962913). Demonstrating this identity typically involves detailed engineering comparisons and possibly verification testing on a sample of the manufactured devices, rather than a clinical "test set" in the traditional sense of a clinical trial.
- Data provenance: Not applicable in the context of a comparative effectiveness study or clinical trial. The data provenance would relate to the manufacturing specifications and design verification documentation of the Ortho Solutions device, showing its equivalence to the predicate. The predicate device's country of origin is not specified, but the manufacturing firm for the new device is based in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as established by experts for a test set (e.g., in an AI or diagnostic device context) is not part of this type of 510(k) submission. The "truth" here is the equivalence to the predicate device, which is a regulatory and technical assessment.
4. Adjudication method for the test set:
- Not applicable. There was no clinical "test set" requiring adjudication in the context of a clinical trial. The adjudication is regulatory, based on the FDA's assessment of the provided documentation for substantial equivalence.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) involving human interpretation with or without AI assistance, which is not applicable to a surgical drill bit.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done. This is also relevant for AI/software-as-a-medical-device (SaMD) products, which does not apply to a physical surgical instrument.
7. The type of ground truth used:
- The "ground truth" in this context is the identity and performance characteristics of the predicate device (Synthes Sterile Drill Bits, K962913). The Ortho Solutions device's performance is demonstrated to be equivalent to this established standard. This is based on a technical and regulatory comparison, rather than pathology, expert consensus on clinical cases, or outcomes data from the new device itself.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for physical surgical instruments in this type of 510(k) submission. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.