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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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