(88 days)
The ADAPT for Gamma3 System, when used with the Stryker Navigation System, assists the surgeon to determine the needed size and position of orthopedic implants during femur fracture surgery using the Gamma3 System.
When used in operation the system should be operated only by trained personnel such as surgeons and clinic staff.
The ADAPT for Gamma3 Software is a surgical navigation system intended to be used with the Gamma3 Nail system, cleared in K200869. The updated software, in conjunction with the ADAPT mobile- Digital Port Connector, allows the ADAPT mobile PC unit to receive and process images from c-arms with flat panel detectors and/or digital signals. The ADAPT 2.1 for Gamma3 software supports all features which were already supported by the existing ADAPT 2.0 for Gamma3 software cleared in K181848.
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is an FDA 510(k) clearance letter for a medical device called "ADAPT for Gamma3," which is a surgical navigation system.
The document discusses the substantial equivalence of the new version of the software (ADAPT 2.1 for Gamma3) to a previously cleared version (ADAPT 2.0 for Gamma3, K181848). It mentions non-clinical testing performed to verify system accuracy and validate product requirements, but it does not detail specific acceptance criteria or the study that demonstrates the device meets them in the way described in the request.
Here's a breakdown of why the requested information cannot be provided from the given text:
- Table of acceptance criteria and reported device performance: This information is not present. The document states that non-clinical testing verified a system accuracy of 2 mm, but this is a single performance metric, not a comprehensive table of acceptance criteria.
- Sample size, data provenance: The document mentions "different simulated use case scenarios – to verify a system accuracy of 2 mm. These scenarios include saw bone tests and simulated use tests," but gives no specific sample sizes for these tests or data provenance.
- Number of experts and qualifications: No information about experts used to establish ground truth is provided.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: The document explicitly states, "Clinical testing was not required for this submission." This implies no human-in-the-loop study comparing human readers with and without AI assistance was performed or required for this 510(k) submission.
- Standalone performance: While non-clinical testing was performed, it's described in terms of verifying system accuracy and validating product requirements, not as a standalone performance study with detailed metrics like sensitivity, specificity, or AUC against a defined ground truth. The primary focus of the document is substantial equivalence to a predicate device.
- Type of ground truth: For the non-clinical tests, the ground truth is implicitly based on engineered or simulated conditions ("simulated use case scenarios," "saw bone tests"). There's no mention of expert consensus, pathology, or outcomes data.
- Sample size for training set: Not mentioned. The document describes software updates, not the initial development or training of a machine learning model.
- How ground truth for training set was established: Not mentioned, as details about a training set are absent.
In summary, the provided FDA 510(k) letter focuses on demonstrating substantial equivalence through non-clinical testing and describes software updates, rather than detailing a specific clinical or non-clinical study that establishes acceptance criteria and proves the device meets them with the level of detail requested.
§ 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).