(162 days)
The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.
The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld, manually manipulated surgical balloon device which dissects tissue planes, intraoperatively and subsequently expands the overlying tissue. This device is a temporary subcutaneous or submuscular implant device. The Spacemaker® Surgical Balloon Dissector/Expander is a single use, disposable device provided sterile to the physician. The major components of the device are a balloon dissector and an injection port/connector.
This document is a 510(k) summary for the Spacemaker® Surgical Balloon Dissector/Expander, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner you're requesting for an AI/ML device.
Here's why and what information is provided:
This device is a Class I manually operated surgical instrument for general use, which was cleared in 1997. At that time, and for this type of device, the regulatory pathway (510(k)) primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria through extensive clinical studies as would be required for higher-risk or AI/ML devices today.
The document states:
- "Testing in Support of Substantial Equivalence: Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."
This indicates that some design-related tests were performed (likely mechanical or material tests according to ASTM standards), but these are not performance studies in the context of diagnostic accuracy, which is what your questions imply for AI/ML.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: This information is not present in the document. The clearance was based on substantial equivalence to existing devices.
- Sample size used for the test set and the data provenance: Not applicable in the context of an "AI/ML" test set. The "tests" mentioned were likely engineering/device performance tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device designed for diagnostic interpretation.
- If a standalone performance study was done: "Specific ASTM tests" were done to evaluate design differences, but not a standalone clinical performance study as would be expected for an AI/ML diagnostic tool. The clearance is based on equivalence.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (this is not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).
Summary of available relevant information from the document:
- Device Name: Spacemaker® Surgical Balloon Dissector/Expander
- Regulatory Pathway: 510(k) (Substantial Equivalence)
- Principle of Operation: Handheld, manually manipulated surgical balloon device which dissects tissue planes and expands overlying tissue.
- Tests Performed: "Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."
- Basis for Clearance: Substantial equivalence to predicate devices (K951878 Spacemaker® and Spacemaker® II, K904265 Inamed Ruiz-Cohen Intraoperative Expander, K862203 McGhan Magna-Site™ Tissue Expander, K843704 McGhan Tissue Expander).
The document is a regulatory clearance for a physical surgical tool from 1997, preceding the widespread use of AI/ML in medical devices and the associated regulatory requirements for performance metrics and studies.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 the limitations in § 878.9.