(90 days)
The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique.
The ACL instrument by Boszotta allows fast and standardized removal of the patellar ligament by an optimal arthroscopic press-fit technique. The standardized diameter of the bone plugs allows optimum bone contact and promotes rapid healing.
The provided document is a 510(k) summary for the Richard Wolf Medical Instruments Corporation's ACL instruments, submitted in 1997. This type of document is for medical device clearance, not for AI/ML software. Therefore, the questions related to AI/ML software performance, such as sample size for training sets, ground truth establishment, MRMC studies, and human reader improvement, are not applicable.
Here's an analysis based on the available information for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
For traditional medical devices seeking 510(k) clearance, formal "acceptance criteria" and "reported device performance" in the sense of quantitative metrics (e.g., sensitivity, specificity for a diagnostic device) are generally not presented in the same way as for AI/ML systems. Instead, the focus is on demonstrating that the device is substantially equivalent to a legally marketed predicate device. This involves showing similar technological characteristics and performance, often through non-clinical laboratory testing, material testing, and sometimes limited clinical experience, rather than formal statistical performance against pre-defined criteria.
In this document, the "performance data" section serves the closest role to reporting on the device's acceptable use and safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity/Reliability: No mechanical problems reported. | "The ACL Instruments by Boszotta have been used in Eisenstadt Hospital for accident cases for about three years. During this time the instruments were used in more than 200 routine interventions. At this time, no mechanical problems...have been reported." |
| Biological Compatibility/Safety: No adverse biological reactions. | "At this time, no...biological incompatibility reactions have been reported." |
| Sterilization Efficacy: Compatible with steam sterilization. | "The steam sterilization following each operation do not show any problems." The device characteristics also state: "All ACL instruments are autoclavable (steam sterilization) for high hygiene demands." (This indicates design for sterilization, and the performance data confirms no problems with its use.) |
| Intended Use Fulfillment: Precisely drills, drives hollow drills, enables graft removal etc., as described in intended use. | The three-year usage in over 200 interventions without reported mechanical issues indirectly supports the device's ability to fulfill its intended functions as described (e.g., ensuring precise drilling, driving hollow drills, etc.). The document indicates: "- The drill alignment device ensures precise drilling of the tibial channel. - The pneumatic drill drives the oscillating hollow drills. - The short hollow drill is used for graft removal from the ligament." etc. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "more than 200 routine interventions"
- Data Provenance: "Eisenstadt Hospital for accident cases," used for "about three years." This is retrospective clinical experience from a specific hospital. The country of origin is not explicitly stated but can be inferred as likely being in Europe given the hospital name, possibly Austria (Eisenstadt is a city in Austria).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For this type of medical device, "ground truth" as a reference standard for AI/ML performance is not established. The "performance data" is observational feedback from clinical use. There is no mention of independent experts evaluating this clinical use data in a structured way to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. There was no formal "test set" and no "adjudication method" in the context of expert review for ground truth establishment. The data represents clinical usage feedback.
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 traditional surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a traditional surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
Not applicable to traditional surgical instruments. The closest concept is "real-world clinical performance" as observed by the users (surgeons) and reported to the manufacturer. The "ground truth" for showing safety and effectiveness is largely based on the absence of reported problems during clinical use and the substantial equivalence to predicate devices, which implies similar clinical outcomes.
8. The Sample Size for the Training Set
Not applicable. This is a traditional surgical instrument. There is no concept of a "training set" for an AI/ML model for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.