(87 days)
The SELECTOR® Integra Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
The Selector Ultrasonic Surgical Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures. The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The Handpieces have a titanium tip and irrigation flue. The required settings on the console are selected by operation of up-down controls on the membrane switch front panel. The console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection. A range of Handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system is available for use within an MRI suite. All handpieces can be sterilized by steam autoclaving or by Ethylene Oxide. A large number of these are in routine use.
The provided text is a 510(k) summary for the Selector® Integra Ultrasonic Surgical Aspirator System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
However, the document does not contain a study that proves the device meets specific acceptance criteria in the way typically found in a clinical trial or performance study focusing on metrics like sensitivity, specificity, accuracy, or diagnostic improvement. Instead, it relies on demonstrating substantial equivalence to already approved devices by comparing technical specifications, function, performance, and intended use.
Therefore, for many of your requested points, the information will be unavailable as the document does not present a performance study in that context.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of clinical performance metrics, nor does it report specific performance data for the device against such criteria. Instead, it focuses on demonstrating that the device's technical specifications and functionality are within acceptable ranges when compared to predicate devices, and that it conforms to relevant safety standards.
Here's a table based on the information provided regarding the device's characteristics and its equivalence to predicates:
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Selector® Integra) |
|---|---|---|
| Indications for Use | Fragmenting, emulsifying, and aspirating soft tissue in various surgeries (Neuro, GI, Uro, Plastic & Recon, General, Ortho, Gynecology, Thoracic, Laparoscopic, Thoracoscopic) | Matches predicate devices |
| Where Used | Hospitals | Hospitals |
| Basic Operating Principle | Ultrasonic action for tissue fragmentation and cavitation, irrigation, aspiration | Ultrasonic action through Titanium Alloy Tip onto biological tissue causes fragmentation and cavitation of tissue. Irrigation system bathes site, aspiration removes unwanted ablated tissue. |
| Vibration System | Piezo (matching two predicates) | Piezo |
| Frequency | 23-36 kHz (range of predicates) | 24 kHz & 35 kHz |
| Irrigation Flow | 1-50 ml/min (range of predicates) | 0-50 ml/min |
| Aspiration Vacuum | 0-660 mmHg (range of predicates) | 0-600 mmHg |
| Tip Amplitudes | Max 210-350µm (range of predicates) | Max 24 kHz: 305µm, Max 35 kHz: 215µm |
| Materials in Contact with Tissue | TiAl6V4 / Titanium Alloy (matching predicates) | TiAl6V4 Titanium Alloy |
| Power Source | 100-240V, 50/60Hz (range of predicates) | 100-240V, 50/60Hz |
| Sterility | Steam, EtO (matching predicates) | Steam, EtO |
| Electrical Safety Standards Met | Various IEC, CSA, EN, FCC, JIS, UL standards (range of predicates) | CSA 22.2 No. 601-1, EN 60601-1, EN60601-1-2, FCC 18, JIS T1001/1002, UL2601-1 (plus IPX 2.7 for footswitch) |
| Tip External Diameters | 1.93-4.5 mm (range of predicates) | 1.95 to 2.5 mm |
| Handpiece Cooling | Water/Air (matching predicates) | Air (matching most predicates) |
| Biocompatibility | Tested and Compliant to ISO 10993-1 | Confirmed |
2. Sample size used for the test set and the data provenance
There is no mention of a "test set" in the context of a clinical performance study. The 510(k) submission relies on comparison to predicate devices and adherence to safety standards. No patient data (retrospective or prospective) is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth is described.
4. Adjudication method for the test set
Not applicable. No test set is described.
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. This device is an ultrasonic surgical aspirator, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human "readers" 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 is a surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate devices. The new device proves "substantial equivalence" by meeting similar technical specifications and performance characteristics, and adhering to recognized safety and sterility standards.
8. The sample size for the training set
Not applicable. The device is not an AI model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned. The submission focuses on device design, materials, and comparison to existing, legally marketed devices.
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