(74 days)
The Modified PowerCut® Gold Surgical System is designed for use in arthroscopic surgical procedures where intra-articular tissue resection, shaving, and/or abrading the knee or shoulder joint is required. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site).
The modified PowerCut® Gold Surgical system will be a reusable, non-sterile, AC powered device. It is designed for use in arthroscopic surgical procedures that require intra-articular tissue resection, shaving, and/or abrading of the knee or shoulder joint. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site). Blades and drills are available separately and are not included in this Premarket Notification. The modified handpiece is composed of various medical grades of stainless steel and aluminum, and have only a brief and incidental contact with the patient.
The provided text describes a medical device, the PowerCut® Gold Surgical Power System, and its regulatory submission. It details the device's intended use, classification, and substantial equivalence to existing devices. The "Summary of Testing" section outlines the performance validation for the modified device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Details | Reported Device Performance |
|---|---|---|
| Functional Performance (Torque Measurements) | Torque parameters specified in the System Design Requirements. | "Torque measurements are recorded at various RPM readings to ensure that torque parameters meet those specified in the System Design Requirements. Test samples passed all acceptance criteria established in the functional protocol testing." |
| Electrical Safety | Meet the requirements of UL-544. | "The modified PowerCut® Gold Surgical System has been tested to meet the Electrical Safety and Thermal protection requirements of UL-544 and IEC 601." |
| Thermal Protection | Meet the requirements of IEC 601. | "The modified PowerCut® Gold Surgical System has been tested to meet the Electrical Safety and Thermal protection requirements of UL-544 and IEC 601." |
| Cleaning and Sterilization (Reusable Device) | Validation of cleaning and sterilization procedures. | "Cleaning and sterilization of this reusable device have been validated and are included within the label copy." |
| Biocompatibility | For materials in brief and incidental contact with the patient (medical grades of stainless steel and aluminum). | "The modified handpiece is composed of various medical grades of stainless steel and aluminum, and have only a brief and incidental contact with the patient. These materials have a long and well-established history of biocompatibility." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: "Quality performance testing is conducted on 100% of finished product systems." This suggests that every manufactured unit undergoes testing for torque measurements. For other tests (Electrical Safety, Thermal, Cleaning/Sterilization), the sample size is not explicitly stated as "100% of finished product systems," but "Test samples passed all acceptance criteria..." implies a representative set was used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document is a 510(k) summary submitted to the FDA in the USA, implying testing was conducted to US regulatory standards, but the physical location of the testing isn't mentioned. It is a report of
prospective testing performed on the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish a "ground truth" in the traditional sense of clinical outcome or diagnostic accuracy. The testing described is for engineering and functional performance, safety, and sterilization. These are typically assessed against pre-defined engineering specifications, regulatory standards (UL, IEC), and documented validation protocols, rather than expert consensus on a clinical "ground truth."
4. Adjudication Method for the Test Set
- Not applicable in the context of this device's performance testing. The "Summary of Testing" describes objective measurements (torque, electrical safety, thermal, cleaning validation) against established criteria, not subjective assessments requiring expert adjudication.
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 a surgical power system for arthroscopic procedures, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical surgical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For functional and safety criteria, the "ground truth" is defined by engineering specifications, regulatory standards (UL-544, IEC 601), and validated protocol criteria.
- For biocompatibility, the "ground truth" is established by the long and well-established history of biocompatibility of the materials used (medical grades of stainless steel and aluminum).
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set is used.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.