(76 days)
The MC1 Plus is indicated for:
a) Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains;
- Relieves muscle spasms;
- Temporarily improves local blood circulation;
- Temporarily reduces the appearance of cellulite.
b) Ultrasonic Diathermy: - Relief of pain;
- Muscle spasms;
- Joint contractures;
- NOT for the treatment of malignancies.
MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.
The provided text is a 510(k) Summary for the General Project MC1 Plus device, a computerized body massager and ultrasound diathermy system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MC1, K091615), rather than describing a study with acceptance criteria for a novel device's performance.
Therefore, the requested information categories (1-7, 9) cannot be fully populated as they pertain to clinical studies designed to establish specific performance metrics against pre-defined acceptance criteria for a new device. This document primarily relies on engineering and electrical safety testing, and performance testing for equivalence to a predicate, not clinical trials to prove device efficacy against acceptance criteria.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a clinical study for intended use. Instead, it demonstrates compliance with recognized electrical safety and performance standards, and comparison to a predicate device.
| Acceptance Criteria Category | Specific Criteria (from standards or predicate comparison) | Reported Device Performance (MC1 Plus) |
|---|---|---|
| Electrical Safety | Conformance to AAMI/ANSI ES60601-1 | Conforms |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 | Conforms |
| Ultrasonic Physiotherapy Equipment Electrical Safety | Conformance to IEC 60601-2-5 (3rd ed.) | Conforms |
| Tissue Heating Performance | Equivalence to MC1 (K091615) in terms of increasing tissue temperature to at least 40°C | "Testing showed that the MC1 Plus increases tissue temperature as required for ultrasonic diathermy.""The two 1 MHz ultrasound transducers can be considered equivalent to the MC1 in terms of heating tissue temperature to at least 40° C." |
| Leakage Current (Ground NC) | <0.500 mA (from IEC 60601-1) | 0.085 mA |
| Leakage Current (Ground SFC) | <1.0 mA (from IEC 60601-1) | 0.107 mA |
| Leakage Current (Patient NC DC) | <0.01 mA (from IEC 60601-1) | <0.001 mA |
| Leakage Current (Patient NC AC) | <0.10 mA (from IEC 60601-1) | <0.01 mA |
| Leakage Current (Patient SFC DC) | <0.05 mA (from IEC 60601-1) | <0.001 mA |
| Leakage Current (Patient SFC AC) | <0.50 mA (from IEC 60601-1) | <0.01 mA |
| Maximum Ultrasonic Power Output | Complies with IEC 60601-2-5 3rd ed. (reduced from prior device) | 15 W (reduced from 21 W) |
| Maximum Ultrasonic Intensity | Complies with IEC 60601-2-5 3rd ed. (reduced from prior device) | 3 W/cm² (reduced from 7 W/cm²) |
| ERA (Effective Radiating Area) | Complies with IEC 60601-2-5 (modified from prior device) | 4.9 cm² (modified from 3 cm²) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of human subjects or patient data. The "performance data" refers to engineering and electrical safety testing of the device itself. There is no information about data provenance (country of origin, retrospective/prospective) because it's not a clinical data study.
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)
Not applicable. Ground truth establishment by clinical experts is not mentioned as this is not a study involving diagnostic interpretation or clinical outcomes adjudicated by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance.
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
Not applicable. This device is a therapeutic massager and ultrasonic diathermy system; it does not involve "human readers" or "AI assistance" for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical therapeutic device, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable. The device's performance stands alone in its function without a human interpretation loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims appears to be:
- Engineering measurements and standards: Conformance to internationally recognized electrical safety and EMC standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-5) through direct testing of the device's electrical parameters and output.
- Comparison to predicate device: Demonstration that the MC1 Plus performs "similarly" to the predicate MC1 in terms of its ability to increase tissue temperature to at least 40°C. This implies that the predicate's established performance serves as the benchmark for this equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, there is no ground truth establishment for a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2016
General Project S.R.L. % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864
Re: K161502
Trade/Device Name: MC1 Plus Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI. ISA Dated: July 19, 2016 Received: July 20, 2016
Dear Ms. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael J.Hoffmann -A
- for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K161502
Device Name MC1 Plus
Indications for Use (Describe) The MC1 Plus is indicated for:
- Therapeutic Massager: a)
-
- Provides temporary relief of minor muscle aches and pains;
-
- Relieves muscle spasms;
-
- Temporarily improves local blood circulation;
-
- Temporarily reduces the appearance of cellulite.
-
Ultrasonic Diathermy: b)
-
- Relief of pain;
-
- Muscle spasms;
-
- Joint contractures;
-
- NOT for the treatment of malignancies.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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{3}------------------------------------------------
510(k) SUMMARY K161502 As required by Section 807.82(c)
-
- Submitter: [807.92 (a)(1)]
General project s.r.1. Via della Gora 15/19 50025 Montespertoli (Firenze) Italy tel: +39 0571 675076 fax: +39 0571 675077 email: info@generalproject.com internet: www.generalproject.com
- Submitter: [807.92 (a)(1)]
-
- Contact Person: [807.92 (a)(1)] Maureen O'Connell Regulatory Affairs Consultant 5 Timber Lane North Reading, MA 01864 tel: (978) 207-1245
-
- Date Summary Prepared: [807.92 (a)(1)] July 19, 2016
4. Device Names: [807.92 (a)(2)]
| Proprietary | MC1 Plus | ||
|---|---|---|---|
| Common | Diathermy, Ultrasonic, For Use in Applying Therapeutic Deep Heatand Therapeutic Massager | ||
| Classification Name | Prod. Code | CFR | |
| Class II, Ultrasonic Diathermy For UseIn Applying Therapeutic Deep Heat | IMI | 890.5300 | |
| Class I, Massager, Therapeutic, Electric | ISA | 890.5660 |
5. Reason for Submission of Special 510(k):
Change of User Interface and power output level to comply with IEC 60601-2-5 3td ed. standard
6. Modification to Existing Device (Predicate): [807.92 (a)(3)]
MC1 computerized body massager and ultrasound diathermy device K091615 (Cleared May 6, 2010)
7. Reason for Device Modification: [807.92 (d)]
To better the usability of the device using a wider display and a software with improved graphic. To provide a better maintenance, a more robust software solution and an easier scalability. To comply the user interface to the status of art, in particular to comply standard IEC 60601-2-5 3rd ed.
-
- Device Description: [807.92 (a)(4)+(6)]
MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.
- Device Description: [807.92 (a)(4)+(6)]
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9. Intended Use: [807.92 (a)(5)]
The MC1 Plus is indicated for:
- a) Therapeutic Massager:
-
- Provides temporary relief of minor muscle aches and pains;
-
- Relieves muscle spasms,
-
- Temporarily improves local blood circulation:
-
- Temporarily reduces the appearance of cellulite.
-
- b) Ultrasonic Diathermy:
-
- relief of pain;
-
- Muscle spasms;
-
- Joint contractures;
-
- NOT for the treatment of malignancies.
-
10. Industry Standards: [807.92 (d)]
General Project declares the conformance to the following standards:
AAMI/ANSI ES60601-1, Medical Electrical Equipment-Part 1: General Requirements for Safety, 3rd ed
IEC 60601-1-2, General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, 3td ed
IEC 62304, Medical Device Software - Software Life Cycle Processes
IEC 60601-2-5, Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment, 3rd ed
11. Information Bearing on the Safety and Effectiveness
The General Project MC1 Plus has the same intended use as MC1 cleared device (K091615). There is no change in materials, classification or labeling. There is no change in the system of control of the device. There are no modifications that have the potential to alter the fundamental scientific technology. The only changes are in the Human Interface and the level of ultrasonic power output. These changes do not affect the safety or effectiveness of the device. Rather, the human interface changes improve the usability of the device using a wider display and a software with a improved graphic and furthermore provide a better maintenance, a more robust software solution and an easier scalability. The maximum ultrasonic power output (now 15 W with max intensity level of 3 W/cm², before 21 W with max intensity level of 7 W/cm²) has changed to comply IEC 60601-2-5 3rd ed. There are no additional characteristics known that should adversely affect the safety and effectiveness of this device. The results of design validation raise no new issues of safety and effectiveness.
12. COMPARISON of DESIGN, SAFETY and EFFECTIVENESS
| Parameters | Subject device K161502 | Predicate device K091615 | Rationale |
|---|---|---|---|
| Manufacturer | General Project | General Project | Same |
| IFU | a. Therapeutic massager | a. Therapeutic massager | Same |
| 1. Provides temporary relief | 1. Provides temporary relief | ||
| of minor muscle aches and | of minor muscle aches and | ||
| pains | pains | ||
| 2. Relieves muscle spasms | 2. Relieves muscle spasms | ||
| 3. Temporarily improves | 3. Temporarily improves | ||
| local blood circulation | local blood circulation | ||
| 4. Temporarily reduces the | 4. Temporarily reduces the | ||
| appearance of cellulite | appearance of cellulite | ||
| b) ultrasonic diathermy | b) ultrasonic diathermy | ||
| 1. Relief of pain | 1. Relief of pain | ||
| 2. Muscle spasms | 2. Muscle spasms | ||
| 3. Joint contractures | 3. Joint contractures | ||
| 4. Not for the treatment of | 4. Not for the treatment of | ||
| malignancies | malignancies | ||
| Type | Ultrasound and vacuum | Ultrasound and vacuum | Same |
| pressure massage | pressure massage | ||
| Product code | IMI, ISA | IMI, ISA | Same |
| Preselected programs | Ultrasound handpiece: 24 | Ultrasound handpiece: 24 | Same |
| programs | programs | ||
| Zonal massage handpiece: 6 | Zonal massage handpiece: 6 | ||
| programs | programs | ||
| Protection grade | IP 20 | IP 20 | Same |
| Operating conditions | Temperature: 15 - 40 °C | Temperature: 15 - 40 °C | Same |
| (59 - 104 °F) | (59 - 104 °F) | ||
| RH 65% maximum | RH 65% maximum | ||
| Max operative altitude: | Max operative altitude: 2000 | ||
| 2000 m (6500 ft) above sea | m (6500 ft) above sea level | ||
| level | |||
| Storage environmental | Temperature: 0 - 45 °C | Temperature: 0 - 45 °C | Same |
| conditions | (32 - 113°F) | (32 - 113 °F) | |
| RH 80% max | RH 80% max | ||
| Dimensions | 700 x 675 x h1740 mm (28" | 560 x 650 x h380 mm | Different, but does not |
| x 26.6" x 68.5") with | (22"x25.6"x15") without | adversely impact safety | |
| articulated arm. | trolley | and effectiveness of the | |
| subject device | |||
| 560 x 650 x h1200 mm | |||
| (22"x25.6"x47.2") with | |||
| trolley | |||
| Weight | 76 kg (167 lbs) with short | 55 kg (121.25 lbs) with | Different, but does not |
| arm | trolley | adversely impact safety | |
| and effectiveness of the | |||
| 78 kg (172 lbs) with | subject device | ||
| articulated arm | |||
| Material | Baydur, Aluminium, | Baydur, Aluminium, | Same |
| SEBS/SEPS Thermoplastic | SEBS/SEPS Thermoplastic | ||
| Polymers | Polymers | ||
| Zonal massage handpiece | |||
| a. Max attainable | -55kPa | -55kPa | Same |
| vacuum | |||
| b. Suction time | 200 - 300ms depending on | 200 - 300ms depending on | Same |
| the selected program | the selected program | ||
| c. Relax time | 500 - 1500ms depending on | 500 - 1500ms depending on | Same |
| the selected program | the selected program | ||
| d. Treatment time | 4 - 8 mins depending on the | 4 - 8 mins depending on the | Same |
| selected program | selected program | ||
| e. Dimensions of the | 42 mm | 42 mm | Same |
| massage head | |||
| Ultrasound handpiece | |||
| a. Applicator size | double applicator diameter42 mm eachapplicator area 13.8 cm²eachtotal active surface 27.7cm² | double applicator diameter 42mm eachapplicator area 13.8 cm² eachtotal active surface 27.7cm² | Same |
| b. Crystal material | PZT | PZT | Same |
| c. Output mode | Continuous or pulsed(sinusoidal wave mode) | Continuous or pulsed(sinusoidal wave mode) | Same |
| d. Ultrasound frequency | 1 MHz (+ 20%) | 1 MHz (+ 20%) | Same |
| e. Modulated frequency | 20 - 60 kHz + 10% | 20 – 60 kHz + 10% | Same |
| f. Ultrasound intensity | 0.5 – 3W/cm² for eachtransmitter in continuousand modulated emissionmode | 1 - 7 W/cm² for eachtransmitter in continuousemission mode1 - 5 W/cm² for eachtransmitter in modulatedemission mode | Different but subjectdevice has reducedintensity which does notadversely impact safetyand effectiveness of thesubject device andcomplies with IEC60601-2-5 |
| g. BNR (Beam non-uniformity ratio) | ≤ 4:1 | ≤ 4:1 | Same |
| h. ERA (EffectiveRadiating Area) | 4.9 cm² | 3 cm² | Different but does notadversely impact safetyand effectiveness of thesubject device andcomplies with IEC60601-2-5 |
| i. Duty cycle | N/A | N/A | N/A |
| j. Pulse duration | 50 – 8.33 µs | 50 – 8.33 µs | Same |
| k. Pulse frequency | 20 - 60 kHz | 20 – 60 kHz | Same |
| l. Treatment time | 5 – 8 mins depending onselection, max activationtime 30 mins | 5 – 8 mins depending onselection, max activationtime 30 mins | Same |
| m. Temporal max power(if pulsed) (W) | 14.70 | 23.91 ± 20% | Different but subjectdevice has reducedtemporal max power(when pulsed) whichdoes not adverselyimpact safety andeffectiveness of thesubject device andcomplies with IEC60601-2-5 |
| n. Temporal max power(if continuous) (W) | 14.60 | 20.55 ± 20% | Different but subjectdevice has reducedtemporal max power(when continuous)which does notadversely impact safetyand effectiveness of thesubject device andcomplies with IEC60601-2-5 |
| o. Instantaneous peakpower | N/A | N/A | MC1 Plus ultrasoundemission modalitymakes the instantaneouspeak power valuemeaningless as it is |
| p. Temporal maxeffective intensity(W/cm2) | 3.00 | 7.97 | equal to the averagevalue and complies withIEC 60601-2-5 |
| q. Temporal avgeffective intensity(W/cm2) | 2.98 without modulation | 6.85 without modulation | The maximum emittedpower has been changedfrom 7 W/cm2 to 3W/cm2 and complieswith IEC 60601-2-5 |
| r. Max suction pressure | N/A | N/A | The average emittedpower has been changedfrom 7 W/cm2 to 3W/cm2 and complieswith IEC 60601-2-5 |
| r. Max suction pressure | N/A | N/A | These values are nolonger meaningful since |
| s. Suction time | N/A | N/A | the machine design hadbeen modifiedeliminating thevacuum suction fromthe ultrasoundhandpiece |
| t. Relax time | N/A | N/A | |
| Leakage current | |||
| a. Ground leakagecurrent NormalCondition (NC)(<0.500 mA) | 0.085 | 0.065 | Similar |
| b. Ground leakagecurrent Single FaultCondition (SFC)(<1.0 mA) | 0.107 | 0.102 | Similar |
| c. Patient leakage currentNC DC(<0.01 mA) | <0.001 | <0.001 | Same |
| d. Patient leakage currentNC AC(<0.10 mA) | <0.01 | <0.001 | Patient leakage currentof subject device is 10xhigher but still underthe acceptable range asper IEC 60601-1 anddoes not adverselyaffect the safety andeffectiveness of thesubject device |
| e. Patient leakage currentSFC DC(<0.05 mA) | <0.001 | <0.001 | Same |
| f. Patient leakage currentSFC AC(<0.50 mA) | <0.01 | <0.001 | Patient leakage currentof subject device is 10xhigher but still underthe acceptable range asper IEC 60601-1 anddoes not adverselyaffect the safety andeffectiveness of thesubject device |
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13. Substantial Equivalence
The MC1 Plus is substantially equivalent to the MC1 cleared in K091615. The MC1 Plus has the same indications for use as the General Project MC1. Regarding technological characteristics, the MC1 Plus includes both massage and ultrasound
{8}------------------------------------------------
diathermy handpieces as do the General Project MC1. The maximum ultrasound intensity has been reduced from 7 W/cm to 3 W/cm to comply standard IEC 60601-2-5 3"d ed; the maximum ultrasonic power output is 15 W, while in MC1 device was 21 W, the ERA is 4.9 cm2 instead of 3 cm2.
Differences between the MC1 Plus and the MC1 device were evaluated in performance and effectiveness testing and the MC1 Plus was found to be substantially equivalent to the MC1 device.
14. Performance Data
The MC1 Plus was tested and found to conform with AAMI/ANSI ES60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-2-5 for electrical safety in ultrasonic physiotherapy equipment. The MC1 was found to conform with these same electrical safety standards. Performance data was presented which showed that the MC1 Plus performed similarly to the previously cleared MC1 in terms of tissue heating. Specifically, testing showed that the MC1 Plus increases tissue temperature as required for ultrasonic diathermy. The two 1 MHz ultrasound transducers can be considered equivalent to the MC1 in terms of heating tissue temperature to at least 40° C. These results are similar to those reported for the MC1.
15. Conclusion
The MC1 Plus is substantially equivalent to the MC1 device in terms of indications for use, electrical safety testing and performance testing which indicated that the MC1 Plus and the MC1 were substantially equivalent in terms of tissue heating.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.