(75 days)
The Swiss OrthoClast® is used for the removal of bone cement during implant revision surgery.
The EMS Swiss OrthoClast® system consists of a pressure regulator/control unit, pneumatic footswitch, handpiece, chisels of various sizes and shapes, a hollow drill and extractor for removal of the cement tip, and the Orthoscope. The Swiss OrthoClast® uses simple pneumatic and ballistic principles to fragment bone cement. A pressure pulse generated by the pressure regulator/control unit causes a moveable projectile in the handpiece to be driven forward to strike the proximal end of the chisel. The impact generates a shock wave along the chisel, which leads to a small, high-speed excursion of the chisel tip. The distal end of the chisel is held in contact with the targeted cement. Repetitive shock waves result in fragmentation of the bone cement. A short tip excursion period followed by a longer rest period prevents the build-up of heat in the fragmentation site. Direct vision into body cavities, such as the femoral cavity, is facilitated using the Orthoscope.
The provided document is a 510(k) summary for the Swiss OrthoClast®, a powered orthopedic surgical instrument used for the removal of bone cement during implant revision surgery. It describes the device, its intended use, and performance testing conducted. However, it does not include specific quantitative acceptance criteria or detailed results like the "reported device performance" typically associated with a table. Instead, it broadly states that tests "confirmed that the Swiss OrthoClast® met the design objectives."
Therefore, I cannot populate a table with specific acceptance criteria and reported performance for each test from this document. I will extract the information that is present and indicate when information is not available.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|---|
| Maximum excursion and velocity of chisel tips | Design objectives (not specified quantitatively) | "Met the design objectives." |
| Handpiece and chisel longevity | Design objectives (not specified quantitatively) | "Met the design objectives." |
| In vitro cement fragmentation efficiency | Design objectives (not specified quantitatively) | "Met the design objectives." |
| Orthoscope temperature elevation | Design objectives (not specified quantitatively) | "Met the design objectives." |
| Risk Analysis | Identify potential hazards | "Confirmed that the Swiss OrthoClast® met the design objectives as identified by the risk analysis." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document. The document mentions "tests" retrospectively but does not provide details on the number of samples (e.g., number of chisels tested, number of in vitro cement models).
- Data Provenance: Not specified. It's likely from in vitro laboratory testing given the test types, but the location (country of origin) and whether it's retrospective or prospective are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to the provided document. The performance tests ("Maximum excursion and velocity of the Swiss OrthoClast® chisel tips," "Handpiece and chisel longevity," "In vitro cement fragmentation efficiency," "Orthoscope temperature elevation") are engineering/physical performance tests, not clinical evaluations that require expert adjudication or ground truth establishment in the traditional sense for diagnostic devices.
4. Adjudication method for the test set
Not applicable. The tests are mechanical/physical performance tests, not image interpretation or diagnostic evaluations requiring 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 is a surgical instrument, not a diagnostic or AI-assisted device. Multi-reader multi-case studies and AI comparative effectiveness are not relevant to this type of device and were not conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manually operated surgical instrument; an "algorithm only" performance study is not relevant.
7. The type of ground truth used
Not applicable in the typical sense of pathology or outcomes data for diagnostic devices. The "ground truth" for these engineering tests would be derived from physical measurements (e.g., actual excursion/velocity, remaining useful life, temperature readings, successful cement fragmentation).
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment.
§ 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.