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510(k) Data Aggregation
(86 days)
EQUINOX CO2 LASER
The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.
The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.
The Equinox CO2 Laser System is a medical device, and the provided text describes its 510(k) summary for FDA clearance. The "study" mentioned is a performance test to demonstrate the device's effects on tissue, rather than a clinical trial with acceptance criteria for statistical endpoints.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., "depth must be between X and Y"). Instead, the performance data seems to be presented to demonstrate the effect and healing response of the device, implying that the observed effects were deemed acceptable for its intended use and comparable to a predicate device. The conclusion of "substantial equivalence" is based on these demonstrated effects.
Reported Device Performance:
| Parameter Group | Energy | Depth (Day 0) | Width (Day 0) | Depth (Day 3) | Width (Day 3) | Depth (Day 14) | Width (Day 14) |
|---|---|---|---|---|---|---|---|
| 120µm Spot Size | 50 mJ | 87.4 µm | 114.1 µm | 59.7 µm | 86.8 µm | 59.7 µm | 86.8 µm |
| 100 mJ | 100.8 µm | 195.5 µm | 83.6 µm | 155.7 µm | - | - | |
| 200 mJ | 158 µm | 221.5 µm | 61.5 µm | 179.2 µm | 59.1 µm | 86.8 µm | |
| 800µm Spot Size | 50 mJ | 50.06 µm | 296 µm | 36.06 µm | 256.01 µm | 31.02 µm | 170.40 µm |
| 100 mJ | 69.2 µm | 360.5 µm | 41.03 µm | 285.5 µm | 25.30 µm | 105.01 µm | |
| 200 mJ | 81.8 µm | 437 µm | 66.37 µm | 401 µm | 20.03 µm | 172.04 µm |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The device was used "on a pig." The exact number of pigs or specific treatment sites on the pig is not detailed, but it indicates a very small sample, likely a single animal experimentation.
- Data Provenance: The data was generated through an experimental study on a pig. The country of origin is not specified but implicitly within the context of an FDA submission. This is a prospective study in the sense that the experiment was conducted specifically to generate this data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for evaluating the histology data. It simply states the "targeted area was biopsied to evaluate the effect." It's implied that qualified personnel (e.g., pathologists or histologists) analyzed the biopsies, but no specific details are provided.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. Given the nature of the study (histology on a pig), it's highly unlikely that a formal adjudication process involving multiple human readers for a "test set" in the context of image interpretation was employed. The evaluation was likely direct analysis of tissue samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data is derived from direct histological analysis of tissue treated by the device, not from human readers interpreting data with or without AI assistance. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of device and study.
6. Standalone Performance Study
Yes, a form of standalone performance study was done. The "Performance Data: Histology data was submitted to support clearance of the device in fractionated mode" describes the direct effect of the algorithm/device on tissue. This is a direct measurement of the device's physical output (thermal damage zones and healing response) without human-in-the-loop performance measurement.
7. Type of Ground Truth Used
The ground truth used was histology (microscopic examination of biopsied tissue). This provides direct biological evidence of the device's effects (depth and width of thermal damage zones and healing response).
8. Sample Size for the Training Set
The document does not mention a training set. This is because the Equinox CO2 Laser System is a physical laser device, not an AI/machine learning algorithm that requires a training set for model development. The performance evaluation is based on direct physical effects.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device type, this question is not applicable.
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(283 days)
EQUINOX CO2 LASER SYSTEM
The Equinox CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.
The Equinox CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.
The Equinox CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.
The Equinox CO2 Laser System's performance for the fractionated mode was shown by histology data. The study involved using the device on a human arm with varying energy levels (10mJ, 40mJ, 70mJ per microbeam). The target area was then biopsied to evaluate the effect, specifically looking at the depth and width of thermal damage zones and the healing response over time.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet to be deemed acceptable. Instead, it presents the histology data from the study and then concludes that based on this data (and similar technology characteristics), the device is substantially equivalent to the predicate device. The performance data itself serves as the support for this claim of substantial equivalence for ablative skin resurfacing.
Therefore, the "acceptance criteria" can be inferred to be the demonstration of typical thermal damage and healing patterns consistent with fractional CO2 laser resurfacing, which the provided data aims to illustrate. The reported device performance is the histology data.
| Performance Metric | 10 mJ (Day 0) | 40 mJ (Day 0) | 70 mJ (Day 0) | 10 mJ (Day 3) | 40 mJ (Day 3) | 70 mJ (Day 3) | 70 mJ (Day 14) |
|---|---|---|---|---|---|---|---|
| Depth of Thermal Damage | 115.01 µm | 200.24 µm | 272.56 µm | 94.78 µm | 164.50 µm | 217.22 µm | 43.87 µm |
| Width of Thermal Damage | 347.30 µm | 358.75 µm | 362.13 µm | 293.71 µm | 313.20 µm | 334.49 µm | 95.28 µm |
(Note: Data for 10mJ and 40mJ at Day 14 were "X", indicating they were not provided or not relevant for the conclusion at those specific energy levels and time points in this summary.)
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document states the device was "used on a human arm." It does not specify the number of subjects or the number of sites on the arm. It implies a single human subject ("a human arm").
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective report of a study that was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide details on the number or qualifications of experts used to establish the ground truth for the histology (e.g., who interpreted the biopsies). It simply states the target area "was biopsied to evaluate the effect."
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
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
No MRMC study was done, as this is a laser device, not an AI diagnostic tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the laser device itself, directly evaluating its physical effects on tissue, which is precisely what the histology study represents. The device's performance was assessed based on the direct results (thermal damage depth and width) in the biological tissue.
7. The Type of Ground Truth Used
The ground truth used was histology from biopsied tissue. This is considered objective biological evidence of the device's effects on human skin.
8. The Sample Size for the Training Set
The document does not mention a training set. This is a medical device performance study, not an AI model requiring separate training data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device performance study.
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