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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 family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are 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 and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos(significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and periorbital wrinkles.

The CoolGlide lasers are also 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 for pseudofolliculitis barbae (PFB).

The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The intended use of the integral cooling system in the Altus handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Optional Pulsed Light Hand Piece:
For the treatment of benign pigmented lesions.

Surgical Applications ::
The lasers are indicated for the incision/excision and cutting, ablation. coagulation/hemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy, gastroenterology, g general surgery, surgery, g head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Indications for use (532nm):
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

The Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece are comprised of the following main components:

• · a laser system console (including software and control electronics);
• · a control and display panel;
• · a permanently attached fiberoptic-coupled handpiece;
• · a skin cooling device integrated into the handpiece;
• a footswitch
• · a remote interlock connector (disables laser when treatment room door is opened)
• · optional pulsed light hand piece that can be removed by either the user or a qualified service person.

The provided text is a 510(k) summary for the Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece. This document is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study reporting specific performance metrics against acceptance criteria for a new, novel AI/software-as-a-medical-device (SaMD) product.

Therefore, the document does not contain the kind of detailed information requested about acceptance criteria, specific device performance, study methodology, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies for an AI/SaMD.

The document primarily focuses on:

• Predicate Devices: Identifying existing legally marketed devices to which the new device is substantially equivalent.
• Indications for Use: Listing the medical conditions and applications for which the device is intended.
• Technological Equivalence: Stating that the new device shares similar design features and functional features with predicate devices.
• Safety and Effectiveness: Concluding that no new questions of safety or effectiveness are raised because it's substantially equivalent to existing devices.

Based on the provided text, I cannot fill out the requested table or provide the specific details of a study proving the device meets acceptance criteria. The document does not describe a study in the sense of demonstrating a novel device's performance against predefined metrics, but rather argues for substantial equivalence to devices already on the market.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Reported Device Performance: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics are provided. The "performance" is implicitly tied to being "substantially equivalent" to predicate devices, meaning it performs similarly to already cleared devices for the stated indications.
2. Sample Size for Test Set and Data Provenance: This information is not relevant to a substantial equivalence argument based on predicate devices. There is no independent "test set" described for performance validation.
3. Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no independent ground truth establishment for a novel performance claim.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not mentioned, as this is typically for evaluating human performance with and without AI assistance, which is not the context here.
6. Standalone Performance: While the device functions as standalone hardware, there isn't a "standalone algorithm performance" study as would be seen for AI/SaMD.
7. Type of Ground Truth: No specific ground truth is described as being used for performance validation of this device.
8. Sample Size for Training Set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How Ground Truth for Training Set was Established: Not applicable.

In summary, this document is a regulatory submission for a medical device based on substantial equivalence, not a scientific publication detailing performance studies for a novel or AI-powered device.

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The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are 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 treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CoolGlide lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).

The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The intended use of the integral cooling system in the Altus CoolGlide laser handpiece is to provide cooling of the skin, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications:
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Indications for use (532nm):
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)}; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses: plaques: cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

Family of Altus Medical CoolGlide Aesthetic Lasers are comprised of the following main components:

• a laser system console (including software and control electronics);
• a control and display panel;
• a permanently attached fiberoptic-coupled handpiece;
• a skin cooling device integrated into the handpiece;
• a footswitch (or finger-operated exposure switch (handswitch) option integrated into the handpiece)
• a remote interlock connector (disables laser when treatment room door is opened).

This document is a 510(k) Summary for the Altus Medical CoolGlide Aesthetic Lasers, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance data against specific acceptance criteria from a clinical study.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be found in the provided text.

The document primarily states that the safety and effectiveness are based on the technological identity and similar indications for use to predicate devices. It does not describe a new clinical study to establish performance against acceptance criteria for this specific submission.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The basis for clearance is "substantial equivalence" to predicate devices, implying that their established performance applies.

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

Not applicable. The document does not describe a new test set or clinical study for this 510(k) submission. Acceptance is based on comparison to predicate devices already on the market.

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

Not applicable. No new test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable. No new test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improvement with AI vs without AI assistance

Not applicable. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. This is a laser device, not an algorithm, and no standalone performance study is mentioned.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness implicitly refers to the established safety and efficacy profiles of the predicate devices cleared by the FDA. There is no new ground truth established for this submission.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, and the document describes its substantial equivalence to existing devices, not the training of an algorithm.

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

Not applicable. This is a medical device, and the document describes its substantial equivalence to existing devices, not the training of an algorithm.

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The family of Modified Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

1064nm:
Dermatology:
The Altus Medical Aesthetic Modified CoolGlide laser systems are 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 and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Modified CoolGlide lasers are also 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 for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Modified CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus Modified CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications ::
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy. gastroenterology, general surgery, a head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Indications for use (532nm):
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

Family of Altus Medical Modified CoolGlide Aesthetic Lasers are comprised of the following main components:

• · a laser system console (including software and control electronics);
• · a control and display panel;
• · a permanently attached fiberoptic-coupled handpiece;
• · a skin cooling device integrated into the handpiece;
• · a footswitch (or finger-operated exposure switch (handswitch) option integrated into the handpiece)
• · a remote interlock connector (disables laser when treatment room door is opened).

The provided text is a 510(k) summary for a medical device (Altus Medical Modified CoolGlide Aesthetic Lasers) and does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and a study proving those criteria.

The document focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting primary clinical study data with specific acceptance criteria, sample sizes, and ground truth methodologies.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness based on their established indications for use and technological similarity.
• Reported Device Performance: No specific performance metrics (e.g., success rates, accuracy, precision, duration of effect) are reported for the new device based on a dedicated study. The document states: "Technologically, the modified CoolGlide family of aesthetic lasers is identical to the previous predicate CoolGlide family (K003202). Therefore the risks and benefits for the modified CoolGlide laser family are comparable to the predicate devices." This implies performance is assumed to be similar to the predicates.

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

• Not Applicable. The submission does not describe a new clinical "test set" for performance evaluation in the way a an AI algorithm would have. It relies on the prior approval and established use of predicate devices.

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

• Not Applicable. No new ground truth establishment is described.

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

• Not Applicable. No new test set and adjudication process are 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:

• Not Applicable. This is a laser device, not an AI or diagnostic imaging device involving human readers or comparative effectiveness in that sense.

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

• Not Applicable. This is a laser device, not an AI algorithm.

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

• Not Applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the multiple predicate laser devices for their specific indications.

8. The sample size for the training set:

• Not Applicable. This document does not describe a training set for an algorithm.

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

• Not Applicable. This document does not describe a training set for an algorithm.

Summary of Information from the Provided Text:

The "study" that proves the device meets (implicit) acceptance criteria is the submission's argument for substantial equivalence to existing predicate devices. The core argument is based on:

• Similar Indications for Use: The modified device has largely the same general indications as numerous predicate laser systems.
• Technological Identity: "...the modified CoolGlide family of aesthetic lasers is identical to the previous predicate CoolGlide family (K003202)." This is the primary "proof."
• Comparable Risks and Benefits: Because of technological identity, the risks and benefits are considered comparable to the predicate devices, which have already been deemed safe and effective.

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device is fundamentally the same as devices already on the market and proven safe and effective for the stated indications. There is no discrete clinical performance study described in this 510(k) summary with specific quantitative acceptance criteria or performance numbers for the new device itself.

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