(147 days)
The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
The TGS v2.0 is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. TGS v2.0 uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills and awls.
The TGS v2.0 consists of the following basic components:
- Robotic Arm
- Guidance Module
- Camera Stand
- Tool and accessories
- Preoperative planning laptop
The provided text is a 510(k) summary for the MAKO Surgical Corp. Tactile Guidance System v2.0. This document focuses on establishing substantial equivalence to previously cleared devices for regulatory approval, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical or technical context like an AI/ML device.
Therefore, the requested information cannot be fully extracted from this document, especially regarding acceptance criteria and a study design to prove it in the context of device performance as typically understood for AI/ML.
However, I can provide the available information and highlight what is missing:
Information Available from the Document:
- Device Name: Tactile Guidance System v2.0
- Intended Use/Indications for Use: To assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically unicondylar knee replacement and/or patellofemoral knee replacement.
- Regulatory Classification: Class II, Stereotaxic Instrument (21 CFR 882.4560).
- Predicate Devices: MAKO Surgical's Tactile Guidance System (K072806), Voyager/Tactile Guidance System-CT (K052851), and Biomet's Acumen™ Surgical Navigation System (K031454 and K031337). The basis for "proving acceptance" is substantial equivalence to these predicates, not performance against specific, quantifiable acceptance criteria presented as part of a novel study.
Missing Information (and why it's missing from this type of document):
The 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not typically a publication of a clinical trial or technical performance study with detailed acceptance criteria and results. Therefore, the document does not contain:
- A table of acceptance criteria and reported device performance: This document does not describe specific numerical performance metrics or acceptance criteria for accuracy, precision, or other performance aspects. It establishes equivalence based on similar technological characteristics and intended use.
- Sample size used for the test set and data provenance: No "test set" in the context of a performance study is mentioned. Performance is assumed to be similar to predicate devices.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no performance study described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This device is a robotic surgical assistant, not an AI diagnostic or interpretive system that "improves human readers."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly detailed, as the device is designed to assist a human surgeon.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed as no specific performance study with ground truth is described.
- The sample size for the training set: Not applicable, as this is not an AI/ML device in the modern sense that requires a large training set for model development (though software development would involve testing).
- How the ground truth for the training set was established: Not applicable.
Conclusion:
This 510(k) summary is a regulatory filing demonstrating that a new version of a robotic surgical assistance system is substantially equivalent to existing, legally marketed devices. It does not provide the kind of detailed performance study and acceptance criteria typically found for a novel device or AI/ML system seeking to prove its own efficacy or performance against specific, quantifiable benchmarks. The "study" here is the comparison to predicate devices, focusing on technological characteristics and intended use, rather than a clinical trial with specific performance endpoints.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).