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The Schwartz Electro-Optics, Inc. CrystaLase 755 DP will be indicated for removal of tattoos of various types and colors, as well as epidermal, pigmented and vascular lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 755 DP laser system.

The Schwartz Electro-Optics, Inc. CrystaLase 755 DP System is a medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

The provided text is a 510(k) summary for the Schwartz Electro-Optics, Inc. CrystaLase 755 DP laser system. This document is a pre-market notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving performance against acceptance criteria for a novel device.

Therefore, the input does not contain the information requested to fill out the table and answer the questions about acceptance criteria and a study proving a device meets those criteria. The 510(k) process for this device relies on substantial equivalence to existing devices, not on new clinical performance data.

Specifically, the document states: "No new indications were sought in this premarket notification and no clinical data was presented." and "From a design and clinical perspective, the predicate and candidate laser devices are of the same technology and have the same intended use. Based upon an anlaysis of the overall performance characteristics for the devices, Schwartz Electro-Optics, Inc. believes that no significant differences exist."

Because no clinical data was presented, I cannot complete the requested information.

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As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, menisous, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles.

Specialties are:

• General Surgery
• Plastic Surgery,
• Podiatry
• Urology
• Gynecology
• Pulmonary Surgery
• Dermatology
• Gastroenterology
• Ophthalmology
• ENT
• Thoracic Surgery
• Oral and Maxillofacial Surgery

These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

The Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase is a medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 2940 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

The provided text is a 510(k) summary for a medical device (laser system) and does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for evaluating AI/algorithm-based diagnostic or screening devices.

Here's why the input does not allow for a complete answer to your request:

• Device Type: This document pertains to a laser surgical device (Schwartz Electro-Optics, Inc. CLR 2940 Erbium CrystaLase), not an AI/algorithm-based system.
• Regulatory Pathway: The submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device. For non-diagnostic devices, this often relies on demonstrating similar technological characteristics and intended use, rather than extensive clinical performance studies comparing an algorithm's output to ground truth.
• No New Indications/Clinical Data: The summary explicitly states: "No new indications were sought in this premarket notification and no clinical data was presented." This confirms that performance data based on clinical studies, which would involve acceptance criteria, test sets, ground truth, and expert evaluation, was not part of this submission.
• Focus on Predicate Device Equivalence: The justification for safety and effectiveness is based on the "substantial equivalence" to existing, cleared predicate devices (K974039 and K971648) which already had their indications cleared.

Therefore, I cannot populate the table or answer questions 2-9 from the provided text. The information requested is relevant to AI/diagnostic/screening devices, which is not what this document describes.

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The Schwartz Electro-Optics, Inc. CrystaLase 755 is indicated for removal of tattoos of various types and colors and benign epidermal pigmented lesions.

Not Found

This 510(k) submission (K973867 for the Schwartz Electro-Optics, Inc. CrystaLase 755) does not contain the information needed to answer your request about acceptance criteria and a study proving the device meets those criteria.

The provided documents are a 510(k) summary and the FDA's clearance letter. These documents are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance study data against specific acceptance criteria.

Here's why the information is missing:

• 510(k) Summary: This document states that "from a technology perspective, theory of operation of all the aforementioned devices are all the same" and "Schwartz Electro-Optics, Inc. believes that the technological characteristics of the CrystaLase 755 are similar to the predicate lasers." It also states "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns." This language indicates a reliance on the predicate device's established safety and effectiveness rather than new, extensive performance studies for the CrystaLase 755 itself.
• FDA Clearance Letter: This letter confirms the device is "substantially equivalent" to predicate devices. Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and it does not necessarily require new clinical or performance data if technological characteristics are similar and do not raise new questions of safety or effectiveness.

Therefore, I cannot fill out the requested table or answer the specific questions about the study details for this particular submission.

This type of information (acceptance criteria, detailed study design, sample sizes, ground truth establishment, etc.) would typically be found in direct performance studies, clinical trial reports, or more detailed sections of a 510(k) submission if the device presented novel technology or significant differences from its predicate. As this submission relies on substantial equivalence and similarity to predicate devices, such detailed a study is not provided here.

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As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 is indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The CLR 2940 may also be used for skin resurfacing and the treatment of wrinkles. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxillofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. is simply requesting the addition of skin resurfacing and the treatment of wrinkles.

Not Found

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is a 510(k) summary and FDA clearance letter for a medical device (CLR 2940 Erbium CrystaLase).

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Continuum Biomedical CB Erbium/2.94), rather than presenting a performance study against predefined acceptance criteria. The clearance letter confirms that the device is substantially equivalent to legally marketed devices based on the indications for use.

Therefore, I cannot populate the requested tables and information as no such details are present in the provided text. The document states: "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns," which is a statement of belief for substantial equivalence, not a report of a study against acceptance criteria.

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The Schwartz Electro-Optics, Inc. CrystaLase 1064/532 will be indicated for removal of tattoos of various types and colors, epidermal and pigmented lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 1064/532.

From a technology perspective, theory of operation of all the aforementioned devices are While the laser mediums are identical, all the systems are similar both all the same. and electronically. Schwartz Electro-Optics, Inc. believes that the mechanically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers. The Continuum Biomedical Medlite and the DermaLase have the ability to deliver laser energy at wavelengths of 1064 nm (Nd:YAG) and frequency doubled Nd:YAG at 532 nm (Green).

The provided text describes a 510(k) submission for the "CrystaLase 1064/532" laser system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed results of a specific clinical study with acceptance criteria often seen for novel AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Here is an attempt to address the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format typically used for performance studies (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for regulatory clearance is "substantial equivalence" to a predicate device.

• Indications for Use
• Technology/Theory of Operation
• Safety and Effectiveness | The manufacturer "believes that the mechanically and electronically technological characteristics of the CrystaLase 1064/532 are similar to the predicate lasers."
  "Schwartz Electro-Optics, Inc. believes that the slight differences in the performance characteristics of these devices raises no concerns."
  The FDA concluded that the device "is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." |

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

This information is not available in the provided text. The document describes a regulatory submission based on technological similarity to predicate devices rather than a performance study with a test set of data.

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

This information is not available in the provided text, as a test set and ground truth in the typical sense of a diagnostic performance study are not described.

4. Adjudication Method for the Test Set

This information is not available in the provided text.

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

An MRMC study is not mentioned and is not applicable to this type of device (a laser system) and this type of regulatory submission (substantial equivalence to a predicate device based on technology and indications, not AI-assisted human performance).

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

This information is not available and is not applicable. The device is a physical laser system, not an algorithm.

7. The Type of Ground Truth Used

This information is not available. The submission relies on establishing equivalence to already cleared devices, not on proving de novo clinical accuracy against a specific ground truth.

8. The Sample Size for the Training Set

This information is not available. The document describes a laser system undergoing regulatory review, not an AI model that requires a training set.

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

This information is not available. This is not applicable to the device described.

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Schwartz Electro-Optics, Inc. is not requesting any additional indications or changing the indications as previously cleared in K954013 received 1/31/96. As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxiliofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated laser. Schwartz Electro-Optics, Inc. seeks no new indications for the CLR 2940 and is only requesting a modification.

From a technology perspective, theory of operation the predicate device is the same as the Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase. The laser mediums are the same, the systems are similar both mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the TriLase 2940 Erbium Laser are similar to the predicate device (Premier Centauri Erbium). The Premier Centauri Erbium has the ability to deliver laser energy at 2.94 microns (2940nm), average power of 5 watts at repetition rates of up to 50 pulses per second. These characteristics are very similar to the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, the device described, the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser (referred to as CLR 2940 elsewhere), is being submitted for 510(k) clearance based on substantial equivalence to a predicate device, not through a performance study against specific acceptance criteria in the traditional sense of a clinical trial for a novel device.

The core of the submission relies on demonstrating that the new device has "similar" technological characteristics and that "slight differences in the performance characteristics of these devices raises no concerns." This is a key aspect of 510(k) submissions where a direct comparison to a legally marketed predicate device is made rather than de novo clinical studies establishing specific performance metrics.

Therefore, many of the requested categories for a new device's acceptance criteria and study information are not explicitly present in this type of submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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 applicable/not provided. The submission is based on a comparison to a predicate device's specifications and existing indications for use, not a clinical study on a 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 applicable/not provided. Ground truth in this context would refer to the established performance characteristics and safety profile of the predicate device, which is already legally marketed.

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

This information is not applicable/not provided. There was no test set requiring adjudication in the context of this 510(k) submission.

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 applicable/not provided. This device is an erbium laser for surgical procedures, not an AI-assisted diagnostic or imaging tool.

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

This information is not applicable/not provided. This device is a surgical laser, not an algorithm.

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

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile and performance characteristics of the legally marketed predicate device (Premier Centauri Erbium and CRL 2940 Erbium CrystaLase), as determined by their prior FDA clearance. The company asserts that the new device's characteristics are "similar" to these predicate devices, making them substantially equivalent.

8. The sample size for the training set

This information is not applicable/not provided. There was no "training set" in the context of this 510(k) submission.

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

This information is not applicable/not provided.

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