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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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The Stryker Cement Removal System (CRS) is indicated for use in revision hip arthroplasty to remove the old PMMA distal cement plug from the area between the distal tip of the primary implant and proximal to any bony restriction within the femoral canal. The use of the CRS is contraindicated for removal of cement distal to any bony restriction within the medullary canal and removal of the cement mantle proximal to the distal tip of the primary implant. Additionally, the CRS is contraindicated for patients with unrestored fractures and severe osteoporosis.

The Stryker CRS consists of a rechargeable handpiece, a disposable, stainless steel tip, a reusable slide hammer, and a battery charger. The CRS is powered by nickel-cadnium batteries located within the handpiece housing. When activated, the handpiece provides power to an attached tip, allowing the tip to generate heat. The heated tip softens the cement plug, allowing the user to insert it into the cement plug. Once inserted, the tip is irrigated with irrigant allowing the cement to quickly resolidfy around the tip. The tip is then connected to a slide hammer which allows the tip and attached cement to be removed through impact loading.

This document describes a medical device, the Stryker Cement Removal System (CRS), and its intended use, contraindications, and a summary of its safety and effectiveness. However, it does not contain the specific information requested regarding acceptance criteria, a detailed study proving device performance, or the methodologies for establishing ground truth, sample sizes, and expert qualifications.

The provided text is a summary of safety and effectiveness, likely from a regulatory submission document (e.g., 510(k) summary). It broadly states that "data collected at the University of Michigan and Michigan State University demonstrated that the CRS does not raise any new safety issues..." but does not detail the nature of this data, the study design, or its specific findings against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information points because the provided text does not contain them.

Here's a breakdown of the requested information and why it cannot be provided from the input:

1. A table of acceptance criteria and the reported device performance: Not present. The document states the device "does not raise any new safety issues" and "does not produce a greater amount of fumes," but these are general statements, not quantifiable criteria with reported performance.
2. Sample sizes used for the test set and the data provenance: Not present. The locations (University of Michigan and Michigan State University) are mentioned, but no details on sample size, retrospective/prospective nature, or data origin (country) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Neither the concept of "ground truth" for this type of device (a cement removal system) nor expert involvement in establishing it is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
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 present. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study and AI assistance are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not present. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. The nature of "data collected" is vague. For a surgical instrument, "ground truth" might relate to successful cement removal, avoidance of adverse events, or objective measurements like temperature control or material strength, but these are not specified.
8. The sample size for the training set: Not present. This is not an AI/machine learning device with a training set in the conventional sense.
9. How the ground truth for the training set was established: Not present, as it's not an AI/ML device.

In summary, the provided text offers a regulatory overview of a medical device but lacks the detailed study design, acceptance criteria, and performance metrics typically found in clinical study reports or comprehensive efficacy analyses.

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