(88 days)
The Freddo is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
The Freddo is a non-invasive therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Freddo device is substantially equivalent as the currently cleared Cryo 6 (K060395).
The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans, and all electrical power components. On the upper front cover, the user interface control it operated via membrane keyboard.
The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via membrane keyboard. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.
The provided text does not contain information about specific clinical studies or performance data for the FREDDO device that would allow for a detailed description of acceptance criteria and a study proving device performance in the manner requested.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Cryo V6.0, K060395) through a comparison of technological characteristics and compliance with general safety and performance standards.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists performance characteristics in a comparison table, but these are specifications rather than acceptance criteria derived from a clinical study.
| Performance Characteristic (for the subject device, Freddo) | Reported Device Performance (Freddo) | Predicate Device Performance (Cryo V6.0) | Discussion/Acceptance Implication |
|---|---|---|---|
| Measurement at device outlet (Temperature) | -17°C to -28°C (± 3°C) | -31°C | Similar, not significantly different |
| Measurement at device outlet (Air speed) | 160 to 780 liters/minute (± 10%) | 100 to 1000 liters/minute | Similar, not significantly different |
| Therapy time, treatment time | 15:00 – 90:00 min timer – user selectable | 1-99 minute timer - user selectable | Similar, not significantly different |
No explicit "acceptance criteria" for clinical effectiveness are provided, as this is a substantial equivalence submission based on technical similarity rather than a new clinical claim. The "acceptance criteria" here implicitly revolve around meeting the performance specifications to be considered substantially equivalent to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on technical verification and validation, and comparison to a predicate device, not a specific clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. Experts were not involved in establishing ground truth for a clinical test set because no such test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as no clinical test set requiring adjudication is described.
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
This information is not provided in the document. The FREDDO device is a cold air therapy device, not an AI-assisted diagnostic or interpretative tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no clinical ground truth was established for the purpose of a clinical performance study. The "ground truth" in this submission relates to the functional performance of the device against engineering specifications and its equivalence to the predicate.
8. The sample size for the training set
This information is not provided in the document. This device is not an AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
This information is not provided in the document, as there is no training set for this type of device.
Summary of available information regarding the study that proves the device meets acceptance criteria:
The "study" demonstrating the device meets performance expectations and is safe and effective largely consists of:
- Compliance with recognized standards: The device was investigated and tested against various IEC and ISO standards related to medical electrical equipment, basic safety, essential performance, electromagnetic disturbances, usability, software life cycle processes, risk management, symbols, and biocompatibility.
- Standards include: IEC 60601-1 Ed. 3.2, IEC 60601-1-2 Ed. 4.1, IEC 60601-1-6 Ed. 3.2, IEC 62366-1 Ed. 1.1, IEC 62304 Ed. 1.1, ISO 14971 Ed. 3, ISO 15223-1 Ed. 4, ISO 10993-1 Ed. 5.
- Software Verification and Validation Testing: Performed according to IEC 62304. All tests were successful and met acceptance criteria, demonstrating suitability for intended use and no identified risks.
- Biocompatibility Testing: Assessed per ISO 10993-1. Concluded that no additional biocompatibility requirements existed because the device does not contact the patient and the user contacts it only via gloved hands.
- Electrical Safety and Electromagnetic Compatibility (EMC): Underwent testing and complies with IEC 60601-1 Ed. 3.2 and IEC 60601-1-2 Ed. 4.1.
- Comparison to Predicate Device (Cryo V6.0, K060395): The submission argues that the FREDDO device has similar technological characteristics, identical intended use, and similar performance characteristics to the legally marketed predicate device, with differences not raising new questions of safety or effectiveness.
In conclusion, the approval of the FREDDO device is based on its substantial equivalence to a predicate device and compliance with established performance and safety standards, rather than a clinical study evaluating its direct clinical performance against specific acceptance criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.