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The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.

The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.

The provided 510(k) summary for the OSCAR 3 ultrasonic surgical instrument does not describe acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Orthosonics OSCAR OE3000DB and OSCAR Bone Resector).

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

• Not present in the document. The 510(k) summary states that "performance testing was carried out for some characteristics" but does not provide a table of acceptance criteria or the specific performance results in terms of metrics. It only generally concludes that "The data do in fact demonstrate equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present in the document. There is no mention of sample sizes for any test sets, nor the provenance of any data (country, retrospective/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/Not present. Since a specific performance study with a "test set" and "ground truth" to evaluate diagnostic or therapeutic accuracy is not described, there's no information on experts or their qualifications for establishing ground truth. The device is a surgical instrument for cutting bone and cement, not a diagnostic tool requiring expert interpretation as ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not present. As there's no diagnostic or interpretative "test set" described, adjudication methods are not relevant or discussed.

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. The device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical surgical instrument, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not present. Given the nature of a surgical instrument for cutting, the concept of "ground truth" in the diagnostic sense is not directly applicable. The "testing" mentioned is likely related to engineering performance (e.g., cutting efficiency, material compatibility, electrical safety), not diagnostic accuracy. The document states "performance testing was carried out for some characteristics," but does not elaborate on the specific nature of these characteristics or how "ground truth" would be established for them.

8. The sample size for the training set

• Not applicable/Not present. This device is not an AI/ML algorithm that would have a "training set."

9. How the ground truth for the training set was established

• Not applicable/Not present. Same as above, not relevant for an ultrasonic surgical instrument.

Summary of what is present regarding "testing":

The document mentions two types of testing that will be carried out or have been carried out:

• G. TESTING:
  • FCC Part 18: "Testing to FCC Part 18 will be carried out prior to marketing the device in the USA." (Electrical emissions/interference)
  • UL 60601-1: "Electrical testing to UL 60601-1 will be carried out by Underwriters Laboratories before marketing the device in the USA." (Medical electrical equipment safety)
  • Performance Testing for Substantial Equivalence: "performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence." However, the details of this performance testing, including specific acceptance criteria and results, are not included in this summary. The purpose of this testing was to confirm substantial equivalence to predicate devices, implying that the OSCAR 3 performs comparably to the devices it is replacing or integrating.

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The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.

The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that it's a 510(k) summary and therefore only provides a high-level overview of the testing conducted for substantial equivalence.

It's important to note that 510(k) summaries are not designed to be comprehensive clinical study reports. They aim to demonstrate substantial equivalence to a legally marketed predicate device, often relying on non-clinical performance testing rather than extensive human clinical trials for devices like surgical instruments. Therefore, many of the requested details (like sample size for test sets, number of experts, MRMC studies, training set details) are typically not found in a 510(k) summary if they don't directly relate to demonstrating equivalence through specific design or performance comparisons.

Acceptance Criteria and Device Performance (Based on available information)

Note on "Reported Device Performance": For a 510(k), explicit numerical performance metrics against specific acceptance criteria are often not detailed in the summary itself, particularly for non-clinical performance. The "reported performance" here is largely based on the claims made for "substantial equivalence" and the comparative advantages stated against predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided 510(k) summary. This document primarily focuses on asserting substantial equivalence based on technological characteristics and the types of testing performed or committed to. For a device like a surgical instrument, non-clinical performance testing (e.g., in vitro bone cutting, temperature measurements) is common, but the sample sizes for such tests are not detailed here.
   • Data Provenance: Not specified. It's safe to assume any performance testing would be non-clinical (laboratory-based), as no human-subject studies are mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. The testing described (FCC, UL, and comparative performance claims) does not indicate a need for expert-adjudicated "ground truth" in the way a diagnostic imaging study would. The focus is on technical compliance and direct performance comparisons.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/None. This type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads), which is not described for this device.

4. 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. An MRMC study is not mentioned and would be irrelevant for this type of surgical instrument. This device is not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in the sense that the device's technical characteristics and performance claims (e.g., quicker cut, cooler operation, reduced soft tissue damage) are assessed independently of a human operator's skill level. The device itself is the "algorithm" and its performance is tested. However, it's not "algorithm-only" in the AI sense, but rather a standalone physical device. The tests mentioned (FCC, UL, and comparative performance) assess the device's inherent characteristics.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical performance testing (e.g., bone cutting), the "ground truth" would be objective measurements (e.g., cutting speed, temperature, tissue damage assessment via established laboratory methods). For regulatory compliance (FCC, UL), the ground truth is adherence to the specified technical standards. No "expert consensus" or "pathology" in a diagnostic sense is mentioned.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no training set for this device.

Summary of Limitations due to 510(k) Context:

This 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" to predicate devices, not a detailed scientific publication of a clinical trial. As such, it highlights the types of testing done (e.g., electrical, EMC, and some unspecified "performance testing") and claims of performance improvements (quicker, cooler cut, reduced collateral damage) without providing the granular data, methodology, or specific sample sizes that would be present in a comprehensive study report or clinical trial. The "acceptance criteria" are largely implied by the need to meet regulatory standards (FCC, UL) and to perform "as well as or better than" predicate devices in key areas relevant to its intended use.

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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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