(21 days)
The Sharplan Model 713 AF Acuspot Micromanipulator is substantially equivalent to the following devices: The Sharplan Model 712 Micromanipulator, the Reliant UniMax Model 2000, and the Heraeus LaserSonics Ultraspot Micromanipulator. It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.
The Sharplan Model 713 AF Acuspot Micromanipulator is an accessory for a CO2 Surgical Laser. It attaches to the distal end of an articulated arm and connects to a surgical microscope. Its purpose is to allow a physician the ability to focus and steer laser beams so that when tissue is visualized, it can be selectively treated.
Here's an analysis of the provided text regarding acceptance criteria and a study to prove device performance:
Based on the provided text, the document is a 510(k) Summary of Safety and Effectiveness for the Sharplan Model 713 AF Acuspot Micromanipulator. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with statistical metrics.
Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) because the submission relies on equivalence, not a standalone performance study.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" in the sense of quantitative performance metrics for the new device. The "performance" is implicitly based on being "substantially equivalent" to the predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Safety | Substantially equivalent to predicate devices (Sharplan Model 712 Acuspot, Reliant UniMax Model 2000, Heraeus LaserSonics Ultraspot Micromanipulator). |
| Overall Effectiveness | Substantially equivalent to predicate devices. |
| Intended Use | Incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers (same as predicate devices). |
| Performance (Functional) | Performs the same function and is of the same technology as predicate devices. The only modification is the addition of an autofocus option, which is believed to raise no concerns regarding safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- N/A. No formal "test set" or clinical study data is presented. The submission relies on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. No ground truth establishment activity for a test set is described.
4. Adjudication method for the test set
- N/A. No test set or adjudication process is 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
- N/A. This device is a micromanipulator, not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. Not an algorithm. The device is hardware (micromanipulator).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. Not applicable, as detailed performance validation via ground truth is not the basis of a substantial equivalence claim for this type of device. The "ground truth" for comparison is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- N/A. No training set is mentioned or relevant for this type of submission.
9. How the ground truth for the training set was established
- N/A. No training set.
Summary of the Study (or lack thereof):
The document explicitly states: "No new indications were sought in the premarket notification and no clinical data was presented."
Instead of a study proving device performance against acceptance criteria, the submission leverages the concept of substantial equivalence. The "study" here is a comparison of the Sharplan Model 713 AF Acuspot Micromanipulator to its predicate devices (Sharplan Model 712 Acuspot, Reliant UniMax Model 2000 Micromanipulator, and the Heraeus LaserSonics Ultraspot Micromanipulator).
The key points of this equivalence argument are:
- Design and Intended Use: The devices, while not identical, perform the same function and are of the same technology.
- Modification: The only modification to the candidate device is the addition of an autofocus option.
- Conclusion: Based on an analysis of the overall performance characteristics, Sharplan Lasers, Inc. believes no significant differences exist, and the modification raises no concerns regarding safety or effectiveness.
Therefore, the "proof" that the device meets "acceptance criteria" (which are implicitly the criteria met by the predicate devices) is the demonstration of substantial equivalence, not a standalone performance study with quantified acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Sharplan Lasers, Inc. The logo consists of a stylized circle with three pie-shaped wedges cut out of it, followed by the company name in bold, sans-serif font. Below the company name is the number K962974 in a handwritten style.
AUG 21 1996 510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Model 713 AF Acuspot Micromanipulator
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of the Sharplan Model 713 AF Acuspot Micromanipulator is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan Model 712 Acuspot, the Reliant UniMax Model 2000 Micromanipulator, and the Heraeus LaserSonics Ultraspot Micromanipulator.
- 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance July 8, 1996
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- Model: Sharplan Model 713 AF Acuspot Micromanipulator
- The Sharplan Model 712 Acuspot Micromanipulator, the 3. Predicate Devices: Reliant UniMax Model 2000 Micromanipulator, and the Heraeus LaserSonics Ultraspot Micromanipulator.
- 4 . Description: The Sharplan Model 713 AF Acuspot Micromanipulator is an accessory for a CO2 Surgical Laser. It attaches to the distal end of an articulated arm and connects to a surgical microscope. Its purpose is to allow a physician the ability to focus and steer laser beams so that when tissue is visualized, it can be selectively treated.
- 5 . The Sharplan Model 713 AF Acuspot Micromanipulator is substantially equivalent to the following devices: The Sharplan Model 712 Micromanipulator, the Reliant UniMax Model 2000, and the Heraeus LaserSonics Ultraspot Micromanipulator. It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.
No new indications were sought in the premarket notification and no clinical data was presented.
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510(k) Summary of Safety and Effectiveness (continued) Sharplan Lasers, Inc. Model 712 Acuspot Micromanipulator
- 6 . From a design and intended use perspective, the aforementioned devices, while are not identical, perform the same function and are of the same technology. The modification to the candidate device, involves the addition of an autofocus option. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Furthermore, this modification raises no concerns regarding the safety or effectiveness of the Sharplan Model 713 AF Acusot Micromanipulator.
- This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.