(77 days)
The Smith & Nephew SURESHOT Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew SURESHOT Targeting System is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.
Subject of this premarket notifications to the SURESHOT Targeting System. The modifications to the SURESHOT® Targeting System V2.1 implement the ability to target for humeral nails, along with the former applications with the META, TAN and FAN Nails previously cleared via K100107. Targeting for humeral nail is implemented in the same way as for META/TAN nails.
The SURESHOT® Targeting System is a computer controlled electromagnetic tracking system. It assists the surgeon in locating and positioning screws in an intramedullary nail implant during orthopedic trauma surgery. The link between the sterile surgical area (patient) and the instrument system is provided through an electromagnetic tracking system. Electromagnetic spatial measurement systems determine the location of instruments that are embedded with sensor coils. When the sensor-embedded instrument is placed inside controlled, varying magnetic fields, voltages are induced in the sensor coils. These induced voltages are used by the measurement system to calculate a 3D virtual position of the instrument. Because the magnetic fields are of a low field strength and can safely pass through human tissue, location measurement of an object is possible without the line-of-sight constraints of an optical spatial measurement system that requires a camera.
The SURESHOT® Distal Targeting System software is intended to be used with existing Smith & Nephew platform, instruments and implants. New instrumentation has been developed for the humeral nail application aspect of the software. The devices subject of this premarket notification include:
- SURESHOT® Distal Targeting System Software V2.1 .
- Humeral Set Stop .
- Humeral Drill Guide Probe .
- Humeral Hexdriver
- Humeral Drill Sleeve .
- . Humeral AO Drill
No new implants are being cleared via this premarket notification
The provided text describes the Smith & Nephew SURESHOT® Distal Targeting System V2.1, a computer-assisted surgical system, and its premarket notification (K110240). However, it does not contain information about specific acceptance criteria or a dedicated study proving the device meets those criteria in terms of quantitative performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices by highlighting similarities in:
- Indications for Use: The system is an intraoperative image-guided localization system to aid surgeons with drill positioning for screws during intramedullary nail implantation.
- Design Features: It's a computer-controlled electromagnetic tracking system. The V2.1 version adds humeral nail targeting capability.
- Sterilization Methods and Operational Principles.
The primary method of demonstrating safety and effectiveness for this type of submission (a Special 510(k) for software modification) is through software verification and validation testing, not through a clinical performance study with defined acceptance criteria for accuracy, sensitivity, or specificity.
Therefore, the requested information cannot be fully extracted as a specific clinical study with detailed performance metrics and acceptance criteria, as one was not presented in the provided document for K110240.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Anticipated for a clinical performance study) | Reported Device Performance (from text) |
|---|---|
| Not specified in the provided document | Not specified in the provided document |
Reasoning: The document states, "Software verification and validation testing was completed... A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device and the software will perform as intended. Clinical data was not needed to support the safety and effectiveness of the subject device." This indicates that a study with defined performance metrics and acceptance criteria was not part of this 510(k) submission. The FDA clearance letter also supports this by stating the device is "substantially equivalent" to predicates, implying a comparison on design and intended use, rather than a new performance study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/Not provided. No clinical test set data was used.
- Data Provenance: Not applicable/Not provided.
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)
- Number of experts: Not applicable/Not provided.
- Qualifications of experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not provided.
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
- MRMC study: No.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: No. The device is described as "an intraoperative image guided localization system" and a "computer assisted orthopedic surgery tool to aid the surgeon," clearly indicating a human-in-the-loop system, not a standalone algorithm. Also, the document explicitly states "Clinical data was not needed to support the safety and effectiveness of the subject device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not applicable/Not provided. The submission relies on software verification and validation to demonstrate proper function, rather than clinical ground truth.
8. The sample size for the training set
- Sample Size: Not applicable/Not provided. This device is an electromagnetic tracking system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software design" mentioned refers to the system's logic and functionality, not a trained model.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/Not provided.
In summary, the provided submission for K110240 is a Special 510(k) focusing on a software modification (adding humeral nail targeting) to an existing device. It relies on software verification and validation and a demonstration of substantial equivalence to predicate devices, rather than a new clinical study with performance metrics and acceptance criteria. Therefore, most of the requested details related to clinical studies, ground truth establishment, and sample sizes are not present in the document.
§ 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).