(85 days)
The Peleton Surgical Single Use Power Tool System is a battery driven tool system for use in Trauma, Orthopaedic and Cardio related Surgical Procedures involving drilling, reaming, pin & wire placement and cutting of bone and hard tissue.
The Peleton Surgical Universal Power System is a battery powered tool for use in cardio-ortho related surgical procedures and is designed for the efficient cutting of bone and hard tissue. Due to the sterile barrier charging, the device is readily charged and available for immediate use in the surgical setting. The Peleton Surgical Universal Power System's lithium-ion polymer battery is always fully charged with more power than is needed for any surgery. Surgical attachments are easily interchangeable and cover every aspect of large bone surgical procedures, including, cutting reaming, sawing and surgical pin insertion and removal etc.
The Peleton Surgical Universal Power System is a double sterile barrier packaging system that includes internal and external electrical charging port features. This double sterile barrier packaging system consists of the device and its components being sealed inside an inner tray with a charging the device and the inner tray charging port. The sealed inner tray is then sealed inside an outer tray with a charging cable connecting the inner tray charging port to the outer tray charging port. The charging port includes various components to ensure a tight seal that maintains the proper sterile barrier.
The Peleton Surgical Universal Power System includes a variety of metallic attachments (ASTM F899) that are used in clinical procedures. The system is compatible with a Sternum Saw, Reciprocating Saw, Keyless Jacobs Chuck, Multi-Fit Hudson/Trinkle Reamer, Cannulated Pin and Wire Driver and Quick Release Drill Chuck. Each attachment is compatible with universal saws, drill bits and reamers from manufacturers of orthopedic accessories.
The single use Peleton Surgical Universal Power System was designed to instantly be ready to the surgical field, reducing operating room time, eliminating the need for multiple batteries/changes on extended cases, eliminating the risk of potential bioburden from improper cleaning from previous cases and reducing the amount of time needed to properly clean and re-sterilize the reusable system.
The provided document is a 510(k) summary for the Peleton Universal Single Use Power System and Attachments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies with acceptance criteria for diagnostic performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of diagnostic accuracy, human reader improvement with AI assistance, or standalone algorithm performance.
Specifically, the document primarily addresses:
- Device Description and Intended Use: Clarifying what the device is and what it's used for (surgical procedures involving bone/hard tissue).
- Technological Comparison: Highlighting similarities and differences with predicate devices, particularly the innovative sterile barrier charging.
- Non-Clinical Testing: Detailing various engineering and safety tests performed to demonstrate the device's functional integrity, material compatibility, and safety (e.g., visual inspection, dimensional inspection, corrosion testing, attachment compatibility, mechanical testing, battery safety, packaging validation, EMC, biocompatibility).
The "Conclusions" section states that "Based on the intended use, indications for use, technological characteristics, and performance data, the subject Peleton Surgical Universal Power System is as safe and was concluded to be substantially equivalent to the applicable predicate devices." This is the core of a 510(k) submission, confirming equivalence for marketing, not diagnostic performance metrics against clinical ground truth.
Therefore, I cannot provide the requested table and study details because the information is not present in the provided FDA 510(k) summary. The device described is a surgical instrument, not an AI/imaging device requiring diagnostic performance criteria.
§ 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.