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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:

1. 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

2. 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).

3. 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.

4. Adjudication Method for the Test Set: Not specified.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

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The Orthosonics OSCAR OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

The currently marketed Orthosonics OSCAR Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, and a set of cement removal probes. The primary change to the system is the addition of a laparoscopic video system, which can aid the clinician in examining the inside of the bone that is having its glue removed. This part of the system would only be used when the ultrasound-powered probes are not being used. The laparoscope and optical coupler are currently marketed medical devices. In order to make room for the video module in the main system unit of the OE3000, the ultrasonic power modules were reduced in physical size. In addition, the currently marketed device now has an optional accessory that was added to the system via a letter-to-file, without filing a new 510(k). The change involves adding a "slap hammer" that can be attached to an "extraction" probe, to aid in removal of a PMMA cement plug that is NOT firmly bonded to the endosteal interface. The Extraction Probe to be used with the slap hammer is a modified version of the piercer probe that was cleared with the original 510(k).

The provided text describes a 510(k) premarket notification for the Orthosonics OSCAR OE3000, a device intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

It explicitly states that the device was tested against safety and EMC standards. However, the document does not contain information regarding acceptance criteria for device performance (e.g., efficacy in removing cement, accuracy of the laparoscopic system, or strength of the slap hammer) nor does it describe a study to prove such performance criteria were met.

Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices, primarily through technological characteristics and safety testing. The statement "The technological characteristics of the OSCAR OE3000 are exactly the same as those of the predicate devices" is central to its claim of substantial equivalence.

Therefore, many of the requested sections regarding performance studies, sample sizes, ground truth, and expert adjudication cannot be extracted from this document.

Here's a summary of what can be extracted:

Acceptance Criteria and Device Performance Study for Orthosonics OSCAR OE3000

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable. The document describes testing to safety and EMC standards, and a demonstration of substantial equivalence based on technological characteristics and intended use. It does not describe a clinical performance test set with a specific sample size of subjects or data, nor does it specify data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• Not Applicable. As no clinical performance test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

• Not Applicable. No clinical performance test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a surgical tool, not an AI diagnostic aid.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a physical surgical instrument system (ultrasonic cement removal, a laparoscopic video system, and a slap hammer accessory). It is not an algorithm that performs in a standalone capacity.

7. Type of Ground Truth Used:

• For Safety and EMC: The ground truth for safety and EMC testing would be the "pass/fail" criteria defined by the respective EN standards (EN60601-1, EN60601-1-1, EN60601-1-2).
• For Substantial Equivalence: The ground truth for demonstrating substantial equivalence was established by comparing the device's technological characteristics, indications for use, and target population against legally marketed predicate devices (K961725, K914084, K903458, K961101) as reviewed by the FDA.

8. Sample Size for the Training Set:

• Not Applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set. The term "training set" is not relevant in this context.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As no training set is described (see point 8), there is no ground truth establishment method for it mentioned.

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