(87 days)
The Orthosonics OSCAR OE3000DB is intended to be used for cutting and removal of bone and acrylic bone cement in orthopedic applications.
The Orthosonics OSCAR OE3000DB consists of a power module which generates the ultrasonic energy and provides overall control of the device, 2 gefferent handsets; one for acrylic bone cement removal and the other for the cutting and removal of bone, and a variety of probes and other accessories. Three independent power modules are mounted in a cart for ease of use.
The provided text does not contain specific acceptance criteria or an explicit study describing how the device meets that criteria. It primarily focuses on the 510(k) summary, which outlines the device's substantial equivalence to predicate devices, its intended use, and general testing performed.
However, based on the information provided, we can infer some aspects related to device performance and studies:
Inferred Information from the Document:
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Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided. The document states that "performance testing was carried out for some characteristics," but it does not detail what those characteristics were, their acceptance criteria, or the specific results.
Acceptance Criteria Reported Device Performance Not specified Not specified -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: The document states "Performance testing was carried out in an animal study". This suggests the data is prospective, and the "country of origin" would likely be where the animal study was conducted, which is not specified but implicitly assumed to be under the sponsor's jurisdiction (Orthosonics Ltd, UK).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not specified. Since it was an animal study for performance testing, the ground truth would likely be based on objective measurements or observations by veterinary or surgical experts rather than, for example, image interpretation.
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Adjudication Method for the Test Set: Not specified.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not mentioned. The device is an "Ultrasonic Surgical Instrument" for bone/cement removal, not an imaging or diagnostic device typically evaluated with MRMC studies comparing human readers with and without AI assistance.
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Standalone Performance: The performance testing mentioned ("animal study") would evaluate the standalone performance of the device itself (the surgical instrument) in its intended function. The document states "performance testing was carried out for some characteristics" and in an "animal study." This implies a standalone evaluation of the device's physical performance.
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Type of Ground Truth Used: For the "animal study," the ground truth would likely involve:
- Direct observation/measurement: Of successful bone/cement removal.
- Pathology/Histology (potentially): To assess tissue effects or completeness of removal.
- Surgical outcomes: Related to the efficiency and safety of the device's action in the animal model.
The document does not detail the specific ground truth metrics.
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Sample Size for the Training Set: Not applicable. This is a surgical instrument, not an AI/ML-based diagnostic device that requires a training set in the typical sense for algorithm development. The "training" for such a device involves engineering design, prototyping, and iterative testing, not data-driven model training.
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How the Ground Truth for the Training Set Was Established: Not applicable (as above).
Summary of what is not explicitly detailed:
The provided 510(k) summary is high-level and does not offer the granular detail requested for detailed acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment methods as one might find for, for example, an AI-powered diagnostic imaging device. It focuses on demonstrating "substantial equivalence" based on similar technology and intended use, with general mention of performance testing.
§ 888.4580 Sonic surgical instrument and accessories/attachments.
(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.