(137 days)
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry.
The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument designed for use in surgical dentistry. The device generates piezo-electric vibrations (ultrasonic energy) for cutting and non-cutting instruments used in surgical dentistry, including oral surgery, implantology, periodontal surgery, and maxillary surgery.
The EMS Piezon Master Surgery device consists of a main chassis containing an irrigation delivery system, an internal electric power supply, a control panel with lightemitting diode (LED) displays, and ultrasonic generator. A one-step footswitch is connected to the main chassis by a footswitch cord and a handpiece containing cutting and non-cutting instruments is connected directly to the main chassis.
The provided document is a 510(k) summary for the EMS Piezon Master Surgery device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or the details of a study with reported performance metrics, ground truth establishment, or human reader effectiveness with AI.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices based on shared intended use, technical specifications, and functional performance. It states that "Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry," but it does not elaborate on the specific tests, their results, or the acceptance criteria used.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance because this information is not present in the provided text.
Based on the document, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "Performance testing has been conducted that confirms that the Piezon Master Surgery is able to perform ultrasonic bone-cutting for use in surgical dentistry." However, it does not provide details on specific acceptance criteria (e.g., bone cutting depth, precision, cutting time, temperature rise, etc.) or the measured performance results against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document states that performance testing was conducted but gives no details about the sample size (e.g., number of bone samples, number of procedures), country of origin, or whether the study was retrospective or prospective.
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 / Cannot be provided. The document does not describe a study involving expert assessment or ground truth establishment for a test set. The performance testing mentioned likely involved engineering or bench-top tests related to the device's functional capabilities (e.g., ability to cut bone) rather than diagnostic accuracy or clinical outcomes assessed by experts in a structured manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. As there's no mention of a test set requiring expert adjudication for ground truth, this information is not relevant to the document's content.
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. This information is entirely irrelevant to the device described. The EMS Piezon Master Surgery is an ultrasonic bone-cutting 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 device is a surgical instrument operated by a human, not an algorithm. Its "performance" refers to its physical capability to cut bone, not an algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Cannot be provided. No "ground truth" in the clinical or diagnostic sense is described or required for the type of performance testing alluded to. The performance testing would likely have focused on the device's functional characteristics (e.g., ability to perform ultrasonic bone-cutting).
8. The sample size for the training set
- Not applicable. The device is a physical instrument, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this device does not involve a training set or ground truth in this context.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.