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1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:

1. Laser console;
2. Internal computer;
3. Control panel and display;
4. Optical delivery system;
5. Hand set with integrated cooling (chilled sapphire optical window);
6. Foot switch
   The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving performance against predefined acceptance criteria through a clinical study.

Here's a breakdown of why this information is absent and what the document does provide:

• No Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" and "Nonclinical Performance Data: None." This immediately tells us that no studies were conducted to gather performance metrics against acceptance criteria for this specific device.
• Substantial Equivalence: The conclusion states: "The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser shares the same indications for use, similar design features (including wavelengths, laser medium, power supply, cooling and control systems), functional features (including power output, repetition rate, energy, spot sizes and energy fluence), and is therefore substantially equivalent to the above legally marketed laser systems currently in commercial distribution." This is the core of a 510(k) submission – demonstrating similarity to a device already on the market, avoiding the need for new clinical trials in many cases.

Therefore, for the specific questions asked, the answers are largely "Not applicable" or "None provided" based on the nature of this 510(k) submission.

Here's how to answer based on the provided document, addressing each point:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable, as no clinical or performance test set data specific to this device is provided.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable.

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

• MRMC Comparative Effectiveness Study: No, not applicable. This is a laser device, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance Study: No, not applicable. This is a physical laser device, not an algorithm.

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

• Type of Ground Truth: Not applicable, as no clinical study or performance data generation for this specific device is described.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable, as no algorithm training or clinical study for this device is described.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable.

Summary based on the document:

This 510(k) submission for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. No new clinical performance data, nonclinical performance data, or studies (such as those involving test sets, training sets, experts, or multi-reader studies) were submitted for this specific device. The device's approval is based on its similar design, functional features, and indications for use as compared to the listed predicate devices.

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The Altus Medical optional infrared handpiece is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Altus Medical optional infrared handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The optional infrared handpiece consists of:

• an "umbilical" cable and connector, that is permanently attached to the hand piece A body and is semi-permanently attached to the laser system (detachable by positive action from the user) that houses:
• electrical cables (to support the thermoelectric coolers associated with the chilled A sapphire window, to provide power and an electrical drive current to the IR quartz lamp, to provide detector signals and to connect a memory device that identifies the hand piece);
• a supply and return water line (to remove the heat generated by the infrared lamp and A thermoelectric cooler);
• the hand piece internals described above; and A
• the hand piece shells housing the internals and connecting to the umbilical. A
  The proximal end of the umbilical cable is semi-permanently attached to the laser system console and the distal end is permanently attached to the body of the delivery hand piece. This hand piece is removable by either the user or an authorized field service engineer for replacement at the proximal end.
  This optional infrared handpiece is for use specifically with the Altus Medical CoolCilide Xeo laser system previously cleared on K023954.

This 510(k) premarket notification describes the Altus Medical Optional Infrared Handpiece, which is intended to provide topical heating for temporary pain relief and muscle relaxation. The document asserts that the device is substantially equivalent to existing infrared heat lamps.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria or quantitative performance metrics for the Altus Medical Optional Infrared Handpiece. Instead, it relies on a qualitative comparison to predicate devices, asserting "substantial equivalence" in technological characteristics and safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not report any specific test data or studies involving human subjects or a test set. The submission is based on a comparison to existing predicate devices and an assertion that no new questions of safety or effectiveness are raised.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific test set or study is described, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

As no test set or study is described, there is no information about an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention any MRMC comparative effectiveness study. The submission focuses on device characteristics and equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is not an AI algorithm. It is a physical medical device (an infrared handpiece). Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this submission.

7. Type of Ground Truth Used

Given that no specific studies or test data are provided, there is no explicit ground truth (e.g., expert consensus, pathology, outcomes data) mentioned in relation to the Altus Medical Optional Infrared Handpiece's performance. The "ground truth" for the substantial equivalence claim appears to be the established safety and effectiveness of the identified predicate devices.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI algorithm, the concept of a "training set" does not apply.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI algorithm, this question does not apply.

Summary of the Study and Acceptance Criteria:

The 510(k) submission for the Altus Medical Optional Infrared Handpiece relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a new clinical study with defined acceptance criteria and performance data.

The "acceptance criteria" here are implicitly that the device's technological characteristics, indications for use, and potential risks/benefits are comparable to those of the predicate devices. The study proving this is a qualitative comparison of technical specifications and intended use against the identified predicate devices:

• K001056 Olympic Warm-up by Olympic Medical
• K022609 PW820 Patient Warmer by Fisher & Paykel
• K023621 BioFlex Professional Therapy System by Meditech International
• K024179 Thermapulse by Palomar Medical Technologies, Inc.

The document asserts that the infrared handpiece shares "the same general indications for use" and relevant "technological characteristics" such as lamp type, timer, wattage, power, wavelength, protective enclosure, spot size, skin contact, cooling, and energy, with its predicate devices. Through this comparison, Altus Medical concludes that "there are no new questions of safety or effectiveness raised by the introduction of this device."

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The Profile BBL (and the light and/or laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for:
• The treatment of tattoos;
• The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
• The treatment of cutaneous lesions including warts, scars and striae;
• The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
• The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
• Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment:
• Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
• Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Profile BBL System emits intense wide spectrum emission with wavelength of 500-1400 nm. It consists of a system console, internal computer, control panel and display, and a treatment head comprised of a light guide with cooling capability and a pushbutton switch.

The provided text is a 510(k) summary for the Sciton Profile BBL System. It establishes substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on the regulatory aspects of device clearance, asserting equivalence based on similar indications for use, design features, and functional features compared to previously cleared devices. It does not present novel performance data or detail any studies designed to meet specific acceptance criteria for the Sciton Profile BBL System itself.

Therefore, the requested information, such as a table of acceptance criteria and device performance, sample sizes, expert qualifications, ground truth details, or MRMC study results, cannot be extracted from the provided text.

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