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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

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.

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The intended use of the CurvTek TSR System is substantially equivalent to the predicate devices listed in this 510(k) application. The device is to be used to drill holes in bone, except for cranio and maxifacial bones, for soft tissue attachment, or wiring/cabling as in the following techniques: Soft Tissue Repair Techniques (Shoulder, Hip, Elbow, Knee, Limb Salvage, Hand and Wrist, Foot & Ankle, Urological) and Wiring/Cabling Techniques (Cervical Cabling, Lumbar Cabling, Osteotomy of Cervical Spine, Arthrodesis, Lateral Transverse Process, Trauma).

The CurvTek TSR System is a pneumatically powered instrument system consisting of a handpiece, disposable single patient use drill bit cartridges, and 510(k) approved accessories. Accessories include Zimmer® (Hall®) style nitrogen hose and sterilization container system.

The provided text describes a 510(k) premarket notification for a medical device called the Biolectron CurvTek TSR System, a pneumatically powered surgical bone drill. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as might be found in a De Novo or PMA application.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets them, nor does it provide details on sample size, data provenance, expert qualifications, or specific performance metrics typically associated with such studies.

Here's why and what information is available:

• 510(k) Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, rather than conducting extensive new clinical performance studies with predefined acceptance criteria.
• Focus on Predicate Devices: The document heavily emphasizes the comparison to predicate devices, listing them multiple times and stating that the new device's intended use and materials are equivalent.

Based on the provided text, I cannot complete the table or answer most of the questions as the information is not present in this 510(k) summary.

However, I can extract the following relevant, albeit limited, information:

1. A table of acceptance criteria and the reported device performance:

• Not applicable. The document does not describe specific acceptance criteria (e.g., precision of drilling depth, torque, speed) or numerical performance metrics for the CurvTek TSR System. The claim is based on substantial equivalence to existing devices.

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. No test set or performance study data is described.

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 ground truth establishment related to performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No adjudication method is described.

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 surgical drill, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a surgical drill, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No ground truth is described in the context of performance evaluation. The "ground truth" for this submission is essentially the legally marketed predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established:

• Not applicable. No training set or ground truth for it is mentioned.

Summary of what is available from the document:

• Device Name: CurvTek TSR System
• Intended Use: To drill holes in bones (except cranio and maxifacial bones) for soft tissue attachment or wiring/cabling.
• Basis for Claims of Substantial Equivalence: Equivalence to several pneumatic surgical instruments/systems/devices, focusing on intended use and materials (stainless steel, aluminum, medical grade plastic).
• Predicate Devices: Romano Modified Glenoid Arcuate Drill (K 885229), Romano Glenoid Arcuate Bone Drill & Disposable Flexi-Bit Units (K 880074), Hall Series 3 Drill and Micro 100, MicroAire Power Master and Series 2000 Pneumatic Power Instrument System, 3M Maxidriver II (K 932307), Synthes Compact Air Drive II (K 971544).

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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.

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.

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