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K Number
K031555
Device Name
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
Manufacturer
SYNTHES (USA)
Date Cleared
2003-07-08

(50 days)

Product Code
LXC
Regulation Number
N/A
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synthes (USA) Compartmental Pressure Monitoring System is intended for the immediate or continuous measurement of intracompartmental pressures.

Device Description

The Synthes (USA) Compartmental Pressure Monitoring System consists of a hand-held monitoring device, a re-sterilizable pressure measurement probe, and an optional extension cable. The hand-held monitoring device houses the operational software and the LCD display. The pressure measurement probe connects directly to the hand-held unit or can be attached using the optional extension cable. A 9-volt battery powers the monitor. The probe is inserted into the target compartment via a 14-gauge catheter supplied by the user.

AI/ML Overview

The provided text does not contain information regarding acceptance criteria, device performance against these criteria, or any details about a study conducted to prove the device meets such criteria.

The document is a 510(k) summary for the Synthes (USA) Compartmental Pressure Monitoring System, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device. It includes:

  • Sponsor and Device Information: Synthes (USA), Compartmental Pressure Monitoring System.
  • Device Classification: Class II.
  • Device Description: Hand-held monitoring device, re-sterilizable pressure measurement probe, optional extension cable, 9-volt battery, and insertion via a 14-gauge catheter.
  • Indications for Use: Immediate or continuous measurement of intracompartmental pressures.
  • Substantial Equivalence: A statement that documentation demonstrates substantial equivalence.
  • FDA Communication: A letter from the FDA confirming the substantial equivalence determination and allowing marketing, subject to general controls.

There is no mention of:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, or study design for any performance testing.
  3. Number or qualifications of experts.
  4. Adjudication method.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the given input.

N/A