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The New Era Laser is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, New Era, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There is one model, FG 2000.

The main components of proposed device shown as following: Handpiece, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch.

The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes Parameter one, two, three, four, five and six mode respectively for different preset parameter combination, and each particular parameter preset mode includes three submode as mode 1, mode 2 and mode 3.

The difference for each mode is only the default parameter, but all parameters for each mode can be adjustable in the parameter range.

The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);

The provided FDA 510(k) premarket notification for the "New Era" laser device aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a novel medical function. Therefore, the typical structure for reporting acceptance criteria and a study proving those criteria (as requested in the prompt) does not directly apply to this document.

The document primarily focuses on showing that the "New Era" laser is identical in all respects to an already cleared predicate device (K161692 Diode Laser Therapy Machine Model FG2000D). This means the "acceptance criteria" here are essentially proof of sameness to the predicate.

However, based on the information provided, I can construct a response that addresses the spirit of your request by interpreting the "acceptance criteria" as the shared specifications and safety standards that both the proposed and predicate devices meet, and the "study" as the non-clinical testing performed to show this equivalence.

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

Key Takeaway: No independent clinical study data proving specific performance outcomes for the "New Era" laser is presented in this 510(k) submission. The entire premise is based on the device being identical to an already cleared predicate device, and thus inheriting its established safety and performance profile.

Acceptance Criteria and Device (Equivalence) Performance:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional performance metrics like sensitivity/specificity for a diagnostic AI, the "acceptance criteria" for a 510(k) based on substantial equivalence revolve around matching the predicate device's specifications, intended use, and safety standards.

Study Proving Acceptance Criteria:

The "study" here is a set of non-clinical tests designed to confirm that the "New Era" device meets the established design specifications and is indeed substantially equivalent to the predicate device.

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

• Sample Size: This is not a study with a "test set" in the sense of a dataset of patient images or clinical outcomes. Instead, it refers to the physical device (New Era, Model FG2000) itself, against which engineering and safety tests were performed.
• Data Provenance: Not applicable in the context of clinical data. The tests are performed on the device hardware. The document states the proposed device is "made by the same manufacturer" as the predicate.

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

• Not applicable. Ground truth for device specifications and compliance with engineering standards is established through validated testing procedures and compliance with international standards (e.g., IEC, ISO). These do not typically involve human expert interpretation in the way AI model ground truth is established.

4. Adjudication Method for the Test Set:

• Not applicable. This is not a clinical study requiring human reader adjudication.

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:

• No. An MRMC study was not done. This 510(k) is for a laser device for hair reduction, not an AI-assisted diagnostic tool. No AI component is described.

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

• No. This is not an AI algorithm. It is a standalone medical device (laser).

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by:
  • Engineering Specifications: The design specifications of the device parameters (e.g., wavelength, fluence, spot size, power supply).
  • International Standards: Compliance with recognized consensus standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). These standards themselves define the "ground truth" for safety and performance requirements.
  • Predicate Device Specifications: The "New Era" device's specifications were compared to those of the predicate device (FG2000D) to demonstrate identity.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. As there is no AI, there is no training set or associated ground truth establishment for a machine learning model.

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The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The New Era Orthopaedics Polyscrew Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

The provided document describes the New Era Orthopaedics Polyscrew Pedicle Screw System, a Class II medical device. As a Class II device approved through the 510(k) pathway, its approval hinges on demonstrating "substantial equivalence" to a predicate device, not necessarily on meeting specific numerical acceptance criteria in the same way a novel device might.

Therefore, the "acceptance criteria" for this device are implicitly tied to the performance of its predicate devices, as demonstrated through non-clinical testing. The study provided focuses on proving this substantial equivalence through mechanical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: For 510(k) submissions, explicit numerical "acceptance criteria" and "reported device performance" in the typical sense of a novel device study are often not stated. Instead, the performance is reported as meeting or being equivalent to the predicate device, which implies satisfying the predicate's established safety and effectiveness.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical mechanical tests (static/dynamic compression, static torsion, dissociation). For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements to achieve confidence in the measurements, but are not usually reported as a single "test set sample size" in the same way as a clinical study. Instead, multiple units of each component or assembly configuration would be tested to derive statistical data (e.g., mean, standard deviation, and comparisons to predicate device performance limits).
• Data Provenance: The data provenance is from non-clinical laboratory testing. The document does not specify the country of origin for the testing, but it is typically conducted in controlled laboratory environments in accordance with international (ASTM) standards. This is not retrospective or prospective in a clinical sense, as it refers to laboratory experiments.

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

• Number of Experts: This question is not applicable to this type of submission. Ground truth, in the context of device performance, is established through standardized engineering tests (e.g., ASTM F1717) and comparison to established predicate device performance and regulatory standards, not through expert consensus on qualitative data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: This question is not applicable. Mechanical tests are quantitative and objective; their outcomes are measured directly based on physical properties and responses to applied forces, not through an adjudication process like one might find in a clinical trial or image interpretation study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The New Era Orthopaedics Polyscrew Pedicle Screw System is a physical implant, not a diagnostic tool requiring human interpretation of results in this manner.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: This question is not applicable. This device is a physical pedicle screw system, not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of an algorithm. Its performance is its mechanical integrity and function as a physical implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical performance standards (e.g., ASTM F1717) and comparison to the established performance of legally marketed predicate devices. The implicit ground truth is that the device must be safe and effective, similar to existing devices, as demonstrated by meeting standardized mechanical testing requirements and being made of recognized biocompatible materials.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This question is not applicable. This device is not an AI/algorithm that requires a "training set." The engineering and design process for such a physical device involves iteration and testing, but not in the sense of a machine learning training set.

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

• Ground Truth for Training Set: This question is not applicable as there is no "training set" for a physical implant device in the context of this submission.

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