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The Dixtal DX-4100 Series Pulse Oximeter monitors are intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2) and pulse rate in neonatal, infant, pediatric and adult patients, in environments where pulse oximetry is indicated for use, when in the judgment of a licensed medical practitioner/physician pulse oximetry is required.

The DX-4100 Series Pulse Oximeter Monitors is a modification to the Philips VM-1 (K081937) SpQz/CO₂ Monitor. The Monitor uses the same picoSAT IP44 SpO₂ engine as the VM-1, the same power supply, battery and technically the same display (same resolution as used in the VM-1) and has the same intended use as the VM-1 (Pulse Oximetry only). The Monitors will use the Dixtal (FDA cleared: K100020) Pulse Oximetry DX Series SpO2 Sensors. A second version of the DX-4100 Series Pulse Oximeter is equipped with the Philips receptacle thereby providing direct connection to the full line of sensors as indicated for the VM-1. Accuracy testing included with the sensor submission was performed with the Philips VM-1 monitor.

The provided text describes a 510(k) summary for the Dixtal DX-4100 Series Pulse Oximeter where substantial equivalence is claimed based on performance data from the predicate device (Philips Sure Signs Monitor, Model VM-1) and previously cleared sensors (Dixtal DX Series SpO2 Sensors). The information regarding the specific acceptance criteria and detailed study supporting device performance is somewhat fragmented and relies heavily on cross-referencing previous submissions.

Here's an attempt to extract and synthesize the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly listed in a table format with numerical targets. Instead, the document states that the conclusion of the risk assessment and performance data is that the device is "safe and effective for its intended use" and "substantially equivalent to the predicate devices." The core performance metric for pulse oximeters is accuracy in measuring oxygen saturation (SpO2).

• Device provides continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO2). | - "Controlled de-Sat (Accuracy) Testing was performed with the Dixtal DX Series sensors and the VM-1."
• "This data was initially submitted in support of the recently cleared Premarket Submission for the Dixtal DX Series Sensors (K100020)."
• Implied to meet accuracy standards required for substantial equivalence, as the device uses the same SpO2 engine as the predicate and cleared sensors.
• Predicate device (VM-1) post-market data indicates a low failure rate and no reportable events, suggesting good performance. |
  | Pertaining to Pulse Rate Accuracy:
• Device provides continuous, non-invasive monitoring of pulse rate. | - "Pulse rate is calculated by measuring the time interval between the peaks of the infrared light waveform."
• Implied to meet accuracy standards required for substantial equivalence. |
  | Safety and Effectiveness:
• Device is safe and effective for its intended use. | - "The Risk Assessment concluded the device is safe and effective for its intended use."
• "Post Market Data specific (only) to the VM-1...indicates less than 0.5% failure rate with no reportable events." |
  | Biocompatibility of Components:
• Materials in contact with patient are biocompatible. | - "The DX-4100 Series Pulse Oximeter Monitors is a bedside monitor that is not intended for contact with patients."
• "The sensors intended for use with the monitor have been previously tested to assure biocompatibility for skin contact devices."
• Listing of sensor materials (silicone, PBT, polycarbonate, PVC, polyurethane) and assertion of no latex, DEHP, or Phthalates. |

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document states: "Controlled de-Sat (Accuracy) Testing was performed with the Dixtal DX Series sensors and the VM-1. This data was initially submitted in support of the recently cleared Premarket Submission for the Dixtal DX Series Sensors (K100020)."
   • Specific sample size for the "Controlled de-Sat (Accuracy) Testing" is NOT provided in this document. It refers to a previous submission (K100020).
   • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin for the de-saturation study. However, the mention of "Post Market Data" for the predicate device (VM-1) covers "April 2009 through June 2010" and mentions ">380 units distributed domestically," implying retrospective real-world data from the US for the predicate.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not explicitly mentioned in this summary. The "Controlled de-Sat (Accuracy) Testing" refers to a physiological challenge study where subjects' oxygen saturation is lowered. Ground truth in such studies typically comes from arterial blood gas analysis performed by clinical staff, rather than "experts" establishing ground truth in the typical diagnostic imaging sense.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not mentioned. This type of adjudication method is usually relevant for studies requiring subjective interpretation (e.g., image reading), which is not the primary method for validating pulse oximetry accuracy.

4. 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:

   • No, an MRMC study was NOT done. This device is a standalone medical device (pulse oximeter) that directly measures physiological parameters like SpO2 and pulse rate. It does not involve human "readers" or AI assistance in the way, for example, an AI-powered diagnostic imaging tool would.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence, standalone performance was assessed. The "Controlled de-Sat (Accuracy) Testing" inherently evaluates the device's (pulse oximeter with its sensors and internal algorithms) ability to accurately measure SpO2 against a reference standard (arterial blood gas) without human interpretation affecting the primary measurement. The DX-4100 series itself is described as a "stand-alone Pulse Oximeter monitor."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "Controlled de-Sat (Accuracy) Testing" for pulse oximeters typically uses arterial blood gas analysis as the gold standard (ground truth) for actual arterial oxygen saturation. This is inferred from the industry standard for such studies.

7. The sample size for the training set:

   • Not applicable/Not mentioned. Pulse oximeters are typically based on well-established biophysical principles (light absorption at different wavelengths) and calibrated using laboratory standards and human de-saturation studies. The term "training set" is more commonly associated with machine learning or artificial intelligence models, which this device does not appear to utilize in the context of its core SpO2/PR measurement.

8. How the ground truth for the training set was established:

   • Not applicable. As "training set" for a machine learning model is not relevant here. The ground truth for the performance evaluation (test set) is inferred to be arterial blood gas analysis, as described above.

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