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The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is indicated for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Dermatology, Plastic Surgery, Podiatry, Neurosurgery, Gynecology, Otorhinolaryngology, Arthroscopy (knee), Open & Endoscopic General Surgery.

The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is safe and effective when indicated for use in specific surgical applications including:

• Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of laser skin resurfacing, laser derm-abrasion, and laser burn debridement.
• Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids, and furrows.
• Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).
• Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.

The Kaplan PenduLaser 115 CO, Surgical Laser with OptoScan II Scanner Accessory consists of the laser, the Scanner Controller Box, a Footswitch Adapter box, the Sahar SofTouch Scanner, and the handpiece. The Controller houses the electronics and power supply and interfaces to the Pendulaser for communication through the Footswitch Adaptor Box.

The provided document is a 510(k) summary for a medical device (Kaplan PenduLaser 115 CO2 Surgical Laser with OptoScan II Scanner Accessory). It indicates that the device is substantially equivalent to previously cleared predicate devices.

However, a 510(k) summary does not include detailed studies with acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics like those for AI/ML devices or new clinical effectiveness studies. Instead, it focuses on demonstrating equivalence to existing devices.

Therefore, many of the requested items cannot be found in this document:

1. Table of acceptance criteria and reported device performance: Not present. The document asserts substantial equivalence without providing specific performance metrics or acceptance criteria for the new device.
2. Sample size used for the test set and the data provenance: Not applicable. There is no mention of a specific test set or a study quantifying performance against acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No such study is described.
4. Adjudication method: Not applicable. No such study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study demonstrates improved human performance with AI and is not relevant to a 510(k) submission based on substantial equivalence to a non-AI surgical laser.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This device is a surgical laser, not an AI algorithm.
7. Type of ground truth used: Not applicable. No specific performance study requiring ground truth is described.
8. Sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what can be extracted from the document related to "acceptance" (which, in this context, is substantial equivalence):

The "acceptance criteria" for this device, as per the 510(k) process, is "Substantial Equivalence" to legally marketed predicate devices.

• Predicate Devices:

  • Coherent UltraPulse 5000 system (K963339)
  • Sharplan SilkTouch/Sharplan 1020 Laser (K860087, K960521, K961935)
  • Kaplan PenduLaser 115 (laser component - K950313)
  • OptoScan II Scanner (scanner component - K964684)

• Basis for Substantial Equivalence (the "study" in this context):

  • Same Indications for Use: The KAPLAN PenduLaser 115 Surgical Laser with OptoScan II Scanner Accessory has the same indications for use and target population as the legally marketed predicate devices.
  • Same Technological Characteristics: The technological characteristics of the combined new device are unchanged from those of the component devices (the laser and the scanner) and are the same as those of the predicate devices. The submission asserts these characteristics are "sufficiently precise to ensure equivalence."

Therefore, the "proof" the device meets the "acceptance criteria" (substantial equivalence) is the detailed comparison of its indications for use and technological characteristics to the predicate devices, as presented in the 510(k) submission. No new clinical performance data or studies (of the type requested) are provided or implicitly required for this type of submission.

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Scanning Device Accessory for use with the CB Diode/532 TM Nd:YAG Laser for general dermatology (soft tissue ablation) and the treatment of vascular and pigmented lesions.

The Scanning Device Accessory is a microprocessor controlled device that generates precisely defined repeatable patterns in an automated sequence to increase treatment speed and facilitate uniform ablation of tissue.

The provided text is a 510(k) summary for a medical device called "Scanning Device Accessory for the CB Diode/532TM Nd:YAG Laser." It explicitly states that no nonclinical or clinical performance data was provided. Therefore, no acceptance criteria or studies proving the device meets those criteria are mentioned.

Here's an analysis based on the information provided:

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

   • Acceptance Criteria: Not specified.
   • Reported Device Performance: Not reported.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

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 as no clinical or nonclinical performance data was provided.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

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 scanning accessory for a laser, not an AI-assisted diagnostic tool. No MRMC study was mentioned.

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

   • Not applicable. This device is hardware, not an algorithm. No standalone performance data was provided.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

8. The sample size for the training set

   • Not applicable as no clinical or nonclinical performance data was provided. This device is hardware and not related to machine learning algorithms requiring training sets.

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

   • Not applicable as no clinical or nonclinical performance data was provided.

Conclusion from the provided text:

The 510(k) summary explicitly states:

• "Nonclinical Performance Data: none"
• "Clinical Performance Data: none"

The basis for clearance was a comparison to an equivalent predicate device, the SoftScanTM Scanning Device, Sahar Technologies, Inc. (K964684). The submission primarily focused on demonstrating substantial equivalence to this already cleared device. The "Conclusion" section states: "The Scanning Device Accessory for the CB Diode/532TM Nd: YAG Laser enhances the clinical application procedure while maintaining the performance characteristics," implying that its performance is presumed to be similar to its predicate.

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