(380 days)
The OW100S (model OW100S-US) is intended for:
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Relief of minor muscle aches and pains
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Temporary increase in local blood circulation
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Activation of connective tissue
The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.
The modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.
There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.
The provided documents describe the medical device OW100S (model OW100S-US), a therapeutic massager, and its substantial equivalence to a predicate device, the TRT, OrthoGold 100 (OW100). The submission does not contain information about a study with acceptance criteria and device performance results as typically described for software or AI-enabled medical devices.
Instead, this submission is a 510(k) premarket notification that demonstrates substantial equivalence to a legally marketed predicate device. The core of the submission relies on:
- Identical Indications for Use.
- Similar technological characteristics, with minor modifications to improve durability (e.g., increased electrode lifetime).
- Performance and bench testing to ensure the modified device meets design specifications and relevant safety standards.
Therefore, many of the requested details, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies, are not applicable or not provided within this type of submission for a non-software/AI device.
However, I can extract the information that is available about performance and the basis for equivalence.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance is based on demonstrating that the subject device (OW100S) is substantially equivalent to the predicate device (OrthoGold 100) and meets applicable safety and performance standards. The "reported device performance" is essentially a comparison of the OW100S's physical and operational characteristics to those of the predicate device, showing that any differences do not impact safety or effectiveness.
Here's a table based on the comparison provided in the submission:
| Product Characteristic | Acceptance Criteria (Implied by Predicate) | Reported OW100S Performance | Comparison / Outcome |
|---|---|---|---|
| Indications for Use | Relief of minor muscle aches and pains; Temporary increase in local blood circulation; Activation of connective tissue. | Same as predicate. | Identical: Indicates the same clinical utility. |
| Modes of Action | Unfocused pressure pulses | Unfocused pressure pulses | Identical |
| Mechanisms of Action | Extracorporeally induced unfocused pressure pulses | Extracorporeally induced unfocused pressure pulses | Identical |
| Maximum and Minimum Intensity Settings | 1 to 16 | 1 to 16 | Identical |
| Number and Size of Treatment Applicator Heads | OP155, Size: 230 x Ø 70 mm | OP155S, Size: 230 x Ø 70 mm | Identical in size and fundamental design (minor upgrade indicated by 'S' suffix). |
| Electrode Lifetime | E1-E10: 100K sw; E-11-E16: 70K sw | E1-E10: 500K sw; E11-E16: 350K sw | Improved: Break circuit and modified water cartridge solution reduce wear over time, but no change to device outputs at selected energy level, therefore no change to safety/effectiveness. |
| Cartridge Solution and Conductivity | Silver chloride solution 600μS/cm | Potassium bromide solution 2300μS/cm | Modified: To support extended electrode life. No change to device outputs at selected energy level, therefore no change to safety/effectiveness. |
| Maximum Penetration Depth | 25.4 mm at energy level 16 | 37.4 mm at energy level 16 | Similar/Slightly Higher: Due to tolerances and statistical effects. Geometry of reflector (defines acoustic field) remained unchanged, implying fundamental safety/effectiveness is maintained. |
| Energy Flow Density PII | 0.00017 - 0.04403 mJ/mm2 at energy level 1-16 | 0.00020 - 0.04900 mJ/mm2 at energy level 1-16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Peak Compressional Acoustic Pressure (pc) | 9.27 at energy level 16 | 11.20 at energy level 16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Peak Rarefactional Acoustic Pressure (pcr) | -1.52 at energy level 16 | 1.22 at energy level 16 (Note: text states -1.22 in table lower down) | Similar/Slightly Lower: Due to tolerances and statistical effects, despite discrepancy between text and explicit table value. Implies values are within acceptable variation for clinical equivalence. |
| Positive Peak Pressure Amplitude (pc) | 0.43 - 9.27 MPa at energy level 1-16 | 0.61 - 11.20 MPa at energy level 1-16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Negative Peak Pressure Amplitude (pcr) | -0.17 to -1.52 MPa at energy level 1-16 | -0.17 to -1.22 MPa at energy level 1-16 | Similar/Slightly Lower: Due to tolerances and statistical effects. |
| Derived Focal Acoustic Pulse Energy (EbT) | 0.022 - 2.278 mJ at energy level 1-16 | 0.020 - 3.370 mJ at energy level 1-16 | Similar: Values differ due to tolerances and statistical effects. |
| Derived Pulse-Intensity Integral (PIIT) | 0.00017 - 0.04403 mJ/mm2 at energy level 1-16 | 0.00020 - 0.04900 mJ/mm2 at energy level 1-16 | Similar/Slightly Higher: Due to tolerances and statistical effects. |
| Risetime (tr) | 1.89 - 0.28 µs at energy level 1-16 | 1.08 - 0.18 µs at energy level 1-16 | Similar: Values differ due to tolerances and statistical effects. |
| Compressional Pulse Duration (tFWHMpc) | 1.23 - 0.77 µs at energy level 1-16 | 0.79 - 0.82 µs at energy level 1-16 | Similar: Values differ due to tolerances and statistical effects. |
| Compliance with Standards | Compliance with relevant IEC standards (listed in document) | Compliance demonstrated in performance testing. | Met: Certification to recognized international standards for medical electrical equipment, lithotripters, usability, and software lifecycle. |
| Hazard Analysis / Risk Management | Risks mitigated to an acceptable level (for predicate) | Performed, and all risks demonstrated to be mitigated to an acceptable level. | Met: Ensures device safety. |
| Software Validation | Software validated (for predicate) | Software validated and demonstrated to be of a Moderate level of concern. | Met: Appropriate validation for the software's risk level. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not discuss a clinical "test set" in the context of patient data. The performance evaluation was based on bench testing and verification and validation (V&V) testing of the device's engineering specifications. Therefore, data provenance from a patient population (country, retrospective/prospective) is not applicable here.
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. The submission focuses on hardware modifications and engineering performance, not on diagnostic accuracy requiring expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
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 not an AI-enabled device, and no MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. Performance was demonstrated through V&V and bench testing of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the engineering specifications and demonstrated performance of the predicate device, alongside international consensus standards (e.g., IEC 61846, AAMI / ANSI ES60601-1, IEC 60601-1-2) for safety and performance testing. The "truth" is that the device, after modifications, still operates safely and effectively within expected parameters compared to the predicate and standard requirements.
8. The sample size for the training set
Not applicable. This is not a machine learning device and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.